Administration Offers Plans to Reform FDA : Health: Proposals include program to let outside experts review safety and efficacy of certain experimental medical devices.

In an apparent effort to head off a Republican-driven overhaul of the Food and Drug Administration, the White House on Thursday proposed a series of agency reforms, including a pilot program that would allow outside experts to review certain experimental medical devices for safety and efficacy.

The FDA, which in recent years has speeded up the approval process for breakthrough and life-saving drugs, has been under increasing attack by GOP lawmakers, the device industry and conservative think tanks for being overly cautious--and too sluggish--in getting new devices onto the marketplace. Critics repeatedly have cited the model in many European countries, where such non-governmental reviews are permitted.

FDA Commissioner David A. Kessler, who announced the proposals in an appearance before a Senate committee, in the past has acknowledged that the agency could do better in device regulation. But he also has pointed out that the agency has limited resources to meet its numerous responsibilities, which--in addition to regulating foods, drugs, cosmetics and devices--include responding to public emergencies, such as product tampering.

Kessler, testifying before the Senate Labor and Human Resources Committee--which has jurisdiction over the FDA--stressed that the agency is engaged in a constant “balancing act” that must weigh protecting the consumer from unsafe or ineffective products against making new technologies available as quickly as possible. The agency must never lose sight of that equation, he said.

“People want access (to new drugs and devices) but, if something goes wrong, they want to be able to blame somebody,” he said. “It’s not very popular being a regulator today. You don’t make any friends when you say no. (But) you can’t deregulate the safety of food and drugs. It’s just not going to work.”

He added: “My bottom line is that the agency should be able to make decisions in an environment of independence.”

Sen. Nancy Landon Kassebaum (R-Kan.), who chairs the committee, called the Administration’s proposals “common-sense and . . . long overdue first steps toward eliminating obsolete and marginally important regulatory requirements.” The measures “are a start, but (I) would look for much greater strides if we are truly going to address the issue,” she added.

And Sen. Judd Gregg (R-N.H.), in stressing the need for changes within the agency, told Kessler: “We don’t sense it (the FDA) is in balance right now.”

Kessler predicted that the reforms could save industry $500 million annually.

Alan Magazine of the Health Industry Manufacturers’ Assn., which also has been lobbying for reforms, called them “a significant step in the right direction.”

*

The two-year experiment with non-government experts, which will begin next fall, will allow the outside review of low- and moderate-risk devices, such as electronic stethoscopes and cholesterol and drug-abuse test kits used in laboratories. These experts would then make a recommendation to the agency, which would have the ultimate say.

Kessler cautioned, however, that “there are legitimate, serious questions as to whether such a system would work in this country--such as whether the capacity exists . . . for such reviews, whether it would provide the same quality control and whether private reviewers could be independent.”

Kessler also called on Congress to approve “user fee” legislation in connection with medical devices, similar to what already exists for drug approvals. This would require companies to pay fees that would be used to cover the costs of reviews. Such additional resources “are essential” in reducing backlogs and speeding review times, Kessler said. Device user-fee legislation was introduced in the last Congress but time ran out on the session before lawmakers could act.

Two weeks ago, the agency announced the elimination of 125 low-risk medical devices--such as bandages--from FDA review and Thursday proposed exempting more than 100 additional items, such as powered finger exercisers and certain kinds of syringes.

Kessler said the agency also would end the so-called “reference list,” a program that deferred agency clearance of device applications until a company corrected manufacturing violations identified during plant inspections. Applications will be delayed “only where there is a relationship between the violation discovered and the pending application,” he said.

Under the new proposals, manufacturers no longer will be required to obtain special agency approval to export unapproved products overseas if other industrial countries want them, Kessler said.

Kessler said the agency also will try to work with other countries in using research conducted abroad so that studies might not have to be duplicated in the United States for approval.

Drug companies no longer will have to construct full-scale manufacturing facilities before their drugs are approved--a requirement that arose from past fears that drugs made from living material could change when they moved from smaller plants to larger ones.

Kessler also said that except in rare instances, the agency will no longer require environmental impact assessments for new drugs because “in virtually all cases, there is no significant impact.” Yet, he said, “these evaluations costs tens of thousands of dollars.”