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Chapter: Pharmacovigilance: Legal Basis - United States

The specific law that governs pharmacovigilance requirements in the United States for drugs is section 505 of the FDCA (21 U.S.C. § 355).


LAW

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 author-ity 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)). Biological products are regu-lated as drugs during the investigational stage; as such, this provision forms the legal basis for safety reporting for biological products as well (21 C.F.R. § 312.2(a);601.21). The details of what must be reported are set forth in the regulations and guidance documents discussed below.

For approved drugs, the basis in law for pharma-coviligance 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or by order with respect to such application, prescribe’ to deter-mine, among other things, whether the drug should be withdrawn from the market due to safety concerns.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 reports. It is the regulations and guidance, 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 to ‘insure the contin-ued 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 gath-ers 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, it is the underlying statute that provides the general legal authority to require pharmacovigilance activities for biological products, whereas the specific standards are set forth in the regulations and guidance documents discussed below.

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