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

Updated GMPs. FDA launched a major initiative in 2002 to update the regulation of GMPs for drugs and biologics. The initative adopts a more risk-based system for inspecting manufacturing facilities and supports new approaches for ensuring product quality. The ultimate goal is to reduce agency oversight of manufacturing processes and postapproval changes, and to provide more regulatory flexibility for companies that establish quality-control systems.

Combination products. The continued squeeze on FDA resources prompted medical-device manufacturers to negotiate a user-fee program in 2002 to support more efficient review of medical-device applications. This has important implications for the growing number of drug-device combination products under development. FDA established the Office of Combination Products in 2002 to better manage market applications for these products.

Response to bioterrorism. In the wake of September 11, 2001, Congress approved legislation to strengthen controls on imported products. The Project BioShield Act of 2004 encouraged the development and regulation of drugs and vaccines to prevent or defend against bioterrorist attacks, a policy reinforced by additional legislation in 2006. FDA has played a lead role in spurring the development of new vaccines and updating production methods to address the need for more preventives and treatments for infectious diseases and biological attacks.

A call for innovation. FDA issued the Critical Path report in March 2004, urging new approaches for bringing new therapies to patients. This launched a major effort to encourage more FDA collaboration with industry to spur research and development and counter a decline in new drugs coming to market. Two years later, the agency issued an Opportunities List of a wide range of research and regulatory initiatives such as biomarker development and toxicity-testing standards that could potentially lead to more biomedical discoveries.

Stress on safety. Evidence linking COX-2 inhibitor painkillers to cardiovascular events caused a major outcry in 2004 that lax FDA policies were permitting unsafe drugs to be marketed. Manufacturers pulled certain products off the market, and FDA launched several initiatives to make oversight of drug safety issues more open and effective. The initiatives included establishing a Drug Safety Board in 2005 and reorganizing FDA's drug-safety offices. Earlier this year, FDA announced broader postmarket surveillance and product-evaluation policies and established a new advisory committee in this area.

Labeling changes. In 2005, FDA issued requirements for manufacturers to submit drug labeling in an electronic format to the Daily Med data bank. Eventually, all labels will follow the new format for professional labeling established by a long-discussed final rule. The rule revises the content and format of labeling for human prescription drugs and biological products. An important innovation is to establish a "highlights" section at the beginning of the label to make it easier for healthcare professionals to access, read, and use the information in approved labeling.

OTC access to Plan B. In August 2006, FDA approved an OTC version of the "morning after pill" Plan B. The three-year controversy over this birth-control product raised concerns about political interference in FDA decisions, but its resolution removed obstacles to the confirmation of cancer specialist Andrew von Eschenbach as FDA commissioner.

2007 and beyond: Building for the future
The need to renew the user-fee program this year provides an opportunity for Congress to increase FDA authority and establish programs that policymakers believe will enhance public access to needed medicines and ensure that medical products are safe and effective. Widely acknowledged as "must-pass" legislation, the user-fee bill may change regulatory programs and policies that will have a broad and serious effect on industry.

The Senate approved a measure in May that raises fees to cover a broader spectrum of FDA preapproval and postapproval activities. The House is expected to approve its version this month. The Senate bill also enables FDA to require more information about drug safety and more disclosure of clinical-trial activities and research results. In reauthorizing programs to encourage pediatric studies of new and approved drugs, the bill reduces the added exclusivity from six months to three months for drugs that reach "blockbuster" status based on sales. One unresolved issue is whether Congress will authorize FDA to approve applications for follow-on or "similar" biopharmaceuticals, a subject that has generated considerable controversy.


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