• 2017
  • The unnumbered Food and Drug Administration Safety and Innovation Act would reauthorize the drug and device user fee programs through FY 2017. (aamc.org)
  • 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)
  • 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)
  • price
  • 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)
  • biotech
  • The Food and Drug Administration currently is unable to approve generic copies of expensive biotech drugs. (redorbit.com)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • companies
  • Last year, two bills sought to close loopholes in the law exploited by companies to keep generics off the market. (cptech.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)
  • Drug discovery and drug development are complex and expensive endeavors undertaken by pharmaceutical companies, academic scientists, and governments. (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)
  • measure
  • The Maryland measure comes as concerns about rising U.S. drug costs have been building for years. (reuters.com)
  • medical
  • Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. (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)
  • 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)
  • increase
  • 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)
  • 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)
  • 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)
  • improvement
  • However, patients in the 10-17 years age group also showed the greatest improvement in appropriate prescription drug use compared to all other age groups over a four-year period. (drugstorenews.com)
  • 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 pharmaceutical drug (also referred to as medicine, medication, or simply as drug) is a drug used to diagnose, cure, treat, or prevent disease. (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)
  • several
  • 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)
  • class
  • The Act stipulates the decision must be made in conjunction with a compilation of evidence, as well as public comment, to generate the class wide drug comparison. (wikipedia.org)
  • bill
  • The bill overwhelmingly was approved by the Democratic-controlled legislature on Monday and hailed by Maryland Attorney General Brian Frosh as a way to check sharply higher prices for crucial generic drugs. (reuters.com)
  • quality
  • 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)