Lack of funding plagues FDA
WASHINGTON – When scientific advisers urged the Food and Drug Administration in February to put a strong warning about suspected heart 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 disclosed in documents and interviews, stems from the 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 sum is scheduled to drop to $900,000 in the coming year. Outside experts estimate 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 see as a dangerous squeeze on the overall FDA budget. Tommy Thompson, who served in President Bush’s first term; Donna Shalala, who served under President Clinton; and Louis Sullivan, who served under President George H.W. Bush, joined consumer and industry groups calling on the administration to substantially boost – and perhaps even double – the agency’s $1.5 billion annual budget, which has seen only modest increases in recent years.
FDA officials declined to discuss the problems with funding for drug safety, saying the issue is under internal review. In a statement, the agency acknowledged that more money is needed for safety and noted that funding to complete the study on attention deficit-hyperactivity disorder – ADHD – “has 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 reforms. 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.
FDA officials estimate the study of ADHD medications, including such well-known brands as Ritalin and Adderall, will cost between $2 million and $3 million. About $1 million has already been committed to the investigation, which is being conducted by outside medical researchers.
The ADHD study is not the only example of a patchwork system.
The FDA bought – at a cost of $500,000 a year – a British database that is considered a state-of-the-art tool for drug safety research.
The General Practice Research Database contains complete medical records on 4 million patients that can be mined for information on reactions to drugs.
But the FDA has acknowledged that its drug safety office doesn’t have enough professionals – epidemiologists, biostatisticians and computer programmers – to take full advantage of the database.
The FDA’s budget crunch has also hurt its ability to safeguard fresh produce, some critics say. That has become an issue in the aftermath of the E. coli outbreak traced to California spinach. The number of inspectors and field office staff has been cut from 2,217 in 2003 to about 1,960.
“The agency is like a fire department running around with a little fire extinguisher,” said Michael Jacobson, director of the Center for Science in the Public Interest, a nutrition advocacy group. “The money situation for foods is probably worse than it’s ever been.”
Earlier this year, the FDA’s food division announced that budget pressures have forced cuts in its headquarters workforce from 950 in 2003 to fewer than 850, with further reductions expected.