Collection, Review, and Recordkeeping of Adverse Product Experience Information
There are three separate regulatory provisions governing the review and reporting of safety information related to marketed drugs and biolo-gics. Separate provisions govern the review and reporting of (1) drugs marketed pursuant to a New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA), (2) biological products, and (3) drugs that are lawfully marketed without an approved NDA. 21 C.F.R. §§ 314.80, 314.98, 600.80, 310.305, respectively. Physicians or other healthcare professionals have no legal obligation to report safety information to either the manufacturer, sponsor or FDA.
As with investigational drugs, any applicant or licensed manufacturer having an approved application or a biologics license must promptly review all adverse product experience information regarding 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, including information derived from commercial marketing experience, post-marketing clinical investigations, postmarketing epidemiological/surveillance studies, reports in the scientific literature, and unpublished scientific papers.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 the same requirements as well. 21 C.F.R. § 310.305.
Applicants or licensed manufacturers also must establish and follow written procedures for the surveillance, 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 manufacturers to retain records of all adverse product experiences, including raw data and any related correspondence, for 10 years. 21 C.F.R. §§ 310.305(f), 314.80(i), 314.98, 600.80(i).
While licensed biological products are generally covered by these standards (21 C.F.R. 600.80), there are some product-specific differences. Licensed blood and blood components (as defined in 21 C.F.R. § 606.3(c)) are exempt from these requirements. Rather, these products must keep adverse reactions records and make those available to the FDA upon request. 21 C.F.R. § 606.170(a). With regard to a "complication of blood collection or transfusion" that is fatal, this information must be communicated to the FDA as soon as possible, followed by a written report within seven days. 21 C.F.R. § 606.170(b). With regard to vaccines, such products must comply with the requirements of 21 C.F.R. § 600.80 as set forth below. In addition, certain childhood vaccines are also regulated by the National Childhood Vaccine Injury Act of 1986 (NCVIA) (Section 2125 of the PHSA). 42 U.S. § 300aa-25. This law requires manufacturers of certain vaccines and healthcare providers who administer such vaccines to report to a separate reporting system known as the Vaccine Adverse Event Reporting System (VAERS). This VAERS program is coadministered 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 program. These manufacturers must meet the other requirements of 21 C.F.R. § 600.80.
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