The Senate Labor and Human Resources Committee this week reopens the FDA reform debate with the first hearing of the 105th Congress on the subject to be held Wednesday. But already, the effort to modernize the agency appears to have less urgency than it did in the 104th Congress. Hill sources insist there is still significant interest in reform legislation, but they concede there are some major tactical questions that have yet to be answered, the most significant of which is whether to tie FDA reform to reauthorization of the Prescription Drug Users Fee Act. The latter statute levies fees on drug companies, which provide a crucial revenue source for the agency, enabling the FDA to review and approve new drugs quicker. The law expires at the end of FY97.
Some industry sources contend the reform landscape has changed significantly with the departure of former FDA Commissioner David Kessler, a controversial figure who was intensely disliked by some key congressional Republicans, including House Commerce Chairman Bliley. Kessler's replacement has not been named yet, which may make FDA reform less pressing, some sources suggested. Said one pharmaceutical industry representative, "Congress doesn't know exactly how much to push ... they have much less of an adversary at FDA, [but] now they don't know what they're up against." A House Commerce Democratic aide said there is "a lot of truth" to the assessment that, for congressional Republicans, Kessler was a major factor in the reform equation.
"A lot of people held the view that it wasn't about FDA's statutory authority ... it was the way the law was being implemented," said the aide.
But a Senate GOP aide close to the issue dismissed the notion that the agency's problems began and ended with Kessler.
"They can characterize it as personality ... we happen to think there are attitudinal problems at FDA from the top down," the Senate aide said, adding that reform remains a "front burner, high priority issue" for many Senate Republicans.
Reform may be less of priority than it was two years ago for the pharmaceutical industry, one industry source suggested, because the FDA has significantly speeded up the drug approval process.
According to a FDA spokesman, the agency last year authorized the manufacture of more than 50 new drugs, twice as many as it had approved in the past.
"It's an acknowledged fact that we can't criticize [the drug approval process] anymore," said the pharmaceutical industry source, adding that the FDA has done a "remarkable job" in improving its performance.
The Senate GOP aide contended if the industry is so pleased with the FDA's progress, there is an argument for codifying those changes in law.
FDA reform proponents are interested in other issues as well, the aide noted, particularly what the aide called "gross lapses" in the approval of food additives and medical devices.
A spokesman for the Grocery Manufacturers of America agreed. The GMA is pushing for a uniform federal standard for food ingredient safety instructions, authority over food health claims for agencies other than the FDA and an expedited review process for food additives.
That process is supposed to take 180 days, but currently takes four to six years, according to the GMA spokesman.
He said the group is optimistic that reform legislation will be introduced soon.
The Senate GOP aide said legislative talks are ongoing, and predicted that a bill will "burst on the scene" in the next several weeks. Reform proponents are aiming for several sponsors among both Republican and Democrat members, according to the aide.
The question of whether to address the PDUFA separately or together with FDA reform has not been decided, but many some Senate Republicans view the pharmaceutical bill as a "carrot in the garden of FDA reform," the GOP aide said. They believe the PDUFA should be part of FDA reform rather than a stand-alone measure, although separate PDUFA legislation "has not been discounted," the aide said.
In the House, the thinking is different, according to the House Commerce Democratic aide.
According to the aide, in a bipartisan meeting last week that included administration representatives, aides to Bliley indicated he may seek to reauthorize PDUFA and consider a limited FDA reform bill that addresses only drug approval and related issues, possibly including so-called off-label, or additional uses, for approved drugs.
"Policy-wise, it may make sense ... process-wise, it may not," said the Democratic aide, adding that too many other interest groups would be left out.
This week, the Senate Labor and Human Resources Committee will hear only from the FDA.
The agency will give a "status report" on where it is, what it has accomplished over the past year, and where it is headed, said a spokesman. "Our message will be that the industry has to be open to change, particularly in an era of limited resources," the spokesman said.
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