Washington Editor
WASHINGTON - There is action under way to improve the FDA's appropriated base of funds to better balance the ratio of funds vs. user fees going forward and improve the agency's ability to handle its mission.
"The dollars no longer match responsibilities," said Steven Grossman, the executive director of a newly formed coalition called the FDA Alliance.
Given that dearth of finances, "everything suffers, because it's a systematic problem" that affects drugs, devices and foods, he told BioWorld Today. "The reality is the agency is asked to do more than it can do with the current resources."
From the drug industry perspective, an overtaxed FDA is a bottleneck in getting new therapies to patients. "Regardless of how much you put in at one end - all the science and exciting stuff we're doing - you don't get any more flow coming out of the other end," said Jeff Myers, the vice president of government affairs for Cephalon Inc.
The Frazier, Pa.-based company is one of 72 members of the FDA Alliance, which includes consumer and patient groups, professional organizations, trade associations, companies and individuals. Despite their occasionally conflicting views, Myers told BioWorld Today, "all of us can agree on one thing: The FDA is under-resourced."
So the FDA Alliance has taken up a lobbying banner to increase the appropriated money available to the agency. Its short-term efforts are centered on the FDA's 2008 budget, which already is in the works and will be unveiled early next year when President Bush presents his entire federal budget for congressional review.
A few months remain to continue the fiscal year 2008 fight, although the FDA Alliance's broader efforts seek to amend agency funding over the long haul to fix resource shortfalls across its multiple divisions. Of note, 62 percent of its current budget pays the salaries of its 10,000-plus employees.
Grossman said his coalition is reaching out to federal departments and congressional appropriations committees that have authority over the FDA's finances. The advocacy work aims to reverse a recent trend in which appropriated funds have flattened or declined while user fee-generated money has increased.
In this year's budget, which totaled a little more than $1.8 billion, about $1.5 billion came from congressional appropriations and the rest from user fees. In the budget proposal for next year, which is being finalized right now on Capitol Hill, the entire amount has increased to $1.9 billion, but $402 million stems from user fees. That means that the agency's appropriated base would essentially remain flat.
That is a problem for several reasons, not the least of which is the negative image cast by critics who contend that the FDA's ever-increasing reliance on user fees makes it too cozy with the industries it's regulating. That's a common charge in regard to its oversight of drug companies, because these days user fees cover about 53 percent of human drug reviews, according to some estimates. When they started, such fees accounted for 7 percent of those same costs.
"Those user fees were never designed to pay completely for the FDA's review of products," Myers said, but that's "likely to happen if Congress doesn't step up and really increase the resources available to the agency."
That would further undermine views of its independence and fan the flames of criticism. "That's not in the best interest of manufacturers," Myers said, "that's not in the best interest of patients, and it's not really in the best interest of Congress."
Those imbalances have grown out of several sources, Grossman said: There hasn't been a strong voice for a better FDA budget; there is a lack of appreciation for the agency's growing responsibilities in new areas such as bioterror and pandemic flu preparations; and there's a history of a lag in funding before the FDA cycles into a better period.
"Some dollars are better than no dollars," he added, "but the reality is that the problem is not going to be solved by incremental dollars at this point."
For comparison purposes, Grossman noted that the FDA's budget is about equal to that of the school system in Montgomery County, Md., where the agency is based. It gets about a quarter of the funding received by the Centers for Disease Control and Prevention in Atlanta, and its budget is only about 7 percent the size of that of the National Institutes of Health in Bethesda, Md.
"We're hoping that the FDA Alliance can really deliver this message," Myers said, "that the FDA should be an independent agency that isn't put in a position to justify resources that they're receiving to do their job."
In the end, the budget goal falls in line with other efforts seeking to strengthen the FDA on multiple fronts, some of which fall beyond the scope of dollars and cents.
Jeffrey Joseph, the vice president of communications for the Biotechnology Industry Organization (BIO), said the trade association has "had some conversations" with the FDA Alliance about its efforts to improve different aspects of the FDA even beyond budget matters.
Such enhancements, he said, could enable the FDA to "operate at its best" in protecting consumers and working with drug companies to most efficiently advance products.
BIO is contemplating whether to join the existing coalition or form a different group with other trade associations with the broad aim of more generally strengthening the FDA.
That wider effort, which has the potential to improve the agency's staffing issues, speed drug approvals and enhance transparency, among other things, could go on for years.
"The budget problems at the FDA are sufficiently broad and deep that we're happy for there to be lots of voices making the point," Grossman said.
The FDA Alliance, a 501(c)(4) nonprofit corporation based in Silver Spring, Md., prohibits current agency employees from participating in its activities.
Of note, though, seven previous commissioners are listed as members, and other past personnel have done work on behalf of the coalition.