Is FDA's generic strategy really all that?

Congressional lawmakers and the FDA alike love to talk about how they’re bringing down the prices of drugs by approving more and more generics at faster and faster rates. And don’t get me wrong, that’s true. The FDA did approve a record 1,171 generics last year, but what about the more perplexing issue of brand drugs that are off patent and just never seem to find generic competitors?

Since 2017, the FDA has been publicly disclosing the names of these drugs in an effort to encourage generic drug makers to come to the FDA with generic applications. Congress too has leaned in on the issue: it passed a law in 2017 that gives the first generic drug companies to bring one of these drugs to market an additional six months of exclusivity. 

But when the newest list of brand drugs without generics came out last week, I wondered: Is the FDA really chipping away at this list? I was surprised by what I saw: The list of drugs is growing, in fact there are now more than 300 drugs on that infamous list, and a number of drugs have stayed on the list since it was first created in 2017.

One generic drug industry expert I spoke to insists it’s too early to judge the FDA’s progress. “You’re never going to get 100 percent of that list [cleared], or anywhere near it,” said Kurt Karst, an attorney at the law firm Hyman, Phelps & McNamara. Karst noted that the list will also always be in flux as more drugs go off patent and that he’s tracked 20 drugs that have received the special designation created by Congress in 2017.  

When asked about the growing list, a spokesman for the FDA told STAT that "The FDA will continue to do all that we can to facilitate a stable, competitive market to increase access to medicines" but that "it’s important to understand that ultimately, decisions on whether to develop a generic drug are made by individual companies."

But it’s sobering news nonetheless.