Only Half of Post-Marketing Commitments Get Published in Peer-Reviewed Journals, Study Shows
Concern about clinical trial transparency, or more accurately the lack of transparency, is an ongoing problem. A new report shows that the lack of transparency also extends to post-marketing commitments that companies agreed to, following regulatory approval of a drug.
On Monday, a study published in BMC Medicine showed that only about half of all post-marketing commitments agreed to between the U.S. Food and Drug Administration (FDA) and drug manufacturers are published in peer-reviewed journals. A post-marketing commitment is not the same as a post-marketing requirement. The requirements are mandated by the FDA as a condition of approval, while post-marketing commitments are agreed to by drug developers but are not mandated by statute or regulation. It’s those commitments that are lacking in transparency, the report shows.
The study, which was first reported by Regulatory Focus, the Regulatory Affairs Professionals Society publication, noted that many of the post-marketing commitments under the 506B of the Federal Food, Drug and Cosmetic Act were not up to date or were insufficient. The study showed that nearly half of post-marketing commitments subject to mandatory reporting requirements under Section 506B did not have a clear up-to-date progress reported publicly in FDA sources. The study, as reported by Regulatory Focus, showed that of the studies subject to reporting requirements, only 12, or 44%, were “neither closed nor had an up-to-date status in publicly available databases on FDA’s website.”
The majority of the trials were posted on ClinicalTrials.gov but only half had corresponding publications in peer-reviewed journals, the researchers said. Also, the researchers noted that some of the post-marketing publications were insufficient. In the study, the researchers said that among the 33 post-marketing commitments for new clinical trials, “the median number of words used to describe the study in publicly available documents was 42, thus providing limited information.”
The study, which was conducted by researchers from various universities across the United States, examined drug approvals between 2009 and 2012. During that time frame, there were 110 new drugs approved. The majority of the trials had at least one post-marketing requirement. Of the 55 trials that required post-marketing studies, 33 of those required new clinical trials. The majority of those 33 drugs, 27, were required to be reported under the Section 506B rules, the study showed.
“Opportunities may exist for FDA and pharmaceutical companies to work together to identify additional post-marketing commitments that support FDA’s lifecycle evaluation process by generating information about the safety, efficacy or optimal use of drugs and biologics in patients,” the researchers said in the conclusion of the study. “Additional post-marketing commitments for clinical trials can help generate data that ensures that patients and physicians have better information to guide clinical decisions, beyond addressing issues typically examined by post-marketing requirements.”