- Generic drug approvals hit an all-time high in 2018 but, after the Food and Drug Administration waved through a noticeably low number in June, one Wall Street analyst worries the agency might be slowing down.
- With a few days left in June, the FDA has approved 37 generic drug applications, according an online database run by the regulator. That's less than half the monthly median of 80 approvals recorded over the nearly two years since the agency began operating under a new generic user fee agreement in October 2017.
- While cautioning that June's numbers are just one month's worth, Raymond James analyst Elliot Wilbur noted the downward slide "warrants careful scrutiny in the months ahead" and could hinder growth prospects for a fragile generic industry, he wrote Thursday in a note to clients.
The reasons behind the monthly dip are unclear, and the FDA did not immediately respond to questions from BioPharma Dive about the June total.
Low approval numbers may reflect agency struggles in dealing with an impurity issue among generic versions of angiotensin II receptor blocker medications, such as valsartan, said Wilbur.
While the agency has touted generic drug approvals as a way to boost market competition, the surge in regulatory OKs has also spurred new scrutiny.
In January, a series of stories published by Bloomberg raised questions on whether the agency could adequately monitor generic manufacturers in India and China, citing the valsartan recalls along with other problems.
But Wilbur sees reason for further worry if June's decline stems from Scott Gottlieb's exit as agency chief earlier this year.
"A more concerning possibility would be that with one of the agency's most vocal proponents, former FDA Commissioner Dr. Scott Gottlieb, now partaking in the fruits of the private sector, the agency has simply taken its foot off the accelerator with respect to pushing through more, as well as higher quality new generic approvals," Wilbur wrote.
To be sure, June's approval rate is similar to the first two months of 2018, which followed the agency's adoption of new impurity standards on Jan. 1, 2018.
Generic drugmakers have suffered in recent years as the copycat drug market turned south and government investigations heated up. Teva's stock has fallen 40% since the beginning of 2019, for example, while shares in Mylan have decreased by 32% over that time period.
With price declines common, ambitions for growing annual sales are now more dependent on new generic approvals, Wilbur wrote.