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FDA Publicly Shames Drug Companies That Block Generic Meds

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Today the Food and Drug Administration published a list of pharmaceutical companies accused of bogging down the development of generic drugs. The makers of brand name drugs are constantly putting up obstacles that delay the development of generic medications, according to generics manufacturers, and this new list calls them out. But it remains to be seen whether major drug companies are capable of shame.

Generic drug makers need the cooperation of the brand name manufacturers to acquire samples of the original drug to ensure that the generic is a safe and identical product. This new list, buried at the bottom of an obscure FDA page, lays out the number of complaints major drug companies have had lodged against them by generics manufacturers.


Drug companies from the list include big names like Novartis, GlaxoSmithKline, Pfizer, and Valeant Pharmaceuticals. Drug maker Celgene tops the list with 13 complaints lodged with the FDA, but the agency doesn’t list which companies made the complaints nor does it really give any detailed information at all.

It’s also important to note that many of the companies listed produce both brand name and generic drugs. Mylan, for example, which is listed as having three complaints lodged against it, is primarily a generics maker, yet it became notorious in 2016 after raising the price of its EpiPen allergy drug by 600 percent over the course of a decade.


The move to name and shame (words, it should be noted, the FDA doesn’t like to use) is part of President Trump’s larger push to lower consumer drug prices. But it’s unclear that any of the Trump regime’s tactics will put a dent in the prices that Americans pay at the pharmacy. Trump’s head of the FDA, Dr. Scott Gottlieb, said that “branded companies are on notice” in a news conference on Tuesday.

Regulating drug prices is basically a non-starter for the Trump White House, and the president’s FDA commissioner is a longtime advocate of allowing drug companies to do whatever the hell they want. In fact, aside from this list, Dr. Gottlieb’s solution to lowering drug prices in the U.S. seems to be getting the rest of the world to actually pay more for their drugs.

Gottlieb said on CNBC yesterday that Europeans “do underpay relative to us for branded drugs, and that’s in part because they do put price controls and utilization restrictions on those drugs.” Gottlieb then claimed that Europeans are “overpaying” on generic drugs, an argument that’s disingenuous at best.

“That’s not a system for success in the long run,” Gottlieb said about European price controls on drugs. “So, I don’t think they’re set up for long-term success.”


That sentiment echoes what President Tump said last week at a White House press conference when he claimed that “foreign, developed nations” are getting a “free-ride by setting drug prices at unfairly low levels, leaving American patients to pay for the innovation that foreign patients enjoy.”

Gottlieb, a former fellow at the libertarian think tank American Enterprise Institute, was strangely hailed as a rare bipartisan pick for the FDA when he was first confirmed by the Senate. Gottlieb was confirmed by a vote of 57 to 42. But his financial disclosure forms ares full of names you’ll recognize from the new FDA list. Gottlieb has served on the board of directors for eight different pharmaceutical companies over his career, four of which so recently that he had to give them up to take his new job at the FDA. He has worked as a consultant for some of those companies, like GlaxoSmithKline, the sixth largest pharmaceutical company in the world.


A cynic might argue that this new FDA list is purely symbolic because it doesn’t actually set out any reforms or even provide drug companies with information they don’t already know. And that cynic would be right. The Trump regime considers this list to be part of a push for “transparency,” but Americans already know who’s fucking them over. What they need is cheaper drugs.

[New York Times | Fierce Healthcare | Ars Technica | CNBC]