Upton leads committee probe of generic drug regulatory process

U.S. Rep. Fred Upton (R-MI) led congressional efforts on Monday to glean answers about the FDA’s regulatory process for approving generic drugs.

Upton, the chairman of the House Energy and Commerce Committee, led the efforts following revelations that the cost of the EpiPen has soared in recent years.

Upton and U.S. Reps. Joseph Pitts (R-PA), chairman of the Subcommittee on Health, and Tim Murphy (R-PA), chairman of the Subcommittee on Oversight and Investigations, sought answers in a letter to FDA Commissioner Robert Califf.

“In 2012, the Energy and Commerce Committee led the effort to pass the first generic drug user fee authorization (GDUFA) program,” the committee leaders wrote. “The goal of the legislation was to expedite the review of abbreviated new drug applications (ANDAs) and clear the backlog of applications at the agency. Improving the generic drug review process will promote competition and ultimately lower the cost of prescription drugs for America’s patients.”

The lawmakers voiced concerns about a lack of generic competition in the epinephrine auto-injector market and questioned how FDA policies could be inhibiting competition in the generic drug market.

Upton, Pitts and Murphy questioned how many ANDAs had been submitted that relied on Mylan Specialty’s EpiPen as the reference drug, and whether the FDA had prioritized review of ANDAs referencing the EpiPen.

The letter also sought a detailed explanation of how the FDA considers whether to approve an ANDA.