2. Generics: Approved but not available
The Food and Drug Administration has been approving generic drugs at a record clip, but a whole lot of those drugs aren't actually available to U.S. patients.
"It's a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb told Kaiser Health News, which analyzed generics' availability using FDA and industry records.
By the numbers: The FDA has approved some 1,600 new generics since the beginning of the Trump administration, per KHN.
- But 43% of them — about 700 drugs — aren't actually on the market.
- Of the generics that would be the first to compete with a brand-name drug, 36% aren't on the market, meaning those brands can still price their products as if a generic had never been approved.
How it works: Consolidation in the drug manufacturing business has kept some generics off the market, especially injectable drugs. So have shortages of certain ingredients.
- Also, some of these newly approved applications were filed years ago, and drugmakers have already moved on to other, more profitable products.
- And then there are "pay-for-delay" agreements — legal settlements in which a brand-name drugmaker pays a would-be generic competitor to stay off the market.
The bottom line: Approving so many generics is one of the most tangible steps the administration has taken to try to lower drug prices. But that only works if the products actually end up coming to market.