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Posted 29 June 2018 | By Michael Mezher
The US Food and Drug Administration (FDA) has sent an untitled letter to drugmaker Perrigo for failing to meet milestones in a required postmarketing study for its testosterone gel product intended for testosterone replacement therapy (TRT) in men.
In an unusual move, FDA Commissioner Scott Gottlieb took to Twitter to admonish the company and emphasize the agency's intent to enforce compliance with postmarketing requirements.
"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," he said.
Gottlieb also noted that the majority of postmarketing requirements and postmarketing commitments are progressing, or have been completed, on the agreed upon schedule.
In 2015, FDA required Perrigo and other drugmakers who market TRT products to conduct postmarketing studies to evaluate the risk of major adverse cardiovascular events (MACE) with those products.
However, FDA says that it learned that Perrigo had decided not to participate in a consortium study with other drugmakers marketing TRT products and had not sought to meet the postmarketing requirement on its own. According to FDA, final protocol submission for the study was due in June 2016.
After notifying Perrigo of its failure to meet the protocol submission deadline, FDA says the company instead requested the agency waive the study requirement, arguing that joining the TRT consortium or conducting the study on its own "would pose an undue financial burden".
Perrigo also argued that because its testosterone gel is an AB-rated product, it is equivalent to a generic and thus should not be beholden to postmarketing requirements despite being approved via a new drug application (NDA) under the 505(b)(2) pathway.
However, FDA says that Perrigo is subject to the postmarketing requirement as such requirements apply to NDAs approved under section 505(b) and that the company failed to show good cause for missing the milestone.
As a result, FDA says it considers the postmarketing requirement to be delayed the product to be misbranded under the Food, Drug, and Cosmetic Act.