FDA’s mission is again at risk and its responsibilities grow each year because Congress enacts new laws, but funding doesn’t keep pace. So warned FDA Alliance for a Stronger FDA president Diane Dorman in an address to the agency’s Science Board 2/27. Dorman said that FDA is facing a similar crisis to one foreseen in 2007 when the Science Board accepted findings and recommendations in a report by its Subcommittee on Science and Technology detailing deficiencies in the agency’s ability to meet its current or emerging regulatory responsibilities.
After the 2007 report, “and with the Alliance’s broad stakeholder advocacy, the prospects for FDA improved,” Dorman said, adding that policymakers acknowledged the underfunding and acted aggressively to reverse it. “Today, in FY 13, the FDA receives slightly more than $2.5 billion in appropriated funding. This amount, might have met the FDA’s funding needs in late 2007 when the Science Board report was issued, but not now.”
Dorman noted that since 2007, Congress has passed six new laws that have strained FDA’s resources. They are:
- Family Smoking Prevention and Tobacco Control Act (2009)
- Biologics Price Competition and Innovation Act (2010)
- Secure and Responsible Drug Disposal Act (2010)
- Combat Methamphetamine Enhancement Act (2010)
- Food Safety Modernization Act (2011), and
- FDA Safety and Innovation Act (2012),
“This is hardly the end of it,” she said, because Congress is already looking at several legislative initiatives for 2013, covering topics such as bio-security, track and trace/counterfeit products, drug compounding, and drug shortages.
Dorman told the Science Board that 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.”
Even without Congress tacking on new laws each year, FDA’s responsibilities would naturally grow each year due to globalization and scientific complexity, Dorman said. For example, she said, food and medical device imports are each growing 10% annually, and drug imports are growing even more quickly at about 13% annually.
Regarding scientific complexity, Dorman identified five areas where FDA is working to improve the review process and respond to more complex science, and “each comes at a cost in additional dollars and manpower.” They are
• Sponsors need more meeting time and other feedback from FDA
• Product applications require more patients, study sites and analysis
• Enhanced timeliness and consistency in product reviews
• Expansion of pre-and post-market safety
• Sustain and increase core programs that enhance innovation and speed approvals
And if all these challenges weren’t enough, Dorman reminded the Science Board that sequestration is the “most immediate threat to FDA’s already-inadequate funding. Just a few days from now, the agency faces a loss of 5.1% of its FY 13 (current year) budget. This is the nominal rate. The Alliance’s analysis, confirmed by OMB testimony, is that the actual impact will be close to 9%.”
