WASHINGTON _ Echoing the partisan rhetoric thatcurrently has the nation's capital deadlocked over thefederal budget, warfare broke out in the HouseCommerce Committee Wednesday as Democrats andRepublicans wrangled over how forthcoming FDACommissioner David Kessler has been with the OversightSubcommittee on a number of issues.

Rep. Henry Waxman (D-Calif.) accused subcommitteechairman Joe Barton (R-Tex.) of not holding a"legitimate hearing." Waxman charged that the hearingwas a "vendetta to bring Kessler in and prosecute him forsome unknown practices that the subcommittee staffalleged but may not be true."

Waxman was infuriated by a memo circulated byBarton's investigations staff which accused Kessler andhis staff of violating the secrecy rules that bind grand jurydeliberations.

The FDA has been involved in a number of investigationsof a Texas physician who sold anti-cancer therapies thathave not received FDA marketing clearance.

Noting that Barton had made a point to swear in Kesslerand a dozen or so of his aides, Waxman askedrhetorically if the "subcommittee staff should not besworn in."

Barton again raised a number of issues that he hasexplored in hearings so far this year including FDAdelays in communicating with manufacturers,intransigence in devising more innovative regulatoryapproaches and charges that FDA officials conductedvendettas against several drug and medical devicemanufacturers.

But unlike earlier hearings, Wednesday's hearing wasstrikingly partisan and strident. Barton on severaloccasions pressed Kessler for his personal knowledge ofcertain agency investigations and seem dissatisfied withKessler's answers.

And Waxman appeared newly determined to defend theFDA.

Waxman, who had modestly defended Kessler inprevious hearings, angrily refused to defend "companiesthat make products that don't work and charlatans whooffer elixirs of hope." He added that it was time to "endthese baseless accusations."

Wednesday's hearings raised suspicions that the HouseCommerce Committee may split ideologically over howto overhaul FDA regulation of drugs and medical devices."Any discussion of FDA reform will induce a certainlevel of partisanship," said Gary Gamerman, an attorneywith Fenwick & West, of Washington and a formerofficial with the FDA's Center for Biologics Evaluationand Research.

However, what is not clear is how the 1996 congressionaland presidential races will color controversial legislation,including FDA reform. "Next year it will be easy topredict how committee members like Barton will fall.What is not clear is what political positions will be stakedout by Waxman and Rep. Ron Wyden (D-Calif.) who thisyear have sounded like converts to the cause of FDAreform," said Gamerman.

"If the Democrats regain either house of Congress, there'sa good chance that there will be less enthusiasm for FDAreform," said Gamerman in an interview with BioWorldToday.

Carl Feldbaum, president of the Biotechnology IndustryOrganization shared Gamerman's conclusion that the1996 election may politicize FDA reform legislation."The issues will become more partisan as we get deeperinto the election year," he said. But Feldbaum reiteratedhis commitment to keeping the debate on FDA reform bi-partisan "because these are issues that affect people'slives, that affect the public health."

As recently as two years ago Kessler was castigated fornot being diligent enough in regulating drug companiesand protecting the public health. "But Barton is makingan extremely positive accomplishment of urging theagency to take more risks to regulate medical productsinstead of thinking like a police agency," said Gamerman.

Gamerman, who serves on House Speaker NewtGingrich's cabinet advising him on FDA reform, said hehopes the Republicans take the issue of FDA reformdirectly to the American people. "The Republicans can'tlet the Democrats take the high road on FDA reform asthey have with the Medicare debate. We need to let theAmerican people decide if they want to be in control ofthe risks" presented by drugs and medical products. n

-- Michele L. Robinson Washington Editor

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