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FDA Public Shames Pharmaceutical Companies Blocking Generic Meds



Photo: Dr. med. Scott Gottlieb, FDA representative, speaks at a hearing from the House Energy and Commerce Committee on federal efforts to combat the opioid crisis on October 25, 2017 (Getty).

Today, the Food and Drug Administration released a list of pharmaceutical companies be accused of stopping the development of generics. According to generics manufacturers, manufacturers of branded medicines are constantly putting up barriers that delay the development of generic medicines and this new list is calling them. But it remains to be seen if the big pharmaceutical companies can be ashamed.

Generic drug companies need brand name collaboration to acquire samples of the original drug to ensure the generic product is a safe and identical product. This new list, buried at the bottom of an obscure FDA page, describes the number of complaints large pharmaceutical companies have filed against them from generic companies.

Big names include Novartis, GlaxoSmithKline, Pfizer, and Valeant Pharmaceuticals. Drug manufacturer Celgene tops the list of thirteen complaints filed with the FDA, but the agency does not list which companies made the complaints, nor does it provide any detailed information.

It is also important to mention that many of the companies listed produce both brand names and generics. Mylan, for example, in which three lawsuits were filed against him, is primarily a generic drug maker, but in 2016 he became notorious after he had increased the price of his EpiPen allergy drug by 600 percent over a decade.

The step to name and shame (words it should be noted that the FDA does not like using) is part of President Trump's greater urge to lower consumer price drugs. But it is unclear whether any of the Trump regime's tactics will dampen the prices Americans pay at the pharmacy. Trump's chief of FDA, dr. Scott Gottlieb said that brand companies were listed at a press conference on Tuesday.

The regulation of drug prices is basically a non-stater for the Trump White House, and the president's FDA envoy is a long-time proponent of allowing the drug companies to do whatever they want. Apart from this list, Dr. Gottlieb's solution to lower drug prices in the US, to get the rest of the world to actually pay more for their medicines.

Gottlieb said on CNBC yesterday, Europeans would pay relatively little for branded drugs, and that's partly because they set price controls and usage restrictions on these drugs. Gottlieb then claimed that Europeans "overpay" on generics, an argument that is at best disingenuous.

"This is not a system for long-term success," Gottlieb said about European drug price controls. "Well, I do not think so that they are focused on long-term success. "

This sentiment reflects what President Tump said at a White House press conference last week when he claimed that" foreign, developed nations "are entering a" free ride. " The drug prices are set at unfair conditions and American patients have to pay for the innovation that foreign patients enjoy. "

Gottlieb, a former scholar of the libertarian think tank American Enterprise Institute, was strangely named a rare bipartisan drug choice for the FDA he was first confirmed by the Senate. Gottlieb was confirmed by a vote of 57 to 42. But his financial disclosure forms are full of names that you recognize from the new FDA list. Over the course of his career, Gottlieb has served on the board of directors of eight different pharmaceutical companies, four of which he recently had to relinquish to take up his new position with the FDA. He has worked as a consultant for some of these companies, including GlaxoSmithKline, the world's sixth largest pharmaceutical company.

A cynic might argue that this new FDA list is purely symbolic because it does not propose reforms. They even provide the pharmaceutical companies with information they do not know. And this cynic would be right. The Trump regime views this list as part of a push for "transparency," but Americans already know who's fucking them. What they need are cheaper drugs.

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


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