By Phyllis Greenberger, MSW, President and CEOSociety for Women's Health ResearchWashington, D.C.
Newswise — The Society for Women's Health Research, a Washington, D.C., based advocacy organization, joined with more than 20 organizations and the three most recent past secretaries of the U.S. Department of Health and Human Services to form the Coalition for a Stronger FDA on Sept. 25.
It is a coalition of bipartisan public servants, patient advocacy groups and industry leaders. These diverse groups rarely agree on anything, which is why our nation's political leaders need to pay attention. All coalition members believe the FDA needs more support from Congress and the urgency of our message grows each day.
In lass than a month since the coalition's launch, we have seen mounting evidence that the FDA simply doesn't have the money it needs to fulfill its mission of protecting public health by ensuring the safety of our food supply and medical products.
Five current or former members of the FDA's Drug Safety and Risk Management Advisory Committee just called for Congress to overhaul the agency. Writing in the Oct. 11 issue of the Archives of Internal Medicine, they echo what the coalition and others have said: the FDA's lack of money, lack of authority, and related internal problems affecting leadership, morale and general operations cripple its effectiveness.
A recent Los Angeles Times investigative report demonstrates the real impact of FDA's problems. The agency may not have the money to complete an important study about suspected cardiovascular health risks in attention deficit disorder drugs taken by millions of American children and adults. This is unacceptable. Safety studies, prompted by concerns of the FDA's leading scientific advisors, should not be shortchanged. Getting the answer wrong " or not getting the answer at all " can mean life and death when it comes to medical treatments.
The FDA has also disclosed that nearly two percent of prescriptions dispensed in the United States last year were for unapproved medicines. The FDA claims it is now cracking down on the problem of unapproved drugs, but without better funding from Congress, it cannot be the watchdog we expect.
The FDA regulates the products that account for 25 cents of every dollar we spend as consumers, but its budget is just a quarter of what the Centers for Disease Control and Prevention receives and less than half that of the Chicago public school system.
Given its chronic funding problems, it is not surprising the FDA has yet to fully enter the information age. The agency still uses a manual paper system to gather post-market reports on the adverse effects of treatments. This hampers the agency's ability to conduct research, including analysis for sex and gender differences, which is critical to understanding if a treatment affects women and men differently.
The Society was successful in securing funding for the Office of Women's Health at the FDA to build a database for the purpose of tracking sex differences, but the data it needs to function properly is stuck in an outdated paper system or in systems that don't communicate well with each other. We have to improve these processes so that researchers, doctors and patients can get the information they need faster.
The responsibility for strengthening the FDA ultimately lies with Congress, and the situation will not improve without better financial support. The FDA's problems are not a case of money misspent or priorities misplaced. The agency's funding has not kept pace with inflation, while its responsibilities have expanded. The longer we wait, the more difficult it will be to protect patients and consumers and restore the public's confidence and trust in this beleaguered agency. For the sake of our collective health and safety, now is the time for Congress to act.
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