Drugmakers accused of stalling biosimilars: FDA’s Gottlieb calls tactics ‘a toxin’


Food and Drug Administration Commissioner Scott Gottlieb on Wednesday [July 18] accused drug makers who manufacture pricey biologic medicines of using “unacceptable” anti-competitive tactics to keep competitors off the market, costing Americans billions.

The tactics — some of which Gottlieb will refer to as a “toxin” — have prevented other drug makers from launching biosimilar medicines, highly similar versions of the same drugs.

“The branded drug industry didn’t build its success by being business naïve. They are smart competitors. But that doesn’t mean we need to embrace all of these business tactics, or agree that they’re appropriate,” Gottlieb said in a speech at the Brookings Institution. “Some of these tactics should be unacceptable to every member of the drug supply chain.”

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Gottlieb’s harsh remarks came as part of a preview of a new “Biosimilars Action Plan” that the administration released Wednesday. But that plan does not focus on some of the anti-competitive tactics Gottlieb criticized, since the FDA doesn’t police intellectual property disputes or rebate agreements with other parties in the supply chain.


It’s an attempt to help lower prices in an especially expensive category; less than 2 percent of Americans use biologic drugs, but they account for almost 40 percent of all prescription drug spending, and for 70 percent of the growth in drug spending between 2010 and 2015, as Gottlieb highlighted Wednesday.

Read full, original post: FDA’s Gottlieb slams drug makers for stalling release of biosimilars

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