The notorious former pharmaceutical CEO, Martin Shkreli, achieved the dubious distinction of being named “the most hated man in America” by several news outlets after raising AIDS and cancer drug prices by 5,000 percent.
While the so-called “Pharma Bro” has since resigned his position after being charged for participating in a Ponzi scheme, the FDA is trying to ensure, with a small regulatory tweak, that Shkreli-style price gouging doesn’t happen again. Ars Technica reports that the FDA’s rule revision has allowed an expedited review process for any generic drug that competes with an off-patent drug made by only one company — exactly the kind of situation that Shkreli exploited.
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.
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