FDA to call out brand name drug companies that block generics


The Food and Drug Administration will publish the names of companies that have been blocking generic competition on a new website in an effort to clamp down on efforts by brand name drug companies to keep prices high.

“It is a pervasive problem,” FDA Commissioner Scott Gottlieb said at a briefing describing the website. The site will highlight companies that have prevented generic companies from getting access to the samples they need to make cheaper versions.

The move is part of the Trump administration’s broader plan to address high drug prices.

Brand name companies sometimes develop a safety strategy with the FDA called a risk evaluation and mitigation strategy that can limit access to their drugs by generic companies. Other times, a brand name drug puts a clause into a contract with a distributor to not provide any products to a generic company, cutting off another avenue to get samples.

A generic drug company needs hundreds of samples of the brand name drug in order to start developing a cheaper copy of the product. Lack of access means delays in generic competition.

The new website set to be rolled out this week will list 150 inquiries from generic companies to the FDA over whether one of 50 drugs has one of the safety strategies. It will also list 20 letters from the FDA to brand name companies surrounding the dispute.

Gottlieb denied the FDA was trying to shame drug companies into abandoning the practice.

“I am just identifying the problem,” he said. “In these cases we don’t know fully whether the root cause is a REMS or a distribution agreement.”



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