WASHINGTON _ Industry advocates hoping for passage of FDAreform legislation this year might be advised to start praying for amiracle. With less than 30 legislative days left in 1996, 17appropriations bills yet to be considered by Congress and apresidential election looming, only true believers could expect suchinvocations to be answered.

Although a handful of lawmakers and congressional aides areworking steadily to fine-tune complex FDA reform bills in both theHouse and Senate, the odds are long. Speaking Monday at a forumsponsored by the Progress and Freedom Foundation (PFF), a non-profit conservative think tank with close ties to House Speaker NewtGingrich (R-Ga.), Rep. Jim Greenwood (R-Pa.) said he still believesthat a floor vote on the House legislation could be scheduled for July.

"We'll do it by all nighters if we have to," said Greenwood, who ischairman of the House Task Force on FDA Reform. "But we won'tget it done unless it's done in a bipartisan fashion." As evidence ofhis even-handed approach, Greenwood said he planned to meet withFDA Commissioner David Kessler for four hours on Tuesday to poreover the three House FDA reform bills "section by section" and toelicit Kessler's concerns. Crafted by Energy and CommerceCommittee members, the three bills deal with the regulation of drugsand biologics, medical devices and food and animal health products.

Greenwood said Kessler told him, "You have the votes to ram [thesebills] through the committee and the [House] floor _ so what are wegoing to do when we get together?" But Greenwood responded byassuring Kessler he wants a bill that can be signed into law. "I'veseen this 104th Congress ram a lot of things all the way to the 99-yard line and create so much bad will that that's where the gamestopped," explained Greenwood. "I'm not interested in doing that.

"I'd like to put a bill on the President's desk that he feels pretty goodabout but a little nervous about _ nervous because we're pushing hima little farther than he'd like to go," said Greenwood.

As originally written, the Drugs and Biologics Reform Act of 1996(H.R. 3199) sought to streamline FDA regulation of new medicinesby instituting a system of third party review of marketingapplications, imposing strict deadlines on FDA actions, allowingcompanies to submit summaries of their clinical data rather than rawdata and altering the efficacy standards required for drug approval,among other things. In addition, the bill eliminated currentprohibitions on the distribution of information about off-label uses ofdrugs by the companies that market and sell those drugs.

According to Kay Holcombe, the lead minority staff member on FDAreform in the Energy and Commerce Committee, House Democratsremain alarmed about core elements of H.R. 3199. She reminded thePFF conference attendees that Republicans must work hard toaddress those concerns, as well as the concerns of the Clintonadministration. "It is going to be extremely important to thepresident's decision that the FDA backs the bill." To date, Kesslerhas opposed key provisions of H.R. 3199 and its companion bills.(See BioWorld Today, May 3, 1996, p. 1.)

Democrats Object To Third-Party Reviews

Holcombe said that third-party review is at the top of the list ofDemocratic objections to FDA reform. While some Democratssupport the idea for medical devices, most believe that thePrescription Drug User Fee Act largely solved the problem of longFDA review times for drugs and biologics. Another potentially majorstumbling block is the distribution of medical literature about off-label uses of marketed products _ Holcombe said patient advocacygroups have strongly objected to the idea.

The proposal to tinker with the FDA's current standards for proof ofefficacy also has provoked controversy, according to Holcombe."The drug bill as introduced changes the standard of efficacy for newdrugs and particularly for drugs to treat life-threatening illnesses,"said Holcombe. "That has caused quite a stir among patients withlife-threatening illnesses who tell us that they don't want to be guineapigs for unproven drugs."

According to Lisa Raines, vice president of government relations forCambridge, Mass.-based Genzyme Corp., potential solutions do existfor some of the current problems. For example, Amgen Inc., ofThousand Oaks, Calif., recently proposed a compromise on themedical literature controversy. The proposal would create a so-called"safe harbor" for companies to distribute information about off-labeluses in certain situations, such as when European approval for theindication already has been granted or when a company already hasfiled a supplemental product license application or new drugapplication with the FDA.

"That's a compromise that addresses some of the most compellingsituations where information needs to be disseminated or should bedisseminated," said Raines. "It's a proposal that could be attractive toeveryone."

Raines downplayed some of the other controversies, noting that eventhe trade association Pharmaceutical Research and Manufacturers ofAmerica opposes third-party review of drugs. "There are reasonableways to address everybody's concerns on these issues," she said."The big issues are resolvable."

According to Jane Williams, majority health policy advisor for theSenate Committee on Labor and Human Resources, the Senate FDAreform bill recently was voted out of committee and only awaits areview by the Congressional Budget Office before it enters the queuefor a floor vote in the Senate. She said Democrats and others in theSenate have a "finite list of concerns" about the bill including itsprovisions for instituting third-party review of medical devices,establishing strict review time frame requirements for the FDA,altering the notification system for manufacturing changes, andredefining the efficacy standards for marketed drugs.

"It's true that many patient groups are opposing the bill but we knowthey don't speak for all patients," said Williams. "We know, forexample, that the AIDS community is split on the issue of FDAreform." Williams said the newly elected Senate Majority LeaderTrent Lott (R-Miss.) has indicated he may be willing to schedulefloor time for the bill, but only if the debate does not become boggeddown in partisan bickering.

"If we go to the floor and everybody insists on discussing every issue,the leadership will pull it," predicted Williams. "Industry will have tobe sensitive to that and try to refrain from encouraging legislators tomake endless amendments." If and when bills pass the House andSenate, a team of legislators will attempt to merge them into one billfor President Clinton's signature.

Holcombe conceded that Congress can sometimes act very quickly ifthe political will is mustered. "If you have a bill that comes out of theHouse that is fairly bipartisan in nature and if you have a similar billout of the Senate, then you have the whole month of August for aconference," she said. After dangling that rosy scenario before PFFconference attendees, she added, "I think it's a long shot." n

-- Lisa Piercey Special To BioWorld Today

(c) 1997 American Health Consultants. All rights reserved.

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