cGMPs

Science Under Fire at FDA; Budget Increases Deemed Inadequate

By Agnes Shanley, Editor in Chief

Last month, an internal Science Board report on FDA found the Agency seriously underfunded and overextended, and alleged that its science base is eroding. Imbalance between demands placed on the Agency and resources at its disposal “is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public,” the report said. “Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of FDA.

As the FDA Science Board report makes clear: our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is definitely better,” commented Mark McClellan, MD, former FDA commissioner and chairman of the new Reagan-Udall Institute, which was designed to enhance FDA’s readiness for future scientific challenges.

The result of a year-long review, the 300-page report concludes that the state of FDA’s scientific and regulatory programs cannot be separated from the lack of resources. “FDA can’t improve its science, prepare for the future, or protect U.S. consumers without significant additional resources,” said Don Kennedy, PhD, former FDA commissioner and editor-in-chief of Science. “The Administration and Congress are starting now on FDA’s fiscal year (FY) 2009 budget and must fix this critical problem.”

This month, FDA is requesting nearly $2.4 billion to protect and promote public health as part of the President’s FY 2009 budget — a 5.7 percent increase over the budget FDA received for the current fiscal year. The FY 2009 request, which covers the period of Oct. 1, 2008 through Sept. 30, 2009, includes $1.77 billion in budget authority and $628 million in industry user fees.

The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. The request also includes funds to cover cost-of-living increases for FDA employees who perform the agency’s scientific and highly specialized public health mission. These investments build on the increases that FDA received for FY 2008, and will help ensure the safety of the food supply and accelerate the availability of new, safe, and innovative medical products.

Budget increases have been requested in these areas:

  • Protecting America’s Food Supply ($42.2 million)
  • Medical Product Safety and Development ($17.4 million, $79.0 million user fees)
  • Management Efficiencies

Free Subscriptions

Pharma Manufacturing Digital Edition

Access the entire print issue on-line and be notified each month via e-mail when your new issue is ready for you. Subscribe Today.

pharmamanufacturing.com E-Newsletters

A mix of feature articles and current new stories that are critical to staying up-to-date on the industry, delivered to your inbox. Choose from an assortment of different topics and frequencies. Subscribe Today.