Advocacy Groups Seek Increased Government Funding for FDA

Making the case that FDA does not have the necessary resources to fulfill its mission of protecting the public health, two organizations recently emerged to lobby the Bush administration and Congress to increase yearly appropriations for the regulatory agency. The FDA Alliance (Silver Spring, MD) was formed in April, and the Coalition for a Stronger FDA (Washington, DC) was launched last month.

The alliance includes seven former FDA commissioners, and the coalition is cochaired by the three most recent secretaries of the U.S. Department of Health and Human Services (HHS; Washington, DC).

“The members of the coalition understand that a stronger FDA is critical to not only protecting the food supply, but also ensuring that the next generation of medical innovations reach the market quickly, and are as safe and effective as possible,” said Tommy G. Thompson, coalition cochair and former HHS secretary.

The coalition announced its formation just three days after the Institute of Medicine (Washington, DC) issued a report on drug safety that cited FDA as being “severely underfunded.” The report—of which FDA was one of the sponsors—urged Congress to substantially increase both funding and personnel for the agency through appropriations from general revenues.

Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO; Washington, DC), a coalition member, expressed concern about the increasing reliance on user fees to fund FDA's work. “If this high rate of corporate funding continues, it will undermine public confidence in FDA's independence,” he said. “While user fees play a key role in providing multiyear predictability and stability for FDA, they were never intended to replace annual federal appropriations.”

Representative Maurice Hinchey (D–NY) concurred. “The way the user fees have been constructed has really corrupted the process of oversight by FDA and broken down the arms-length relationship that should exist between the regulator and the regulated,” he said. Hinchey has introduced a bill that would revise the system by building firewalls between industry and FDA.

“FDA has been underfunded and understaffed for many years, and it is time for Congress to recognize the importance to public health of a strong and vibrant FDA,” said Wayne Pines, former FDA associate commissioner and FDA Alliance board member. Pines is currently president of regulatory services and healthcare at APCO Worldwide (Washington, DC), a communications consultancy.

FDA Alliance executive director Steven Grossman added, “Americans are often surprised that FDA does not have more resources. FDA's budget is about the same as the budget of the Montgomery County, MD, school system, where FDA headquarters is located.”

Both the coalition and alliance include representatives of patient, consumer, and industry groups. Although the groups' concerns are primarily focused on FDA's role in drug approval and oversight, the device industry will be represented by both AdvaMed (Washington, DC), a member of the coalition, and the Medical Device Manufacturers Association (MDMA; Washington, DC), which has joined both groups.

“AdvaMed is proud to be a part of the Coalition for a Stronger FDA and looks forward to working with the coalition to fulfill its goals,” said AdvaMed president and CEO Stephen J. Ubl. “The complexity and speed of medical technology innovation continues to increase, but unfortunately FDA funding levels have not kept pace. In order for FDA to continue to protect and promote the public health as it does, it is imperative the agency be given adequate resources to do its job.”

“These nonpartisan, nonprofit coalitions are advocating for increases in FDA resources, including appropriations, information technology, human resources, and personnel retention,” said Mark Leahey, MDMA executive director. “MDMA looks forward to being an active participant in these groups and ensuring that FDA has the resources it needs.”

FDA user fees for both drugs and devices are up for congressional review in 2007.

FDA's regulatory oversight—which includes food, drugs, cosmetics, medical devices, veterinary products, and other goods—represents about 25% of every consumer dollar spent in the United States. The agency's budget for fiscal 2007 is $1.8 billion, an amount the alliance and coalition consider inadequate given the range and scope of the agency's responsibilities.

© 2006 Canon Communications LLC

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