Regulatory Impact of Selected U.S. FDA Postmarketing Safety Registries Conducted for Drugs Used to Treat Inflammatory or Autoimmune Conditions.

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  • Author(s): Guiriansoro Z;Guiriansoro Z; Oussova T; Oussova T; Weissfeld J; Weissfeld J
  • Source:
    Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2024 Dec; Vol. 33 (12), pp. e70034.
  • Publication Type:
    Journal Article; Research Support, U.S. Gov't, P.H.S.; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
  • Language:
    English
  • Additional Information
    • Source:
      Publisher: Wiley Country of Publication: England NLM ID: 9208369 Publication Model: Print Cited Medium: Internet ISSN: 1099-1557 (Electronic) Linking ISSN: 10538569 NLM ISO Abbreviation: Pharmacoepidemiol Drug Saf Subsets: MEDLINE
    • Publication Information:
      Original Publication: Chichester, West Sussex : Wiley, 1992-
    • Subject Terms:
      Registries* ; Product Surveillance, Postmarketing*/methods ; United States Food and Drug Administration*/legislation & jurisprudence ; Autoimmune Diseases*/drug therapy ; Drug Labeling*/legislation & jurisprudence ; Drug Labeling*/standards; Humans ; United States ; Pregnancy ; Inflammation/drug therapy ; Inflammation/chemically induced ; Adverse Drug Reaction Reporting Systems/legislation & jurisprudence ; Adverse Drug Reaction Reporting Systems/statistics & numerical data ; Female ; Drug-Related Side Effects and Adverse Reactions/epidemiology
    • Abstract:
      Purpose: Assess the regulatory impact of selected FDA postmarketing safety registries on drug product labeling updates.
      Methods: Postmarketing safety studies were identified in internal record repositories for the Center for Drug Evaluation and Research, U.S. FDA, in March and September 2021. Studies eligible for review included prospectively enrolling patient registry studies conducted to assess the safety of drug products used to treat inflammatory or autoimmune conditions. These studies were requested between 1999 and 2011.
      Results: This paper analyzed 10 safety (non-pregnancy) registries and four pregnancy registries (n = 14). Only four safety registry studies were successful in reaching their targets for both patient enrollment and patient follow-up or drug exposure. These registries were either multi-center, multinational studies or studies using participants from a health insurance or health maintenance organization. None of the safety registries led to safety labeling updates, regardless of targets' achievement for study enrollment and follow-up: six did not detect a new safety signal and four provided inconclusive results. Two pregnancy registries reached their targets for patient enrollment, and all four resulted in safety labeling updates, as required by the Pregnancy and Lactation Labeling Rule guidance.
      Conclusions: While six non-pregnancy registries did not detect a new safety signal, four did not produce safety results considered sufficiently robust to warrant specific regulatory action including safety-related labeling updates. The lack of safety signal detection in these observational studies should not imply the absence of safety signals. Appropriately designed, prospective, randomized controlled safety studies are the most reliable way to obtain interpretable safety data.
      (Published 2024. This article is a U.S. Government work and is in the public domain in the USA. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)
    • References:
      Am J Epidemiol. 2021 Jun 1;190(6):1159-1168. (PMID: 33423046)
      Drug Saf. 2004;27(4):215-28. (PMID: 15003034)
      JAMA. 2017 May 09;317(18):1854-1863. (PMID: 28492899)
      JAMA. 2018 Nov 27;320(20):2077-2078. (PMID: 30422300)
      Value Health. 2014 Nov;17(7):A445-6. (PMID: 27201205)
      Drug Saf. 2018 Jan;41(1):87-94. (PMID: 28840499)
      Pharmacoepidemiol Drug Saf. 2017 Feb;26(2):208-214. (PMID: 28028914)
      Drug Saf. 2022 Apr;45(4):305-318. (PMID: 35182362)
      BMC Med. 2019 Jun 17;17(1):117. (PMID: 31203816)
    • Grant Information:
      Oak Ridge Institute for Science and Education; U.S. Food and Drug Administration
    • Contributed Indexing:
      Keywords: labeling update; postmarketing safety registry; regulatory action
    • Publication Date:
      Date Created: 20241201 Date Completed: 20241201 Latest Revision: 20241201
    • Publication Date:
      20241204
    • Accession Number:
      PMC11609129
    • Accession Number:
      10.1002/pds.70034
    • Accession Number:
      39617731