FDA names drugmakers potentially acting to delay cheap generics

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(Reuters) – The U.S. Food and Drug Administration on Thursday listed drugmakers, including Celgene Corp (CELG.O), Johnson & Johnson (JNJ.N), Gilead Sciences (GILD.O) and Novartis AG (NOVN.S), who the regulator says are potentially blocking access to samples of their drugs to delay generic competition.

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

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.

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 and in open market.

Industry lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) said it was concerned that the FDA list lacks context and conflates a number of issues.

“It is important to differentiate between those products for which FDA has received complaints as opposed to those products for which it has received a request for a safety determination letter,” PhRMA said.

Celgene, for example, argued that the three of its products on the FDA list all carry risk of significant side effects, including severe birth defects.

“Therefore, these therapies are subjected to rigorous safety controls that have been developed by the company and approved by the FDA,” Celgene said in a statement. It noted that two of the three drugs already have generic versions licensed to enter the market in coming years, including multiple myeloma treatment Revlimid, by far the company’s biggest selling product.

RBC Capital Markets analyst Brian Abrahams said in a research note that the effect of the FDA’s list will likely be limited.

“Though such efforts maintain the public concern about biopharma’s role in high drug prices and potentially anti-competitive practices, other than creating negative optics for these companies we see minimal impact such a list will have on actual generic risk,” he said.

The list of dozens of companies can be found on the FDA’s website.

Reporting by Michael Erman in New York; Additional reporting by Tamara Mathias and Manas Mishra in Bengaluru; Editing by Susan Thomas and Bill Berkrot

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