Los Angeles Times Examines FDA Funding Levels

Main Category: Public Health
Also Included In: Pharma Industry / Biotech Industry
Article Date: 12 Oct 2006 - 0:00 PDT

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An FDA study on the cardiovascular risks of attention deficit hyperactivity disorder drugs might be "halted in midstream" because the "agency doesn't have the money to finish it," the Los Angeles Times reports. According to the Times, the "threat to the study ... stems from chronic shortchanging of the nation's drug safety program" and "is one symptom of a federal agency increasingly constrained by a budget that has failed to keep up with costs." FDA has earmarked $1.6 million this year for postmarket drug safety studies, with funding expected to drop to $900,000 next year. Experts estimate that FDA needs $20 million to $100 million annually to conduct such studies. A recent report from an Institute of Medicine panel found that FDA 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." FDA's food division budget, "which tries to keep tainted foodstuffs from supermarket shelves," is "even more dire," the Times reports. The agency's food division cut its headquarter workforce from 950 employees in 2003 to fewer than 850 this year. Robert Brackett, director of the food division, wrote in a letter to industry groups that FDA "has been presented with unique challenges, and we will not be able to take on the same large number of objectives we have identified in previous years." Brackett added, "The challenges are likely to continue (in 2007) and beyond for domestic agencies in the federal government." Michael Jacobson, director of the Center for Science in the Public Interest, said, "The agency is like a fire department running around with a little fire extinguisher." He added, "The money situation for foods is probably worse than it's ever been." Recently, three former HHS secretaries, along with consumer and industry groups, launched an effort to encourage the administration to significantly boost FDA's $1.5 billion budget.

ADHD Study
FDA committed $1 million for the ADHD drug study, although agency officials estimate that $2 million to $3 million is needed. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, said, "If the FDA lacks the resources to complete the study of cardiovascular risks of ADHA drugs, the consequences can have a profound adverse impact on public health." Nissen added, "The makers of these agents have no incentive to study the hazards of their own drugs. Therefore, the FDA will likely represent the only entity capable of objectively assessing the safety of the ADHD drugs" (Alonso-Zaldivar, Los Angeles Times, 10/7).

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