Three Decades of Drug Regulation and Legislation - Pharmaceutical Technology

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Three Decades of Drug Regulation and Legislation
The US Food and Drug Administration has pursued many new initiatives since 1977. The agency began accepting abbreviated applications for generic versions of drugs, collected user fees to support drug review, launched the Critical Path Initiative to encourage innovation, and worked to harmonize its regulatory standards with those of Europe and Japan. New challenges such as AIDS and bioterrorism have affected regulatory policy in recent years. The author reviews FDA's changes in policy and philosophy during..


Pharmaceutical Technology


Generic-drug marketing. In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch–Waxman Act after its lead Senate and House sponsors. This act launched the modern generic-drug industry. The legislation allows FDA to approve abbreviated applications for generic versions of brand-name drugs that rely on much of the innovator firm's preclinical and clinical testing. An important provision permits generics companies to access innovator research data early to develop and test generics before patent expiration.

At the same time, brand-name companies gained as many as five years' additional patent protection for new medicines to make up for the time lost when their products went through FDA's approval process, which often lasted two or three years at that time. The legislation attracted some inexperienced operators to this fast-growing industry, leading to fraudulent activities and a subsequent enforcement crackdown. Congress approved legislation in 1992 that stiffened penalties for illegal acts involving abbreviated drug applications.

Curbs on illegal drug distribution. The Prescription Drug Marketing Act of 1988 provided FDA with added authority to prevent the diversion and resale of prescription drugs, including drug samples. FDA is just now implementing provisions requiring wholesalers to establish pedigree systems that track the movement of approved drugs through the distribution system, thus thwarting sales of adulterated and counterfeit products.

1990s: Expanded authority and resources
David Kessler became FDA commissioner in 1990 and promised to crack down on fraud and abuse, and to compel manufacturers of drugs and food products to meet regulatory requirements. As head of the agency until 1997, he engineered the first prescription-drug user-fee program and the resulting expansion of FDA staff and authority. Other key developments are outlined below.

International harmonization. Beginning in 1990, FDA joined regulators and manufacturers from Europe and Japan to establish the International Conference on Harmonization. In 1992, the group adopted a formal process for reaching agreement on common standards and policies for testing and registering new drugs and biologics in the three regions.

User fees. The Prescription Drug User Fee Act of 1992 requires manufacturers of drugs and biologics to pay fees to support a more efficient FDA review process for market applications and supplements. A five-year "sunset" provision required reauthorization of the user fee program in 1997 and 2002. The program must be renewed again by September 30, 2007.

Rules for dietary supplements. The Dietary Supplement Health and Education Act of 1994 established specific labeling requirements for vitamins and other supplements. It gives FDA authority to establish good manufacturing practices (GMPs) for these products, which has drawn on GMPs for drugs.

Greater oversight of drug advertising. In 1996, FDA established the Division of Drug Marketing, Advertising, and Communications within the Center for Drug Evaluation and Research to oversee a growing volume of professional and consumer advertising. Regulation increased in 1999, when FDA issued a final guidance requiring balanced risk and benefit information in broadcast advertising.

Modernized drug regulation. In reauthorizing the user fee program in 1997, Congress enacted the FDA Modernization Act (FDAMA), which revised and extended many agency practices. Among its multiple provisions, it clarified and streamlined policies governing clinical research, application-review procedures, marketing rules, and postmarketing surveillance requirements.

Incentives for pediatric studies. A key provision in FDAMA granted a drug six months of added exclusivity if the manufacturer conducted additional studies to add pediatric information to the product's label. This initiative was expanded in 2002 under the Best Pharmaceutical for Children Act and again by the Pediatric Research Equity Act of 2003.

2000 to date: New challenges and opportunities
Jane Henney, FDA's only female commissioner, headed the agency from 1999 to 2001. She was succeeded by Mark McClellan in 2002. They undertook many initiatives to revise agency policies and practices that continue to shape FDA operations, including the following.


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