Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance
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Introduction and Objective
Adverse event reports from industry-sponsored programs, such as patient support programs, have contributed to a rise in the number of individual case safety reports in the US Food and Drug Administration Adverse Event Reporting System database. This study aimed to characterize individual case safety reports from industry-sponsored program and non-industry-sponsored program sources and compare their usefulness in safety signal detection.
Individual case safety reports of six drug and biological products were identified in the Food and Drug Administration Adverse Event Reporting System database between the date of Food and Drug Administration product approval and the first quarter of 2017. A random subset of industry-sponsored program and non-industry-sponsored program individual case safety reports were then compared to identify differences in reporters, outcomes, data completeness, and usefulness. The ‘usefulness’ of individual case safety reports was assessed by manually reviewing the availability of key information in the narrative (e.g., temporality, comorbidities).
Compared with non-industry-sponsored program reports, more industry-sponsored program reports were associated with a serious outcome (51.4% vs. 58.8%, p = 0.02) and were reported by consumers (35.5% vs. 50.4%, p < 0.01). Industry-sponsored program reports tended to contain more data elements than non-industry-sponsored program reports (i.e., age, sex, indication for use), but completeness was variable across products. No significant difference in usefulness was identified between non-industry-sponsored program and industry-sponsored program individual case safety reports (30.6% vs. 28.5%, p = 0.42). Useful reports that contained at least one serious, unlabeled adverse event represented only 4% and 6.2% of the non-industry-sponsored program and industry-sponsored program report cohorts, respectively.
Our study suggests that reports obtained from industry-sponsored programs in the Food and Drug Administration Adverse Event Reporting System database contain more data elements but are similar to non-industry-sponsored program reports with regard to ‘usefulness’ in signal detection.
The authors acknowledge Anhtu Nguyen, Yueqin Zhao, and Rima Izem for their assistance with the design of this study and the four manufacturers for their contribution to this study.
LH and DK wrote the manuscript; DK, LH, CK, MM, EW, and GDP designed the research and contributed to the data collection and manual review of the data sources; DK, MM, and LH analyzed the data; and all authors contributed edits to the manuscript.
Compliance with Ethical Standards
No sources of funding were used to assist in the preparation of this study.
Conflict of interest
Dipti Kalra, Lisa Harinstein, Cindy M. Kortepeter, Monica A. Muñoz, Eileen Wu, and Gerald J. Dal Pan have no conflicts of interest that are directly relevant to the contents of this article. The views expressed are those of the authors and do not necessarily represent the position of, nor imply endorsement from, the US Food and Drug Administration or the US Government.
This study was granted an exemption for review by the US Food and Drug Administration Institutional Review Board.
Consent to Participate
For this type of study, formal consent is not required. The study did not meet the definition of a clinical trial.
- 1.US Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) public dashboard. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm. Accessed 20 May 2018.
- 3.US Food and Drug Administration. The guidance for industry: postmarketing safety reporting for human drug and biological products including vaccines. https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. Accessed 22 Nov 2018.
- 4.International Conference on Harmonisation (ICH). Post-approval safety data management: definitions and standards for expedited reporting E2D. 2003. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_Guideline.pdf. Accessed 1 May 2018.
- 5.US Food and Drug Administration. The guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment. https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. Accessed 22 Nov 2018.
- 6.International Conference on Harmonisation (ICH). Maintenance of the ICH guidelines on clinical safety data management: data elements for transmission of individual case safety reports E2B(R2). http://www.ich.org/products/electronic-standards.html. Accessed 22 Nov 2018.
- 7.Electronic Code of Federal Regulations. Title 21: Food and Drugs Part 314. https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl. Accessed 21 July 2017.