FDA calls out drugmakers suspected of ‘gaming’ the system to delay generics

The FDA on May 16 released a list of drug companies that may be using “gaming tactics” to delay generic competition from hitting the market.

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The list includes 52 branded drugs from more than 30 different drugmakers, including Novartis, GlaxoSmithKline and Gilead Sciences. The agency believes these drug companies may be blocking generic drugmakers’ access to the branded drug samples they need to bring their own cheaper versions to the market.

“No patients should be priced out of medicines they need to support their health,” said FDA Commissioner Scott Gottlieb, MD. “We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval.”

The FDA published the list as part of its Drug Competition Action Plan, which the agency rolled out last spring.

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