WASHINGTON _ The Biotechnology IndustryOrganization (BIO) issued a press release this weektouting the endorsement by the National GovernorsAssociation (NGA) and American Legislative ExchangeCouncil (ALEC) of FDA reform. However, the positionspresented by the NGA and ALEC in resolutions approvedat their most recent policy meetings are expected to besuperfluous to the unfolding Congressional debate onhow to streamline FDA regulation of drugs and medicaldevices.

"The players in the debate are the regulated industrieswhenever regulatory reform is considered. And to asecondary extent, consumers," said Steve Jenning, aide toHouse Commerce Health Subcommittee member RonWyden (D-Ore.).

"The NGA is not a player on FDA reform," he said in aninterview with BioWorld Today. The NGA represents thenation's governors. ALEC is a clearinghouse for modelstate legislation.

The final decisions about FDA reform are expected to bemade by a small group of Congressional aides andrepresentatives from the drug and medical deviceindustries. "The affected industries and the Republicanswill make the final decision about FDA reform," saidRandy Fenninger, a lobbyist for seven physician specialtyorganizations in Washington, among those the AmericanUrological Association.

"So far the major players have been the Health IndustryManufacturers Association, BIO, and PharmaceuticalResearch Manufacturers of America," Fenninger said."Also working effectively to tend the political fences arethe larger drug firms such as Merck," Fenninger said inan interview with BioWorld Today.

"The only reason the governors may get involved is ifthey get concerned about losing jobs at home," he stated.

Fenninger cautioned against interpreting the NGAstatement as more than what it's worth. "The NGA is amajor player on the issue of welfare reform andMedicaid. Nobody competes with them," Fenninger said.

"Maybe BIO thinks that the governors want FDA block-granted," said Jenning, referring to the current frenzy ofactivity to turn many federal programs into block grantsadministered by the states.

The NGA policy statement focused on the need to saveU.S. jobs and reduce the drain of American drug anddevice industries locating overseas. "Within the industrythere is a belief that outdated and antiquated export lawsencourage companies to locate manufacturing facilitiesoutside of the U.S. The laws are thought to no longerhave any meaningful public health purpose," according tothe NGA resolution.

The governors called for a "reexamination of the policiesand procedures at the FDA to facilitate better and morerapid access to new therapies and cures. The review andapproval of new drugs . . . must be as prompt as possible.However, the safety of the public must be preserved."

The American Medical Association (AMA), which isopposing BIO on the issue of patenting of medicalprocedures, is not expected to be active on FDA reform."The AMA won't be important," Jenning added.

An AMA spokeswoman confirmed that she did notexpect the association to weigh in on FDA reform bylobbying for or against a particular bill or provision inproposed legislation. "We plan to look at the [Sen.Nancy] Kassebaum [R-Kan.] bill when it is introduced inSeptember to determine if we will be involved. But theproblem is there are so many issues requiring theattention of the AMA that it's hard to address anotherone," she told BioWorld Today.

So far the only tangible action taken by the AMA wasapproval by its House of Delegates, the association'sofficial policy making body, of a resolution urging a wait-and-see approach to FDA reform.

The AMA House of Delegates in June 1995 set aside amuch stronger proposal from the American College ofPhysicians (ACP), the largest U.S. associationrepresenting internists, which urged the AMA to activelyoppose efforts to weaken FDA's rigorous evaluations ofdrugs and medical devices.

However, no lobbying blitz is expected from the ACPdespite its stronger stand on FDA regulation. "We'reconcerned about maintaining safety and efficacy asimportant criteria for the evaluation of drugs but will notlobby for FDA reform," said Kathleen Haddad, ACP'ssenior associate for public affairs.

The House of Delegates resolution directed theassociation to continue to monitor the FDA, work withthe agency on controversial issues and to support anadequate budget for the FDA.

The House of Delegates did not approve proposals fromphysicians that would have continued to require the FDAto demand evidence of safety for therapeutic drugs anddevices while changing requirements for efficacy fromabsolute proof to proof of highly probably efficacybecause "physicians are capable of determining theultimate efficacy of a medication or device," according tothe rejected resolution. n

-- Michele L. Robinson Washington Editor

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

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