Washington DC—Oregon’s Senator Jeff Merkley today questioned a top official at the Food and Drug Administration (FDA) about the FDA’s role in the generic drug marketplace in light of the dramatic increase in the price of EpiPens this summer.
At the hearing, Senator Merkley asked the FDA’s Director of the Center for Drug Evaluation and Research Dr. Janet Woodcock how pharmaceutical company Mylan became the only major player in the market for EpiPens, how generic drugs can help drive down the cost of healthcare and how appropriators and the FDA can work together to clear the backlog of 4,000 generic drugs awaiting approval. As the Ranking Member on the Senate Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Senator Merkley is a key decision maker in overseeing the FDA.
Merkley said, “Something is terribly wrong when the dose of a drug costs one dollar, but a pre-loaded injector costs $600. Yet that is exactly the case with EpiPens. This dramatically demonstrates the need for FDA to have a functional accelerated pathway for the approval of generic competitors. It shows the repercussions of one major player having too much power within a market. We need generic drugs to serve as a viable and affordable alternative. Every family deserves access to affordable, quality healthcare—especially when it comes to lifesaving drugs.”
This summer, Mylan raised the price of its lifesaving product, the EpiPen, to more than $600 for a pack of two. In 2010, the same product was available for around $100. EpiPen’s major competitor was fully recalled from the market in October 2015 because of dosing issues, making Mylan the only major player left in the market. Epinephrine, the actual drug in EpiPens, is extremely inexpensive – about $1 per dose.
Around 43 million people in the United States, and one in 13 children, are at risk for anaphylaxis, and the EpiPen is their best option.
This summer’s EpiPen crisis drew attention to the lack of less expensive generic alternatives—for EpiPens and thousands of other drugs. Generic drugs significantly drive down the cost of healthcare. Eighty-eight percent of prescriptions filled in the U.S. in 2014 were filled using generic drugs, but generics only account for 28 percent of total drug spending. In 2014, generic drugs produced $254 billion in health system savings. However, the FDA Office of Generic Drugs, the arm of the FDA responsible for approving all generic drugs, currently maintains a significant backlog of drugs awaiting approval. Since 2012, generic drug applications submitted to FDA have grown significantly. The backlog is now around 4,000.