WASHINGTON _ The Biotechnology Industry Organization (BIO)has chosen FDA reform as one of three top political priorities for1995, according to the trade association's president, Carl Feldbaum.The other two issues are price controls and capital formation.

Feldbaum told attendees of the Second National BiotechnologySummit here on Tuesday that the ever-growing number ofWashington-based think tanks and policymakers hatching plans tooverhaul the FDA has thrust the issue "to the top of the biotechagenda." The summit was organized by BIO and GeneticEngineering News.

House Speaker Newt Gingrich (R-Ga.) spoke at a BIO gathering lastSeptember, calling for the dismantling of the FDA as it exists todayto be replaced by an agency of scientific entrepreneurs who wouldserve for a maximum of five years and return to industry. Feldbaumcalled Gingrich's speech "intense, professorial and provocative" andpraised him for raising the issue "in his own zealous, forceful way."

A BIO task force, headed by Amgen Inc. CEO and ChairmanGordon Binder, will address the issue of FDA reform and report itsfindings to BIO's board of directors on Feb. 8 through 10. Feldbaumsaid that the industry needs to document its complaints about theagency, rather than just presenting a list of "whines."

"Let me just say that BIO will proceed carefully and judiciously onthe issue of FDA streamlining," said Feldbaum. "We accept, as apremier principle, that there must be an independent, credible agencythat the public is confident of."

BIO also plans to oppose price controls in 1995, "in any form" thatthey might appear, said Feldbaum. A continuing goal of the industrywill be to remove the so-called "reasonable pricing clause" fromNational Institutes of Health Cooperative Research and DevelopmentAgreements.

Finally, BIO plans to pursue legislative and other initiatives toremedy the industry's dire financial condition and improve its accessto capital. One challenge in this regard may be acquainting newmembers of Congress with the peculiarities and "fragile nature" ofthe biotechnology industry, said Feldbaum. "We will be burningshoe leather on Capitol Hill," he promised. "We plan to set upmeetings between our 570-plus member companies and theirpolitical representatives continually." (The 104th Congress has 86freshman representatives and 11 freshman senators.)

CEI Launches FDA `Educational Campaign'

The Competitive Enterprise Institute (CEI), a pro-free enterpriseWashington think tank, is set to unveil a new radio and televisionadvertising campaign today that focuses on educating the publicabout FDA delays. The CEI's Sam Kazman, who spoke at a BioEast'95 session on Tuesday, asserted that victims of "drug lag" _ thetime it takes for FDA to approve a new product _ "are politicallyand journalistically invisible."

CEI has proposed that the agency maintain its safety and efficacystandards, but that it become a "certifying agency," rather than a"veto" organization. "Products not certified by the FDA would haveto carry a clear warning to that effect on the label," explainedKazman. "Those who trust the FDA would choose not to buy thoseproducts and life for them would change very little. But others wouldhave the right to choose for themselves. This would give the public achoice."

Kazman said he fears that the public is more afraid of newtechnology than it is afraid of technology stagnation. As a result, CEIwill launch a small-scale, mostly regional campaign "to changepublic impressions of the FDA." CEI plans to spend $30,000 initiallyto run a radio advertisement "several times a day" on twoWashington-based stations and on one national talk show. Inaddition, the group will run a 30-second television advertisement(featuring a David Kessler look-alike crowing about a drug approvalwhile the camera pans a cemetery to represent patients who diedwaiting for the drug's approval) on a local District of Columbiastation.

A transcript of the radio spot follows:

(sound of stormy seas_)

Lookout: Man overboard!

Deckhand: Hang on, I'll get a rope.

Captain: Hold it, what do you think you're doing?

Deckhand: What do you mean? This guy's going to drown if I don'tget him this rope.

Captain: Let me see the paperwork on it.

Deckhand: Paperwork? But he's drowning!

Captain: I don't care what his condition is, he can't have that ropeuntil I say it's safe. Give me the files.

Deckhand: Yes sir, but _

Captain: OK, now put a tensile strength meter on it and let's see whatit will hold.

Deckhand: _ but _

Captain: Better safe than sorry. (Sounds change to indicate storm haspassed.) _ well, that checks out too and there's minimal fraying, aswell. OK, we're ready. Ahoy out there! The rope I'm about to throwyou meets all federal standards. Hello? Hello?

Narrator Voiceover: When it comes to approving new medical drugsand devices, the federal government's overcaution can be deadly.Think about this, if the government approves a drug that will startsaving lives tommorrow, then how many people died yesterdaywaiting for the government to act?

Captain: Hello? Hello? Hello?

Narrator Voiceover: A message from the Competitive EnterpriseInstitute of Washington, DC. Call (202) 331-1010.

After hearing a tape of the advertisement, Abbey Meyers, presidentof the National Organization for Rare Disorders and chair of theBioEast '95 session at which Kazman spoke, questioned whethersignificantly weakening the FDA might not lead to the marketing of"snake oil." "How would you like it if someone threw you a rope andit turned to tissue paper when it hit the water?" she said.

Whitman, Lowry Win BIO Awards

Feldbaum also announced on Tuesday that New Jersey GovernorChristine Todd Whitman and Washington Governor Mike Lowrywill be recipients of BIO's new "Governor of the Year" award inFebruary. Whitman, one of the rising stars in the Republican party, isslated to address biotechnology CEOs at the BIO board meeting onFeb. 9 and Lowry (a Democrat) will have his award hand-deliveredby Feldbaum later that month. n

-- Lisa Piercey Washington Editor

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

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