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FDA - Monitoring Postmarketing Study Commitments
FDA requires all new drugs that are likely to be used in pediatric patients to demonstrate, prior to approval, their safety and efficacy in relevant pediatric populations. However, FDA may defer this requirement until after the drug is approved for use in adults. When FDA grants a deferral, it requires the applicant to conduct postmarketing studies to demonstrate the safety and efficacy of the drug in pediatric participants. If the applicant fails to conduct such studies, FDA may consider the drug misbranded and may authorize an injunction, seizure, or other action. See: Pediatric Research Equity Act of 2003; 21 CFR § 314.55; 21 U.S.C. §§ 331-334; and 63 Federal Register 66,631, December 2, 1998, Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients.
* Animal efficacy rule.
FDA may approve a drug based solely on animal studies when clinical studies in humans cannot be conducted ethically. Under these circumstances, FDA requires the applicant to conduct postmarketing studies to verify and assess the safety and efficacy of the drug in humans. If the applicant fails to perform the studies with due diligence, FDA may withdraw the drug. See 21 CFR § 314.610 and 21 CFR § 314.620.
* Determination to revoke approval.
FDA may require an applicant to conduct a postmarketing study after the drug is already approved if information is needed to determine whether the approval of the drug should be revoked. This is typically used for cases in which there is a serious concern about safety. (FDA does not track these situations in its database of postmarketing study commitments.) See 21 U.S.C. §§ 355(e) and 355(k).
[9] 21 U.S.C. § 356b.
[10] Department of Health & Human Services, Food and Drug Administration, “Report to Congress on Postmarketing Studies (FDAMA 130),” April 2002.
[11] 21 U.S.C. § 356b.
[12] Prior to FDAMA, drug applicants were required to report on postmarketing studies. 21 CFR § 314.81. However, Section 130(a) of Title I of FDAMA
(1) requires applicants to provide more detailed information on the status of their commitments and
(2) made certain information publicly available.
[13] 65 Federal Register 64,607, October 30, 2000, Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports.
[14] 21 CFR § 314.81(b)(2)(vii).
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