EpiPen Concerns Lead Republicans to Press FDA on Generic Rx Policies

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By Bronwyn Mixter

Aug. 29 — Republicans on the House Energy and Commerce Committee Aug. 29 questioned the FDA about its speed in approving generic drugs following concerns about the high price of EpiPens.

In an Aug. 29 letter, the lawmakers asked the Food and Drug Administration about the issues involved in bringing competitors to Mylan's allergy treatment EpiPen (epinephrine) onto the market. The letter was signed by full committee Chairman Fred Upton (R-Mich.), Health Subcommittee Chairman Joseph Pitts (R-Pa.) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-Pa.). Meanwhile, other House lawmakers also sent a letter to Mylan asking about the price increase of EpiPen.

Mylan has attracted scrutiny for increasing the treatment’s price 400 percent in nine years—EpiPen cost $57 for a single pen when the drugmaker bought it in 2007. The company is currently selling a set of two EpiPens for $600.

“In 2012, the Energy and Commerce Committee led the effort to pass the first generic drug user fee authorization (GDUFA) program,” the letter to the FDA said. “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 said they “are concerned about the lack of generic competition in the epinephrine auto-injector market.”

Among other things, the lawmakers asked the FDA how many applications have been filed for a generic version of EpiPen, how many of those applications have been rejected or withdrawn and how many are pending.

They requested that the FDA respond by Sept. 9.

An FDA spokeswoman told Bloomberg BNA in an Aug. 29 e-mail that the agency “is authorized to review applications for new drugs for safety and effectiveness but does not have the authority to review or approve drug prices, which are set by manufacturers and distributors.”

“We are reviewing the questions posed in the letter and will respond directly to the Congressional members,” she said.

Letter to Mylan

Reps. Jason Chaffetz (R-Utah) and Elijah E. Cummings (D-Md.) also sent a letter Aug. 29 to Heather Bresch, the chief executive officer of Mylan, requesting documents and communications regarding the increasing price of EpiPens.

Chaffetz is the chairman of the House Oversight and Government Reform Committee, and Cummings is its ranking member.

“Mylan has a virtual monopoly over the epinephrine auto-injector market,” the letter said. “While families and schools are struggling to keep up with your company’s unreasonable price increases, Mylan has profited richly from its pricing strategy.”

Chaffetz and Cummings requested documents related to the company’s revenues from sales of EpiPens since 2007, manufacturing costs and the amount of money the company receives from federal government health-care programs.

They asked Bresch to respond by Sept. 12.

Mylan didn't return a request for comment on the letter.

Josh Miller-Lewis, the deputy communications director for Sen. Bernie Sanders (I-Vt.), also told Bloomberg BNA in an e-mail that Sanders “is very concerned about the skyrocketing costs of prescription drugs and specifically EpiPens” and he “is considering next steps to stop the rising cost.”

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The letter to FDA is at http://src.bna.com/h7D .

The letter to Mylan is at http://src.bna.com/h7E.

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