FDA Needs More Postmarket Commitment Authority: Study

Researchers from Harvard and Yale Universities and Kaiser Permanente say that among postmarket requirements and postmarket commitments issued to new FDA-approved drugs between 2013 and 2016, about 75% of those due by 2020 were not submitted on time. Writing in a JAMA Internal Medicine Research Letter, the researchers say the frequency and degree of lateness varied by reporting authority and study characteristics.

“Delays in delivering needed postapproval safety and efficacy information for novel drugs have implications for patient care, particularly for unresolved clinical questions and populations excluded from preapproval trials,” the report concludes. “To address this problem, Congress should consider providing FDA with more authority, such as the ability to institute automatic civil monetary penalties when pharmaceutical manufacturers do not fulfill their requirements and commitments on time.”