WASHINGTON _ The Progress and Freedom Foundation (PFF)unveiled a draft policy paper and disclosed new operational detailson its effort to replace the FDA last week. The four-year "MedicalInnovation Project" was launched in late 1993 with the express goalof creating a new testing and certification system for drugs andmedical devices in the U.S.

On Friday, PFF announced that Louis Sullivan, former Secretary ofHealth and Human Services under President Bush, will serve as chairof the project's 14-member advisory committee. PFF spokeswomanElizabeth Wright told BioWorld that the Medical Innovation Projectalso hired three new staffers to address legal, scientific andinstitutional issues. A final plan could be ready as early as next Fall.

"I am confident that we can develop an effective approach to replacethe current process while maintaining the highest standards for safetyand efficacy," Sullivan said in a prepared statement. "America is indanger of losing its edge in health care technology. We must see to itthat the best and most advanced life saving technologies are broughtquickly to American citizens."

PFF has close ties to House Speaker Newt Gingrich, an outspokencritic of the FDA who touted the Medical Innovation Project in arousing speech to the Biotechnology Industry Organization lastSeptember. The Washington-based think tank gets about 10 to 15percent of its funding from drug companies _ including GenzymeCorp., which donated $5,000 after the Nov. 8 elections (PFF'scurrent annual budget exceeds $2 million). The rest of the private,non-profit group's contributions come from corporations, privatecontributors and foundations.

The draft white paper released by PFF outlines how a new processfor drug and medical technology certification could be designed "toaccommodate the dramatic increase in the number of new productslikely to occur in the immediate future." After a period of publiccomment scheduled to end on Feb. 24, 1995, the white paper will beused as the basis for a final proposal. The Medical Innovation Projectintends to recommend an alternative to the FDA "in complete andcomprehensive form, ready for implementation."

PFF sent copies of its draft, along with a solicitation for comments,to a lengthy list of hand-picked reviewers (who may or may not careto comment) including FDA Commissioner David Kessler, Healthand Human Services Secretary Donna Shalala, the directors ofnumerous patient advocacy groups and at least a dozen senators andrepresentatives with relevant expertise.

The project's framework for change is based upon the premise thatthe market, supplemented by the tort system, already providessubstantial incentives to companies to produce safe and effectiveproducts. Reinforcing those incentives is a managed-care health caredelivery system in which cost-conscious providers are loath toprovide coverage for unsafe or ineffective medical treatments.

New Agency To Build On Market Incentives

In this context, the draft argues, the FDA's review and approvalsystem is outdated _ current regulatory requirements forinformation on safety and efficacy may be too high, for example.Yet, the document notes that, "Proposals for change should build onthe many incentives already available in the market for thegeneration and dissemination of accurate information on quality,safety and efficacy, but should also recognize that patients havecome to rely on the third-party stamp of approval that the FDA nowconfers."

The Medical Innovation Project's white paper ends with a long list ofquestions focusing on four issues, including: institutional issues (Canthe FDA be restructured? Can the European regulatory systemprovide a template? Can private entities be trusted with productcertification duties?); legal issues (How should product liabilityexposure be divided in a system in which there is greater privateresponsibility for the introduction of new drugs and devices? Whatwould be the liability exposure of private certifiers?); patentprotection issues (Speeding the entry of new drugs and devices tomarket would increase the effective patent life of products _ whatwould be the implications of that?); and scientific issues (How muchdrug testing is enough? What is the appropriate balance of pre- andpost-market drug and device testing, i.e., is the U.S. too heavilyweighted toward pre-market safety and efficacy testing? Who shouldbe responsible for experimental and statistical design of clinicaltrials? Should efficacy requirements be revised?).

A copy of the Medical Innovation Project's Feb. 3, 1995 whitepaper, "The future of medical innovation," is available from PFF.Public comments will be accepted until Feb. 24. Contact ElizabethWright, PFF, 1250 H Street, Suite 550, Washington, DC 20005.Phone: (202) 484-2312. n

-- Lisa Piercey Washington Editor

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

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