BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Thursday, 13 November 1997.

Dr. Miller describes the shortcomings of the primary provisions of the bill, its significant omissions and ultimate impact: "the costs of drug development will continue to rise, fewer drugs will be developed and market competition will erode. Patients will suffer higher prices and benefit from fewer breakthrough drugs."

-0-

Congress has lost a stunning opportunity to reform the FDA. The authorization for the agency's critical "user fees" -- approximately $100 million paid by regulated industry to help the FDA expedite the approval of new medicines -- expired on Oct. 1. The need for another five-year reauthorization provided a strong incentive for the Clinton administration to accept meaningful reforms.

Characteristically, however, the Congress settled for a half-baked compromise dictated by the FDA itself and by Democratic defenders of expansive federal regulation.

FDA reforms are overdue. Physicians surveyed routinely report that the FDA's policies actually threaten the well-being of their patients. In large part this is because the U.S. drug approval system is significantly slower, more costly and intrusive than that of other industrialized nations. Seventy-three percent of drugs approved by the FDA during 1987-93 had already been approved abroad.

The FDA has constantly sought out new mandates and promulgated new requirements, regardless of the costs to patients and regulated industry. The average time required to take a drug from research lab to patient's bedside has more than doubled since 1964, from 6.5 to 14.8 years. Between 1990 and 1993 alone, the FDA pushed the average cost of bringing a new drug to market from $359 million to more than $500 million, by far the highest price tag in the world.

The legislation, which was passed on November 9th and which the White House has promised the president will sign, approaches FDA reform in several inconsequential ways:

First, it changes the FDA's mission, adding the obligation for "promptly and efficiently reviewing clinical research" and making decisions "in a timely manner." But it is naive to think that this symbolism will have any impact on the agency's thirty-year tradition of risk-aversion and foot-dragging.

Second, it calls upon the FDA to develop a plan by 2000 for clearing the legendary backlog of products awaiting approval. With this provision, Congress has made itself a hostage to an endless series of demands for additional resources the agency will claim are essential for meeting the required goal.

Third, it permits the FDA to approve a drug for marketing on the basis of a single clinical trial where previous statutory language referred to "trials," plural. That is largely symbolic. The FDA could easily have made a case for approval on the basis of a single, definitive trial under the previous language. But the point is moot: The average number of trials performed to support approval of a new drug is currently more than 40.

Fourth, it codifies many policies that are already in place, adding nothing to the status quo but attempting to convey the impression of a lengthy list of improvements.

The most important provision in the legislation offers drug companies greater latitude in supplying scientifically sound information to doctors about drugs' "off-label" uses (those not yet approved by the FDA). Companies are currently prohibited from distributing such critical information.

But even this improvement comes at a high price -- substantial additional paperwork involved in convincing the FDA that formal applications for approval of the new uses are forthcoming. And the FDA's discretion in these matters provides yet another "stick" for regulators to use coercively on drug companies.

A welcome provision permits manufacturers to submit "health care economic information," such as data on a drug's cost-effectiveness to hospitals and HMOs.

The bill contains other minor improvements, such as loosened restrictions on health claims for food products and expanded use of third parties, including academic institutions, to review medical devices.

One sneaky provision actually increases the scope of the FDA's regulation by expanding the agency's jurisdiction to activities that occur completely within a single state. For the first time, the FDA explicitly will have regulatory authority over such small-scale research by an academic or practicing physician testing an innovative therapy.

The bill also creates a new program, to be implemented by the Agency for Health Care Policy and Research and the FDA, to investigate "ways to improve the effective use" of drugs and medical devices. Too bad no one informed the Congress that the era of big government is over and that such activities are now more properly performed in the private sector.

What is most worrisome about the legislation is what it fails to include.

Many critical reforms recommended repeatedly by blue-ribbon panels are conspicuously absent. These include reducing the redundancy of regulation of early-stage clinical trials, which could be overseen solely by hospital-based review boards. This pivotal change would reduce significantly the time and costs involved in the initial clinical trials of a drug, a particular advantage for smaller companies.

Neither does the bill include a binding reciprocity provision that, for example, would limit FDA review of a new drug to a maximum of, say, 60 days after its approval in the UK or by the European Medicines Evaluation Agency. The FDA would then have to show cause why the drug should not be marketed in the United States, or it would automatically be approved.

The legislation nearing approval is disappointing, and conservative congressional staffers are justifiably furious that its contents have been dictated by congressional Democrats and Clinton political appointees at the FDA.

Much of the blame belongs to House Commerce Committee Chairman Thomas J. Bliley (R, Va.), who represents Virginia's tobacco producing region and is considered by many to be the tobacco industry's most potent lobbyist in Washington. Bliley has trod lightly in approaching FDA reform in return for the agency returning the favor on tobacco regulation.

Following the 105th Congress' failure to accomplish significant FDA reform, the costs of drug development will continue to rise, fewer drugs will be developed and market competition will erode. Patients will suffer higher prices and benefit from fewer breakthrough drugs. Those are the effects of congressional Republicans' poltroonery.

-0-

Dr. Miller is a Senior Research Fellow at the Hoover Institution and author of Policy Controversy in Biotechnology: An Insider's View (R.G. Landes Co. and Academic Press, 1997).

--30--smm/sf* crd/sf

CONTACT: Hoover Institution, Stanford University Henry I. Miller, M.D., 650/725-0185 Michele M. Horaney, 650/725-7293

Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. URL: http://www.businesswire.com

Copyright (c) 1997/BUSINESS WIRE. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854.
971113
BW971105

Copyright © 1997 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.

Always watch for outdated information. This article first appeared in 1997. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1997. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .