How the FDA Grew - Pharmaceutical Executive

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How the FDA Grew


Pharmaceutical Executive


1983: The Orphan Drug Act is passed, offering pharma incentives, including seven years' market exclusivity, priority review, and waiver of NDA fees, to develop drugs for rare diseases.

1984: The Hatch-Waxman Act gives the FDA authority to approve cheap generic versions of brand-name drugs based on short-term equivalency data and gives brand-name drug manufacturers five years' additional patent protection as the original clinical trials extend the length of time it takes to bring a drug to market.

1987: The FDA institutes an expanded access program for drugs in Phase II or III for untreated life-threatening diseases such as AIDS and cancer, as well as a parallel-track program for patients disqualified from the clinical trials for such drugs.

1990: The Anabolic Steroid Act introduces the category of controlled substances for the increased regulation of prescription drugs to police illicit trafficking.

1991: The FDA institutes a fast-track review for drugs for life-threatening diseases.

1992: The Prescription Drug User Fee Act (PDUFA) requires drugmakers to pay fees for product applications and requires the agency to use the money to hire additional reviewers.

1995: The FDA declares cigarettes a drug-delivery device and begins restricting their marketing.

1997: The Food and Drug Administration Modernization Act reauthorizes PDUFA and institutes the most extensive set of agency reforms since 1938, including measures to incentivize drugmakers to test drugs for children by adding six months' of patent exclusivity and to regulate off-label advertising.

1998: The FDA claims the authority to regulate human cloning.

2000: The Supreme Court rules that the FDA does not have the authority to regulate tobacco as a drug.

2004: The FDA publishes guidelines for "the critical path" to help speed therapeutic breakthroughs from discovery through development to market. A scandal linking Merck's Cox-2 inhibitor Vioxx to thousands of heart attacks and related heart problems leads to congressional grilling of FDA officials, a spike in public concern over drug safety, and, in the 2007 reauthorization of PDUFA, the creation of REMS, or Risk Evaluation and Mitigation Strategies, to force drugmakers to more stringently moniter post-marketing use and adverse events.

2009: President Barak Obama signs the Family Smoking Prevention and Control Act and establishes the FDA Center for Tobacco Products, opening the way for agency regulation. The Supreme Court rejects the FDA preemption policy put forth by its Bush-appointed general counsel in 2002 protecting drug companies from liability suits in state courts.

2010: Under new commissioner Margaret Hamburg and deputy Josh Sharfstein, a new Transparency Initiative is launched to demystify the agency's decision-making processes and other functions. The healthcare reform law requires the FDA to develop a pathway for the approval of biosimilars. The FDA rescinds the 2008 approval of ReGen's Menaflex patch form the market, admitting that it had OK'd the device mistakenly due to political pressure from four New Jersey congressmen and its own previous commissioner, Andrew von Eschenbach. The agency has never before taken such an action or made such admissions or charges.


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