Administration Revamps Drug-Approval Policies : Health: Quayle says the new measures will speed medicine to patients and save money. Critics argue that the ideas are nothing new and may be unsafe.

The Bush Administration said Thursday that it is implementing several steps announced last November to speed the approval of new drugs.

Vice President Dan Quayle, appearing with top health officials at a news conference, asserted that the measures would save millions of lives and billions of dollars. He hailed the “reforms” as products of the Competitiveness Council he heads and said they are part of the President’s regulatory-relief initiative.

Quayle said the most important step would shorten by months or even years the time needed to approve “breakthrough” drugs for patients with life-threatening or serious illnesses, such as AIDS, cancer, Alzheimer’s disease, depression and cystic fibrosis.

Critics charged that this move and two others are not new, and that a fourth is potentially unsafe.

“This represents a really sick kind of grandstanding on the part of Vice President Quayle to make it appear that he has caused the FDA (Food and Drug Administration) to do things they have been doing for some time,” said Dr. Sidney Wolf, director of the consumer-oriented Health Research Group.

Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Energy and Commerce subcommittee on health and the environment, was also critical. He said Quayle’s proposal to expedite the approval of AIDS drugs “sounds good but isn’t new. It is a hoax to imply it will do more than the FDA is already doing.”

Under an accelerated approval process described by Quayle, sponsors of a drug can demonstrate its efficacy by citing improvements in bodily condition--such as blood cholesterol level--instead of waiting for clinical trials to determine whether patients get better or sicker when using the drug.

The FDA has already been using this process with a new AIDS drug, DDI.

Similarly, Quayle spoke of a related “new policy” called “parallel track.” Under it, promising new drugs can be made available to patients with life-threatening diseases while clinical tests are being conducted separately.

DDI has been on such a parallel track for months.

One certifiably new policy announced Thursday calls for the FDA to hire outside experts to review new anti-allergy, anti-infective, anti-inflammatory and analgesic drugs.

“The program is designed to reduce the backlog of pending applications while freeing the agency’s own reviewers for the urgent task of processing new therapies for serious and life-threatening diseases,” said Health and Human Services Secretary Louis W. Sullivan.

Wolf protested that outside groups lack the FDA’s expertise and would be open to conflicts of interest, possibly leading to the endorsement of unsafe drugs.

The Administration backed off one controversial proposal to accept drugs that had been approved by other countries, even if their standards are lower than those of the United States.

The FDA did issue new guidelines for using animal testing data developed in Europe and Japan. Officials said this would speed drug development and reduce the number of animals used for testing here.