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to deter-mine, among other things, whether the drug should be withdrawn from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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