Washington Editor

WASHINGTON - After digesting the proposed FDA budget for fiscal 2008, advocates for more funding called the $2.1 billion request a good start in what's widely considered a tight financial environment.

"The president deserves credit," said Steven Grossman, executive director of the FDA Alliance. "On paper, this exceeds the break-even number of $80 million to $100 million to keep programs and staff intact and begins the process of strengthening the agency."

His conclusion, that the new request is about $120 million more than the FDA would receive in this current fiscal year, is based on a comparison to the nearly $2 billion in budget money that would finance its operations under an amended continuing resolution that the House of Representatives recently passed. It's soon expected to clear the Senate, too, and become law.

But Grossman is calling for more funding to get the FDA into a "long-term growth pattern" over the next five years. The money is needed for the FDA to "fulfill its mandate and be innovative in its approach" to regulation, oversight, inspections, approvals and monitoring, a full plate of responsibilities that many believe are chronically under funded, he said.

To get there, he told BioWorld Today, Congress should provide another $100 million to $125 million in appropriated funding for fiscal 2008.

That would boost the agency's total budget to the $2.2 billion-plus recommended by the FDA Alliance, an association of consumer and patient groups, professional organizations, trade associations, companies and individuals who include seven previous FDA commissioners.

That $2.2 billion includes money needed continue operating at current levels - the aforementioned $80 million to $100 million needed each year for mandated pay raises, rent increases and other upkeep costs - plus another $150 million to $170 million above that level.

These sentiments were echoed the Coalition for a Stronger FDA, a diverse group comprised of consumer advocates, non-profit organizations, patient groups and industry associations with food and healthcare interests, as well as the last three secretaries of the Department of Health and Human Services.

Calling the proposed FDA request "a step forward," Bill Hubbard, a former associate commissioner of the FDA and now a senior advisor to the coalition, said his group "hopes for more in the future, and we intend to be lobbying Congress for substantially increased appropriations."

As part of its five-year plan to expand the agency's budget, the coalition is seeking $175 million in increases for fiscal 2008 over the last budget proposal of almost $2 billion, which it used as the basis of its comparison, including a $40 million boost for drug reviews.

Hubbard said the extra funding would provide faster and safer product approvals, promote new drug technologies, enhance the FDA's post-approval surveillance capabilities and further integrate emerging science into the regulatory process.

The coalition is promoting the promise of efficiency in the drug development and regulatory pathways. Despite speedy product reviews these days, drugmakers aren't generating a corresponding number of new approvals, and Hubbard told BioWorld Today that partnerships between the FDA and the industry on clinical trial designs and biomarkers, for instance, would identify "the winners sooner and nurture those through the finish line."

That benefits patients, who could get newer therapies more quickly, and drug companies, that could drop unpromising product candidates more swiftly. "Everybody's a winner," Hubbard said.

"We believe that if the drug program got $40 million each year for the next five years, so that by the fifth year you had an increase in that program of $200 million, you would have the capacity to deal with these drug safety concerns and the capacity to develop this Critical Path concept," he added.

For members both the alliance and the coalition, the advocacy work next moves to Capitol Hill. President Bush's budget proposals are moving to both chambers' budget and appropriations committees. Hubbard's group already has briefed the FDA's authorizing committees, which don't have power over the funding but are nonetheless important to the process.

"So far, we've had a very polite reception," he said. "You never know until the process is over how much success you've had, but every little bit helps."

So far, Grossman said both coalitions' efforts seem to be paying off, given the higher fiscal 2007 level for the FDA through the amended continuing resolution while most other government agencies are being held flat at fiscal 2006 levels.

"The two advocacy organizations," he added, "are having an impact in terms of getting people to think about this and think about its consequences."

The committees typically hold hearings and markups over the spring and wrap their budget work and vote in the summer, ahead of beginning the next fiscal year on Oct. 1.

The proposed FDA budget includes a little more than $1.6 billion in discretionary budget authority, supplemented by nearly $444 million in various user fees. Included in the total is $571 million for human drugs and $216 million for biologics, with industry-specific user fees to cover $307 million of those costs. The budget request also calls for $139 million in drug safety-related funding.

President Bush's total $2.9 trillion budget proposal for fiscal 2008 largely avoids big increases in domestic spending, including healthcare in general, and instead directs funding increases to the war in Iraq and other defense-related costs.