Enforcement

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Chapter: Pharmacovigilance: Legal Basis - United States

Generally, the FDA evaluates compliance with these safety reporting standards through inspections of manufacturers, sponsors and clinical investigators and of relevant records maintained by such entities.


ENFORCEMENT

Generally, the FDA evaluates compliance with these safety reporting standards through inspections of manufacturers, sponsors and clinical investigators and of relevant records maintained by such entities (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 [to refuse] to permit access to or verification or copy-ing of any such required record’ (FDCA § 301(e); 21 U.S.C. § 331(e)). By committing this prohibited act or causing someone else to do so, a manufacturer, sponsor (including any culpable individuals) or clini-cal investigator may be found liable under either the civil or the criminal penalties of the FDCA and the PHSA (FDCA § 303(a); 21 U.S.C. § 333(a); PHSA § 351; 42 U.S.C. § 262).

Food and Drug Administration has several enforce-ment steps that can be taken if the agency deter-mines that an entity or individual is not submitting required safety information, is submitting false infor-mation or is otherwise not in compliance with the applicable laws and regulations. Generally, the first step is to send the entity or individual a warning letter briefly describing what the FDA investigation has found and concluding that the conduct violates one or more provisions of the law. The FDA will ask for prompt action to correct the conduct described by the agency and will usually note that if prompt action is not taken, then further regulatory action may result. In most such letters, the FDA identifies product seizure (FDCA § 304; 21 U.S.C. § 334) and/or injunc-tion (FDCA § 302; 21 U.S.C. § 332) as two possible actions that could be taken without further warning. Since the early 1990s, FDA has issued more than a dozen warning letters in the area of safety reporting. In virtually every instance, the entity or person subse-quently took the necessary corrective action to ensure future compliance with safety reporting standards. These warning letters are available on the FDA website.

Food and Drug Administration may also revoke an approved NDA for a drug or the approved license for a biological product if a manufacturer does not comply with its safety reporting obligations (21 C.F.R. §§ 314.150(b)(1), 601.5(b)(iv)).

In addition, FDA can initiate a criminal prosecu-tion, regardless of whether the agency has sent a warn-ing letter or whether the recipient has implemented corrective action. Violations of the FDCA subject any culpable entity or individual to both misdemeanour and felony criminal convictions that can involve substan-tial fines and prison sentences. If records are kept or submitted that are knowingly false and they are material to the FDA’s compliance assessment, then the entity or individual may also be in violation of several provisions of the general federal criminal code, including the False Statements Act (18 U.S.C. § 1001). Such criminal violations are felonies with substan-tial monetary penalties and jail sentences. In the late 1980s, the FDA brought several criminal prosecu-tions against pharmaceutical companies for violations of pharmacovigilance reporting laws and regulations.

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