FDA generic approvals hit a new record, but the effort's not paying off yet

The FDA doesn’t regulate drug prices, but it's been using one of its most important powers—namely, approving more cheap generics—to drive down costs. And in fiscal 2019, it racked up enough of those approvals to set a new record.

The agency this week said it had cleared 1,171 generics during its 2019 fiscal year, which ended September 30. That smashed its previous record of 971 generic nods, set in fiscal 2018.

And among the latest round of approvals were 125 first-time generics, arguably the most important kind because they set up competition to previously protected—and pricey—branded meds. Those first-time generics included an opioid overdose drug, plus meds to treat breast cancer and pulmonary arterial hypertension, acting commissioner Ned Sharpless said in a statement.

But the onslaught of new approvals hasn't necessarily delivered big savings, recent research shows. And that's on top of previous analyses that found a significant number of newly approved copycats hadn't hit the market months later.

A study published in JAMA this week said the agency's efforts to bolster generic approvals hasn't paid off as of the end of last year. Researchers found that while the overall number of generic approvals "increased slightly" from July 2016 to December 2018, the proportion of approvals for meds that faced limited competition or recent shortages remained the same. 

The FDA approved 1,832 generics between July 2016 and December 2018, the team found. Of those, about 20% were generics to medicines that faced “limited competition,” or two or fewer generic competitors. Another 39% were generics for drugs that had faced a shortage sometime in the previous five years. Those approval numbers were steady, according to the report.

In all, the “results suggest that there have not yet been noticeable effects of the FDA’s initiatives to expand approvals for generic drugs at risk for price spikes and shortages,” the authors wrote. The work isn’t in vain, though, as the team wrote that “continued attention is needed to foster approval of generic drugs with limited competition and prior shortage.” 

The researchers cautioned that their study didn’t consider whether the generics companies actually launched their copycats after winning approval. Kaiser Health News did dig into those numbers, though, looking at the 1,600-plus generics approved from January 2017 through December 2018. 

More than 700, or about 43%, of those products hadn't been launched as of early January, KHN found. Perhaps more importantly, 36% of the first-time generics weren't yet for sale at that point.

Approving more generics is one of several drug pricing initiatives introduced by former FDA commissioner Scott Gottlieb back in 2017. Others include publishing and regularly updating a list of drugs with limited competition and highlighting alleged “gaming” of regulations by branded drugmakers that can stifle competition. 

Despite efforts by the FDA and others to take on high drug prices, U.S. prices remain higher than any other country. President Donald Trump has made the issue a priority, but some of the administration's efforts have faced setbacks. Gottlieb resigned earlier this year, and the administration walked back its proposal to take on drug rebates after a Congressional Budget Office review. HHS still hopes to force drugmakers to include prices in TV ads. 

The FDA is forging ahead with its copycat approvals push, Sharpless said. The agency plans to publish more guidance and meet with generic drugmakers to foster generics development. "We will continue to do all that we can to facilitate a stable, competitive market to increase access to medicines," Sharpless said.

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