FDA Budget Malnourished
A study of ADHD drug risks may be halted as the agency struggles to keep up with demands.
By Ricardo Alonso-Zaldivar, Times Staff Writer
October 7, 2006
WASHINGTON — When scientific advisors urged the Food and Drug Administration in February to put a strong warning about suspected cardiovascular risks on attention-deficit drugs taken by millions of children and adults, agency officials said more clinical evidence was needed.
Now, the FDA-funded study meant to authoritatively answer questions about the drugs for attention-deficit hyperactivity disorder may be halted in midstream. The reason: The agency doesn't have the money to finish it.
The threat to the study, as revealed in documents and interviews, stems from chronic shortchanging of the nation's drug safety program. It is one symptom of a federal agency increasingly constrained by a budget that has failed to keep up with costs. This crunch is even more dire in the food division, which tries to keep tainted foodstuffs from supermarket shelves.
Even as concerns grow, the agency has budgeted only $1.6 million for such safety studies of medications already on the market, and that number is scheduled to drop to $900,000 in the coming year. Outside experts estimate that the agency needs $20 million to $100 million a year to conduct such studies.
Recently, three former secretaries of Health and Human Services sounded a public alarm about what they saw as a dangerous squeeze on the overall FDA budget. Tommy G. Thompson, who served in President Bush's first term; Donna Shalala, who served under President Clinton; and Louis W. Sullivan, who served under President George H.W. Bush, joined consumer and industry groups in calling on the administration to substantially boost — perhaps double — the agency's $1.5-billion annual budget, which has increased only modestly in recent years....
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