Food and Drug Administration Reporting Standards for Marketed Drugs and Biological Products

FOOD AND DRUG ADMINISTRATION REPORTING STANDARDS FOR MARKETED DRUGS AND BIOLOGICAL PRODUCTS

Collection, Review and Recordkeeping of Adverse Product Experience Information

Three separate regulatory provisions govern the review and reporting of safety information related to marketed drugs and biologics. Separate provi-sions govern the review and reporting of (1) drugs marketed pursuant to a New Drug Application (NDA) or an Abbreviated NDA (ANDA), (2) biological prod-ucts and (3) drugs that are lawfully marketed with-out an approved NDA (21 C.F.R. §§ 314.80, 314.98, 600.80, and 310.305), respectively. Only sponsors of an approved application or biologics license are required to report safety information to the FDA. Physicians and other healthcare professionals have no legal obligation to report safety information to the manufacturer, to the sponsor or to the FDA.

As with investigational drugs, any applicant or licensed manufacturer holding an approved appli-cation or a biologic license must promptly review all adverse experience information pertaining to its product (21 C.F.R. §§ 314.80(b), 314.98, 600.80(b)). This requirement covers information obtained or received from any foreign or domestic source, includ-ing information derived from commercial market-ing experience, post-marketing clinical investigations, post-marketing epidemiological/surveillance studies, reports in the scientific literature and unpublished scientific papers (Id.). Prescription drug products marketed for human use without an approved drug application must meet these requirements as well (21 C.F.R. § 310.305).

Applicants or licensed manufacturers also must establish and follow written procedures for the surveil-lance, receipt, evaluation and reporting of post-marketing adverse product experiences (21 C.F.R. 310.305(a), 314.80(b), 314.98, 600.80(b)). The regulations require applicants or licensed manu-facturers to retain records of all adverse product experiences, including raw data and any related corre-spondence, for 10 years (21 C.F.R. §§ 310.305(f), 314.80(i), 314.98, 600.80(i)).

Although licensed biological products are gener-ally covered by these standards (21 C.F.R. 600.80), there are some product-specific differences. Licensed blood and blood components (21 C.F.R. § 606.3(c)) are exempt from these requirements. Instead, adverse reaction records for these types of products must be retained and made available to the FDA upon request (21 C.F.R. § 606.170(a)). Any fatal ‘complication of blood collection or transfusion’ must be communi-cated to the FDA as soon as possible, followed by a written report within 7 days (21 C.F.R. § 606.170(b)).

Vaccines must comply with the requirements of 21 C.F.R. § 600.80 as set forth below. In addi-tion, certain childhood vaccines are also regulated under the National Childhood Vaccine Injury Act (NCVIA) of 1986 (section 2125 of the PHSA) (42 U.S. § 300aa-25). This law requires certain vaccine manufacturers and healthcare providers who admin-ister such vaccines to make reports to a separate programme known as the ‘Vaccine Adverse Event Reporting System’ (VAERS). The VAERS programme is co-administered by FDA and the Centers for Disease Control (CDC), which is a separate unit of the federal Department of Health and Human Services. If a vaccine falls under the jurisdiction of NCVIA, then any adverse event is to be reported only to the VAERS programme. Nonetheless, these manufacturers must meet the other requirements of 21 C.F.R. § 600.80.