US lawmakers ask Mylan to justify price hikes for EpiPen

Members of the US Senate's Judiciary Committee have asked Mylan to provide documentation supporting price increases for the allergy treatment EpiPen (epinephrine), which for a pack of two has risen from $100 in 2008 to more than $600 this year. Specifically, the committee asked the drugmaker to clarify how the cost was determined and whether improvements have been made to the product to justify the price hikes. Committee chairman Charles Grassley remarked "the substantial price increase could limit access to a much-needed medication." 

The list price of the auto-injector was about $57 when Mylan obtained the drug in 2007 as part of its purchase of Merck KGaA's generic unit.

Senator Amy Klobuchar separately called on the US Federal Trade Commission (FTC) to investigate the price increases. "Although the antitrust laws do not prohibit price gouging, regardless of how unseemly it may be, they do prohibit the use of unreasonable restraints of trade to facilitate or protect a price increase," commented Klobuchar. The senator added "the FTC should investigate whether Mylan Pharmaceuticals engaged in activity, such as using incentives or exclusionary contracts with insurers, distributors, or pharmacies, to deny an alternative product access to the market." 

Commenting on the news, FTC spokesman Justin Cole stated "the commission takes seriously its obligation to take action where pharmaceutical companies have violated the antitrust laws and will continue to closely scrutinise drug market competition on consumers' behalf." 

Meanwhile, Mylan explained "with changes in the healthcare insurance landscape, an increasing number of people and families are enrolled in high-deductible health plans, and deductible amounts continue to rise." The drugmaker continued "this change to the industry is not an easy challenge to address, but we recognise the need and are committed to working with customers and payors to find solutions to meet the needs of the patients and families we serve." 

Earlier this year, Teva announced that the launch of its generic version of EpiPen would be delayed until at least next year after the FDA identified "major deficiencies" in its application. Previously, Sanofi voluntarily recalled its epinephrine auto-injector Auvi-Q in the US after discovering the product could have inaccurate dosage delivery and later returned US rights to the product to kaléo. 

For related analysis, see Spotlight On: Mylan may be courting danger with EpiPen pricing strategy.

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