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Bipartisan Legislators Claim Victory in Restoring FDA User Fees

Credits: TAP Staff

Omnibus Package Restores Sequestered Funds Vital to Medical Research, Innovation

WASHINGTON, D.C.—Reps. Leonard Lance (R-NJ) and Anna G. Eshoo (D-CA) welcomed the announcement that the omnibus appropriations package introduced by Congressional budget leaders restores $85 million in sequestered user fees paid to the Food and Drug Administration (FDA) in fiscal year 2013.  The bipartisan team has led the effort in calling for an immediate fix to reverse the sequester of FDA user fees, arguing the intent of sequestration was to curtail public spending, not private dollars spent on medical innovation. Doing so hinders the agency’s ability to meet congressionally-mandated responsibilities while putting patient safety at risk. 

“The action by the U.S. House to correct the sequester of the FDA user fees now ensures that the agency will have the tools and resources to ensure that millions of Americans will continue to benefit from medicines and medical devices that are safe and effective,” said Lance, a member of the House Energy and Commerce Health Subcommittee.  “The release of these funds will benefit patients, public health and medical innovation.”

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“I’m thrilled that the Omnibus Appropriations Act reflects the bipartisan support of Members of Congress to roll back the sequester of fiscal year 2013 user fees, and to encourage the Administration to end the practice of sequestering industry-paid fees moving forward,” said Eshoo, who is a senior member of the Energy and Commerce Committee. “Because user fees are 100 percent private sector dollars and cannot be used to pay down the deficit, it’s critical that Appropriators recognized that these funds are targeted specifically for the approval of safe and effective drugs and devices and should not be entangled in the sequester. I will continue to push the Administration to allow the FDA to access their user fees in full so that patients receive the best care possible.”

As a result of sequestration, the Office of Management and Budget (OMB) made a decision to include FDA user fees in sequestered resources despite the fact that they are not government funds and cannot contribute to reducing the deficit. User fees by law cannot be diverted to the general treasury for deficit reduction and instead sit in budgetary limbo unavailable to the FDA for human drug review or for any other purpose. 

In fiscal year 2013, sequestration prevented the FDA from utilizing nearly $85 million industry-paid user fees for the approval of new drugs and devices. Last week, Lance and Eshoo spearheaded a letter asking top congressional appropriators to exempt the FDA’s user fees from the sequester. The duo also introduced bipartisan legislation (H.R. 2725) that would exempt FDA user fees from cuts under sequestration.

The effort has been supported by a number of organizations.

  1. AdvaMed
  2. California Heathcare Institute (CHI)
  3. Medical Device Manufacturers Association (MDMA)
  4. Genentech
  5. Gilead
  6. Patient Services Inc.
  7. The National Health Council
  8. Leukemia Lymphoma Society
  9. PhRMA
  10. ALS Association
  11. BIO
  12. HealthCare Institute of New Jersey
  13. American Cancer Society Cancer Action Network, Inc.
  14. Johnson and Johnson
  15. Generic Pharmaceutical Association
  16. USAgainst Alzheimer's
  17. Bavarian Nordic
  18. American Society of Clinical Oncology
  19. Research!America
  20. NORD
  21. BIOCOM
  22. American Association of Orthopedic Surgeons
  23. National Multiple Sclerosis Society
  24. Parkinson’s Action Network
  25. National Organization for Rare Disorders
  26. USAgainst Alzheiemer’s
  27. Life Technologies
  28. GPhA

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