Mylan has confirmed they are being scrutinized by the Federal Trade Commission over changes made to their hugely successful EpiPen drug.
The EpiPen, which injects epinephrine to stave off anaphylactic shock, underwent a series of minor changes before fighting off FDA approvals for generics which now differed from the updated version. The FTC now suspects Mylan of making the alterations primarily to delay and deter competitors from creating and marketing their imitators.
In a statement, Mylan confirmed that they “received an information request from the FTC months ago as part of a preliminary investigation,” before denying any wrongdoing.
The EpiPen has been a source of controversy since Mylan’s acquisition of the drug, with prices having risen by over 500% since its acquisition in 2007. With no direct competitors to the EpiPen and no generics, Mylan has had a clear monopoly over the drug, allowing it to vastly increase its profits. Mylan has defended those price hikes by pointing to its continued development of the product, further research, and marketing campaigns which now require the product to be kept on hand in public buildings.
Mylan have also made some steps to undercut the competition themselves, releasing their own ‘generic’ which sells at around half the price of the original EpiPen brand.
Teva Pharmaceutical attempted to market a generic to compete with Mylan, although the FTC rejected the drug after Mylan contested it with a citizen petition. The FDA rejected the petition, although did not reject entirely listening to Mylan’s advice after the company claimed that the cap on Teva’s product made it inferior to the capless Mylan EpiPen.
The FTC are also investigating the possibility that Mylan made specific deals with competitors to improperly delay their development of generics.
However, even with restricted competition, it seems that Mylan are set to lose some of their profits on the drug. Ronny Gal, an analyst for Bernstein, predicted an $800m drop through to 2018 due to the increasing progress of alternatives on the market. While Mylan may or may not have been successful in delaying the competition, it seems they won’t be able to hold back the tide forever.
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