The FDA quietly changed the rules to block the next Martin Shkreli

The FDA quietly changed the rules to block the next Martin Shkreli

by Beth Mole at arstechnica

http://arstechnica.com/science/2016/03/the-fda-quietly-changed-the-rules-to-block-the-next-martin-shkreli/

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With a tiny change to the rules, the Food and Drug Administration made it a bit harder for Martin Shkreli and his ilk to make a killing by jacking up the prices of off-patent drugs.

The regulatory tweak now allows a “priority” or expedited review process for any generic drug that would compete with an off-patent drug that is only made by one company—the kinds of drugs that have seen skyrocketing price tags of late. The faster review process could cut the window for a pharmaceutical company to have a monopoly over the drug from years to months, sharply cutting profits from potential price gouging.

In an e-mail to Bloomberg, FDA spokesperson Sandy Walsh wrote that the agency expects as many as 125 generic drug applications will now be fast-tracked due to the change. The agency previously expedited reviews of generics that would compete with newly off-patent brand name drugs.

The FDA’s revision comes amid nationwide outrage over the price-gouging ways of the pharmaceutical industry, with several companies in particular standing out, including Valeant Pharmaceuticals and Martin Shkreli’s former company Turing Pharmaceuticals. Both companies—and the latter's reviled former-CEO—have been summoned before the House and Senate to explain seemingly heartless price increases of life-saving medications.



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