President Bush is fond of saying that it’s his job to protect the citizens of this nation. Indeed, in August, he asserted: “Our most solemn duty in the federal government is to protect the American people.� In general, when the Commander-in-chief has made such pronouncements, he has been on either the offensive or defensive about his administration’s controversial policies to tackle the evil terrorists. He has not typically been emphasizing his other protective duties, which one might argue have oft been neglected, left unduly fallow by a leader who would rather erect elaborate fences than tend his flock or field. Thus do debacles such as that which tragically unfolded in the aftermath of Hurricane Katrina occur. Thus do agencies such as the Food and Drug Administration—which “is responsible for protecting the public health�—find their support withering on the vine, as evidenced by the following story in today’s Los Angeles Times:
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.
FDA officials declined to discuss problems with funding for drug safety, saying the issue was under internal review. In a statement, the agency acknowledged that more money was needed for safety and noted that funding to complete the ADHD study had “not yet been identified.�
A special fact-finding panel of the Institute of Medicine recently put the troubles in blunt terms in a report that called for significant FDA changes. Funding for drug safety is “especially inadequate [and] resource limitations have hobbled the agency’s ability to improve and expand this essential component of its mission,� the panel concluded. [full text]
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