WASHINGTON _ FDA Commissioner David Kessler last weekfailed to diffuse support in the Senate Labor and Human ResourcesCommittee for legislation that would privatize many FDA reviewsand eliminate other drug regulations.

"The hearings ratified the central goal of committee chairwomanNancy Kassebaum's (R-Kan.) bill: to foster a collaboration betweenthe FDA and new product sponsors to facilitate the assimilation ofthese therapies into patient care," said Jane Williams, Kassebaum'saide.

"The first day of the hearing also focused everyone's attention on thefact that we should be looking at total development time not just thetime the agency takes to review a product," she said.

One biotech lobbyist found no hints that the reform legislation wouldnot proceed. "The testimony presented at the two days of hearingsmade a strong and compelling case for bipartisan FDA reform," saidDavid Beier, vice president of government affairs for South SanFrancisco-based Genentech Inc.

Biotechnology Industry Organization (BIO) president Carl Feldbaumobserved that "the hearings easily could have veered off in partisanpolitics. But they didn't. They stuck to the issues," he told BioWorldToday. He noted that moderate Democrats Tom Harkin (Iowa) andBarbara Mikulski (Md.) "made it clear there is bipartisan support forFDA reform legislation."

Feldbaum said he was pleased that Kessler "exhibited amenability toexplore the issues surrounding total drug development time."

Kessler's personal charm and considerable intellect failed to persuadecommittee members that there was no need to legislate wholesalechanges in the way the FDA reviews drugs. Kessler "got nicked," atthe hearing, said one top industry lobbyist. "While Kessler is the verybest at this type of interplay" with members of the committee, hestumbled several times, according to a lobbyist who requestedanonymity. "Several members were taken aback by his repeatedrequests for guidance about where to put the resources at the FDA tospeed drug approvals," the lobbyist said. "After six years on the job,he should know," the lobbyist said.

On the other hand, Kessler may have scored some points when heexplained the risks posed by the legislation. "Kessler made a viablepoint that Congress cannot demand compliance with absolute reviewtime limits and then if a problem arises exsanguinate the FDA inpublic for the problem," said Bruce Mackler, a partner in Fenwick &West, a law firm based in Palo Alto, Calif. Mackler specializes inbiotechnology law.

"Congress can't have it both ways," he stressed. Mackler recalledthat two years ago Kessler was whipsawed by then House CommerceCommittee Chairman John Dingell (D-Mich.) "for not being carefulenough in reviewing the Shiley heart value and then nine months laterwas criticized for moving too slowly."

The issue of promotional materials will be much tougher to resolve.Committee debate on what promotional materials drug companiescan disseminate to practitioners will be deliberate, said Feldbaum."This is not a simple set of issues. But the tenor and tone of thehearings indicated a willingness among the committee members todeal with the intricacies of the issue."

Feldbaum cautioned that while Kassebaum's hearings laid animpressive record for the need for FDA reform legislation, "we arealready deep into the political year. I wish the hearings had takenplace five months ago," he stated. "The question now is whether wehave enough time" for Congress to enact a bill this year, he said.

Markup sessions on Kassebaum's bill (S. 1477) have not beenscheduled but Kassebaum wants to report the bill out of fullcommittee by March 15, 1996, said committee spokesman MikeHurok. That deadline may get bumped because of the stacks ofreauthorizations the committee must address, he added.

Hearings begin this week before the House Commerce Committee'shealth and oversight subcommittees. Legislation still has not beenintroduced by either health subcommittee chairman Mike Bilirakis(R-Fla.) or oversight panel chair Joe Barton (R-Tex.). n

-- Michele L. Robinson Washington Editor

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