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

drugs

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.”

Related article:  Corvids are more brainiac than birdbrain: Crows may be able to reflect and ponder their own mind

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

Outbreak
Outbreak Daily Digest
Biotech Facts & Fallacies
Genetics Unzipped
Infographic: How dangerous COVID mutant strains develop

Infographic: How dangerous COVID mutant strains develop

Sometime in 2019, probably in China, SARS CoV-2 figured out a way to interact with a specific "spike" on the ...
Untitled

Philip Njemanze: Leading African anti-GMO activist claims Gates Foundation destroying Nigeria

Nigerian anti-GMO activist, physician, and inventor pushes anti-gay and anti-GMO ...

Most Popular

News on human & agricultural genetics and biotechnology delivered to your inbox.
glp menu logo outlined

Newsletter Subscription

Optional. Mail on special occasions.
Send this to a friend