Mylan draws heat around EpiPen cost
Controversy is bringing about a call for potential regulatory changes
If you weren’t trapped in a cave for a while toward the end of summer or taking a long hike through the Amazon rainforest or the like, you almost certainly have heard mention of the recent and vocal complaints around Mylan Inc.’s price increases over the years for the popular EpiPen product, which combines patented delivery technology with the drug epinephrine, commonly used to treat allergic reactions, including anaphylaxis, in an emergency situation.
The product, which is popular because of its efficacy and ease of use, must be replaced annually. Several years ago, that wasn’t a huge problem, with a price tag of $100 for two. But over the past several years, that price has increased to around $600 per pair, despite the fact that the product hasn’t really changed in any significant way since Mylan acquired the product from Merck & Co. in 2007. For patients—or, in many cases, parents of children who rely on the EpiPen—the increasing cost is made worse by the lack of access to any comparable generic version and the recall of a competitor, Sanofi’s Auvi-Q, in late 2015.
The pricing strategy, which has drawn comparisons to Martin Shkreli, the former hedge fund manager who raised the price on a drug to treat infections in AIDS patients by 5,000 percent, led to varying levels of comment. One of the more measured criticisms came from the American Medical Association’s president, Dr. Andrew W. Gurman, who wrote in part in August, “With Americans across the country sending their children back to school this month, many parents and schools are encountering sticker shock over the cost of EpiPens. Although the product is unchanged since 2009, the cost has skyrocketed by more than 400 percent during that period ... With many parents required to buy two or more sets of EpiPens just to keep their children safe, the high cost of these devices may either keep them out of reach of people in need or force some families to choose between EpiPens and other essentials.”
Groups like Public Citizen said much the same, but with use of words like “immoral,” “greed” and “sham solution”—that last one aimed at Mylan’s announcement that it would help deal with the affordability issue with coupons, discount cards and patient assistance programs rather than simply lowering the price. Critics were also largely unimpressed with the announcement by Mylan that it would release its own generic version of EpiPen for $300 for a pair.
Mylan was also criticized for blaming the price hikes on insurance coverage problems.
Given that we don’t often cover products once they pass trials and reach the market, why are we pointing all this out? Mainly because it is driving some calls for the U.S. Food and Drug Administration (FDA) to do something in the pre-commercialization phase of drug pipelines to help prevent near-monopolies like the EpiPen situation.
For example, Pharmaceutical Care Management Association President and CEO Mark Merritt noted that potential solutions for high drug prices that policymakers could consider include accelerating FDA approvals of drugs that face no competition and incentivizing greater use of biosimilars.
Stephen J. Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, wrote more extensively that:
“To help increase access to generic medicines, including combination products, we need the [FDA] to bolster support for the development of new combination products, such as epinephrine auto-injectors, by improving the review process and continuing its efforts to address the backlog of new generic drug applications. We should also explore financial incentives that could encourage generic entry, such as a targeted grant program to support generic manufacturing investments and maintain production for eligible products. Focusing on pragmatic solutions such as these will enhance the private market and ensure we continue to deliver innovative treatment options to patients.
“We also need to address the regulatory framework that governs the development and review of combination products. Innovator and generic biopharmaceutical companies face a range of challenges in developing combination products. These include but are not limited to: additional dosing and other scientific studies that may be required for approved medicines being delivered through the use of a device; and different regulatory paradigms for medicines, biologics and devices that result in inefficiencies and make review processes more complex as companies must work with multiple FDA review centers.
“Through the proposed Prescription Drug User Fee Act (PDUFA) VI agreement, America’s biopharmaceutical research companies support efforts that would address the hurdles in bringing new combination products to the marketplace. These include the use of an independent third-party review to improve the FDA’s combination product review process, building FDA staff capacity and access to scientific expertise and improving coordination among FDA’s review centers. Importantly, these improvements will not only enhance the regulatory framework that governs the development and review of combination products, but also increase competition.”
It is also worth noting that the Mylan controversy may bode well for existing and future alternatives to the EpiPen.
Impax Laboratories Inc. recently provided an update on its epinephrine injection, USP auto-injector, 0.15 mg and 0.3 mg, the authorized generic of Adrenaclick, with President and CEO Fred Wilkinson noting, “With all the recent news related to epinephrine auto-injection products, we are increasing our mission to inform patients, caregivers and the professional community regarding the availability of this epinephrine auto-injector product.”