Senator Kevin O’Toole (R-Essex, Bergen, Morris) sent a letter to the FDA calling for the agency to work swiftly to approve generic epinephrine auto-injectors to combat Mylan’s apparent monopoly on the market. O’Toole sponsors a bill to combat Mylan’s EpiPen price hike by providing a tax credit to retailers who keep the drug affordable.
“It is baffling to me that although EpiPens have been on the market for many years, the FDA has yet to approve any generics,” Senator O’Toole said. “It seems that Mylan’s deplorable price hike was, in part, a response to competition from generic EpiPens that were awaiting FDA approval. I strongly urge the FDA to uphold its mission to serve the public health by speeding innovations that make medicine more affordable. We cannot stand by and allow Mylan to put lives at risk. Families need affordable options now.”
— Sen. Kevin O'Toole (@kevinjotoole) August 26, 2016
Sen. O’Toole’s letter was distributed today, Aug. 26, 2016, to Dr. Robert M. Califf, who serves as the U.S. Commissioner of the Food and Drug Administration. The full text of the letter is below.
Dear Dr. Califf:
As I’m sure you and your office are aware of the recent news reports regarding the borderline monopolistic price increases of over 500 percent in less than 10 years by Mylan NV regarding their Epi-Pen product, I write to you today asking for intervention by the FDA on this matter.
While I find it troubling that any one company can hold an exclusive patent on a public health product until 2025, what puzzles me even more is that there appears to be no generic products in the marketplace to ensure Mylan does not hold a monopoly on epinephrine auto-injectors. Your mission statement clearly outlines that the “FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable…”
Certainly your agency can not be satisfied by the speed of innovation regarding epinephrine auto-injectors given that Mylan holds a virtual monopolistic grip on the market and therefore can unconscionably raise the price of Epi-Pens to over $600. As a matter of fact, it has been cited in news outlets that the cause of the most recent price increase of Epi-Pens by Mylan was a direct result of generic competition from Teva Pharmaceuticals. Your agency delayed its approval of Teva’s generic epinephrine auto-injector, yet Mylan never lowered their price.
It is clear to me and so many others that Mylan’s pricing strategy is driven in large part by the fact that they are the only product on the market. Such behavior was the impotence for the enactment of the Sherman Anti-Trust Act. While the FDA is not charged with addressing monopolistic behavior, your agency is charged with “advancing the public health by helping to speed innovations that make medicines…more affordable.”
I respectfully request, on behalf of the constituents that I represent here in New Jersey, that your agency adhere to your mission statement and work to “speed innovations” and work with any company seeking to provide patients with alternatives for auto-injectors so that no one is subject the Mylan’s apparent bottom-line driven pricing strategy. This behavior simply cannot be tolerated, and the only way to do that is by the FDA adhering to their fundamental charge.
I thank you for taking my letter into consideration, and am available should you wish to speak further on this matter.
Kevin J. O’Toole
New Jersey Legislative District 40