hould the Food and Drug Administration have approved the Addyi pill for female sexual dysfunction?
The question has been asked repeatedly ever since the agency endorsed the drug last summer, following an orchestrated campaign that charged FDA officials were biased against such drugs for women while men had many options to combat impotence. The regulator was then criticized for approving the drug, despite safety concerns and data showing the pill was not very effective.
Now, the FDA has responded to its numerous critics, some of whom argued the agency lowered the bar by granting approval. But FDA officials did so in a rather understated fashion. Anyone who hoped the agency might have acknowledged missteps will be disappointed.
In a four-page essay published in The New England Journal of Medicine, a group of agency staffers recounted the unusual events surrounding the Addyi regulatory review and the ensuing controversies. And they did a nice — albeit, somewhat perfunctory — job of summarizing the many twists and turns.
The piece, however, did not offer a mea culpa or indicate that FDA officials have second thoughts about how the Addyi review was handled.
Instead, they mentioned how the drug was previously bounced by an FDA advisory committee – and the agency itself – in the past for poor showings in clinical trials. And they reviewed results of more recent clinical trial work, which continued to raise questions about effectiveness and side effects that could occur if Addyi is taken with some other drugs or mixed with alcohol.
The essay acknowledged there was debate about the extent to which medicines should be used to treat female sexual dysfunction. And the staffers made a point of stressing that the FDA ordered follow-up studies to resolve safety concerns and implemented a so-called risk program that requires physicians to undergo a brief certification before they are allowed to write prescriptions.
But about the only time the FDA staffers displayed anything other than clinical detachment was when they referred to “erroneous claims” the agency had approved more than 20 pills to help men with sexual problems. That campaign, by the way, was partly funded by Sprout Pharmaceuticals, which held the rights to the drug. (Sprout is now owned by Valeant Pharmaceuticals.)
In short, the essay is a helpful cheat sheet for anyone who missed the to-do.
The FDA has previously used NEJM as a forum to explain its views. Last year, for example, several agency staffers defended their decision to approve a drug known as Brisdelle to reduce hot flashes during menopause, even though an advisory panel recommended against such a move. And two months ago, FDA officials disclosed a request for drug makers to run new studies in testosterone-lowering drugs to resolve ongoing safety concerns.
As for Addyi, the agency staffers wrote how “robust” discussions are always held when drugs are reviewed for approval and that a variety of views — from inside and outside the FDA — were considered. The essay concludes with the notion that the FDA can take regulatory action if the additional study data suggests a need to rethink whether the drug is truly suitable. “This seems like a reasonable approach that balances safety and access,” they wrote.
Meanwhile, demand for the pill remains anemic. Through Nov. 27, a total of 689 prescriptions were written, up from 80 through the end of October, according to IMS Health, the market research firm. The poor showing is likely due to publicity over side effect concerns and a lack of consumer advertising, which Sprout volunteered not to run for 18 months.