Lawmakers Want Answers From Mylan, FDA, FTC After EpiPen Price Hike
By Jof Enriquez,
Follow me on Twitter @jofenriq
A spike in the price of EpiPen auto-injectors has drawn heated responses from patients, lawmakers, and the wider public, who are calling on authorities to rein in soaring prices for the lifesaving devices.
EpiPen — a pen-like device used in the emergency treatment of life-threatening allergic reactions (anaphylaxis) — is sold in two-packs now costing about $600, whereas the price was $100 in 2009. The price surge has prompted an online petition from parents of children with food allergies, which has grown to more than 80,000 people sending more than 121,000 letters to Congress, and subsequent widespread media coverage.
Having heard their constituents clearly, lawmakers now want immediate action from Mylan and regulators to address the matter. Sen. Amy Klobuchar (D-MN) called on the Senate Judiciary Committee last week to investigate the product's price hike.
"Many Americans, including my own daughter, rely on this life-saving product to treat severe allergic reactions," she wrote in a statement, according to CNN. "Not only is this alarming price increase unjustified, it puts life-saving treatment out of reach to the consumers who need it most."
Mylan announced that it will offer coupons, good for up to $300 off an EpiPen two-pack, to customers whose insurance doesn't pay the full cost. But some lawmakers are unconvinced that the move is enough, and sent letters to Mylan seeking answers.
"The only fair and effective relief is a substantial price reduction for everyone who needs access to this life-saving drug, not just a special break for people who are in particular health plans and have the extra hours in their work day to navigate a bureaucratic labyrinth of discounts. I will continue to push for a federal investigation and Congressional action," said Sen. Richard Blumenthal (D-CT), according to CNN.
Mylan spokeswoman Nina Devlin reportedly responded through an email, per NPR, "We have reached out to every member of Congress who has sent us a letter, and we look forward to meeting with them and responding to their questions as soon as possible."
The American Medical Association (AMA) weighed in on the issue, stating, “Although the product is unchanged since 2009, the cost has skyrocketed by more than 400 percent during that period. The AMA has long urged the pharmaceutical industry to exercise reasonable restraint in drug pricing, and, with lives on the line, we urge the manufacturer to do all it can to rein in these exorbitant costs.”
Experts say Mylan has cornered over 90 percent of the auto-injector market as of 2016-2017, but has done little to improve a product that can justify a substantial price increase.
In a statement, Mylan claims that EpiPen's "product features have been updated over time to help provide ease of use in emergency situations. Some of the features include a flip-top carry case designed for single-handed opening during an emergency situation, a never-see-needle design that offers needle protection for patients and caregivers, and a unique design that helps facilitate fast retrieval and a steady grip to assist in the administration process."
"Ensuring access to epinephrine — the only first-line treatment for anaphylaxis — is a core part of our mission," said Mylan.
Sen. Klobuchar urged the Federal Trade Commission (FTC) to investigate whether Mylan has used incentives and exclusionary contracts to deny an alternative product to hit the market, reports CNN.
“The commission should also report to Congress on why these outrageous price increases have become common and propose solutions that will better protect consumers within 90 days,” Klobuchar said, according to The Intercept.
Sens. Klobuchar, Blumenthal, Charles Grassley (R-IA), Patrick Leahy (D-VT) and Ron Johnson (R-WI) want the U.S. Food and Drug Administration (FDA) to explain how Mylan has become a near-monopoly on epinephrine auto-injectors in the United States, while also noting the "extremely inexpensive" cost of epinephrine.
“We are concerned that Mylan has not faced much competition for its product. One of its competitors, Auvi-Q, was recalled in October 2015 [Teva’s EpiPen generic was also rejected in March] giving Mylan a near monopoly with its product. News reports indicate that generic versions of the EpiPen have been subject to additional questioning by the FDA and have yet to be approved,” the senators wrote in a letter to FDA Commissioner Dr. Robert M. Califf.
The senators asks FDA to look into the possibility of making EpiPen and over-the-counter medication rather than a prescription, and asks how many alternatives to the EpiPen FDA is currently considering, according to RAPS.
Sanofi in October 2015 voluntarily recalled its Auvi-Q device with voice features after FDA found it to have potentially "inaccurate dosage delivery, which may include failure to deliver the drug." Later, FDA rejected Teva Pharmaceutical’s generic version of the EpiPen, citing “certain major deficiencies” in Teva’s application, delaying product release until 2017 at the earliest.
Consumer Reports notes that a cheaper, authorized generic of Adrenaclick is available in certain outlets.
"While generic Adrenaclick isn't the same technology and is used differently than EpiPen, both auto-injectors contain the same drug, epinephrine, available in the same dosages," said Barbara Young, Pharm.D., of the American Society of Health-System Pharmacists, reports the non-profit advocacy group.