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FDA Official Details Challenges of Approving EpiPen Generic at Senate Hearing

A Wednesday Senate hearing about how the Food and Drug Administration plays a role in the generic drug marketplace shifted in large part to a company whose CEO was testifying across the Capitol.

While Mylan CEO Heather Bresch was testifying before a House Oversight panel about the rising cost of EpiPens, Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration, told the Senate Appropriations Subcommittee focused on agriculture and the FDA that it was often difficult for the agency to approve the first generic drugs to enter the market.

While the agency and Congress have taken steps in recent years to try to speed the approval process for generic drugs to bring more competition to the pharmaceutical market, challenges still remain to do so. The agency still has a “backlog” of drugs waiting to be approved, and though officials say it is growing shorter, Woodcock said the agency still isn’t where it could be.

In the past year, lawmakers have called for more competition to drive down pharmaceutical prices, pointing to the generic drug program as an obvious solution. Similar calls have come since news broke last month of the list price of EpiPens rising more than 400 percent since Mylan acquired the product in 2007.

“I have an interest in working to ensure that drugs are available to all Americans at affordable prices,” Sen. Jerry Moran (R-Kans.) said in an opening statement. “The FDA’s role in the drug approval process is critical to expanding the pharmaceutical market and driving down costs for consumers.”

Lawmakers on both sides of the aisle suggested during the hearing that more competition to compete with Mylan’s EpiPen was necessary. They questioned why other forms of epinephrine that the FDA has approved aren’t marketed like EpiPens.

One reason lies in Mylan’s patents around its autoinjector device that last until 2025, Woodcock said.

Other companies have had to pull EpiPen competitors off the market, one because of performance problems, she said. One of the reasons that generic drugs are slow to come to market is that the agency is rarely able to approve generic drugs on their first application, Woodcock said.

“It’s possible to approve drugs very rapidly if in fact the application meets our standards, but we can’t approve substandard generic drugs,” she said. “It would erode the confidence of the public in the generic drug program.”

Instead, the agency often returns a report to drugmakers with a list of things that need to be improved or fixed with an application for the agency to approve the product.

Woodcock suggested to Sen. Susan Collins (R-Maine) that if Congress were to pass legislation with too many steps involved in an effort to increase competition in the market, they could ultimately slow down the process if the legislation is too complicated. A bill that required several steps could give drug companies more opportunities at which they could sue the agency or submit a citizen petition which could ultimately delay the availability of a product.

Collins chairs the Senate Special Committee on Aging, which has been conducting an investigation into rising drug costs this year.

“Many of these drugs are so valuable that companies will do a great deal to delay generic competition,” Woodcosk said. “So I think in considering what you might do about this this … fines and everything might simply be considered the cost of doing business because there’s so much at stake in delaying generic competition.”