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  • 2016
  • Health benefit plan cost trend rates for 2016 will increase for most medical plan options and increase substantially for prescription drug coverage to double-digit rates, according to forecasts compiled in the 2016 Segal Health Plan Cost Trend Survey, Segal's nineteenth annual survey of health plan cost trends. (drugstorenews.com)
  • and legislation, such as the Senate's 2016 CREATES Act, that removes barriers and advance more timely patient access to generic and biosimilar medicines. (wikipedia.org)
  • makers
  • The massive US Senate healthcare reform measure passed on Thursday with support from the multibillion drug industry, but makers of cheaper generic rivals are feeling left out in the cold. (correntewire.com)
  • WASHINGTON (Reuters) - Maryland lawmakers have passed a first-in-the-nation measure that lets the state attorney general sue generic drug makers that sharply raise prices in a move aimed at fighting what legislators call "price-gouging. (reuters.com)
  • FDA's
  • The speed of FDA's action will determine how quickly safe and effective generic biologics become available to patients," Waxman wrote in a letter addressed to President Obama. (redorbit.com)
  • Fees would supplement appropriated funds to cover FDA's costs associated with reviewing certain applications and investigational submissions for brand and generic animal drugs. (wikipedia.org)
  • The legislation would extend through fiscal year 2018, and make several technical changes to, FDA's existing fee programs for brand and generic animal drugs, which expire at the end of fiscal year 2013. (wikipedia.org)
  • provision
  • A 2011 study by the Office of the Inspector General observed that the financial burden posed by the rising costs of branded drugs was mitigated by the provision of rebates from pharmaceutical manufacturers. (pmlive.com)
  • This has become controversial in recent years, as pharmaceutical companies have used the provision to keep generics off the market by protecting their drugs with extra patents of poor quality, filing lawsuits to protect the patents even when the lawsuit will be lost, but getting the extra market exclusivity anyway. (cptech.org)
  • 2001
  • In January 2001, the other generic industry trade association in operation at the time, the National Association of Pharmaceutical Manufacturers (NAPM), merged with the newly formed GPhA, which completed the consolidation of three U.S.-focused generic trade associations into one national advocacy organization. (wikipedia.org)
  • Food and Drug Admin
  • The Food and Drug Administration currently is unable to approve generic copies of expensive biotech drugs. (redorbit.com)
  • In 2011 and 2012, GPhA and the U.S. Food and Drug Administration negotiated the Generic Drug User Fee Act (GDUFA), which requires manufacturers of generic prescription drugs to pay application fees when submitting Abbreviated New Drug Applications (ANDAs) seeking approval for generic products. (wikipedia.org)
  • The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. (wikipedia.org)
  • biopharmaceuticals
  • Another key distinction is between traditional small-molecule drugs, usually derived from chemical synthesis , and biopharmaceuticals , which include recombinant proteins , vaccines , blood products used therapeutically (such as IVIG ), gene therapy , monoclonal antibodies and cell therapy (for instance, stem-cell therapies). (wikipedia.org)
  • price
  • While this legislation will not prevent large price increases outright, the influence driving it - an increasingly informed and vocal public via social media - is likely to shape the future of pharmaceutical pricing practices. (pmlive.com)
  • Given their efficacy in the branded drug market, imposing inflation penalties for generic drugs appears to be a viable method of price control. (pmlive.com)
  • Significant price hikes in the pharmaceutical industry are not a new phenomenon, nor does this legislation effectively prevent them from happening. (pmlive.com)
  • Drug Price Competition and Patent Term Restoration Act of 1984. (cptech.org)
  • H.R.1316: The Prescription Drug Price Transparency Act--issues related to ensuring the continuity of MAC pricing. (opensecrets.org)
  • LEGISLATION proposed by Assemblyman Martin A. Herman, Democrat of Woodbury, that would encourage drug-price advertising and the sale of generic rather than brand-name drugs has been attacked by Gerard C. Hunt, chairman of the New Jersey Health Products Information Committee, as uneconomical, unnecessary and dangerous. (wikipedia.org)
  • it is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners use the law and related regulatory processes to extend their high rent-earning intellectual property rights particularly over highly profitable (either in total sales volume or price per unit) "blockbuster" drugs. (wikipedia.org)
  • A drug tourist may also cross a sub-national border (from one province/county/state to another) in order to purchase alcohol or tobacco more easily, or at a lower price due to tax laws or other regulations. (wikipedia.org)
  • approval
  • Rep. Henry Waxman, D-Calif. praised the President for his approval of generic biologics as a part of the fiscal year 2010 budget, but he urged the President to take steps that would prepare for and even begin to approve biotech drugs in advance of legislation. (redorbit.com)
  • It allows generics to win FDA marketting approval by submitting bioequivelence studies (as opposed to clinical data, which is costlier to compile). (cptech.org)
  • FDA Generic Approval How Market Forces Are Pushing the Agency. (cptech.org)
  • biotech
  • In March, Chairman Waxman introduced bipartisan bill H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act," which would give the FDA the ability to approve more affordable generic copies of biotech drugs. (redorbit.com)
  • but Waxman's bill) does not strike the necessary balance for patients or the economy," said Jim Greenwood, president of BIO, which spent $1.9 million in the first quarter on lobbying efforts on an array of issues, including generic biotech. (redorbit.com)
  • Antibiotics
  • Antimicrobials (including antibiotics and antifungals) and other drugs can only be used by veterinarians and livestock owners in the U.S. for treatment, control, or prevention of diseases. (wikipedia.org)
  • There are also global concerns over the use of antibiotics for growth promotion or therapy purposes because of the potential for some drugs to enter the human food chain despite rigorous withdrawal measures and testing to prevent antibiotic residues in food, increasing antibiotic resistance in animals, a potential although largely unproven link to antibiotic-resistant infections in humans, and what some consider antibiotic misuse. (wikipedia.org)
  • However, any antibiotics deemed medically important to humans by the CDC are illegal to use as growth promoters in the U.S. Only drugs that have no association with human medicine - and therefore no risk to humans - are allowed to be used for this purpose. (wikipedia.org)
  • It is also important to note that some drugs listed below are ionophores, which are not antibiotics and do not pose any potential risk to human health. (wikipedia.org)
  • exclusivity
  • It also grants a period of additional marketing exclusivity to make up for the time a patented pipeline drug remains in development. (cptech.org)
  • jurisdictions
  • Governments generally regulate what drugs can be marketed, how drugs are marketed, and in some jurisdictions, drug pricing. (wikipedia.org)
  • Drug tourism has many legal implications, and persons engaging in it sometimes risk prosecution for drug smuggling or other drug-related charges in their home jurisdictions or in the jurisdictions they are visiting, especially if they bring their purchases home rather than using them abroad. (wikipedia.org)
  • The act of traveling for the purpose of buying or using drugs is itself a criminal offense in some jurisdictions. (wikipedia.org)
  • Competition
  • DSN talked to Cardinal Health SVP independent sales Steve Lawrence about the big news from Cardinal's 2012 Retail Business Conference, including a best practices competition for its customers, its Women in Pharmacy program and Cardinal's joint outreach program with the Ohio State University College of Pharmacy aimed at preventing prescription drug abuse. (drugstorenews.com)
  • Requiring brand-name companies and the first generic applicants to provide copies of out-of-court settlements to the FTC and the Department of Justice to ensure that competition is not compromised. (cptech.org)
  • FTC to Study Generic Drug Competition. (cptech.org)
  • H.R.2212/S.974: CREATES Act--provisions related to removing barriers to generic competition. (opensecrets.org)
  • Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. (opensecrets.org)
  • Regulations
  • The legislation also includes an AAMC-endorsed proposal to require the Secretary of Health and Human Services to issue proposed regulations establishing a unique device identifier system no later than Dec. 31, 2012, finalize the regulation within six months of the close of the comment period, and implement such a system within two years for certain devices [see Washington Highlights , March 23 ]. (aamc.org)
  • In 1993, under the NAFTA-induced Canadian Notice Of Compliance (NOC) regulations, drug safety, quality and efficacy regulators at Health Canada were prevented from issuing an authorization for market entry, until all of the relevant patents on a brand name product had been proven to have expired. (wikipedia.org)
  • the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. (wikipedia.org)
  • companies
  • In response, companies must become more aware of and sensitive to community sentiment surrounding drug pricing. (pmlive.com)
  • Last year, two bills sought to close loopholes in the law exploited by companies to keep generics off the market. (cptech.org)
  • Drug discovery and drug development are complex and expensive endeavors undertaken by pharmaceutical companies , academic scientists, and governments. (wikipedia.org)
  • while opponents argued that reduced profit margins could lead pharmaceutical firms to cut research and cause drug companies to leave the state. (wikipedia.org)
  • GPhA members include more than 30 pharmaceutical manufacturers and an additional 60 other companies that manufacturer and distributor bulk pharmaceutical chemicals, supply contract research services, or provide other goods and services to the generic drug industry. (wikipedia.org)
  • restrict
  • Other drugs may be used only under strict limits, and some organizations and authorities seek to further restrict the use of some or all drugs in animals. (wikipedia.org)
  • efficacy
  • Linkage evergreening is the process whereby pharmaceutical safety, quality and efficacy regulators are required to 'link' their normal evaluation with an assessment of whether an impending generic product may infringe an existing patent. (wikipedia.org)
  • medications
  • In preparing for this legislation, manufacturers should first consider re-evaluating their overall pricing strategies, gauge long-term ramifications and determine how inflation penalties on generic medications could affect a drug's profitability. (pmlive.com)
  • costs
  • The Maryland measure comes as concerns about rising U.S. drug costs have been building for years. (reuters.com)
  • The bill did not touch on branded prescription drugs new to the market since their manufacturers have development and patent costs they are entitled to recoup, Frosh said. (reuters.com)
  • Officials Question the Rising Costs of Generic Drugs", The New York Times, 7 October 2014. (wikipedia.org)
  • medical
  • When, in the late 1950s, many thought that the social cost of barbiturates was beginning to outweigh the medical benefits, a serious search began for a replacement drug. (wikipedia.org)
  • One of the key classifications is between traditional small molecule drugs, usually derived from chemical synthesis, and biologic medical products, which include recombinant proteins, vaccines, blood products used therapeutically (such as IVIG), gene therapy, and cell therapy (for instance, stem cell therapies). (wikipedia.org)
  • Consumer Safety Officers, more commonly called Investigators, are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. (wikipedia.org)
  • increase
  • Healthcare reform in the US has made substantive changes to the Medicaid Drug Rebate Program in recent years, including the increase of rebate percentages for covered drugs and the incorporation of Medicaid Managed Care Organization (MCO) programmes. (pmlive.com)
  • The bill allows Maryland's state authority on Medicaid, a federal healthcare program for the poor, to let the attorney general's office know when it sees patients being charged an "unconscionable increase" for essential generic drugs. (reuters.com)
  • Stimulants or "uppers" increase mental and/or physical function, hence the opposite drug class of depressants is stimulants, not antidepressants. (wikipedia.org)
  • prevent
  • Robinson voted in favor of legislation which would require the fingerprinting of gun buyers, prevent purchasing of guns by the mentally ill, a ban on assault weapons, and banning magazines that hold over 10 bullets. (wikipedia.org)
  • A medication (also referred to as medicine , pharmaceutical drug , or simply drug ) is a drug used to diagnose , cure , treat , or prevent disease . (wikipedia.org)
  • measure
  • It's important to note that, because generics have historically been a cheaper alternative to branded drugs, the prices in some cases decreasing over time, it was originally determined that a similar cost-control measure was not necessary. (pmlive.com)
  • available
  • The first such drug, chlordiazepoxide (Librium), was discovered accidentally by Leo Sternbach in 1955, and made available in 1960 by Hoffmann-La Roche, which has also marketed the benzodiazepine diazepam (Valium) since 1963. (wikipedia.org)
  • A drug tourist may cross a national border to obtain a drug that is not sold in one's home country, or to obtain an illegal drug that is more available in the visited destination. (wikipedia.org)
  • similar
  • In reality, the omission of a similar inflation penalty for generics has allowed drug prices in that market to rise primarily unchecked. (pmlive.com)
  • Meanwhile, the House Energy and Commerce Committee postponed an April 26 markup of similar legislation until May 8 to afford more time to reach a bipartisan consensus on the bill. (aamc.org)
  • Massachusetts, New York, Rhode Island and Tennessee have similar legislation pending, the conference said. (reuters.com)
  • several
  • Predictably, a large proportion of generics have progressed considerably above the rate of inflation in the past several years. (pmlive.com)
  • Depressants are used medicinally to relieve the following symptoms: Anxiety Generalized anxiety Social anxiety Panic attacks Insomnia Obsessive-compulsive disorder Seizures Convulsions Depression An alcoholic beverage is a drink that contains alcohol (also known formally as ethanol), an anesthetic that has been used as a psychoactive drug for several millennia. (wikipedia.org)
  • Health
  • The Act gave states permission to create Drug Utilization Review ("DUR") boards to manage state specific drug purchasing and formulary decisions for state purchased health care such as Medicaid programs, injured workers programs, and state employee benefits. (wikipedia.org)
  • market
  • Drugs brought to market prior to 1 April 2013 will use the third quarter of 2014, while drugs introduced after this date will use the fifth full calendar quarter after the market entry date. (pmlive.com)
  • Legislation to address abuses of the REMS program to allow generic drugs to come to market faster. (opensecrets.org)
  • The legislation takes aim at a generic drug market that makes up 88 percent of U.S. pharmaceutical sales and totaled $75 billion in 2015, according to Frosh's office. (reuters.com)
  • The FTC recommended only one evergreening injunction against a potential generic market entrant be permitted per product, and an expedited process of resolving such claims. (wikipedia.org)
  • allows
  • The Act also allows drugs listed as preferred to be eligible for "sealed non-transparent rebates" to occur from the manufacturer of the drug to the state agency. (wikipedia.org)
  • Committee
  • The work for which he is best remembered began when Leland co-authored legislation with U.S. Rep. Ben Gilman (R-New York State) in establishing the House Select Committee on Hunger. (wikipedia.org)
  • products
  • Since the legalization of marijuana in Colorado and Washington state, many drug tourists from states and countries where cannabis is illegal travel to these states to purchase cannabis and cannabis products. (wikipedia.org)