Researchers Suggest Changes to Shorten Postmarketing Requirement Timelines
A new study from researchers at Yale and Dartmouth published in the Journal of General Internal Medicine finds that drugmakers often take much longer to complete US Food and Drug Administration (FDA) mandated postmarketing requirements (PMRs) than expected based on completion timelines listed on ClinicalTrials.gov.The authors argue that both FDA and drugmakers should “consider strategies to shorten times allotted for PMR milestones,” and suggest that PMRs could be identified earlier in the review process to reduce the time between approval and PMR protocol submission.
Background
FDA has the authority to require sponsors to complete PMRs as a condition of accelerated approval and under the Pediatric Research Equity Act (PREA) and Food and Drug Administration Amendments Act. The agency can also mandate PRMs for drugs approved under the animal efficacy rule, though very few products are approved via this pathway.
However, as more of the evidence generated for new drugs and biologics has shifted to the postmarket phase, concerns have been raised over drugmakers’ timeliness in completing postmarketing studies, though FDA’s own reporting shows that most PMRs progress on schedule.
Study
To determine the timeliness of PMRs, the authors of the paper looked at PMRs for all 110 new drugs and biologics approved from 2009-2012.
Of those, 66 products were approved for 73 indications with at least one PMR that met the authors inclusion criteria. In total, those products were required to complete 119 clinical PMR studies, 95 of which were clinical trials and 53 of which were pediatric studies required under PREA.
“Across PMR authorities, median times permitted by FDA for manufacturers to submit protocols for PMR clinical trials ranged from 3 to 15 months, while median times allowed for study completion after protocol submissions were approximately 2-13-fold longer than that required for primary outcome ascertainment,” the authors write.
While time between approval and protocol submission was much higher for pediatric PMRs, the authors explain that this is likely due to FDA deferring such studies until more safety information is available from other studies.
The authors also found that PMRs for drugs with accelerated approval took the longest time from protocol submission to study completion, with a median of 72 months, or roughly two years longer than expected.
Study