Reuters
FDA commissioner Scott Gottlieb
Food and Drug Administration commissioner Dr. Scott Gottlieb has a plan to tackle high drug prices.
"Simply put, too many patients are priced out of the medicines they need," Gottlieb said Thursday at the FDA's budget hearing.
The FDA is responsible for regulating food and drugs. It's also responsible for regulating medical devices, blood donations, veterinary products, cosmetics, and tobacco. The FDA doesn't directly play a role in setting drug prices.
Even so, Gottlieb said there are a few main ways he thinks the agency can help.
- By stopping the industry from gaming regulations to get more time without competition beyond what Congress intended.
- Making it more straightforward for complex generic drugs to get to market. Complex drugs are devices like the EpiPen or inhalers that competitors have a hard time getting approved. It's something Gottlieb has been advocating for for years.
- Getting through of the backlog of generic drug applications.
Gottlieb also wants to make it more difficult for drugs that are off patent to jack up the price of the medication because they don't face any competition. The biggest example of this was Daraprim, the decades-old drug that then-Turing CEO Martin Shkreli increased in price from $13.50 to $750 a pill.
To keep that from happening in the future, Gottlieb said he plans to publish a list of drugs that have fallen off patent where the FDA hasn't received any applications for a generic drug version of that drug.
"We believe greater transparency in these circumstances can help entice competitors into the market," Gottlieb said.
Gottlieb's comments hint at the changes that could come to drug pricing under the Trump administration. President Donald Trump has said that drugmakers are "getting away with murder," and expressed an interest in negotiating drug prices, something the government isn't allowed to do for Medicare and Medicaid.
In March, Trump also tweeted that he's working on "a new system where there will be competition in the drug industry." Since then, Trump hasn't said much on the topic.