Blumenthal: Mylan's Announcement Today Raises as Many Questions as Solutions

[WASHINGTON, D.C.] – U.S. Senator Richard Blumenthal (D-CT) released the following statement today after Mylan, the manufacturer of the EpiPen Auto-Injector, announced plans to offer a generic alternative:

“More must be done—and more quickly—to make this life-saving drug more affordable. Myl‎an may appear to be moving in the right direction, but its announcement raises as many questions as solutions—including why the price is still astronomically high, and whether its action is a preemptive strike against a competing generic. Investigations are still vitally necessary into possible antitrust lawbreaking, and I will press for Senate hearings as well as FTC subpoenas. Mylan must be held accountable to lower prices now, stop future price increases, and answer for any past illegal misconduct.”

“A system in which public outrage is required to address these kind of unjust situations is not efficient. When it comes to affording life-saving products for their families, consumers should not have to depend on the benevolence of monopolists.”

Blumenthal was one of the first Senators to respond to Mylan’s excessive prices increases for a drug to treat extreme, life-threatening allergic reactions. He has called for an investigation by the Federal Trade Commission, and hearings by the Senate Judiciary and Commerce Committees, on which he sits.

Last Monday, he demanded that Mylan lower the price of the EpiPens to an affordable, accessible level. The full text of Blumenthal’s letter is available here. He then joined Connecticut mothers, nurses and doctors to call on Mylan to end the unconscionable price gouging that is threatening to put the life-saving product out of reach for families, schools and first responders.

Blumenthal also joined U.S. Senators Chuck Grassley (R-IA), Patrick Leahy (D-VT), Amy Klobuchar (D-MN, and Ron Johnson (D-WI) last Wednesday in asking the Food and Drug Administration (FDA) to answer questions about its approval process and other steps for alternatives to the EpiPen. 

“We are also concerned that the substantial price increase from Mylan could limit access to a much-needed medication,” the Senators wrote to FDA Commissioner Robert M. Califf. “Given the importance of this topic, it is imperative to understand the FDA’s role with respect to EpiPens and its approval of generic equivalents that could help to increase competition and lower prices if introduced.”

The Senators sought an explanation of what factors could be behind the lack of competition for the EpiPen.  They asked whether the FDA is taking steps to ensure an adequate supply of self-injectable epinephrine, since the number of people with peanut allergies has tripled in the last 20 years.  The letter asked whether the FDA has taken steps to ensure an efficient, safe process for alternatives to the EpiPen, without being hampered by backlogs, and whether certain situations such as drug shortages warrant changes to the typical FDA approval timeline.  It also asked whether the agency has considered whether the EpiPen could become an over-the-counter medication and for a description of that process.  Finally, the Senators asked how many alternatives to the EpiPen are under review at the FDA and for a description of where each alternative stands in the process.

The Senators’ letter is available here.

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