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. 2019 Jun 17;17(1):117.
doi: 10.1186/s12916-019-1344-3.

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

Joshua D Wallach  1   2   3 , Anita T Luxkaranayagam  4   5 , Sanket S Dhruva  6   7 , Jennifer E Miller  8 , Joseph S Ross  4   8   9   10
Affiliations

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

Joshua D Wallach et al. BMC Med. .

Abstract

Background: Postmarketing commitments are clinical studies that pharmaceutical companies agree to conduct at the time of FDA approval, but which are not required by statute or regulation. As FDA increasingly adopts a lifecycle evaluation process, greater emphasis will be placed on postmarket evidence as a component of therapeutic evaluation. Therefore, the objectives of this study were to determine how often postmarketing commitments agreed upon by pharmaceutical companies at first FDA approval lead to new clinical trials and to establish the characteristics and rates of completion and dissemination of postmarketing commitments.

Methods: For new drugs and biologics approved in 2009-2012, we used public FDA documents, ClinicalTrials.gov, and Scopus, to determine postmarketing commitments and their characteristics known at the time of FDA approval; number subject to reporting requirements, for which FDA is required to make study status information available to the public ("506B studies"), and their statuses; and rates of registration and results reporting on ClinicalTrials.gov and publication in peer-reviewed journals for all clinical trials.

Results: Among 110 novel drugs and biologics approved by the FDA between 2009 and 2012, 61 (55.5%) had at least one postmarketing commitment at the time of first approval. Of 331 total postmarketing commitments, 33 (10.0%) were for new clinical trials; 27 of these were 506B studies subject to public reporting requirements, of which 12 (44.4%) did not have a recent (i.e., up-to-date) or closed (i.e., fulfilled or released) status provided publicly by the FDA. Although two postmarketing commitments were insufficiently described in FDA records to perform searches on ClinicalTrials.gov, nearly all (28, 90.3%) of the 31 remaining postmarketing commitments for new clinical trials were registered on ClinicalTrials.gov. Among the registered trials, 23 (23 of 28, 82.1%) were classified as completed or terminated, of which 22 (95.7%) had reported results. When considering all 29 completed or terminated clinical trials, registered or unregistered on ClinicalTrials.gov, only half (14, 48.3%) were published in peer-reviewed journals.

Conclusions: While only 15% of postmarketing commitments agreed to by pharmaceutical companies at the time of FDA approval were for new clinical trials, these trials were nearly always registered with reported results on ClinicalTrials.gov. However, only half were published, and despite FDA public reporting requirements, recent status information was often unavailable for 506B studies.

Keywords: FDA; Lifecycle evaluation; Pharmaceutical regulation; Postmarketing commitments; Postmarketing requirements.

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Conflict of interest statement

In the past 36 months, JDW received research support through the Meta Research Innovation Center at Stanford (METRICS) from the Laura and John Arnold Foundation. JSR received research support through Yale from Johnson and Johnson to develop methods of clinical trial data sharing, from Medtronic, Inc. and the Food and Drug Administration (FDA) to develop methods for postmarket surveillance of medical devices (U01FD004585), from the Centers of Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting, from the FDA to establish a Center for Excellence in Regulatory Science and Innovation (CERSI) at Yale University and the Mayo Clinic (U01FD005938), from the Blue Cross Blue Shield Association to better understand medical technology evaluation, and from the Agency for Healthcare Research and Quality (R01HS022882). SSD receives support as a Scholar in the Yale University/Mayo Clinic FDA CERSI. JEM and JSR receive funding from the Laura and John Arnold Foundation in connection with the Good Pharma Scorecard.

Figures

Fig. 1
Fig. 1
Postmarketing requirements and postmarketing commitments for 110 new drugs and biologics approved by the US Food and Drug Administration between 2009 and 2012
See this image and copyright information in PMC

References

    1. Wallach JD, Ross JS, Naci H. The US Food and Drug Administration’s expedited approval programs: addressing premarket flexibility with enhanced postmarket evidence generation. Clin Trials. 2018;15(3):243–246. doi: 10.1177/1740774518770657. - DOI - PubMed
    1. Psaty BM, Meslin EM, Breckenridge A. A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report. JAMA. 2012;307(23):2491–2492. doi: 10.1001/jama.2012.5545. - DOI - PubMed
    1. U.S. Food and Drug Administration (FDA). Guidance for Industry: Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act. April 2011. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat.... Accessed 10 Nov 2017.
    1. U.S. Food and Drug Administration (FDA). Postmarketing Requirements and Commitments: Introduction. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-m.... Updated January 12, 2016. Accessed 10 Mar 2017.
    1. Department of Health and Human Services Office of Inspector General. June 2006. FDA’s Monitoring of Postmarketing Study Commitments. https://oig.hhs.gov/oei/reports/oei-01-04-00390.pdf. Accessed 10 Sept 2018.

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