WASHINGTON_The Republican-sponsored FDA reformlegislation that emerged from the Senate Labor and HumanResources Committee late Thursday night is an imperfect legislativepackage that remains the subject of intensive political negotiations.

The high stakes of FDA reform were underscored Friday whenPresident Bill Clinton, Health and Human Services Secretary DonnaShalala and FDA Commissioner David Kessler announced new FDAprocedures to expedite the review of cancer treatment drugs.

The political alliances that resulted in bipartisan support for theGOP's Senate bill during committee markup may unravel before thelegislation reaches the Senate floor. On the first day of the markup,several liberal Democrats broke ranks with Sen. Edward Kennedy(D-Mass.) and backed an amendment sponsored by Sen. Dan Coats(R-Ind.) to create a demonstration project to privatize some reviewsof medical devices, including critical ones such as surgical implants.

Most of the Democrats continued to cross over on Thursday whenSen. Nancy Kassebaum's (R-Kan.) FDA reform package (S. 1477),the FDA Performance and Accountability Act, was approved by a 12-4 vote.

The Democrats voted with the Republicans because of what theyperceived as FDA's refusal or inability to approve medicalproducts_particularly medical devices_expeditiously. SeveralDemocrats made statements prior to the final vote indicating whatcompromises needed to be incorporated into the bill before theythrow their support behind it. Most of the Democrats' concernsinvolve the privatization of FDA regulatory authority. Sen. BarbaraMikulski (D-Md.), who counts among her constituents a number ofmedical device and biotech firms, said just prior to the final vote, "Iwill reserve final judgment until I see what bill eventually reaches theSenate floor to ensure there are adequate protections of the publichealth. My primary criteria will be public safety."

Privatization Questioned

Mikulski said she was still concerned about the "hammers," theprivatization of drug and device reviews that would be imposed onthe FDA if it missed deadlines for product approvals.

Sen. Paul Wellstone (D-Minn.) said he "echoed Mikulski's concerns"and said he voted against the bill because he regarded theprivatization provisions a "threat to public safety." Wellstone added apublic scolding for FDA Associate Commissioner for Policy BillSchultz and other top agency officials who, Wellstone said, "couldhave resolved many of these outstanding issues if the FDA had doneits job." Schultz and other FDA officials had lobbied the committeeto incorporate several amendments that would have struck provisionsconsidered most onerous by the agency. Sen. Tom Harkin (D-Iowa)voted for the bill but said he "reserved the right to change my vote onthe Senate floor."

Kennedy, who on the first day of the markup failed to persuade thecommittee to reject several Republican sponsored-amendments, didnot offer his package of amendments sought by the FDA lateThursday night. He and Kassebaum agreed to search for acompromise before the bill goes to the Senate floor. Even Kassebaumdistanced herself from the bill. "No one on this committee intends tochange the safety standard at FDA" and promised to work withKennedy on a compromise.

The task of getting the FDA reform plan to the Senate floor now fallsto Senate Majority Leader Bob Dole (R-Kan.) who must juggle thedemands of his Presidential bid with scores of bills that are awaitingfloor action. With only 30 legislative days left in this session ofCongress before the House and Senate adjourn for a long campaignrecess, several more pressing prices of legislation may bump FDAreform this year. n

-- Michele L. Robinson Washington Editor

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