WASHINGTON _ The Biotechnology Industry Organization (BIO)is almost done preparing a "near-term" agenda for change at theFDA, according to President Carl Feldbaum. BIO's task force onFDA reform, headed by Gordon Binder, CEO of Amgen Inc.,reported its findings to the trade association's board of directors onWednesday.

Within a week or two, BIO plans to release a summary list ofproblems it sees at the FDA, accompanied by a list of solutions.Feldbaum said that BIO will initially focus on "practical, functional"changes at the agency.

"We think, unlike some others, that there is great utility in pursuing anear-term, achievable agenda," Feldbaum told BioWorld. Forexample, industry representatives have long argued for an overhaulof outdated regulations that govern the manufacturing processes forbiologic products.

Here in Washington, the appeal of fine-tuning existing FDAregulations has paled in comparison to the prospect of doing awaywith the agency altogether, greatly diminishing its power, anddecentralizing or privatizing the entire regulatory review process.

Numerous conservative, pro-free enterprise policy think tanks _such as the Progress and Freedom Foundation, the CompetitiveEnterprise Institute, the Washington Legal Foundation and Citizensfor a Sound Economy _ have pushed for a revolutionary change inthe way drugs and devices are regulated in the U.S. These groups,joined by some prominent Republican lawmakers (who now chairkey Congressional committees), have charged that FDA overregulation and over caution is killing both patients and U.S. industry.

Despite the heated debate, the political viability of radical change atthe FDA remains untested. One wild card is whether the public,generally unfamiliar with the complexities of drug development, willsupport changes that could be portrayed by critics as easing safetyand efficacy requirements for companies.

Feldbaum said that BIO will also examine ideas for long-term,fundamental reform of the FDA and that it will work with thinktanks, patient advocacy groups, Congress, Clinton administrationofficials, FDA officials and other trade associations as it crafts itsown proposal. Ideas for far-reaching reform of the FDA willcomprise "phase two" of BIO's efforts, he said.

More than 150 of BIO's 580 members have contributed ideas onFDA reform via fax, phone, letters and teleconferences since Dec. 7."The operative principle we have heard from almost everyone is _do nothing that would compromise safety, either real or perceived,"said Feldbaum. BIO's aim, he said, is to suggest changes at the FDAthat could get safe drugs to patients faster and at less expense.

"Rather than wage a rhetorical war, I want us to stay practical,"explained Feldbaum. "Let's deal with the possible and the concrete,not the atmospherics."

Execs `Bury The Hatchet' With Administration

A breakfast meeting in late January between top Clintonadministration officials and biotechnology CEOs presented anopportunity "to bury the hatchet of health care reform," according toFeldbaum. The meeting, initiated by the administration, allowedindustry executives to lay out "a comprehensive biotechnologyagenda," from tax and patent policy changes to FDA reform.

Among the high-ranking government officials present were DeputyAssistant Secretary for Health William Cor, Commerce SecretaryRon Brown, Deputy Secretary of Commerce David Barram, PatentCommissioner Bruce Lehman, Director of the White House Office ofScience and Technology (OSTP) Policy John Gibbons, and OSTPAssociate Director of Science M.R.C. Greenwood. Another meetinglater in the day at the White House included Vice President AlGore's Senior Domestic Policy Advisor Greg Simon and WhiteHouse Deputy Chief of Staff Erskine Bowles.

Among the biotechnology executives who attended the meetingswere Robert Abbott of Viagene Inc., James Barrett of GeneticTherapy Inc., Robert Beckman of Intergen Co., Gordon Binder ofAmgen Inc., Patricia Cloherty of Patricof & Co. (a venture capitalfirm), Charles Heimbold of Bristol-Myers Squibb, Peter Linsert ofMartek Biosciences Corp., Harry Penner of Neurogen Corp., RobertSerenbetz of DNA Plant Technology Corp., and Henri Termeer ofGenzyme Corp.

According to Feldbaum, participants reported that Administrationofficials "did more listening than talking" at the meeting. "It wasvery cordial and substantive," he added. As a result, BIO has invitedPresident Clinton to address its annual meeting, scheduled to be heldin San Francisco this May.

Administration sources said that "significant structural changes" arebeing considered for the FDA. Indeed, President Clinton's SpecialAssistant for Health Policy, Chris Jennings, has been tapped to directa White House team studying the FDA regulatory review process.But while increased efficiency and downsizing government dovetailwith Gore's "Reinventing Government" initiative, sources saidtinkering with food and drug safety regulations must be donecarefully.

Senator Hatfield Addresses Biotech CEOs

Sen. Mark Hatfield (R-Ore.) told biotechnology CEOs gathered inWashington for BIO's annual CEO conference that continuinginvestment in medical research is key to containing health care costs.Last year, Hatfield co-sponsored legislation to create a MedicalResearch Trust Fund that would funnel a percentage of proceedsfrom a tobacco tax to the NIH. The bill expired along with last year'shealth care reform proposals.

"The ultimate cornerstone of cost containment is the cure and bettertreatment of disease and that comes from medical research," saidHatfield, who hailed recent advances in the treatment of testicularand breast cancer, as well as leukemia. Hatfield is now chairman ofthe Senate Appropriations Committee, a post he could use to exerciseconsiderable influence over how government funds are disbursed.His strong support of the NIH bodes well for biomedical research.

Hatfield also said on Thursday that he is concerned about the ethicalimplications of widespread use of genetic information. He said theU.S. needs to establish an advisory body (which would not includeregulators or politicians) to set parameters and have discussionsabout genetic issues.

"This advisory group would be independent of industry andgovernment, a place of discussion," he said. According to Hatfield,the White House plans to publish a proposal for just such a geneticsethics advisory body in the Federal Register "very soon." n

-- Lisa Piercey Washington Editor

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