Is the U.S. Food and Drug Administration’s historic mission being jeopardized because it’s under funded? Diane E. Dorman, president of the Alliance for a Stronger FDA, recently provided testimony supporting that assertion at a recent a FDA Science Board hearing. The Alliance believes the agency’s historic mission is again “at risk” due to severe underfunding and increasing responsibilities legislated by Congress.
According to Dorman, the FDA has been shorted financially for years: “When we started in 2006, FDA appropriations stood at slightly less than $1.5 billion for an agency tasked with overseeing 100% of drugs, vaccines, medical devices, and personal care products and 80% of our nation’s food supply. Altogether, the products and industries regulated by FDA account for nearly 25% of all consumer spending in the United States. In short, FDA was the victim of decades of underfunding.”
She offered that, with the Alliance’s support and through advocacy, the FDA improved and that policymakers acknowledged the underfunding and acted aggressively to reverse it. Noting that in FY 13, the FDA receives slightly more than $2.5 billion in appropriated funding, Dorman exclaimed “This amount, might have met the FDA’s funding needs in late 2007 when the Science Board report was issued … BUT NOT NOW.”
Unfortunately, she pointed out “$2.5 billion is dramatically less than the amount the FDA needs.” She concluded this portion of her remarks saying “Even without the possibility of funding cutbacks, the American people will lose if FDA does not receive increased funding.”
Two months before the Science Board declared FDA to be “an agency at risk,” said Dorman, the FDA Amendments Act of 2007 was signed into law, renewing the prescription drug and medical device user fee programs. It added a slew of new responsibilities, notably in food and drug safety, regulatory science, clinical trial registries, and establishment of a program for risk evaluation and mitigation strategies for new drugs.
“FDA’s efforts in the critical area of drug reviews and approvals were slowed substantially for nearly two years,” remarked Dorman. “The new responsibilities--combined with delays in funding of existing and new programming--had severe consequences.” Since 2007, Congress has identified a number of new needs that fall within FDA’s jurisdiction. Some six new laws have been passed in the intervening five years:
1. Family Smoking Prevention and Tobacco Control Act (2009)
2. Biologics Price Competition and Innovation Act (2010)
3. Secure and Responsible Drug Disposal Act (2010)
4. Combat Methamphetamine Enhancement Act (2010)
5. Food Safety Modernization Act (2011), and
6. FDA Safety and Innovation Act (2012), including re-authorization of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
Dorman pointed out that this is hardly the end of it. According to her, Congress is already looking at a number of legislative initiatives for 2013, covering topics such as:
• Bio-security
• Track and trace/counterfeit products,
• Drug compounding, and
• Drug shortages.
“Ultimately,” said Dorman, “the real problem is Congress’ failure to acknowledge FDA as a funding priority despite the austere budget environment. Transforming FDA’s mission and responsibilities needs to be met by the necessary resources to do the job well. The current appropriations level is totally inadequate to make up for decades of underfunding AND all of the new laws enacted since 2007. … Is FDA’s mission again at risk? Absolutely, yes. And those who have the most to lose are the American people."