• In 2018, he introduced legislation to protect young people from the dangers of conversion therapy. (wikipedia.org)
  • In an effort to speed up decision-making about whether the public should pay for new drugs, ever since April 2018 companies can submit applications to CADTH up to 180 days before Health Canada approves the drugs. (healthcoalition.ca)
  • The Biden initiative calls on FDA to fully implement agency plans issued in 2017 and 2018 to advance competition in prescription drug markets by clarifying the approval framework for these products, including standards for interchangeability and for biologics licensing. (pharmtech.com)
  • The generic drugs market is estimated to have reached $257.3bn in 2018 and is expected to grow at a CAGR of 8.8% in the first half of the forecast period. (visiongain.com)
  • Asia-Pacific held 31% of the generic drugs market in 2018. (visiongain.com)
  • What were the market shares of the leading national markets in the global generic drugs market in 2018? (visiongain.com)
  • Which particular national markets will be the main drivers of growth in the global market for generics from 2018 to 2029? (visiongain.com)
  • How will the industry sector evolve as legislations around patents and patent expiries change during the period between 2018 and 2029? (visiongain.com)
  • Drafted by the Ethics, Law, and Humanities Committee - a joint committee that includes the AAN, the American Neurological Association, and the Child Neurology Society - the statement was prompted by a 2018 report from the AAN Neurology Drug Pricing Task Force to address challenges associated with high drug costs. (medscape.com)
  • In 2015, according to the Centers for Medicare and Medicaid Services, health care spending totaled nearly 18 percent of our Gross Domestic Product, and prescription drugs were about 10 percent of that spending, and closer to 15 percent when you consider prescription drugs administered in hospitals. (senate.gov)
  • Prior to the 4th of July break, Senate and House Committees approved more than a dozen health policy bills, covering topics including: surprise medical bills, health pricing transparency, drug prices and competition, various Medicare policies, and public health program reauthorization, among others. (lexology.com)
  • The President is calling on the leadership of the Senate to put politics aside and pass a prescription drug benefit for Medicare. (archives.gov)
  • The proposed rule makes this job easier by reducing the cost of a Medicare prescription drug benefit. (archives.gov)
  • Paul's daily chemotherapy costs $750 per day and has a Medicare co-payment of $575 for a three-week cycle of drugs. (jasonpye.com)
  • If Congress succeeds in passing a Medicare prescription drug benefit this year, the debate over preferred drug lists - now raging in numerous states - is likely to explode onto the national stage. (fraserinstitute.org)
  • Medicare could finally start negotiating with the drug companies on price. (familiesusa.org)
  • Despite offering multiple strategies for tackling high drug prices, the Biden proposal largely leaves it to Congress to move forward on the more contentious proposals, such as granting Medicare authority to negotiate pharma reimbursement. (pharmtech.com)
  • As the former top-ranking Democrat on the Senate Aging Committee, McCaskill embarked on a statewide tour of Missouri during which she heard directly from seniors on issues ranging from Medicare and Medicaid to prescription drug prices. (senate.gov)
  • The rise in healthcare costs and the inclusion of prescription drug coverage by the Medicare Program are just two of the catalysts for this growing field. (llrx.com)
  • The plan proposes, among other things, allowing Medicare to negotiate prices with drugmakers for some drugs. (wypr.org)
  • It would direct the secretary of health and human services to negotiate with drugmakers on the price of their medications for Medicare. (wypr.org)
  • To be in the pool of eligible drugs, a drug has to cost Medicare a lot and not have any generic competition. (wypr.org)
  • The price agreed on for Medicare after negotiation would be available to commercial insurers as well, though they could also try to negotiate lower prices. (wypr.org)
  • Right now, there's no limit for how much seniors and others on Medicare spend on drugs out of pocket - unlike in most insurance plans. (wypr.org)
  • Right now, after enrollees have spent several thousand dollars on drugs, they're on the hook for 5% of ongoing costs, their prescription drug plan pays 15% and Medicare pays 80% - drug companies don't pay any part of it. (wypr.org)
  • Patients pay nothing after they hit the new cap, drug companies pay 30% and Medicare and health plans pick up the rest. (wypr.org)
  • Stacie Dusetzina , a health policy professor at Vanderbilt University who has written extensively about Medicare Part D, says that drug prices were overall "much lower" in 2003, when Medicare Part D became law. (wypr.org)
  • Before that, Medicare didn't cover drugs at all. (wypr.org)
  • There is strong interest in measures that tie the prices of U.S. prescription drugs to median prices in other developed countries, and to allow Medicare to negotiate drug prices. (pharmexec.com)
  • Both also have said Medicare should negotiate prices with drugmakers, though Trump's campaign website doesn't mention this. (modernhealthcare.com)
  • A Kaiser Family Foundation survey last month found 77% of Americans say prescription drug costs are unreasonable, with 82% backing giving Medicare the power to negotiate drug prices. (modernhealthcare.com)
  • That's particularly true for Democratic plans to give Medicare the power to negotiate prices for the Part D drug benefit program. (modernhealthcare.com)
  • It successfully lobbied Congress in 2003 to bar Medicare from negotiating prices in the new Part D program. (modernhealthcare.com)
  • Indeed, fierce criticism from doctors and patients has the CMS taking a second look at its recent proposed rule to reduce Medicare Part B payments to doctors who administer expensive drugs in their offices, the most common mode for cancer chemotherapy drugs. (modernhealthcare.com)
  • To examine generic drug costs, I analyzed the National Average Drug Acquisition Cost (NADAC) data, which the Centers for Medicare & Medicaid Services (CMS) collect and publish. (drugchannels.net)
  • When Medicare was enacted in 1965, people took far fewer prescription drugs and they were cheap. (nybooks.com)
  • At the end of 2003, Congress passed a Medicare reform bill that included a prescription drug benefit scheduled to begin in 2006, but as we shall see later, its benefits are inadequate to begin with and will quickly be overtaken by rising prices and administrative costs. (nybooks.com)
  • Sanders said Congress should authorize the Department of Health and Human Services to negotiate with pharmaceutical companies to bring down the cost of drugs purchased through Medicare. (truthdig.com)
  • Sanders' office repeated what it has said many times: that the senator would soon introduce legislation to provide a single-payer system of health care to extend Medicare services to all Americans. (truthdig.com)
  • She said her new measure will increase transparency for drug companies that are setting high prices, end the restriction that prevents the federal Medicare program from using its buying power to negotiate lower drug prices for its beneficiaries, and stop drug company monopoly practices that keep prices high and prevent less expensive generics from coming to the market. (senate.gov)
  • The House Ways and Means Committee also held a hearing on lowering drug prices, specifically for Medicare beneficiaries. (canceradvocacy.org)
  • The authors provide a thorough examination of the components that impact Medicare Part D drug costs, including a discussion about the proposed rule to eliminate rebates. (canceradvocacy.org)
  • At the request of McCaskill, minority staff of the Committee on Homeland Security and Governmental Affairs reviewed price increases for the 5-year-period, 2012 to 2017, across the top 20 most-prescribed brand-name drugs for seniors in the Medicare Part D program. (medscape.com)
  • According to the most recent National Heath Expenditure data published by the Centers for Medicare & Medicaid Services, retail prescription drug spending grew at an average pace of 4.8% between 2006 and 2015, with two of the highest-growth years occurring in 2014 and 2015 at 12.4% and 9.0%, respectively. (medscape.com)
  • Even with Medicare coverage, many older individuals also face substantial out-of-pocket costs, particularly for specialty and brand-name drugs. (medscape.com)
  • According to one independent study, Medicare beneficiaries' out-of-pocket spending on prescription drugs is expected to increase from 41% of per capita Social Security income in 2013 to 50% in 2030, the report notes. (medscape.com)
  • This high-profile, bipartisan legislation would hold patients harmless from "surprise" medical bills for out-of-network services provided at an in-network facility, with payment to out-of-network providers set at the median contracted rate for in-network providers in the geographic area (a controversial "benchmark rate" proposal). (lexology.com)
  • The bipartisan legislation would make it illegal for brand-name drug manufacturers to use anti-competitive pay-off agreements to keep more affordable generic equivalents off the market. (senate.gov)
  • Senator Says Bipartisan Legislation Would Combat Brand-Name Pharmaceutical Companies Unfairly Blocking Lower-Cost Generic Drugs WASHINGTON, D.C [02/06/2019]-This week, U.S. Senator Tina Smith (D-Minn.) continued one of her top health care priorities-lowering the skyrocketing costs of prescription drugs-by supporting bipartisan legislation led by Sen. Patrick Leahy (D-Vt. (senate.gov)
  • I am calling for bipartisan legislation that achieves the goal of dramatically lowering prescription drug prices," Trump said. (healthleadersmedia.com)
  • In addition, McCaskill's bipartisan legislation to boost competition for generic drugs and help lower prescription costs was signed into law by Trump. (medscape.com)
  • We hope other states will pass similar legislation, building off of the landmark bill that Maryland enacted on prescription drug price gouging in 2017, and the legislation to protect consumers from unduly expensive brand-name prescription drugs that the Maryland legislature is currently considering . (familiesusa.org)
  • These topics were explored at an FDA public meeting in July 2017, where industry representatives and medical authorities discussed citizen petitions, labeling issues, late formulation changes, and use of REMS to stymie new generic testing. (biopharminternational.com)
  • Similar issues were raised at a November 2017 Federal Trade Commission (FTC) workshop on "Understanding Competition in US Prescription Drug Markets. (biopharminternational.com)
  • At a July 2017 hearing before the House Judiciary Committee, Gottlieb outlined leading barriers to generic-drug development related to agency initiatives for bringing more generic drugs to market (4). (biopharminternational.com)
  • In examining drug pricing issues at a hearing in December 2017, the House Energy & Commerce Health subcommittee discussed proposed legislation to enable generic and biosimilar access to needed brand supplies and other measures to support development of affordable drugs. (biopharminternational.com)
  • In June 2017, Gottlieb implemented a Competition Action Plan for bringing complex generic therapies and combination products to market as key to moderating high drug costs (5). (biopharminternational.com)
  • Prices increased for every drug on the list between 2012 and 2017. (medscape.com)
  • Although 48 million fewer prescriptions were written for the top 20 most commonly prescribed brand-name drugs for seniors between 2012 and 2017, total sales revenue resulting from these prescriptions increased by almost $8.5 billion during the same period. (medscape.com)
  • Novartis' Sandoz division says that price pressures may lead to reductions in its US product portfolio and a greater focus on developing biosimilars and complex formulations. (biopharminternational.com)
  • In opening the meeting, FDA Commissioner Scott Gottlieb emphasized that more streamlined development and approval of generic drugs and biosimilars is key to ensuring consumer access to needed medicines. (biopharminternational.com)
  • A related area of focus involves facilitating the development, testing, and approval of generic drugs and biosimilars. (pharmtech.com)
  • Similarly, FDA and FTC are instructed to identify and address deceptive, false, and misleading statements designed to undermine consumer confidence in the safety and effectiveness of generics and biosimilars. (pharmtech.com)
  • And FDA should collaborate with the Patent and Trademark Office to prevent patent extensions designed to delay competition from generics and biosimilars. (pharmtech.com)
  • There is one area in which prices appear to have dipped: In the 2019 and 2020 health insurance years, the rate of ACA premium increases slowed and, in some cases, declined, Blumberg said. (salon.com)
  • Legislation that takes effect in January will require drug companies to justify large price increases. (empirecenter.org)
  • A recent GAO study looked at 1,400 generic drugs over a five-year period and found that over 300 of them had seen "extraordinary price increases" of 100% or more. (familiesusa.org)
  • From the beginning, the investigation strived to understand why companies can make these large price increases and to identify which policies should be considered to counter these disturbing practices. (senate.gov)
  • Meanwhile, FDA is responding to the clamor for relief by exploring strategies to safely import drugs in situations where there are dramatic price increases or serious shortages. (pharmexec.com)
  • Now the Institute plans to expand into evaluating whether price increases of "high-impact" marketed therapies are justified by clinical evidence. (pharmexec.com)
  • The impasse has left patients, insurers and healthcare provider groups pushing for immediate relief from the most egregious price spikes, like Mylan's 550% list price increases over eight years on EpiPen epinephrine auto-injectors, a must-have product for counteracting allergic reactions. (modernhealthcare.com)
  • One drugmaker, Allergan, recently promised to voluntarily limit price hikes on its products to once a year and keep them to single-digit percentage increases. (modernhealthcare.com)
  • There has been a greater willingness to target profiteering on generic and older branded products, where triple-digit price increases seem absurd on their face. (modernhealthcare.com)
  • A small number of drugs have experienced mega-increases (exceeding 1,000 percent) over the past three months. (drugchannels.net)
  • The table below shows the 10 drugs with the greatest percentage increases. (drugchannels.net)
  • In the table, I exclude two sole-source branded products-Epitol (carbamazepine) and Cormax (clobetasol)-that experienced increases comparable to their generic equivalents. (drugchannels.net)
  • 2 As a spokeswoman for one company explained, "Price increases are not uncommon in the industry and this allows us to be able to invest in R&D." 3 In 2002, the average price of the fifty drugs most used by senior citizens was nearly $1,500 for a year's supply. (nybooks.com)
  • Twelve of the 20 most commonly prescribed brand-name drugs for seniors had price increases of over 50% during the 5-year period. (medscape.com)
  • She joined Senator Susan Collins (R-ME) to launch an in-depth investigation into prescription drug price increases and recently introduced legislation to end taxpayer subsidies to end taxpayer subsidies drug companies receive for the billions of dollars they spend on prescription drug advertising each year, which currently is fully tax-deductible. (medscape.com)
  • He has introduced legislation to increase transparency while holding big pharmaceutical companies and the Administration accountable . (senate.gov)
  • Increasing transparency , holding pharmaceutical companies accountable for their role in setting high prices. (senate.gov)
  • Although the draft legislation is getting most of its press for provisions addressing drug costs and surprise bills, which are two key areas of public concern, it has a section dedicated to increasing the price transparency for healthcare services. (hfma.org)
  • The draft HELP legislation's price transparency provisions related to "gag," "anti-tiering," "all-or-nothing" and "most favored nation" clauses are probably better thought of as individual and group market managed care contracting provisions. (hfma.org)
  • It will probably be something along the line of a requirement for plans and providers to provide good faith out-of-pocket cost estimates, which is in line with HFMA's Price Transparency Taskforce Report. (hfma.org)
  • While the price transparency and surprise bill elements are a step in that direction, it might be fair to call this a missed opportunity. (hfma.org)
  • Unlike his previous two State of the Union speeches, Trump mainly avoided discussing the Affordable Care Act and instead focused on new policies like the administration's price transparency rule and efforts to lower prescription drug prices. (healthleadersmedia.com)
  • Trump heralded the administration's price transparency rule, which will go into effect in 2021 , saying it will save families "massive amounts of money for substantially better care. (healthleadersmedia.com)
  • On the topic of improved price transparency, Trump said patients should never be "blindsided" by medical bills but did not address the issue of surprise medical billing, which has stalled on Capitol Hill in recent months. (healthleadersmedia.com)
  • Absence of regulatory tools: Without regulatory tools, such as documented operating procedures, erratic application of legislation and lack of transparency of law enforcement will result. (who.int)
  • President Bush announced a new rule to lower prescription drug costs for millions of Americans by improving access to generic drugs, which are safe and effective and can be much less costly alternatives to brand-name prescription drugs. (archives.gov)
  • The proposed rule is expected to lead to savings in drug costs of over $3 billion per year for Americas consumers. (archives.gov)
  • As for health care costs: Growth has slowed, but costs are still going up, said Robert Berenson, a health policy analyst at the Urban Institute who studies hospital pricing. (salon.com)
  • When you have a squeeze on healthcare costs, that's generally good for generics, because it's a lower cost of therapy. (drugtopics.com)
  • Pharmacy has said the proposed reimbursement for about 30% of all generics will be less than what it costs them to buy the product. (drugtopics.com)
  • Hospital costs are rising fast, and Connecticut and New York legislators say they're trying to regulate the culprits, like prescription drug and out-of-network service prices. (empirecenter.org)
  • State Comptroller Kevin Lembo says he will negotiate directly with hospitals and health care providers to contain costs, instead of creating one drug plan for the whole state. (empirecenter.org)
  • Families USA: In what ways could federal policymaking help states tackle high prescription drug costs? (familiesusa.org)
  • "Competition, not sweetheart deals between branded and generic companies should determine prescription drug costs," said Klobuchar. (senate.gov)
  • Congress is paying attention to these concerns as it seeks strategies for managing drug costs and outlays. (biopharminternational.com)
  • By promoting competition in the generic drug marketplace, the bill would help lower costs and improve the accessibility of decades-old prescription drugs. (senate.gov)
  • Patients, families and government programs shouldn't have to cope with increased drug costs to help name brand companies' bottom lines. (senate.gov)
  • This legislation will help end the unfair practices that drive up prescription drug costs and deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace. (senate.gov)
  • "Everywhere I go in Montana, I hear the same thing: prescription drug costs are too high," Tester said. (senate.gov)
  • Tester has a proven record of fighting to lower prescription drug costs. (senate.gov)
  • The investigation concluded that the only explanation for the high costs was the company's greed: Gilead was charging as much as it could get away with for the drug because it could. (iacenter.org)
  • Prescription drugs can be found at lower prices - outside the U.S. In Egypt Harvoni costs $10 per pill. (iacenter.org)
  • Today's hearing is the first of three bipartisan hearings the Senate health committee will hold on prescription drug costs. (senate.gov)
  • Alexander announced that the second hearing is planned for July and will be a deeper dive into the prescription drug process-"beginning with a manufacturer's development of a drug, the different steps through which the drug travels before arriving in the patient's hands, how this is paid for, and what the costs are at each of the different steps. (senate.gov)
  • This is the first of three hearings we plan to hold on prescription drug costs. (senate.gov)
  • Next month, the committee will hold a second hearing to hear about the process-beginning with a manufacturer's development of a drug, the different steps through which the drug travels before arriving in the patient's hands, how this is paid for, and what the costs are at each of the different steps. (senate.gov)
  • The bill, HR 3, titled the Elijah E. Cummings Lower Drug Costs Now Act , is highly unlikely to get through the Senate, and the White House has announced that President Trump would veto it if it came to his desk. (wypr.org)
  • Additionally, representatives raised concerns about high prescription drug prices and the role of pharmacy benefit managers (PBMs) in driving up costs, along with the need for legislation to ensure fair reimbursement for patients' medications (H.R. 2880). (jdsupra.com)
  • Congressional leaders are opening investigations and calling industry leaders to testify at hearings on drug costs and pricing strategies. (pharmexec.com)
  • Both Cummings and Senate Finance Committee chair Chuck Grassley (R-Iowa) scheduled hearings in late January on a range of initiatives to lower costs for patients, as Grassley looks for support from Senate Republicans and Democrats for strategies to curb high drug prices. (pharmexec.com)
  • The attack on high drug costs has been a boon for the Institute for Clinical and Economic Review (ICER), which has emerged as an unofficial arbiter of justified drug pricing in the US. (pharmexec.com)
  • Insurers are protesting that specialty drug costs are forcing them to jack up premiums. (modernhealthcare.com)
  • But despite the growing political furor, the odds of significant federal action on drug costs this year or next are slim, experts say. (modernhealthcare.com)
  • This affects families and children, and it's a potentially life-threatening situation," said John Rother, CEO of the National Coalition on Health Care and head of the Campaign for Sustainable Rx Pricing, a broad coalition of groups advocating market-based approaches to curbing drug costs. (modernhealthcare.com)
  • Other drug companies are shifting the blame to insurers, arguing that health plans are pushing excessive costs on members through high deductibles and copayments. (modernhealthcare.com)
  • Among the generic drugs in this quarterly sample, 77 (3.0% of the total) more than doubled in costs. (drugchannels.net)
  • Prescription drug costs are indeed high-and rising fast. (nybooks.com)
  • Since prescription drug costs are rising so fast, payers are particularly eager to get out from under them by shifting costs to individuals. (nybooks.com)
  • Another key contributor to drug spending is physician prescribing choices when comparable alternatives are available at different costs. (nih.gov)
  • DULUTH, MN [08/08/18]-U.S. Sen. Tina Smith (D-Minn.) said today that for far too long the health and financial well-being of families in Minnesota and across the country has been harmed by the skyrocketing price of prescription drugs, and she announced plans to introduce legislation designed to hold large pharmaceutical companies accountable for high prices and bring down costs for both consumers and taxpayers. (senate.gov)
  • Some Democratic House representatives vocally rebuked Trump's points on drug pricing, expressing support for the Elijah E. Cummings Lower Drug Costs Now Act, which passed in the chamber in December. (healthleadersmedia.com)
  • Gilead shares some of its HIV/AIDS drug patents with the Medicines Patient Pool, which in turn licenses the patents to generic makers so that patients in poor nations can receive treatment at much lower costs. (aol.com)
  • The House Energy and Commerce Committee held a hearing titled, "Strengthening health care system: legislation to lower costs and expand access. (canceradvocacy.org)
  • Soaring drug prices are driving up healthcare costs each year, the report notes. (medscape.com)
  • McCaskill has made tackling rising healthcare and prescription drug costs a top priority in the Senate. (medscape.com)
  • It highlights ethical concerns from high drug costs, policy proposals that might temper the problem, and how clinicians can adjust to the current reality of pharmaceutical pricing and better advocate for changes to the healthcare system. (medscape.com)
  • Out-of-pocket costs for neurologic medications have risen dramatically over the past decade, with the fastest rise reported among drugs for multiple sclerosis. (medscape.com)
  • Commenting on the statement for Medscape Medical News, Ilana Katz Sand, MD, associate director of the Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center, New York City, noted that clinicians are already acutely aware of the effect high drug costs have on their patients' medical decisions. (medscape.com)
  • More than 40 pharmaceutical companies, many of them the world's largest and most powerful companies, will be taking the South African government to court to try to stop it enacting legislation aimed at reducing the price of medicines for South Africans. (bmj.com)
  • The Medicines and Related Substances Act of 1997 was fought strenuously by the multinational drug companies during its passage through parliament. (bmj.com)
  • Although the law also seeks to regulate the marketing and distribution of medicines in South Africa, it is seen largely as a test case, with international implications, for the use of parallel importing of cheaper drugs and generic substitution for brand name drugs. (bmj.com)
  • Having dug itself into an enormous fiscal hole, the province just announced it will further lower the prices it pays for the 10 best-selling generic prescription medicines to 20 per cent of their brand-name equivalents, down from the current 25 per cent. (fraserinstitute.org)
  • Worried about rising expenditures for prescription drugs, many states are employing preferred lists to encourage doctors to prescribe older, lower-priced drugs and forego the latest, more expensive medicines. (fraserinstitute.org)
  • The U.S. Pharmacopeia was first officially recognized with the Drug Importation Act of 1848, enacted to stop the importation of poor-quality medicines by drug makers in Europe, who stamped the products "good enough for America. (usp.org)
  • Despite this, Innovative Medicines Canada (IMC), the lobby group for Big Pharma, put out a call in November 2022 for the Canadian government to suspend consultations on guidelines aimed at lowering prescription drug prices. (healthcoalition.ca)
  • IMC warned that if the new guidelines went ahead, drug launches would be delayed and "Canadian patients will be deprived of potentially life-saving new medicines. (healthcoalition.ca)
  • Despite this success, generic-drug makers face multiple legal and competitive hurdles to ensuring patient access to less costly, high-quality medicines. (biopharminternational.com)
  • The White House also revives support for importing less expensive drugs from Canada, directing FDA to work with states and tribes to establish procedures to obtain lower-cost medicines without imposing risks to public health. (pharmtech.com)
  • Six pharmaceutical companies are currently under investigation for conspiring to fix prices of generic medicines under a civil action filed by 20 states. (iacenter.org)
  • The industry has been aided by opposition from physician and patient advocacy groups, who fear that cost-benefit calculations will be used to cut them off from high-priced but effective medicines. (modernhealthcare.com)
  • The medicines strategy places the revised drug strategy within a more operational, responsive and comprehensive framework. (who.int)
  • It aims to help to save lives and to improve health by closing the huge gap between the potential that essential drugs have to offer and the reality for millions of people that medicines are unavailable, unaffordable, unsafe, of poor quality or improperly used. (who.int)
  • 1 WHO medicines strategy: framework for action in essential drugs and medicines policy 2000-2003, Geneva, WHO, 2000 (document WHO/EDM/2000). (who.int)
  • A global framework for expanding access to essential drugs has been built on the basis of the WHO medicines strategy, the work of UNAIDS and other United Nations agencies on access to HIV- related drugs, and the outcomes of the Director-General's round tables with the pharmaceutical industry and public interest groups. (who.int)
  • The new law will give Maryland a necessary tool to combat unjustified and extreme prices for medicines that have long been on the market and that are essential to our health and well-being. (healthcareforall.com)
  • She added that the drug represented part of J&J's 'commitment to advance innovative medicines that help address serious public-health issues. (aol.com)
  • Harvard's Global Health and Aids Coalition campaigned in 2012 to pressure Merck to share a patent for AIDS drug raltegravir with the Medicines Patient Pool. (aol.com)
  • Insufficient financial control: Lack of price controls, non-transparent price mark-ups, lack of competition, and taxes and tariffs on medicines all tend to raise prices and lower access to essential medicines. (who.int)
  • encourage higher margins for affordable generic medicines and lower margins for expensive brand-name medicines. (who.int)
  • Institute adequately resourced mechanisms to monitor prices of medicines, with participation of civil society and consumer groups. (who.int)
  • Essential Drugs and Medicines Policy. (who.int)
  • If pharma companies want to get their drugs publicly covered, they first have to submit them to the Canadian Agency for Drugs and Technologies in Health (CADTH). (healthcoalition.ca)
  • A major complaint of generic-drug makers is that pharma companies block access to reference drug samples needed for bioequivalence testing and biosimilar development by abusing restricted distribution programs such as Risk Evaluation and Mitigation Strategies (REMS). (biopharminternational.com)
  • He warned pharma companies to "end the shenanigans" that delay the approval of generic competitors and extend a drug's monopoly beyond intended timeframes (3). (biopharminternational.com)
  • A Trump administration drug importation program prompted two states to develop and seek FDA certification of such importation plans, a process that has been challenged by brand pharma companies. (pharmtech.com)
  • Brand pharma companies also face continued pressure from generic drugmakers for legislation to limit apparent anti-competitive behavior. (pharmexec.com)
  • Collins is examining claims that pharma companies raise list prices in order to offset deep discounts demanded by payers and has asked the administration for data on the role of rebates, discounts, and coverage decisions in shaping what consumers pay and how insurers benefit from these arrangements. (pharmexec.com)
  • Drugs for Neglected Diseases Initiative, or DNDi, a not-for-profit group that focuses on making more drugs available for treating neglected diseases, counts several big pharma companies as partners. (aol.com)
  • The plan would include flat reimbursement on drug refills, upfront information on treatment cost and affordable pricing. (empirecenter.org)
  • S 1416, Affordable Prescriptions for Patients Act of 2019, which would authorize the FTC to challenge certain brand manufacturer practices (e.g., "product hopping" and "patent thickets") that could discourage generic drug and biological use. (lexology.com)
  • As a result, patients will benefit from greater and more predictable access to safe, effective, low-cost generic alternatives to brand-name drugs. (archives.gov)
  • It only affects 150 patients in the U.S. per year, but this is the reality that befell Paul Kleutghen of St. James, N.C. Paul, a career veteran of the pharmaceutical industry, now has to take daily chemotherapy, and a regiment of three different drugs. (jasonpye.com)
  • It is a free market approach to lowering prices for patients and caregivers across the nation. (jasonpye.com)
  • Meanwhile, New York Governor Andrew Cuomo has signed legislation that protects patients from excessive out-of-network hospital emergency charges and follow-up inpatient care. (empirecenter.org)
  • If we can go after these titans of corporate greed (think Martin Shkreli, the now-incarcerated "pharma bro"), we'll be able to limit price spikes for patients across the state. (familiesusa.org)
  • Working with Regeneron and Sanofi, Express Scripts directly delivers drug-specific savings to patients, making PCSK9 therapy more affordable and more accessible. (express-scripts.com)
  • But companies don't test their new drugs on patients who can't tolerate or don't get better on older ones. (healthcoalition.ca)
  • Patients suffering from periodic paralysis and all other Americans concerned about price spikes for rare-disease treatments do, in fact, deserve an explanation of recent company decisions," McCaskill wrote to Pauls. (senate.gov)
  • When these companies use unfair practices to keep drug prices artificially high, patients suffer. (senate.gov)
  • Some states have recently required doctors to electronically send prescriptions to pharmacies instead of giving written prescriptions to patients, making it harder for them to seek lower prices. (iacenter.org)
  • We want to know as prescription drugs move from FDA approval through a complex process and into the hands of patients, where does the money go? (senate.gov)
  • The United States leads the world in innovative biomedical and pharmaceutical research and development-and American patients benefit from having access to most life-saving drugs first. (senate.gov)
  • Patients are complaining their drugs are unaffordable. (modernhealthcare.com)
  • Yet the issue of how to make drugs more affordable for individual patients and society is so complex and sensitive-and drug industry opposition so formidable-that a comprehensive, politically viable approach to solving the problem has yet to emerge. (modernhealthcare.com)
  • Not only do these patients go without needed treatment but their doctors sometimes wrongly conclude that the drugs they prescribed haven't worked and prescribe yet others-thus compounding the problem. (nybooks.com)
  • The increasing cost of prescription drugs in the United States has become a source of concern for patients, prescribers, payers, and policy makers. (nih.gov)
  • The same pharmaceutical company came to the rescue of patients in need of allergy medication after Mylan Pharmaceuticals upped the price of the Epipen to $400 - which is 600% more than they were originally marketed for. (healthcareforall.com)
  • When a drug company doubles or triples - or multiplies by 50 - the price of medication, it imperils the health and finances of patients and their families, and it threatens public health," said Maryland Attorney General Brian Frosh, according to CBS News. (healthcareforall.com)
  • Prevent "anti-tiering" and "anti-steering" clauses in contracts between providers and health plans that restrict the plan from directing or incentivizing patients to use specific providers and facilities with higher quality and lower prices. (hfma.org)
  • The PACED Act will improve our patent system and protect patients and consumers from higher drug prices by eliminating this egregious loophole. (patentdocs.org)
  • Ensuring a fair system for drug pricing and coverage rules that balance the goods of individual patients with the needs of broader populations when resources are limited remains more important than ever," Tsou said. (medscape.com)
  • She has a number of patients who have rationed their medication or stopped taking it altogether when their co-pays increased or they lost access to a co-pay assistance program because their insurance company chose to cover a still-expensive generic drug with no assistance program over a slightly costlier brand-name medication that comes with patient discounts. (medscape.com)
  • It's a terrible thing and it's happening to all patients," Katz Sand said, adding that the old credo of 'Yeah, the drug prices are high, but they are covered by insurance' is not a sustainable argument anymore. (medscape.com)
  • Almost half of all prescriptions filled today are for generic drugs, and generic alternatives exist for many commonly-used brand name medications providing an equally safe and effective but much less expensive alternative for millions of Americans. (archives.gov)
  • The VA already does this and pays considerably lower prices for prescriptions. (familiesusa.org)
  • In 1972, the NDP government of Manitoba passed a law making it mandatory for pharmacists to substitute cheaper generic drugs for those named on prescriptions, unless prohibited by the physician writing the prescription. (healthcoalition.ca)
  • And we've got the power to do something about it with a bill that's got support on both sides of the aisle to make life-saving prescriptions more affordable by giving Montanans easier access to affordable generics. (senate.gov)
  • More than 4 billion prescriptions are written for drugs each year for Americans who then receive those drugs at 60,000 drug stores, from doctors or hospitals and from online pharmacies. (senate.gov)
  • Others, too embarrassed to admit that they can't afford to pay for drugs, leave their doctors' offices with prescriptions in hand but don't have them filled. (nybooks.com)
  • S 1227, the Prescription Pricing for the People Act of 2019, which would require the Federal Trade Commission (FTC) to study the role of PBMs in the pharmaceutical supply chain and provide Congress with related policy recommendations. (lexology.com)
  • Committee members emphasized the need for bipartisan support of legislation that will provide full-measure regulations on AI use. (jdsupra.com)
  • I'm prepared to work with the FDA and Congress to see what we can do to prevent these types of sudden price spikes. (senate.gov)
  • The legislation stems from the only bipartisan investigation into the causes, impacts, and potential solutions to the egregious price spikes for certain drugs, which was led by McCaskill and Collins last Congress. (senate.gov)
  • It is precisely targeted to stop these abuses, and I'm committed to working on behalf of Vermonters in Congress to see that CREATES and other vital efforts to lower prescription drug prices are signed into law. (senate.gov)
  • Despite all these hearings, at who knows what cost, Congress has yet to pass any legislation that would restrict pharmaceutical companies from charging whatever they want. (iacenter.org)
  • In 2015 the U.S. Congress held hearings to investigate Gilead Sciences for raising the cost of drugs, including Harvoni. (iacenter.org)
  • While his contempt of Congress comes from the point of view of people in the billionaire class that Congress actually protects, in a way Shkreli underscored an important problem: The U.S. remains the only developed country with no real oversight to restrict what drug companies can charge the public. (iacenter.org)
  • Congress passed the Prescription Drug Marketing Act (PDMA) in 1987 prohibiting anyone other than U.S. pharmaceutical manufacturers from importing prescription drugs. (iacenter.org)
  • Congress has been grilling drug company executives over their big price hikes. (modernhealthcare.com)
  • As I discuss in Congress Grills Generic Drug Makers Over Price Inflation , Senator Sanders and U.S. Representative Elijah E. Cummings (D-MD) have been probing generic manufacturers. (drugchannels.net)
  • President Donald Trump also called on Congress to deliver a bipartisan plan to lower prescription drug prices. (healthleadersmedia.com)
  • He said that last year marked the first time in 51 years that prescription drug prices went down but added that Congress can do more to lower prescription drug prices. (healthleadersmedia.com)
  • Senator Ernst: 'Congress cannot look the other way as some pharmaceutical companies attempt to stifle competition and prevent Americans from accessing affordable generic drugs. (patentdocs.org)
  • Legislation approved by Congress and signed into law by then-President Bush in 2007 allows the FDA to award this voucher to a company that receives approval for a drug or biologic that targets a neglected tropical disease. (aol.com)
  • In Congress, health care hearings continued this week as the Senate Committee on Aging hosted a two-part series on prescription drug prices. (canceradvocacy.org)
  • President Trump promised in his State of the Union address to fix the "injustice" of high drug prices. (jasonpye.com)
  • Both the Trump administration and Congressional leaders agree on the importance of making prescription drugs more affordable and accessible, and all sides are lining up proposals to grab the spotlight. (pharmexec.com)
  • Both Clinton and GOP nominee Donald Trump favor letting consumers buy cheaper drugs from foreign countries. (modernhealthcare.com)
  • In an effort to build momentum during an election year, President Trump floated the idea of an executive order to lower pricing. (ons.org)
  • Trump signed legislation last year to ease the introduction of cheaper generic drugs. (ons.org)
  • 132 lawmakers in this room have endorsed legislation to impose a socialist takeover of our healthcare system, wiping out the health insurance plans of 180 million very happy Americans," Trump said. (healthleadersmedia.com)
  • On the prescription drug front, Trump highlighted the administration's challenge to the pharmaceutical industry and pointed to the record number of generic drugs to receive approvals from the Food and Drug Administration last year. (healthleadersmedia.com)
  • Trump specifically referenced conversations he has had with Senate Finance Chairman Chuck Grassley, R-Iowa, who recently told Stat News that Trump has not advocated enough for a bipartisan drug pricing bill he coauthored with Ranking Member Sen. Ron Wyden, D-Ore. (healthleadersmedia.com)
  • In his first State of the Union address, President Donald J Trump pledged to work to reduce prescription drug prices. (medscape.com)
  • Trump added, "That is why I have directed my administration to make fixing the injustice of high drug prices one of my top priorities for the year. (medscape.com)
  • Drug manufacturers would no longer be allowed to list patents in the FDA Orange Book for drug packaging, drug metabolites, and intermediate forms of a drug. (archives.gov)
  • Permitted listings include patents on active ingredients, drug formulations, and uses of a drug. (archives.gov)
  • This will significantly reduce opportunities to list inappropriate patents just to prevent fair competition from generic drugs. (archives.gov)
  • Under FDAs past interpretations of the Hatch-Waxman law and the Orange Book patent listing process, drug manufacturers have been able to file additional patents on packaging, ingredient combinations, and other minor matters in order to get repeated 30-month automatic stays in court that significantly delay access to generic drugs. (archives.gov)
  • Brand name drug companies ("Branders"), however, are fighting to retain their monopoly on patents. (llrx.com)
  • These Branders have found loopholes in the Act by which they extend their patents and tie up generic approval. (llrx.com)
  • A wealth of knowledge as to patents, generic drugs and the regulation of the industry can be found on www.fda.gov . (llrx.com)
  • The most important factor that allows manufacturers to set high drug prices is market exclusivity, protected by monopoly rights awarded upon Food and Drug Administration approval and by patents. (nih.gov)
  • Tight profit margins on conventional generics discourage investment in modern manufacturing systems, resulting in contaminated and violative products that lead to recalls and shortages. (biopharminternational.com)
  • This regulatory action will close loopholes in the implementation of the Hatch-Waxman law, which governs how generic drugs can compete with brand-name drugs. (archives.gov)
  • We need to work with pharma and the government for common-sense legislation and regulatory changes. (express-scripts.com)
  • Generic drugs account for nearly 90% of prescription drugs in the United States due to policies that facilitate their development and regulatory approval. (biopharminternational.com)
  • Lee said: "If we're ever going to bring the cost of health-insurance premiums and prescription drugs under control we must reform the Food and Drug Administration's excessively onerous, time-consuming regulatory process. (senate.gov)
  • Poor implementation of drug regulations: Inadequate infrastructure, fragmented drug regulatory functions and a lack of overall accountability lead to lapses in implementation and to duplication of efforts. (who.int)
  • and rectify regulatory gaps by modifying existing legislation or introducing new legislation. (who.int)
  • Innovative regulatory and legislative measures to stim- have found converting pharmacologic targets into com- ulate and facilitate the development of new antimicrobial mercially viable drugs to be difficult. (cdc.gov)
  • In the drug scheduling, subsidy restrictions, central directives, second half, we outline measures that regulatory agencies educational guidelines, amendments to prescribing infor- may use to help control resistance and facilitate drug mation, and indication review. (cdc.gov)
  • Directory of official drug regulatory agencies in the European Region. (who.int)
  • These regulations govern when generic drugs can compete with brand-name drugs. (archives.gov)
  • FDA-approved generic drugs are safe and effective alternatives to many brand-name prescription drugs, at a cost that is often only one-third as great. (archives.gov)
  • WASHINGTON - U.S. Sen. Chuck Grassley of Iowa joined Sen. Patrick Leahy of Vermont and other leading Judiciary Committee senators to reintroduce legislation to combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block entry of lower-cost generic drugs. (senate.gov)
  • Grassley said: "Generic alternatives to brand-name medications provide consumers with greater choice and more affordable prescription drug options, but anti-competitive practices by some brand-name pharmaceutical companies block access to these lower-cost generics. (senate.gov)
  • The Act attempts to increase competition and drive down drug prices while simultaneously maintaining the brand name drug companies' incentive to invest in new research. (llrx.com)
  • Big pharmaceutical companies block the development of generic versions of their brand name drugs so they can raise prices without competition. (senate.gov)
  • The DOJ charged former pharmaceutical executives Jeffrey A. Glazer and Jason T. Malek with colluding over the course of seven years with "unnamed brand-name corporations and individuals" to fix prices and rig bids on drugs used to treat bacterial infections, acne and diabetes. (iacenter.org)
  • Making policy action tricky is that rising prices for generic, brand-name and biologic products each have different causes, and each requires a different set of policies to bring under control. (modernhealthcare.com)
  • With brand-name drugs, many stakeholders have bought into the idea that lower prices will reduce the financial incentives for developing new breakthrough products. (modernhealthcare.com)
  • to stop brand-name pharmaceutical companies from blocking lower-cost generic drugs to market. (senate.gov)
  • Per capita prescription drug spending in the United States exceeds that in all other countries, largely driven by brand-name drug prices that have been increasing in recent years at rates far beyond the consumer price index. (nih.gov)
  • More-affordable generic drugs could be made more widely available, he continued, by making illegal the brand-name industry practice of paying potential competitors to keep lower-priced generics off the market. (truthdig.com)
  • On average, brand-name drugs cost 10 times more than generics. (truthdig.com)
  • Over the past 5 years, the cost of many of the most popular brand-name prescription drugs used by older Americans increased at nearly 10 times the rate of inflation, according to a new report from US Senator Claire McCaskill (D-MO). (medscape.com)
  • Under the Hatch-Waxman law passed in 1984, generic competition is allowed when a new drugs patent and market exclusivity protection expires, or when a 30-month stay terminates. (archives.gov)
  • It eliminates some loopholes that brand pharmaceutical companies have been using to prevent generic competition from gaining access to the market. (jasonpye.com)
  • Fierce competition between brand and generic-drug makers adds to these difficulties. (biopharminternational.com)
  • Next came an FDA "hit list" of off-patent, off-exclusivity brand drugs that lack approved generic competition and thus are eligible for expedited review and assistance in developing new versions of these products (6). (biopharminternational.com)
  • To spur competition in the health care arena, HHS is directed to issue a comprehensive plan within 45 days to map out ways to combat high drug prices and "price gouging" and enhance domestic pharmaceutical supply chains. (pharmtech.com)
  • In the Senate, where broad agreement is needed to advance such pricing proposals, the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights opened the discussion of these issues at a hearing this week on "cracking down on anticompetitive conduct in prescription drug markets. (pharmtech.com)
  • McCaskill has previously introduced the bipartisan Increasing Competition in Pharmaceuticals Act with Senator Susan Collins (R-Maine) to improve the Food and Drug Administration's approval process for certain generic applications. (senate.gov)
  • The bipartisan CREATES Act respects intellectual property rights and encourages greater competition that will inevitably lower the price of prescription medications for the American patient. (senate.gov)
  • The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act ("Act"), was passed to expedite the FDA's approval of generic drugs. (llrx.com)
  • The legislation, which will increase market competition and lower prescription drug prices, passed the Senate Judiciary Committee last year but did not come up for a full U.S. Senate vote. (senate.gov)
  • There's at best an outside chance they could come together on narrow measures to enhance competition in the generic market. (modernhealthcare.com)
  • And protecting competition by blocking unfair and anticompetitive drug monopolies and helping more generic competitors come to market. (senate.gov)
  • Climbing prescription drug prices threaten the health and wellbeing of families and individuals who depend on lifesaving medications. (familiesusa.org)
  • Basically, some companies find existing medications where there are only one or two manufacturers, buy the rights to make the drugs, and then raise the prices exorbitantly. (familiesusa.org)
  • The market for purchasing drugs can be complex, but with MAC pricing, multi-sourced generic medications are kept as affordable as possible in the U.S. (express-scripts.com)
  • Although I appreciate that the FTC heeded our call for increased enforcement, today's action illustrates the need for our legislation to help ensure people have access to the medications they need at a price they can afford by putting an end to these harmful agreements. (senate.gov)
  • Our legislation would curb these harmful tactics and help ensure that consumers have timely access to lower-cost generic medications. (senate.gov)
  • The bill, which was passed 38-7 in the Senate and 137-2 in the House of Representatives, would allow the state's attorney general to seek legal action against pharmaceutical companies for price gouging life-saving medications. (healthcareforall.com)
  • High prescription drug prices are forcing too many families to choose between the medications they need to survive and other life necessities, like groceries or rent. (senate.gov)
  • A new position statement from the American Academy of Neurology (AAN) and other organizations warns soaring prices for neurologic and other prescription medications is leading to rationing of care and diverting clinicians' time from the clinic to insurance bureaucracy. (medscape.com)
  • S 440, the Preserving Access to Cost Effective Drugs Act, which would bar patent owners from asserting sovereign immunity, including the sovereign immunity accorded to an Indian tribe, in certain drug patent disputes. (lexology.com)
  • Implement Federal Trade Commission (FTC) recommendations for improving access to generic drugs by making significant changes in the use of automatic 30-month stays and in the drug patent listing process. (archives.gov)
  • The intent of the law is to provide incentives to develop valuable new drug treatments through patent protection, but also to facilitate access to generic versions of the drug after the innovators patent expires. (archives.gov)
  • In recent years, however, access to generic drugs has sometimes been delayed by litigation. (archives.gov)
  • WASHINGTON, DC - U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) today issued the following statements on the announcement that the Federal Trade Commission (FTC) filed suit against Endo Pharmaceuticals Inc. and several other drug companies for violating antitrust laws by using pay-for-delay settlements to block consumers' access to lower-cost generic versions of Opana ER and Lidoderm. (senate.gov)
  • The senators are the lead sponsors of the Preserve Access to Affordable Generics Act, which would crack down on anti-competitive pay-offs and make sure consumers have access to cost-saving generic drugs they need. (senate.gov)
  • The executive order further advises FDA to implement recent legislation designed to prevent brand manufacturers from limiting access to drug samples needed to test new generic products. (pharmtech.com)
  • The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace. (senate.gov)
  • I look forward to getting this important tool passed so we can improve access to lower-cost generic drugs. (senate.gov)
  • Access to innovative drugs is a major reason why. (senate.gov)
  • The third hearing is planned for the fall to hear from Norm Augustine and consider a report Augustine is leading from the National Academy of Sciences-the result of a project called "Ensuring Patient Access to Affordable Drug Therapies. (senate.gov)
  • This report is the outcome of a project called "Ensuring Patient Access to Affordable Drug Therapies. (senate.gov)
  • The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act, which is also supported by Minnesota Senator Amy Klobuchar (D-Minn.), would deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace. (senate.gov)
  • The availability of generic drugs after this exclusivity period is the main means of reducing prices in the United States, but access to them may be delayed by numerous business and legal strategies. (nih.gov)
  • Measurement of access to essential drugs is being refined through definition of relevant indicators. (who.int)
  • Last week, she introduced legislation to ensure students in Minnesota and across the country can access mental health services in their schools. (senate.gov)
  • Senator McCaskill: 'We watched a company brazenly try to exploit a potential legal loophole to game the system in an effort to protect their bottom line-and keep Missourians from access to cheaper generic drug options in the process. (patentdocs.org)
  • Access to drugs and finance : basic economic and financial analysis. (who.int)
  • Last year, Americans were expected to spend more than $328 billion on prescription drugs. (senate.gov)
  • today chaired a bipartisan Senate health committee hearing to examine the path a FDA-approved prescription drug takes from the manufacturer to patient, and how this path affects what the patient pays, saying "Americans want to know who pays for prescription drugs and where that money goes. (senate.gov)
  • A lead proposal is to make it easier for Americans to purchase less costly, but supposedly safe, drugs from Canada. (pharmexec.com)
  • Americans now spend a staggering $200 billion a year on prescription drugs, and that figure is growing at a rate of about 12 percent a year (down from a high of 18 percent in 1999). (nybooks.com)
  • A new piece of legislation aimed at stopping the "unconscionable" spikes in drug pricing has been passed with enthusiastic bipartisan support in Maryland. (healthcareforall.com)
  • In addition, the 'biosimilar pathways' provisions of the Patient Protection and Affordable Care Act opens the door for generics manufacturers to bring generic versions of biotech drugs to market, presenting another potential boon for generics. (drugtopics.com)
  • Klobuchar and Grassley introduced similar legislation in 2010 following a resurgence of patent settlement agreements. (senate.gov)
  • WASHINGTON - After a public report that a decades-old drug-that was provided free of charge as recently as 2016-had suddenly seen its price soar to a cost of more than $15,000 per bottle, U.S. Senator Claire McCaskill is demanding answers from Strongbridge Biopharma, which acquired the drug and relaunched it earlier this year. (senate.gov)
  • While the December 2016 findings of the U.S. Senate Special Committee on Aging should clearly be grounds to indict the CEOs of pharmaceutical companies responsible for price gouging, the odds are against this ever happening. (iacenter.org)
  • Early in 2016 the House Committee on Oversight and Government Reform called Mylan CEO Heather Bresch to testify after the outrageous rise in the price of the lifesaving EpiPen. (iacenter.org)
  • In December 2016, the U.S. Justice Department brought criminal charges against two pharmaceutical executives for conspiring with other drug makers to fix generic drug prices. (iacenter.org)
  • We reviewed the peer-reviewed medical and health policy literature from January 2005 to July 2016 for articles addressing the sources of drug prices in the United States, the justifications and consequences of high prices, and possible solutions. (nih.gov)
  • Sen. Smith said that due in part to these high prices, spending on retail prescription drugs reached $328 billion in 2016, a nearly 30 percent increase from 2010. (senate.gov)
  • In 2016 alone, spending on prescription drugs topped $328 billion. (medscape.com)
  • Price hikes on established products, moreover, have generated a backlash and allegations of collusion and price gouging. (biopharminternational.com)
  • In 2014 the Senate Subcommittee on Primary Health and Aging held a hearing to investigate steep and unexpected price hikes on some generic drugs. (iacenter.org)
  • Democratic presidential nominee Hillary Clinton has proposed unprecedented federal review of price hikes. (modernhealthcare.com)
  • The powerful drug industry traditionally has been able to fend off government efforts to counter price hikes. (modernhealthcare.com)
  • 1) generic drug, (2) pharmaceutical drug, (3) Hatch-Waxman Act, (4) pharmaceutical patent, (5) abbreviated new drug application, (6) generic pharmaceutical, and (7) pharmaceutical patent extension. (llrx.com)
  • and regulating certain pharmacy benefit manager (PBM) pricing practices. (lexology.com)
  • Drug importing, advertising, rebates, and industry practices are on the table as legislators zero in on pharma pricing strategies. (pharmexec.com)
  • One Illinois legislator is taking action so that residents in his state will no longer have to suffer without recourse when generic drug manufacturers engage in the practice of price gouging. (familiesusa.org)
  • Families USA has been proud to work with State Representative Will Guzzardi from Illinois' 39th District on HB 4900 , legislation that Rep. Guzzardi introduced in the state legislature to create generic drug pricing fairness and stop price gouging in Illinois. (familiesusa.org)
  • HB 4900 will empower our Attorney General to go after some of the worst actors in the pharmaceutical industry: generic and off-patent drug manufacturers who engage in price gouging. (familiesusa.org)
  • changes to Alabama's price-gouging statute. (alabamaretail.org)
  • Should the bill be passed by Republican Gov. Larry Hogan, it will be one of the first pieces of legislation to take action against pharmaceutical price gouging in the United States. (healthcareforall.com)
  • The most noted examples of price gouging during the last few years was the hedge fund manager of Turing Pharmaceuticals, Martin Shkreli, buying the rights to a medication known as Daraprim. (healthcareforall.com)
  • citation needed] In addition, he helped close a tax loophole that was costing Maryland roughly $10 million a year by passing legislation that stops a common business practice of artificially lowering taxable profits by paying rent, a deductible business expense, to shell companies controlled by the same parent company. (wikipedia.org)
  • And that our prices that we pay for drugs, particularly generic drugs, is artificially high. (empirecenter.org)
  • High drug prices are the result of the approach the United States has taken to granting government-protected monopolies to drug manufacturers, combined with coverage requirements imposed on government-funded drug benefits. (nih.gov)
  • Without patent monopolies and related protections, drugs would almost invariably be cheap. (truthdig.com)
  • Drug manufacturers would be limited to only one 30-month stay per generic application, to resolve allegations that a generic drug maker is infringing a drug patent. (archives.gov)
  • However, between 2015 and 2020, an 'innovation drought' period experienced by the brand manufacturers will catch up with the generic market and create an opportunity drought for generics as fewer generics are introduced, Long said. (drugtopics.com)
  • The unknown here is that since brand manufacturers are committed to filling 50% of the donut hole (with the government closing an additional 25%), there might be more brand loyalty and less switching to generics. (drugtopics.com)
  • In Connecticut, Attorney General William Tong has amended and expanded his office's complaints against 20 of the nation's largest generic drug manufacturers for what he says is their role in driving up prices. (empirecenter.org)
  • Yet another patient appears on Global TV News unable to get an expensive prescription drug reimbursed by the Ontario provincial government, and the Minister of Health and Long-Term Care responds that the provinces and territories are working together to negotiate with manufacturers to get the best possible prices for drugs. (fraserinstitute.org)
  • Drug manufacturers are taking advantage of this by jacking up the prices of naloxone, the drug that interrupts opioid overdoses. (familiesusa.org)
  • The U.S. is the only country that allows pharmaceutical manufacturers to set drug prices with no limitations. (iacenter.org)
  • Manufacturers found guilty of price hiking can be fined up to $10,000 per infraction. (healthcareforall.com)
  • Gaps in legislation for drug regulation: Without comprehensive legislation to support drug regulation, some areas of pharmaceutical activity may not be covered by the regulations. (who.int)
  • the waterpipe industry operates relatively freely and there is considerable scope for better legislation and regulation. (who.int)
  • Drug companies sue. (bmj.com)
  • While new drugs often come on to the market at incredibly high prices, pharmaceutical companies also hike prices even for older generic and off patent drugs at rates so high that they become out of reach for consumers and strain budgets for employers and governments. (familiesusa.org)
  • Drug companies did not wait longer to introduce new drugs here compared to the U.S. There was a decline in the per cent of drugs first approved by the FDA and then by Health Canada , but the same thing happened in Australia where drug prices were not being lowered. (healthcoalition.ca)
  • After companies submit drugs for approval in the U.S. or the EU, they take an extra year before submitting them to Health Canada. (healthcoalition.ca)
  • If drug prices were the reason for the wait, then companies should be submitting applications sooner in Switzerland compared to Canada. (healthcoalition.ca)
  • But a substantial proportion of that time difference is in the hands of drug companies. (healthcoalition.ca)
  • Drug companies have been making threats for over 50 years every time governments do something that threatens their profits. (healthcoalition.ca)
  • The deals alleged are clear examples of pharmaceutical companies sharing monopoly profits and consumers paying the price. (senate.gov)
  • Time and again we've seen pharmaceutical companies acquire decades old prescription drugs and gouge consumers-and it's time we explored every possible way to prevent this practice," McCaskill said. (senate.gov)
  • For too long, a few predatory name brand companies have used anticompetitive strategies to delay entry of lower cost generic drugs. (senate.gov)
  • In the House, Oversight and Reform Committee chair Elijah Cummings (D-Md) has requested pricing and cost information from a dozen leading biopharma companies as part of a broad investigation he has opened into strategies to reduce prescription drug prices. (pharmexec.com)
  • Pricing varies greatly, but this refers to what the companies call the average wholesale price, which is usually pretty close to what an individual without insurance pays at the pharmacy. (nybooks.com)
  • And she's introduced legislation torequire pharmaceutical companies to disclose how they're using the billions in tax breaks they've received. (senate.gov)
  • The companies must be willing to give away or charge low prices for their drugs to satisfy activists. (aol.com)
  • The intention of the shorter review period is to provide a financial incentive for companies to develop drugs for neglected diseases. (aol.com)
  • This report demonstrates that the pricing decisions made by these drug companies are outrageous. (medscape.com)
  • Here Families USA interviews Rep. Guzzardi on how high prescription drug prices hurt Illinois families, and how HB 4900 will help make drugs more affordable in the state. (familiesusa.org)
  • Practically everyone is frustrated by high prescription drug prices. (wypr.org)
  • Another high-profile initiative is to require price disclosures in drug TV commercials, which was proposed last year by the White House and is popular on Capitol Hill. (pharmexec.com)
  • To review the origins and effects of high drug prices in the US market and to consider policy options that could contain the cost of prescription drugs. (nih.gov)
  • As reported by Medscape Medical News , the president said that drug prices are too high and said that one of his "greatest priorities" would be to find a way to bring them down, calling them "very, very unfair. (medscape.com)
  • However, between 2011 and 2020, there was no change in the timing between when drugs were approved by the United States Food and Drug Administration (FDA) and then by Health Canada. (healthcoalition.ca)
  • The Food and Drug Administration ("FDA") is one of the oldest consumer protection agencies in this country. (llrx.com)
  • However, the U.S. Food and Drug Administration makes it very difficult for individuals to import prescription drugs for personal use unless the drug is for a serious condition and not available in the U.S. Even then, no more than a three-month supply can be imported. (iacenter.org)
  • As of this writing, one of two people being vetted as the next Food and Drug Administration commissioner is Jim O'Neill, a managing director at Mithril Capital Management, run by one of Donald Trump's billionaire donors and advisors. (iacenter.org)
  • The Food and Drug Administration (FDA) could be the key barrier. (drugchannels.net)
  • A few weeks ago, the Food and Drug Administration granted accelerated approval for J&J's new tuberculosis drug Sirturo. (aol.com)
  • On Tuesday, Dr. Scott Gottlieb, commissioner of the Food and Drug Administration, announced that he would be resigning in the next month. (canceradvocacy.org)
  • S 1224, the "Stop STALLING Act," to authorize the FTC to take action against entities that file "sham" citizen petitions to attempt to interfere with approval of a competing generic drug or biosimilar. (lexology.com)
  • It also gives generics legal recourse to obtain the samples they need to gain FDA approval. (jasonpye.com)
  • FDA also published more product-specific guidance documents to help speed approval of complex products, synthetic peptides, and generic versions of opioids with abuse-deterrent features. (biopharminternational.com)
  • and multiple FDA user fee agreements, which have helped fund the FDA and modernize our drug and device approval process. (senate.gov)
  • On the surface, this might seem like just another drug approval. (aol.com)
  • While the House of Representatives took an important first step this year by passing legislation to provide drug coverage, the Senate failed to act. (archives.gov)
  • In a letter to Strongbridge President and CEO Matthew Pauls, McCaskill requested additional information on the drug Keveyis, including a detailed description of the factors contributing to the company's pricing decision and total gross revenue from the company's sales of the drug. (senate.gov)
  • McCaskill has also introduced legislation with Collins to prohibit pharmacy gag laws that lead to consumers overpaying for prescription drugs. (medscape.com)
  • That's largely because the price of hospital and doctor care continues to increase, he said, which makes health care more expensive. (salon.com)
  • The state also plans to introduce changes to how it regulates prescription drugs in the state employee health plan. (empirecenter.org)
  • Nova Scotia s minister of health Maureen McDonald has announced her government s intentions of introducing legislation this spring aimed at getting fairer drug prices. (fraserinstitute.org)
  • In his latest article for The Conversation , Canadian Health Coalition Board Member Dr. Joel Lexchin unpacks the pharmaceutical lobby's "falsehoods and half truths" about the urgent need for drug control measures in Canada. (healthcoalition.ca)
  • The Federal Trade Commission (FTC) and Department of Justice (DoJ) also will review merger guidelines to prevent patient harm from certain hospital mergers and assess the need for controversial rules requiring hospitals to disclose the prices they negotiate with health insurance firms. (pharmtech.com)
  • Released on September 14, the legislation would reauthorize funding for a number of healthcare workforce programs that are due to expire on September 30, including Community Health Centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education program, among others. (jdsupra.com)
  • 1 Drugs are the fastest-growing part of the health care bill-which itself is rising at an alarming rate. (nybooks.com)
  • and to promote rational use (namely, the therapeutically sound and cost-effective use of drugs by health professionals and consumers). (who.int)
  • In the Philippines, a regional course allowed countries to share their current economic and political perspectives of health systems, thereby encouraging them to update their national drug policies. (who.int)
  • People should not have to go without the medication they need just because their elected officials aren't willing to challenge the drug and health care industry lobby. (truthdig.com)
  • The skyrocketing prices of prescription drugs are an example of the web of bureaucracy and red tape in the American health care system," Sanders added. (truthdig.com)
  • "The number one issue I hear about from Minnesotans is the cost of health care, and specifically the cost of prescription drugs," said Sen. Smith. (senate.gov)
  • Prevent "most-favored-nation" clauses in contracts between providers and health plans that protect an insurance company's dominant position in a market by requiring that the insurance company be given the most favorable pricing of any health plan in the market. (hfma.org)
  • Strategies for addressing antimicrobial drug resistance entific evidence concerning its effect on human health and stress the need for new drugs ( 1-3 ), and yet the rate of the effectiveness of available interventions. (cdc.gov)
  • Legislation for smoke-fre workplaces and health of bar workers in Ireland: before and Anderson P (20 6). (who.int)
  • How to investigate drug use in health facilities : selected drug use indicators. (who.int)
  • The primary counterweight against excessive pricing during market exclusivity is the negotiating power of the payer, which is currently constrained by several factors, including the requirement that most government drug payment plans cover nearly all products. (nih.gov)
  • associated with efficacy correlate poorly between animal biologic methods) and suggest the need for better clinical models and humans, parameters of antimicrobial drug data to reassess susceptibility breakpoints for these agents. (cdc.gov)
  • The US House of Representatives returned from recess this week and held a legislative hearing on drug shortages. (jdsupra.com)
  • However, the need to lower prescription drug prices is one of these rare breeds. (jasonpye.com)
  • This legislation helps lower prescription drug prices without instituting big government price controls or antitrust enforcement. (jasonpye.com)
  • More information on Tester's efforts to lower prescription drug prices is available HERE . (senate.gov)
  • The White House is considering multiple options to lower prescription drug prices amid the COVID-19 coronavirus pandemic, such as linking some U.S. drug prices to lower prices paid overseas or banning drug rebates to simplify a convoluted drug pricing system. (ons.org)
  • Right now, new generic drug approvals take 30 months, so new supply can't bring down prices. (drugchannels.net)
  • The FDA has a policy to expedite reviews to combat shortage, but there is a backlog of applications for generic approvals. (drugchannels.net)
  • and allowing for the safe importation of cheaper drugs from other countries, like Canada. (senate.gov)