Gottlieb calls out Perrigo for missed postmarket study deadline
- Food and Drug Administration head Scott Gottlieb is taking a page from President Donald Trump's playbook and turning to Twitter to warn drugmakers that the agency will take action if required postmarketing studies aren't carried out on time.
- Gottlieb specifically singled out a subsidiary of Perrigo, which missed a deadline for compliance with a postmarketing requirement for a cardiovascular outcomes study to assess the heart risk of the company's testosterone replacement therapy.
- "Postmarketing studies are important, providing additional evaluation after a drug is approved. A company is responsible for adhering to the timetable for completing postmarketing studies, and the #FDA is prepared to take action when companies fail to comply," Gottlieb wrote on Twitter.
The FDA can require drug companies to complete postmarketing trials, or studies conducted post-approval, for a number of reasons, including to assess associated drug risks.
In Perrigo's case, the generics maker did not meet a milestone date for final submission of study protocol for the required cardiovascular study.
1/3 We’ve advised Perrigo that it failed to comply with #FDA postmarketing requirements for a study intended to determine the cardiovascular effects of testosterone replacement therapy product, Testosterone Gel, by the agreed upon deadline. https://t.co/BbRZNp3h1E pic.twitter.com/ZmrRZox1hF— Scott Gottlieb, M.D. (@SGottliebFDA) June 22, 2018
Over three years ago, the FDA issued letters to all companies that produced testosterone replacement therapies, indicating that a clinical study would be required to evaluate the risk of major heart events in men taking the drugs.
Then, last fall, regulators were informed that Perrigo had decided not to join a consortium that planned to conduct the needed study.
According to the FDA's letter, Perrigo argued that joining the consortium would place an undue financial burden on the company, as would conducting the study independently. Perrigo also claimed that it would not need to comply with the postmarketing requirements because its testosterone gel is equivalent to a generic.
The FDA didn't buy that argument, however, writing the company remains subject to the requirement and that, under the Federal Food, Drug, and Cosmetic Act, its product is considered misbranded.
Perrigo could not be reached for comment before publication.
While it's not clear if the FDA will take further action against Perrigo, Gottlieb warned as much on Twitter for those companies that don't comply.
Overall, he said, the majority of postmarketing requirements and commitments are on schedule. In addition to safety concerns, such requirements can be used in the cases of an accelerated approval.
Typically, when drugs are approved based on early signs of efficacy, the FDA requires further confirmatory studies to more fully assess patient outcomes.
Since taking office, Gottlieb has placed an emphasis on the agency's flexibility, seeking to boost generic drug competition as well as help drugmakers reach markets sooner.
For those worried about whether drugmakers will actually complete those studies, Gottlieb's tweets could offer some mild reassurance.
"FDA remains committed to making sure industry fulfills their PMRs in a timely manner and that studies are transparent to the public," Gottlieb wrote.
- Food and Drug Administration Untitled letter to Perrigo Israel Pharmaceuticals Ltd.
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