Committee Continues Investigation into Drug Pricing, Seeks Documents from FDA on Generics Applications

Published: Dec 15, 2015

WASHINGTON—After months of reviewing the drug approval process and consumer price increases, Oversight Committee Chairman Jason Chaffetz (R-UT), along with 12 Committee members, sent a letter to U.S. Food and Drug Administration (FDA) Acting Director Stephen Ostroff, M.D. today, requesting documents and information on the FDA’s process for reviewing generic drug applications.

Throughout this year, bipartisan Committee staff have met with a wide range of stakeholders, including pharmaceutical manufacturers, insurance companies, pharmacy benefits managers, trade groups, the FDA, the U.S. Government Accountability Office, the U.S. Department of Health and Human Services, and more. A recurring theme points to declining competition in the marketplace due to barriers to entry for generic drugs. This raises questions about the FDA’s process for approving generic drug applications.

Key excerpts from the letter are below:

“Recent significant price increases for certain generic drugs, however, will make health care more expensive for patients, who will ‘pay more in copayments and premiums to cover the rising costs of drugs.’ Industry analysts have cited ‘declining market competition’ as one of the factors driving the recent price increases. This raises questions about the efficiency of the Food and Drug Administration’s process for reviewing Abbreviated New Drug Applications (ANDA).

“Under the Generic Drug User Fee Amendments of 2012 (GDUFA), the FDA will receive approximately $1.5 billion over five years from industry fees to speed the public’s access to safe and effective generic drugs. To help the Committee understand the FDA’s process for reviewing generic drug applications, please provide the following documents and information…

“Over the past year, resale prices of priority review vouchers (PRV) have climbed from $67.5 million to $350 million. Skyrocketing PRV resale prices, and the recent acquisition of KaloBios, have raised questions about potential exploitation of the PRV Program by those who may be applying for PRV not to develop new therapies but rather solely to capitalize on the PRV resale market. Please provide all documents and communications referring or relating to any FDA investigation, FDA’s enforcement mechanisms to address such conduct, and steps by the FDA to prevent abuses of the PRV Program.”

Click HERE to see the full letter.

The letter is signed by:

Chairman Jason Chaffetz (R-UT)
Oversight and Government Reform Committee

Chairman Will Hurd (R-TX)
Subcommittee on Information Technology

Chairman Jim Jordan (R-OH)
Subcommittee on Health Care, Benefits, and Administrative Rules Chairman

Chairman Mark Meadows (R-NC)
Subcommittee on Government Operations

Chairman Cynthia Lummis (R-WY)
Subcommittee on the Interior Chairman

Chairman John Mica (R-FL)
Subcommittee on Transportation and Public Assets

Rep. Rod Blum (R-IA)
Member of Congress Rep.

Rep. Scott DesJarlais (R-TN)
Member of Congress

Rep. John Duncan (R-TN)
Member of Congress Rep.

Rep. Jody Hice (R-GA)
Member of Congress

Rep. Glenn Grothman (R-WI)
Member of Congress

Rep. Buddy Carter (R-GA)
Member of Congress

Rep. Gary Palmer (R-AL)
Member of Congress