FDA names drug companies that may ‘game’ the system to stall generics

The Food and Drug Administration (FDA) on Thursday published a list of drug companies that it said could be “gaming” the system to delay competition from cheaper generics.

“No patients should be priced out of medicines they need to support their health,” FDA Commissioner Scott Gottlieb said in a statement.

{mosads}“We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval,” he added.

The new disclosures are part of the plan President Trump announced last week to lower drug prices. 

Specifically, the FDA is publishing a list of 52 branded drugs whose makers could be using delay tactics to prevent generic drug companies from getting the samples they need to bring competitors to market. Various drug companies are called out on the list, including Celgene, Novartis and GlaxoSmithKline.

The delay tactics can cut down on competition and allow drug companies to keep prices higher.

Congress has also looked at legislation to crack down on these tactics. One bipartisan bill, known as the CREATES Act, has so far been stalled amid intense lobbying from the pharmaceutical industry.