The specific law that governs pharmacovigilance requirements in the United States for drugs is section 505 of the FDCA. 21 U.S.C. § 355. Section 505(i) of that law gives the FDA the authority to regulate investigational drugs. As part of that authority the FDA must, by regulation, require ''the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such drug ... as the Secretary finds will enable him to evaluate the safety and effectiveness of such drug in the event of the filing of an application ... '' 21 U.S.C. § 355(i)(1)(C). As discussed above, biological products are regulated as drugs during the investigational stage and therefore this is the legal basis for safety reporting for biological products as well. 21 C.F.R. § 312.2(a); § 601.21. The specifics of what must be reported are set forth in the regulations and guidances discussed below.
For approved drugs, the basis in law for pharmacoviligance is section 505(k) of the FDCA. 21 U.S.C. § 355(k). That provision states, in part, for approved drugs that: '' ... the applicant shall establish and maintain such records, and make such reports to the Secretary, of data relating to clinical experience and other data or information, received or otherwise obtained ... as the Secretary may by general regulation, or by order with respect to such application, prescribe...'' in order to determine, among other things, whether the drug should be withdrawn from the market due to safety concerns. As with investigational drugs, the law merely gives the FDA the authority to require such records and make such reports, but it is the regulation and guidances, as discussed below, which set forth the specific standards.
For biological products approved under the PHSA, the FDA has been given the legal authority to set standards for such products that '' ... insure the continued safety, purity and potency of such products...'' 42 U.S.C. § 262(d). The standards, according to the law, must be set forth in regulations. The FDA gathers further legal support for these legal requirements from the drug misbranding provisions of the FDCA (21 U.S.C. §§ 352(a) and (f)(1)). As with drugs, there is a general legal authority to require pharmacovigilance activities for biological products but the specific standards, as discussed below, are set forth in regulations and guidances.
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