WASHINGTON _ Cracks have started to appear in thethin veneer of bipartisan support for FDA reformlegislation. Differences among House and Senate staffersassigned to draft FDA reform bills surfaced at the falllegislative conference held by the Biotechnology IndustryOrganization (BIO).

Attempts to reform the agency may be stymied by effortson the part of some conservatives in Congress to penalizethe FDA for the outspoken stand taken by FDACommissioner David Kessler against tobacco use amongchildren. "The tobacco interests in Congress may upsetthis bipartisan consensus," said Steve Jenning, aide toRep. Ron Wyden (D-Ore.), who was the first to introducean FDA reform bill.

Representatives from tobacco states already have led twounsuccessful attempts on the House floor to gut the FDAbudget or make sizable reductions. Fallout from thetobacco controversy is expected to be especially chargedin the House Commerce Committee when Chairman TomBliley (R-Va.), an outspoken champion of tobaccofarmers, takes up FDA reform legislation.

Jenning defended the FDA's budget when HouseCommerce Committee aide and Bliley aide JohnCohrssen emphasized that while he is not recommendingthat the agency's budget be reduced, he noted "there hasbeen a problem with the way the agency has beenmanaged and its priorities."

Any cuts in the FDA's budget would be "bad forconsumers and bad for the industry," said Jenning. "Anyattempts to cut the agency off at the knees in the Housewill have consequences for manufacturers who want toget their products through the agency faster," he said.

The partisan testiness appears to bear out predictions thatmuch of the debate over FDA reform will prove to becontentious. Perhaps the biggest unanswered question ishow Congress will assure that the drug approval safetyand efficacy standard is not compromised by efforts tominimize unnecessary regulation. "The overriding riddleis how we can reform the agency and still protect thepublic," said Jenning.

The Congressional staffers said they still were indisagreement over how widely drug companies candisseminate information but that some compromise wasafoot. Jane Williams, aide to Senate Labor and HumanResources Committee Chairwoman Nancy Kassebaum(R-Kan.) told BioWorld Today that the FDA is"intrigued" with her proposal to speed up regulatoryaction on supplementary indications so that labeling canbe changed quickly and new labeling information can bedistributed to physicians without delay. FDA has longmaintained that it wants to exercise absolute control overlabeling while several members of Congress haveindicated there may be a middle ground.

The Republican and Democratic staff members alsodisagreed over whether the FDA should recognize drugsapproved by regulatory bodies in other industrializednations. Williams indicated that there may be a specialapproval mechanism for drugs aimed at life-threateningdiseases. Cohrssen said the "issue of reciprocity is worthexploring."

While all staffers agreed that the FDA probably wouldcome to the top of Congress' action list early next year,Williams cautioned that FDA reform will move inCongress only if it is not weighted down "with hundredsof amendments. We need to come to a consensus and nothold back for a perfect bill that meets all objections," shetold the BIO conference. n

-- Michele L. Robinson Washington Editor

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