Tuesday, June 16, 2009

A Cure for What Ails FDA

by Margaret Anderson, COO, FasterCures

No agency is asked to do more, with less, than the Food and Drug Administration. It regulates 80 percent of U.S. food supply, every drug, vaccine, and medical device, consumer cosmetics, and could potentially now have a hand at regulating tobacco products. One entity is charged with ensuring the safety of everything from spinach to statins, produce to pacemakers, totaling over $1 trillion in consumer products; 25 cents of every dollar consumers spend in the U.S. every year. No government entity is more important than FDA to the daily lives – and safety – of Americans.

Unfortunately, the importance of the FDA is often lost in the din of political arguments over health reform. But no one is well-served by omitting FDA reform from the health reform debate; indeed, it could be argued that both the health and welfare of every American is guarded within FDA’s walls. The healthcare debate should begin with FDA. Yet, we rarely hear about FDA unless there’s a recall, or a salmonella outbreak, a political skirmish over a “controversial” drug, or when its already stretched scope is further expanded. We hope that the newly formed Transparency Task Force, in its effort to make more information available and foster better understanding of decision-making within the FDA, will also shed light on the breadth and depth of the agency's scope.

Every day, far too many patients receive diagnoses that are tantamount to death sentences, and every day, researchers uncover promising new treatments. But before any treatment can reach a patient’s local pharmacy, it must first go through the approval process. If you have a system based on rigorous standards that doesn’t have enough resources to meet those standards, either science or safety suffers.

Last February, former FDA chief counsel Peter Barton Hutt warned a Congressional panel of an agency that was “barely hanging on by its fingertips.” His comments were followed by testimony of several other experts, all of whom agreed that the agency has neither the financial nor human resources to do its job. Indeed, the FDA’s own science board arrived at the same conclusion.

We hope that the Senate’s swift voice vote approval of Dr. Margaret Hamburg as Commissioner indicates a renewed commitment to strengthening the FDA. It’s a start, and not an insignificant one. But for the FDA to maximize its effectiveness, further steps must be taken.

Once regarded as the regulatory gold standard of the world, the FDA has a way to go to come back. A New England Journal of Medicine piece co-authored by Hamburg and Deputy Dr. Joshua Sharfstein outlines the call to action. We agree with their assertions, and add these as our own:

FDA needs consistent, strong leadership. We have every confidence that Drs. Hamburg and Sharfstein will meet that overarching need. Just as important, FDA needs political and financial support from both the White House and Capitol Hill. FDA also needs to redefine its mission, streamline its institutional portfolio, and bring its IT systems into the 21st century. An updated mission, and the infrastructure to achieve it.

For too long, medical research has not been a political priority, and the tide of progress has been stemmed because of it. The FDA, charged with protecting 300 million people, has a budget that mirrors that of the school budget in Montgomery County, Maryland. Good news for Montgomery County; less so for the rest of us. FDA needs increased appropriations from Congress, especially for initiatives such as the Reagan-Udall Foundation and the Critical Path Initiative.

  • The Reagan-Udall Foundation was established to address weaknesses within the FDA’s scientific infrastructure. Though Reagan-Udall was aimed at establishing a public-private partnership to modernize medical product development, accelerate innovation and enhance product safety, Congress failed to appropriate seed funding.

  • In an effort to explain the reasons for declining productivity in the field of medical research, FDA launched the Critical Path initiative. More and more money is being spent on medical research, with fewer and fewer results. Critical Path was created to find out why. Critical Path can go a long way toward answering the question that has stymied researchers and activists: why aren’t we getting more bang for our research buck, and what can be done to fix it?

Our mission here at FasterCures is exactly what our name implies. We work to help foster a climate conducive to smart, productive medical research that doesn’t waste time or money. FDA is a critical element in the fight to save lives by saving time. We hope that Congress and the White House will work with Dr. Hamburg to provide her with the resources she needs to govern the FDA, and depoliticize the drug research process. Millions of lives are at stake, and patients shouldn’t be held hostage by politics. When elephants fight, it’s the grass that suffers.

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