Regulatory Focus™ > News Articles > Senators Question Mylan CEO Over EpiPen Pricing, Generic Plans

Senators Question Mylan CEO Over EpiPen Pricing, Generic Plans

Posted 31 August 2016 | By Michael Mezher 

Senators Question Mylan CEO Over EpiPen Pricing, Generic Plans

A group of 20 Senate democrats on Tuesday sent a letter to Mylan CEO Heather Bresch, questioning her about her company's actions in response to criticism over price increases for its life-saving EpiPen, which rose in price more than 400% over the past decade.

The letter comes just one day after the House Oversight and Government Committee launched an investigation into Mylan's "virtual monopoly over the epinephrine auto-injector market." In a separate letter to Bresch sent Monday, Committee Chairman Jason Chaffetz (R-UT) and Ranking Member Elijah Cummings (D-MD) call on Mylan to turn over internal documents on its sales, communications, contracts and reimbursements related to its EpiPens.

Senators Question Mylan

The senators, including Elizabeth Warren (D-MA) and former Democratic presidential contender Bernie Sanders (D-VT), say the EpiPen is "exorbitantly expensive" and warn that its price has driven some patients to carry expired EpiPens, or even forego carrying them altogether.

Following criticism from parents, members of Congress and presidential candidate Hilary Clinton, Mylan said it would increase its copay assistance program for some patients, and on Monday announced it would launch an authorized generic version of the autoinjector for $300 per two-pack, half the price of the branded version.

Despite Mylan's moves to allay concerns about patient access to its EpiPens, the senators question the company's choice to release an authorized generic and increase its copay assistance program instead of offering a discount on the product.

"These changes will help some customers who are struggling to afford EpiPens. Your discount programs, however, represent a well-defined industry tactic to keep costs high through a complex shell game. When patients receive short-term co-pay assistance for expensive drugs, they may be insulated from price hikes, but insurance companies, the government, and employers still bear the burden of these excessive prices," the senators write.

Patient Assistance Program

Last week Mylan announced it was increasing its patient assistance programs to give eligible patients a $300 credit (previously it was $100) towards a pack of EpiPens, and said it would double the income limit on its program to provide free EpiPens to uninsured patients to 400% of the federal poverty level ($97,200 for a family of four).

In response, the senators ask Mylan to answer a slew of questions about its "Savings Card" assistance program, including how many patients used the program, whether those patients had a copay, the cost of EpiPen prescriptions filled using a Savings Card to insurers, and the number of patients that have received free EpiPens from the company.

Additionally, patients enrolled in Medicare and Medicaid are ineligible for the copay assistance program due to a government's ban on couponing for the two programs, prompting the senators to ask Mylan how it has worked to ensure access to such patients while ensuring they do not receive Savings Cards.

The senators then raise questions about Mylan's "EpiPen4Schools" program, which Stat News reports may have violated antitrust laws by prohibiting participating schools from buying competing products. Specifically, the senators ask Mylan to provide them with the program's terms and conditions and how many schools participated in the program.

Authorized Generic

The senators also grill Mylan over its planned authorized generic EpiPens, saying the cost is still three times higher than the branded version's cost in 2007 and questioning how the company can justify the $600 price tag of the branded version.

Furthermore, the senators say the savings brought on by the planned authorized generic will depend on whether Mylan limits their supply in favor of producing more of the branded version.

"Will Mylan commit to filling all orders for the authorized generic version of the EpiPen so the generic alternative is available to all epinephrine auto-injector consumers?" the senators ask.

Another issue the senators are concerned about is whether Mylan will extend its patient assistance programs to include the authorized generic versions as well, or if not, how the company plans to ensure patient access to the generic.

Senate Letter

House Letter

Tags: Mylan, EpiPen

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.