How the FDA Grew

Pharmaceutical Executive, Pharmaceutical Executive-11-01-2010, Volume 0, Issue 0

A timeline of some of the landmark legislation, court decisions, and drug scandals that helped forge the FDA

With nearly 10,000 employees and an annual budget of $2.3 billion, the Food and Drug Administration (FDA) regulates about one-quarter of all consumer goods sold in the US, including foods, prescription and OTC drugs, medical devices, vaccines, veterinary products, cosmetics, and, most recently, cigarettes. Even amidst the current antiregulatory climate, the FDA remains largely exempt from the pitchforks and torches. Here is a timeline of some of the landmark legislation, court decisions, and drug scandals that helped forge the FDA. — Walter Armstrong

1903: The Biologics Control Act is passed by Congress to control the "purity and safety of serums, vaccines," and other products used to prevent or treat disease in humans, the first-ever federal regulatory authority over drugs.

1906: The first Pure Food and Drug Act is passed prohibiting interstate commerce in "misbranded" or "adulterated" foods, drinks, and drugs.

1912: The Sherley Amendment is enacted to prohibit drug labels making "false and fraudulent" claims of "curative or therapeutic effects" that are intended to defraud the purchaser.

1927: The federal Bureau of Chemistry is reorganized into two separate entities, with all regulatory functions housed in the new Food, Drug, and Insecticide Administration, a name shortened to the Food and Drug Administration in 1930.

1938: Following scandals of radioactive beverages, blindness-inducing cosmetics, and, in particular, the deaths of 107 people from the so-called Elixir of Sulfanilamide, formulated from an untested toxic solvent, the Federal Food, Drug, and Cosmetic Act gives the FDA broad new regulatory powers, including requiring that all drugs be proven safe before being marketed. From 1938 to 1962, the agency would review some 13,000 New Drug Applications (NDAs).

1950: An appeals court rules that a drug's label must include the specific treatment for which it is shown to be effective, confirming the FDA's authority to pull unsafe or ineffective drugs off the market.

1951: The Durham-Humphrey Amendment codifies certain drugs as restricted to prescription-only use.

1959: Sen. Estes Kefauver holds the first major congressional hearings into shady pharmaceutical industry practices, responding to public concerns over the high price and uncertain efficacy of many drugs.

1962: Thousands of birth defects in newborns caused by the new sleeping pill Thalidomide rock Western Europe. The rejection of FDA approval for Thalidomide wins the agency increased credibility. Calls for increased regulation of the drug industry lead to the Kefauver-Harris Drug Amendments, increasing safety standards and requiring for the first time that all NDAs must show "substantial evidence" of efficacy before marketing. Thus was born the FDA approval process as we know it today.

1966: The Fair Packaging and Labeling Act is passed, as the FDA contracts with the National Academy of Sciences to evaluate the effectiveness of some 4,000 drugs approved on the basis of safety alone between 1938 and 1962.

1970: An appeals court rules that commercial success does not constitute evidence of a drug's safety and efficacy, upholding the 1962 drug effectiveness amendments. The first patient package insert (for oral contraceptives) is required by the FDA, listing risks and benefits.

1976: The Medical Device Regulation Act is passed requiring manufacturers to prove safety and efficacy with the FDA. The Vitamins and Minerals Amendments are passed forcing the FDA to regulate these products as foods rather than as drugs.

1977: The FDA establishes its Bioresearch Monitoring Program for quality of data submitted by manufacturers and protection of human subjects in clinical trials by focusing on preclinical trials in animals, institutional review boards, and other measures.

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.