Report 6 of the Council on Scientific Affairs (A-05)

Enhanced Physician Access to Food and Drug Administration (FDA) Data

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Summary

Objective. To review the system for drug approval and postmarketing surveillance in the United States, its legal requirements, the type of information available to the Food and Drug Administration (FDA) and its public availability, and to recommend specific actions for enhancing the transparency of this process, particularly as it relates to the availability of clinically relevant information that affects risk/benefit decisions involving the use of prescription drug products.

Methods. The primary sources of information for this report are the laws, regulatory requirements, and interpretations thereof governing the drug approval process; namely, the federal Food, Drug, and Cosmetic (FD&C) Act and amendments; the corresponding FDA portion of the Code of Federal Regulations (Title 21), which interprets the FD&C Act and related statutes; and other relevant guidance documents generated by the FDA. Additionally, literature searches were conducted in the MEDLINE database for English-language articles published between 1995 and March 2005 using the search term drug in combination with approval, regulation, safety, and post-marketing surveillance to compile relevant opinions and ideas that have been suggested by others on how to improve the process of drug approval and safety assessment, particularly after drugs have been approved for marketing.

Results. An elaborate system of laws, regulations, and guidances governs the drug approval process in the United States. Pharmaceutical manufacturers, the FDA, and the end users (physicians and patients) all play essential roles in minimizing the risks and enhancing the benefits of prescription drug products. Currently, the FDA is prohibited from disclosing information about Investigational New Drugs (INDs) and New Drug Applications (NDAs) unless that information has already been publicized. In any event, most physicians have little interest in the content and information comprising IND and NDA applications. Nevertheless, a considerable amount of clinical data and documentation related to premarket assessments and the FDA review and approval of new drugs is publicly available. Although the FDA has improved the efficiency of the drug review process, similar improvements in postmarketing surveillance have not occurred. Recently, a series of high-profile developments (drug withdrawals; use of antidepressants in children; concerns about the cardiovascular toxicity of COX-2 inhibitors) have directed attention to a knowledge gap between important clinical research data available to the FDA and what is generally available to physicians and the public. This has occurred against a backdrop of increased direct-to-consumer advertising and targeted promotional efforts, especially during the early phase of new product availability, that contributes to a surge of patient exposure in the absence of comprehensive safety information.

Conclusion. Several steps can be taken immediately to improve drug safety and reduce the knowledge gap between the FDA and physicians about the risks and benefits of certain drug products. Chief among these are steps to establish a more transparent process with respect to clinical research data obtained by the FDA. This process can be enhanced by the development of a comprehensive clinical trial registry, creation of an independent drug safety board within the FDA, better risk communication for marketed products, the use of more active and directed postmarketing surveillance activities, and conducting mandatory postmarketing studies where needed.

RECOMMENDATIONS

The following statements, recommended by the Council on Scientific Affairs, were adopted by the AMA House of Delegates as AMA directives at the 2005 AMA Annual Meeting:

The AMA:

1. Urges the Food and Drug Administration (FDA) to issue a final rule, as soon as possible, implementing modifications to the format and content of the prescription drug package insert with the goal of making the information more useful and user-friendly to physicians. (Directive)
2. Urges the FDA to collaborate with physician organizations to develop better risk communication vehicles and approaches. (Directive)
3. Urges the FDA to apply new tools to gather data after drugs are approved for marketing, including a broader use of targeted post-approval studies, institution of active and sentinel event surveillance, and data mining of available drug utilization databases. (Directive)
4. Will monitor the design and implementation of any independent drug safety board that may be instituted within the FDA, or external to the agency, and respond as appropriate. (Directive)
5. Supports adequate funding to implement an improved FDA postmarketing prescription drug surveillance program. (Directive)

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