On September 21, 2016, the U.S. House Oversight and Government Reform Committee held a hearing to discuss the rising price of EpiPens. The two witnesses at this hearing were Heather Bresch, the Chief Executive Officer of Mylan, Inc., and Dr. Doug Throckmorton, the Deputy Director of the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA).
Most of the questions from the members of the committee were directed at Ms. Bresch. Committee members repeatedly emphasized that EpiPens and the drug they inject are a life-saving product, making them a vital purchase for families across America. As the topic of the hearing suggests, Ms. Bresch was called on to provide information to the committee about the drastic price increase in EpiPens since the product was acquired by Mylan in 2007. The cost for a pack of 2 EpiPens in 2007 was about $100 and the current price sits over $600. When asked, Ms. Bresch stated that Mylan receives an average of $274 in per-pack revenue but when various costs are taken out of this figure, the per-pack profit that Mylan sees is $100. However, on Monday, September 26, Mylan stated in a new regulatory filing to the Securities and Exchange Commission (SEC) that the company makes approximately $166 per-pack in profit. Multiple members of the committee lamented a lack of transparency not only from Mylan but also in the entire drug acquisition and pricing processes.
While facing criticism for the rising prices of EpiPens, Ms. Bresch mentioned the patient assistance programs that Mylan has in place and placed repeated emphasis on a generic version of EpiPen that Mylan plans to introduce at $300, a move that she characterized as “unprecedented.” However, this product still needs final FDA approval and Ms. Bresch stated that they hope to make it available by the end of the year. In addition, Ms. Bresch discussed efforts that Mylan has made to place EpiPens into schools. However, Ms. Bresch has received criticism for a potential conflict of interest in this effort. Ms. Bresch’s mother, Gayle Manchin, was head of the National Association of State Boards of Education in 2012 when Ms. Manchin led efforts that encouraged states to require that schools purchase devices that fight anaphylactic shock. Ms. Bresch’s father is Senator Joe Manchin (D) from West Virginia.
Dr. Throckmorton was also questioned by the members of the committee. Some members of the Committee expressed disappointment in the approval process at the FDA, stating that the FDA process was too slow and that it could be contributing to a lack of competition in the marketplace. The questions for Dr. Throckmorton often focused on the backlog of generic applications that the FDA had. Dr. Throckmorton stated that there were about 100 applications remaining in the queue from 2012 and that beginning in October, the FDA is committing to a 10-month time frame for new applications. In addition, Dr. Throckmorton said that the FDA is currently reviewing around 2,300 generic drug applications.
The full hearing can be watched here.