Skip to main content

Advanced Search

Advanced Search

Current Filters

Filter your query

Publication Types



Newsletter Article


EpiPen Price Move Not Enough for Lawmakers

By Andrew Siddons, CQ Roll Call

August 25, 2016 -- Mylan N.V.'s bid Thursday to roughly halve the $600 price of its EpiPen injector for some customers failed to pacify congressional critics. Instead, it renewed their calls for a serious look at the root causes of high pharmaceuticals costs, with the Senate Judiciary Committee emerging as a leader in these efforts.

"This step seems like a PR fix more than a real remedy, masking an exorbitant and callous price hike. This baby step should be followed by actual robust action," Sen. Richard Blumenthal, D-Conn., a Judiciary committee member and former state attorney general, said in a statement.

On Wednesday, Blumenthal also joined the leaders of the Judiciary Committee in calling for a look into why the life-saving EpiPen doesn't have more competition in the United States. Chairman Charles E. Grassley, R-Iowa, and Sen. Patrick J. Leahy of Vermont, the ranking Democrat on the panel, along with Blumenthal and two other colleagues, questioned what steps the Food and Drug Administration (FDA) could take to increase competition for EpiPen.

Stumbles by other drugmakers have made it likely Mylan will have the market to itself at until at least 2017 for the convenient prefilled injections of epinephrine. The drug treats the severe allergic reaction known as anaphylaxis.

For now, Mylan Chief Executive Officer Heath Bresch's response to criticism has been to offer a $300 savings card for EpiPen. Bresch is the daughter of Sen. Joe Manchin III, D-W.Va., who on Thursday said he expected Mylan to have a "more comprehensive and formal response" to the allegations from lawmakers.

"I look forward to reviewing their response in detail and working with my colleagues and all interested parties to lower the price of prescription drugs and to continue to improve our health care system," Manchin said in a statement.

Blumenthal dismissed the coupon as 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." For consumers whose insurance coverage requires a higher out-of-pocket expense, using the coupon from Mylan will save $300 on the $600 they might otherwise spend. Insurers and their customers will still face high prices, though, when coupons are not used.

"Once again, they aren't reducing their price; they are only offering to pay for some patients' copays," said Jeff M. Myers, the president and chief executive of Medicaid Health Plans of America, the trade group for managed care companies. "It's a pricing charade based on cost shifting."

Vicious Cycle

Critics of pharmaceutical pricing practices argue that expenses like this have driven up insurance premiums to the point where many consumers end up on the cheaper but higher-deductible plans requiring them to pay the full cost of an EpiPen. That cost burden is also picked up by taxpayer-funded Medicare and Medicaid.

"The true cost of the drug is costing all of us money, whether or not you have allergies," said Adriane Fugh-Berman, a professor of pharmacology at Georgetown University Medical Center.

The vicious cycle doesn't end there: the more a company spends subsidizing the expense paid directly by the consumer, the more it can raise the list price, according to the Pharmaceutical Care Management Association, which represents the companies who provide drug coverage for healthcare plans.

"To help cover the $4 billion spent annually on copay coupons, manufacturers can simply raise prices," Mark Merritt, the association's president, said in testimony earlier this year during a House hearing on drug prices. "Because insurers and plan sponsors foot this bill, these programs increase premiums."

The coupons also don't necessarily make their way to all the people who would benefit to them. While an EpiPen coupon is available to some via Mylan's website, in many cases people rely on their doctors for the information. Many doctors only get that information from drug company representatives—a practice that many frown upon.

Grassley expressed that concern. "When drug companies offer patient assistance cards, it's usually not clear how many patients benefit," he said in a statement.

Despite all of the bad publicity, Mylan will not likely face any real economic pressure to lower the price of EpiPen for at least another year. That's because the company's injector currently faces no direct competition in the United States. A similar epinephrine auto-injector from Sanofi was recalled in October 2015 over concerns that it wasn't injecting accurate doses. In March 2016, rival generic drug-maker Teva Pharmaceuticals had an application for its EpiPen clone rejected.

Lawmakers on Senate Judiciary pressed the FDA on its efforts to boost competition in this area. "It would be helpful if the FDA could clarify whether any barriers exist to the approval of safe alternative products to the EpiPen," Grassley, Leahy, and other lawmakers wrote Wednesday in a letter to FDA Commissioner Robert M. Califf.

While the Food and Drug Administration's (FDA) standard for generic drugs is to demonstrate that it is equivalent to the original drug, a complicating factor for potential competitors to EpiPen is that they must do more than replicate the drug itself, epinephrine. In this case, for the generic competitor to win approval, it would also need to accurately mimic the delivery device—the pen—and demonstrate that it delivers the drug at the exact same rate and in the exact same way.

"The agency creates a very high bar for satisfying its principles, and we are seeing the consequence of that, in this case, in the form of a perpetual monopoly that really shouldn't exist but for the regulatory barrier," said Scott Gottlieb, a physician and former FDA official who is now a fellow at the American Enterprise Institute. Gottlieb also serves as an adviser and consultant to several drug companies, including GlaxoSmithKline and Vertex Pharmaceuticals.

Even if Sanofi and Teva hadn't run into trouble, it's unclear what affect the products would have had on the current market. According to an FDA analysis, the second generic competitor of a product typically has a price that's around 50 percent of the original. That would mean a $300 EpiPen—which is still three times the price it cost in 2007, when Mylan acquired the product.

Publication Details