Senate Labor to work for full FDA funding with Appropriations Cmte., Jeffords promises.

SENATE LABOR TO WORK WITH APPROPRIATIONS CMTE. FOR FULL FDA FUNDING COMMITTEE to "make sure that the FDA has the full level of funding it needs to perform its vital functions across each of the centers," Labor Chairman James Jeffords (R-Vt.) told FDA topsiders at a March 19 hearing on agency funding for FY 1998 and other issues. "It is essential to note that under PDUFA, these user fees by law may not be collected unless the appropriations committees make them available to the FDA 1992 level of appropriated funds to the agency, updated for inflation," Jeffords remarked. "The Administration's proposal puts this important principle at risk" by cutting the agency's budget by 8% without unauthorized user fees, Jeffords maintained.

Jeffords expressed support for swift reauthorization of prescription drug user fees with reform provisions. "I believe that PDUFA must be reauthorized -- I will not have FDA employees used as bargaining chips," Jeffords declared. The chairman said he expects to move PDUFA reauthorization and FDA reform together in a single bill that could reach the Senate floor by "mid-year".

FDA acting Commissioner Michael Friedman, MD, said failing to reauthorize PDUFA would have "disastrous" consequences for FDA's professional staff, who would be facing an increased workload with fewer resources.

Jeffords praised FDA for "working harder on approving" prescription drugs but chided the agency for lagging behind in reviewing other types of applications, such as those for generic drugs. He noted that in 1996, FDA's average review time for generic drugs from receipt to approval was "12 months longer" than the 180-day limit set by law.

The Vermont Republican added that the Clinton Administration's proposed budget reduction takes place at a time when "when FDA's workload is increasing; [and] the FDA has embarked on two new major initiatives" in tobacco and food safety. "How do you plan to do so much with less, and do you have a new plan," Jeffords asked, addressing how the agency would operate with a reduced budget of about $852 mil.

Friedman replied that FDA's "budget authority for next year gives us an amount of money [with which] we think we can do a great deal of good for the public health, and that we can encompass the two new programs that you alluded to" through increased efficiency.

It "does give me concern as to whether...[the Appropriations Committee] will allocate any additional funds or whether they will take a look at trying to generate funds the Administration suggests via user fees," Jeffords noted. He also complained that the Administration's budget contains few line items, making it difficult to review.

Sen. Dan Coats (R-Ind.) concurred that the Administration's proposal underfunds FDA. "I share the concerns on the budget in terms of resources being suggested for you this year. I think they are inadequate." Coats added that he and Sen. Barbara Mikulski (D-Md.) and other members of the committee have discussed a longer-range plan to "hopefully provide a unified [FDA] campus with more modern equipment and facilities."

However, Coats warned Friedman that "until Congress [and] the Administration [are] able to move on entitlement reform [for] agencies like yours [and] NIH, all of the funding that comes through our discretionary part of the budget is going to get squeezed."

"I also agree that PDUFA should not be used for deficit reduction," Coats remarked. "It was specifically designed for a specific purpose [and] that is why we have confidence in it, that's why we have support for it, and that's what it ought to be used for."

At the hearing, erstwhile FDA critics struck a conciliatory note: "As you know, I've had my fights with FDA. I think it's time we fought for FDA," Mikulski commented. Coats concurred. "We have worked together on the critic side of the issue, and I share her belief that now is the time to move forward constructively."

"We have had a change in leadership, [HHS] Secretary [Donna] Shalala is anxious to bring about FDA reform this year, and I appreciate the spirit in which you are approaching that," Coats told Jeffords. "Hopefully, we will approach that on a bipartisan basis." Coats commended FDA "for the steps you have taken under PDUFA and accelerating drug approval."

Ranking Minority Member Edward Kennedy (D-Mass.) objected to the Administration's use of so-called "deficit reduction" user fees. The program "wasn't meant to be a substitute in terms of other appropriations," Kennedy remarked. "I had the opportunity to talk with a number of people in the Administration [who say] `times have changed'...and we are going to use that in terms of our deficit reduction, which I think is a very considerable mistake."

Kennedy chided Friedman for testifying that the agency can meet all its requirements and take on more. "I always think that is sort of putting the cart before the horse," he commented. "I basically think that if you could say if you give us `x' amount of money...this is what we are going to be able to do, and this is what we are not going to do, is really a more responsible position."