Reuters
FDA commissioner Scott Gottlieb
The FDA just took a step that could increase competition and prevent price gouging on drugs that seemingly jump in price overnight.
In May, Food and Drug Administration commissioner Dr. Scott Gottlieb said he wanted 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, a 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, the FDA on Tuesday published a list of more than 200 drugs that have fallen off patent where the FDA hasn't received any applications for a generic drug version of that drug.
Before now, it wasn't too clear which drugs had generic alternatives and which didn't. That left room for drug companies to buy up those drugs without people noticing and quietly raise their prices. The list could help keep a closer eye on the pool of drugs without generic competition. Ideally, other companies could make generic alternatives to increase competion, lower prices, and keep the drugs from becoming the target of price hikes.
"No patient should be priced out of the medicines they need, we must do our part to help patients get access to the treatments they require," Gottlieb said in a tweet. "Competition and access are foundational elements to continued pharmaceutical innovation, public health improvement," he said in a follow-up tweet.
The list includes everything from simple chemical compounds to antibiotics, and glucagon hydrochloride, an emergency diabetes drug that raises the level of blood sugar when it falls too low.
Here's the full list:
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 has 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.
List of Off Patent Off Exclusivity Drugs with No Approved Generic by Lydia Ramsey on Scribd