Post-Marketing Commitments: FDA’s Revised Metric Paints Bleaker Picture
This article was originally published in The Pink Sheet Daily
Compliance rates for post-marketing requirement and commitment reporting drop when FDA takes annual reports into consideration.
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FDA’s John Jenkins disputes accusations that the pharmaceutical industry does not take post-marketing studies seriously and that the agency is lax on enforcement. According to updated data from FDA, Phase IV studies are being completed in a timely manner, Jenkins argues – and when they aren’t, the agency is taking action.
Cures 2.0 Would Mandate More FDA Centers of Excellence But Oncology-Style Funding Gaps Could Doom Plan
The two new intercenter institutes, one to focus on a common group of diseases and the other on rare diseases, appear to be unfunded mandates, which could hinder the agency’s ability to get them up and running.
The PASTEUR Act would delink some of an antibiotic’s revenue from prescription sales, with the goal of revitalizing the antibiotic pipeline with additional private investment while encouraging good public health stewardship of critically needed medicines.