- Despite promises the Affordable Care Act (ACA) would lower health care costs, the ACA has exacerbated the costs of prescription drugs as consumers shift to high-deductible plans.
- The price for a two-pack of EpiPens has increased more than 500 percent in the last decade, rising from $100 to more than $600.
- A lack of transparency exists in the drug-pricing market and Mylan’s finances and figures did not add up under scrutiny.
- The epinephrine auto-injector market lacks the competition necessary to lower costs for consumers. FDA could not reveal how many applications for new entrants into the epinephrine auto-injector market are pending or how long those applications have been in process.
- To examine the steep price increases in the EpiPen product.
- To examine the FDA’s role in promoting competition in this market and impediments to the timely review and approval of new entrants
- Mylan’s Epipen has a dominant market share of epinephrine auto-injectors and additional entrants face a complex regulatory framework at FDA.
- Generic drugs play an important role in offering affordable alternatives to costlier brand named drugs like the EpiPen.
Oversight and Government Reform Committee Chairman Jason Chaffetz (R-UT): “It’s unprecedented to raise the price 500 percent, so you’re raising it to lower it but your net revenue goes up.”
Rep. Mick Mulvaney (R-SC): “So if you can really charge $600 for it and people will pay for it, why aren’t more people rushing in to make this stuff, so they get a piece of this huge market? Because it’s too hard to get the darn stuff approved and that’s what I wish we were talking about.”
Rep. Tim Walberg (R-MI): “Won’t this in fact just shift the full cost of EpiPens to government payers such as Medicaid, Medicare, health insurers, employers, eventually leading to an overall increase in premiums and other co-pays of consumers?”
Witnesses and testimonies
|Heather Bresch||Chief Executive Officer||Mylan, Inc.||Document|
|Dr. Doug Throckmorton||Deputy Director, Center for Drug Evaluation and Research||Food and Drug Administration||Document|