The Food and Drug Administration sought to defend itself from critics who say it has played a part in the soaring cost of the EpiPen allergy treatment.
The head of drug regulation said Wednesday that the FDA has a part to play to ensure generic competition and drive down costs. Republican lawmakers have criticized the agency because the EpiPen has no generic competition, letting the manufacturer, Mylan Pharmaceuticals, raise the price to $600.
“The good news is that the FDA has already approved four epinephrine auto-injectors to treat anaphylaxis in an emergency, and two are currently marketed,” said Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, in a blog post Wednesday.
However, Woodcock doesn’t mention that the main competitor was recalled last year due to safety concerns.
Currently the “EpiPen does not have any FDA-rated therapeutic equivalents,” Woodcock said.
She pointed to moves the FDA has made to encourage manufacturers to develop new auto-injectors. These include a 2013 regulatory guidance offering advice on how to design and test the product and February guidance on how to determine if patients can use the device effectively.
The agency also prioritizes and expedites review of generic drug applications if they are the first application for a brand name drug, “making sure that the first applicants to make a generic are moved to the head of the queue and given priority review.”
That likely would have little impact on sparking EpiPen competition because the drug has been generic for decades.
Woodcock said the FDA doesn’t regulate drug prices, only ensures that medications are safe and effective. Some critics have said that the agency should take into account value when approving new products, as to help control prices.
The agency has worked to improve the generic drug approval process through a new user fee program. Under the program, a generic drug maker pays the agency a fee every time it submits an application and the agency uses that money to hire more reviewers and speed up approvals.
As part of the program, the FDA has promised to tackle a backlog of thousands of generic drug applications. As of July 1, the FDA has 4,036 applications it needs to look at, according to agency data.
The FDA will likely have to defend its generic drug approval process next week during a hearing before the House Oversight and Government Reform Committee. The agency’s deputy director of the Center for Drug Evaluation and Research is expected to testify with Mylan CEO Heather Bresch.
