Editorial: Wrong people to underfund
Thursday, Oct. 12, 2006 | 7:24 a.m.
The Food and Drug Administration is struggling to finish an important study on medications that treat attention deficit disorder. Why? Budget woes.
Unfortunately, that troubling revelation reported by the Los Angeles Times is just one example of a broader story that is cause for immediate alarm - the FDA doesn't have the money to do its job. One indicator:
The FDA has set aside a mere $1.6 million for safety studies of medications currently on the market - and it plans to trim $900,000 of that next year, the Times reported. Nonagency experts estimate the FDA needs far more, perhaps $20 million to $100 million a year.
The agency's drug safety budget is "especially inadequate, (and) resource limitations have hobbled the agency's ability to improve and expand this essential component of its mission," according to a report from the Institute of Medicine.
Demands on the agency have far outpaced modest budget increases at the agency in recent years. For example, the FDA has been flooded by a spike in reports about bad drug side effects, perhaps reflecting the public's increased use of prescription drugs, expanded awareness about drug risks, and better reporting, the Times reported.
The ADHD drug study is a telling example. Some scientists are concerned about the effects of the drugs on the heart. The medicines, mostly used by children but increasingly by adults, often help patients concentrate.
But the drugs are known to raise blood pressure, which can be a risk factor for heart disease and stroke. The FDA has hired researchers to examine patient records to analyze whether drugs that include Ritalin and Adderall may predispose patients to heart problems. But the agency only has $1 million for the study and it needs $2 million to $3 million.
What's going on? FDA officials decline to talk about funding shortages for drug safety programs, saying the matter is under review. But outsiders say the problem is real. Three former secretaries of health and human services from the Bush, Clinton and George H.W. Bush administrations recently backed consumer and industry groups that urge a massive increase - perhaps a doubling - of FDA's $1.5 billion annual budget.
We add our voice to the urgency. The FDA's work directly affects our daily lives. It regulates the food and medicine we ingest. We eat our food, take our pills - and trust the FDA is protecting us from harm.
The agency should promptly complete an honest, thorough accounting of its funding needs and Congress should meet them.
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