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FDA moves to lower drug prices.
Thu May 17, 2018 3:40pm

FDA names drugmakers potentially acting to delay cheap generics
Michael Erman

(Reuters) - The U.S. Food and Drug Administration on Thursday named a number of drugmakers it said could be improperly blocking access to their medicines in order to delay generic competition.

But many of the companies immediately pushed back, saying that the FDA list may be out of date and that some of the drugs on it already have generic competitors.

Releasing the list of drugmakers, which includes Celgene Corp (CELG.O), Johnson & Johnson (JNJ.N), Gilead Sciences (GILD.O) and Novartis AG (NOVN.S), is part of the Trump administration’s efforts to pressure companies to lower drug prices.

Last week, U.S. President Donald Trump unveiled a “blueprint” aimed at doing that, but critics have said the proposals did not do nearly enough to substantially decrease the cost of drugs for consumers. Shares of drugmakers rose on Friday after his speech.

The agency said companies on the list may be using FDA safety regulations and other tactics in order to deny access to their medicines from generic drugmakers hoping to copy them.

Generic drugmakers may not be able to develop alternatives without access to samples of branded products they intend to copy, the FDA 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,” FDA Commissioner Scott Gottlieb said in a statement.

Gottlieb, who has made faster approvals of cheaper generic medicines a priority, said this should be true even in cases where there is limited access to drugs for safety reasons.

He said the FDA is notifying the Federal Trade Commission, which can investigate anti-competitive acts, of cases where drugmakers may be blocking access to their products if there is no safety reason.

The FDA said it has also heard of some drugmakers adopting tactics to make it hard for generic companies to purchase branded drugs even at a fair value in the open market.


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