Change for America on Science and Tech Policy, Part 3: The FDA

One out of every four dollars Americans spend goes toward products the safety of which rests in the hands of the Food and Drugs Administration. But as Virginia Cox points out in her chapter on the agency in the forthcoming book Change for America: A Progressive Blueprint for the 44th President, “Consumers today are understandably skeptical about the safety of their food and medical products, yet the [FDA] is struggling to keep pace with breakthroughs in science, an expanding global market, and years of underfunding.”

Change for America is a joint project between CAP’s sister organization, the Center for American Progress Action Fund, and the New Democracy Project, and offers recommendations for the next president and administration on priorities for a broad swath of executive branch departments and offices. Cox spent nearly a decade at FDA and the Department of Health and Human Services, and is now senior vice president at the Consumer Healthcare Products Association. Her recommendations focus on restoring the reputation of this embattled office, which has lost more than 1,000 scientists over the past few years in the face of insufficient funding and a mushrooming workload. Here’s a look at some of the key guidance she offers:

Increase Funding and Recruit and Retain a Workforce That Can Keep Pace With New Technological Demands

“Less than 4 percent of [the FDA's] workforce is under 30 years of age, and 44 percent are over 50,” she explains. “Almost 50 percent of its managers and supervisors are eligible for retirement in the next five years.”

Protect the Food Supply

The agency released a comprehensive Food Protection Plan in November 2007, but in the intervening year, the Bush administration declined to request funding for implementation. Cox recommends that the president-elect and his transition team work with Congress to appropriate the necessary funding and give FDA the necessary authority to implement the plan. Moreover, FDA should implement science-based controls for food safety monitoring and require that manufacturers can regularly assure the FDA that they are producing safe products. Food safety is important to avert contamination like the salmonella outbreak of this year, and the potential for a bioterrorism attack on the food supply is all the more reason to act.

Improve Drug Safety

The new administration must, within its first year in office, make sure that the FDA implements plans to conduct more thorough postmarket monitoring to ensure that drugs are still safe after they’ve gone on sale to the public.

Reduce Risk From Abroad

“A recent GAO report showed that 80 percent of all drugs sold in the United States are made, in whole or in part, overseas,” Cox writes, and FDA needs to make sure that those pharmaceuticals and other products are safe before they enter the United States. “The new administration will need to develop and implement a comprehensive risk-based approach to overseeing foreign inspections.”

Long-Term

Beyond the first year in office, Cox argues that FDA must set up protocols to ensure the safety of products made from cloned or genetically engineered animals (an issue Rick Weiss has covered here and here). As well, the agency must adapt to assure the safe and environmentally-friendly use of nanotechnology (see Weiss’s coverage here and here) and monitor the judicious application of genomic research for personalized medicine (Weiss, again).

Finally, FDA has an important role to play in addressing the deceleration of drug development through its Critical Path Initiative, which is designed “to help modernize the drug-development system by creating a process to identify new critical therapies, to prioritize innovation, to work with the nongovernmental scientific community, and to streamline processes,” but requires administration support to move forward with a more detailed plan.

For full listing of chapters in the book, including several that are available for download now, in advance of the January 5 release, visit the CAPAF project page.

Tags: FDA, pharmaceuticals, transition

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