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FDA Releases the Status of Post-Market Studies
(Thursday, April 25, 2024) Recently, accelerated approval of drugs and other expedited approval programs have been questioned widely since they rely on limited pre-market evidence for approval and extended post-market commitments. It has been speculated that companies may not meet their post-market commitments in a timely fashion, if at all, and that the FDA may not enforce the post-market requirements. FDA’s annual report on the status of the post-market requirements (PMR) and post-market commitments (PMC) says otherwise. Expedited approval programs have become an invaluable tool to get life-saving drugs and biologics to patients quickly. The basic premise of any expedited approval program is to evaluate the most critical aspects of the safety and effectiveness of a new product in the pre-market clinical trials and defer less critical clinical and non-clinical questions to the post-market life of the product where the product testing is done in parallel to its commercial availability. By reducing the pre-market requirements, you can expedite the commercial availability of the product thereby helping the patients and also incentivizing the developers to do the studies they might not be able to do otherwise. The developers make a commitment to the FDA on the timeline for the PMR/PMCs. A key element of PMR or PMC is that if these studies provide negative information about the approved product, the product must be taken off the market. The doubters have been concerned that manufacturers have a commercial conflict of interest to delay their PMR/PMC. FDA’s annual report on the status of PMR/PMC shows that 93% of the manufacturers provided annual updates on the status of the PMR/PMC, a vast majority of whom (83%) were on time. More than 78% of the manufacturers were on the FDA-agreed schedule for PMCs and 70% for the PMRs. The manufacturers with accelerated approval were on time 80% of the time. The pediatric post-market studies had the highest rate of delay with only 24% being on schedule but in many of those cases, according to the FDA, “initiation of these studies may be deferred until additional safety information from other studies has first been submitted and reviewed before beginning the studies in pediatric populations”. The report should address the main critique of the accelerated program. Each year, the FDA establishes about 295 PMRs and 77 PMCs, of which almost all are met within 3-5 years of the FDA approval. The FDA report concludes that the FDA is satisfied with these numbers and, by extrapolation, so should be us. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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