The U.S. Food and Drug Administration: Drug Information Resource for Formulary Recommendations

BACKGROUND: The U.S. Food and Drug Administration (FDA) is the regulatory agency responsible for approving all pharmaceutical products marketed in the United States. While the FDA does not conduct research for developing pharmaceutical products, the agency does review all of the scientific evidence that a pharmaceutical sponsor submits and ensures that it demonstrates U.S. regulatory standards for the product and meets approval requirements. OBJECTIVES: To provide insights, for the managed care pharmacist, into the agency’s decision-making process and into the recommendations for appropriate usage and regulatory recommendations for risk mitigation by pharmaceutical sponsors. METHODS: The FDA website contains a vast amount of clinically useful and meaningful information. This review focused on specific topics within the website that can be useful for the managed care pharmacist, including the following: (a) the FDA’s review and evaluation of new drug applications (NDA), supplemental new drug applications (s-NDA), and biological new drug applications (BLA); (b) materials regarding a therapeutic product presented to a public FDA advisory committee meeting; and (c) the postmarket requirements and commitments database that provides information on the studies that a sponsor must conduct to maintain a product’s approval for marketing in the United States. RESULTS: This review examined the drug information contained on the FDA’s website and summarized the FDA’s medical and technical review, analysis and decision processes. Detailed drug information provided to the FDA by the pharmaceutical sponsor demonstrating a product’s efficacy and safety is publically available upon the product’s approval. CONCLUSIONS: For the managed care pharmacist involved with formulary review and recommendations, the FDA’s website contains information that is available to provide insight into the agency’s evaluation process and decision making for marketed pharmaceutical products. Use of these materials and understanding the regulatory context under which medical products are reviewed and approved may assist managed care pharmacists in making informed recommendations for use of the products within the context of their health systems.