Enforcement

Generally the FDA evaluates compliance with these safety reporting standards through inspections of manufacturers, sponsors, and clinical investigators and relevant records maintained by each entity. FDCA § 704; 21 U.S.C. § 374; PHSA § 351(c); 42 U.S.C. § 262(c). Under the law, it is a prohibited act to fail to "... establish or maintain any record, or make any report, required under section ... 505(i) or (k) ... or the refusal to permit access to or verification or copying of any such required record.'' FDCA § 301(e); 21 U.S.C. § 331(e). Committing this prohibited act or causing someone else to do so, makes the manufacturer, sponsor (including any culpable individuals) and clinical investigators liable either under the civil or criminal penalties of the FDCA and the PHSA. FDCA § 303(a); 21 U.S.C. § 333(a); PHSA § 351; 42 U.S.C. § 262.

If the FDA determines that anyone is either not submitting required safety information, submitting false information or otherwise not in compliance with the applicable laws and regulations, then there are generally several enforcement steps that the FDA will take, although they are not required to take them sequentially. The first would be to send the entity or person a Warning Letter which briefly describes what the FDA investigation has found and concludes that the conduct violates one or more provisions of the law. The FDA asks for prompt action to correct the conduct described by the FDA. The agency routinely states that if prompt action is not taken, then further regulatory action by the FDA may result. In most such letters, the FDA identifies product seizure, FDCA § 304; 21 U.S.C. § 334, or injunction, FDCA § 302; 21 U.S.C. § 332, as two possible actions that could be taken without further warning. In the decade of the 1990s, there were a dozen or more Warning

Letters issued on this topic by the FDA. In virtually every instance, the entity or person took the necessary corrective action to ensure future compliance with the safety reporting standards. These Warning Letters are available on the FDA Website at http://www.fda.gov/foi/ warning.htm. In addition, if a manufacturer does not comply with its safety reporting obligations, then the FDA may revoke an approved NDA for a drug (21 C.F.R. § 314.150(b)(1)) or the approved license for a biological product (21 C.F.R. § 601.5(b)(iv)).

Another serious step that could occur, even if the recipient of the letter corrects the actions that the FDA objects to, is the initiation of a criminal prosecution. Violations of the FDCA subject any culpable entity or individual to both misdemeanor and felony criminal convictions that can involve substantial fines and prison sentences. If there are records kept or submitted which are knowingly false and they are material to the FDA's compliance assessment, then there are also potential violations of several provisions of the general federal criminal code, including the False Statements Act. 18 U.S.C. § 1001. Such criminal violations are felony violations with substantial monetary penalties and jail sentences. In the late 1980s, the FDA brought several criminal prosecutions against pharmaceutical companies for violations of pharmacovigilance reporting laws and regulations.

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