By Mark B. McClellan, M.D., Ph.D. - 03/05/07 06:10 PM EST
This year, Congress will enact legislation that will have a tremendous impact on the future of the Food and Drug Administration and its ability to save lives and improve the health of Americans. A key part of that legislation needs to be sufficient resources for the agency to do its job.
The FDA’s mandate is as broad and important as virtually any federal agency. It is charged with ensuring the safety of the drug supply, getting medical devices to market as quickly and safely as possible, and protecting families from manmade and natural food contamination.
Nevertheless, as the Institute of Medicine recently concluded, the FDA is chronically and woefully underfunded, leaving large gaps in our nation’s ability to guarantee the safety of our food and drug supply. Lack of funding also threatens the nation’s status as the world leader in medical technology innovation.
Unfortunately, the fiscal year 2008 request put forward by the administration this month doesn’t much change the picture, thanks to a tight budget environment with important competing demands on taxpayers’ dollars. The administration’s FDA request includes modest increases in the right areas, including strengthening food safety, at $10.6 million; modernizing drug safety, at $11.2 million; and medical device safety and review, at $7.2 million.
But they are insufficient to give the FDA the resources it needs. The president’s budget barely gives FDA enough funds to operate at last year’s level, and does little to make up for the steady loss of staffing that the agency has endured for the past decade. Indeed, this overstretched agency has lost 1,000 staffers over the past 10 years in their food, drug and medical device safety programs. These chronic budget shortfalls prompted leading consumer, patient, non-profit and industry groups to come together as the Coalition for a Stronger FDA to urge the administration and Congress to increase the agency’s budget in line with its increased responsibilities.
As part of a five-year process to significantly expand the agency’s budget, the Coalition is seeking $175 million in increases for 2008 over the fiscal year 2007 budget, including increases of $115 million for food safety programs, $40 million for drug reviews, and $20 million for medical device programs.
The increases will allow the FDA to build confidence in the public health system, speed innovation in medical technology, ensure the United States remains competitive in foreign markets, and boost public confidence in the agency and its mission.
Specifically, a $115 million increase in the food budget would allow the FDA to hire more food inspectors, speed approvals for safe new food technologies and products, and provide leadership in protecting the food supply from manmade threats.
A $40 million increase in the drug budget would allow the FDA to provide faster and safer approval of pharmaceuticals that are transforming health care and saving lives, promote new drug technologies that will ensure continued U.S. leadership in drug innovation, and improve the agency’s surveillance capabilities over new drugs once they reach the market.
A $20 million increase in the medical device budget would allow the FDA to give FDA the capability to oversee rapidly advancing technology in the molecular medicine, wireless systems, robotics and nanotechnology fields; and maintain balance between user fees and appropriations to assure prompt and effective approval processes; and fund the Critical Path program to improve the science of product development for devices.
Make no mistake: The FDA’s scientists and employees make it the gold standard for consumer protection in the world. They work tirelessly to ensure that food we consume, the drugs and medical devices we use, and the other products it regulates are as safe and effective as possible.
But in an environment of tight budgets and rapidly advancing technologies, the Coalition and its member organizations are deeply concerned that Congress is continually increasing the responsibilities of FDA without correspondingly increasing appropriations.
As a nation, we must make sure the FDA has sufficient resources to protect the food supply while fulfilling its mission to review and approve life-saving drug and medical device advances for patient use. The President’s budget is a good starting point, but Congress must do significantly more to give the FDA the additional funding it needs. What are the stakes? The patients with serious and life-threatening diseases who await drugs that the FDA must approve depend on our leaders to fund the process for getting those drugs to them; the industries that FDA regulate are seeking a stronger FDA, because they know that a vibrant FDA will ensure the safety of their products and create a level international playing field; but most importantly, we need to view strengthening the FDA as if our lives depend on it — because they do.
Mark B. McClellan is the former commissioner of the Food and Drug Administration and administrator of the Centers for Medicare and Medicaid Services. He is an honorary co-chairman of the Coalition for a Stronger FDA.