Agency starts name-and-shame campaign on drug companies and generics
Moving to implement President Trump’s drug-pricing plan, the Food and Drug Administration on Thursday started naming brandname drug makers who shut out competition by preventing generic makers from obtaining samples of their product.
FDA Commissioner Scott Gottlieb said a generic manufacturer typically needs 1,500 to 5,000 units of the brand drug to perform the tests needed to win regulatory approval of their products, yet more than 150 generic drug developers have complained to the agency about tactics that shut them out.
The FDA published the names of dozens of companies that may have been blocking access, hoping sunshine will change their behavior.
“We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval,” Dr. Gottlieb said.
The FDA said companies are using a variety of tactics to stall the sale of generics.
They may cite the presence of a Risk Evaluation and Mitigation Strategy (REMS) — a program the FDA applies to certain drugs to ensure their benefit outweigh their risks — to refuse distribution, or impose conditions on sales that generic makers cannot meet.
Others brand companies put restrictions in their contracts with drug distributors, wholesalers or specialty pharmacies to prevent those intermediaries from selling samples to generic makers.
“I want to be very clear: A path to securing samples of brand drugs for the purpose of generic drug development should always be available,” Dr. Gottlieb said.
“I want to be very clear: A path to securing samples of brand drugs for the purpose of generic drug development should always be available,” Food and Drug Administration Commissioner Scott Gottlieb said as he moves to implement President Trump’s...