Private industry will lend a helping hand to the Food and Drug Administration if suppliers and some politicos have their way.
The FDA is an overly ambitious public guardian, they charge. It keeps good medical products from consumers far too long because it so thoroughly screens for dangerous products (Feb. 1, 1993, p. 35). If only it would follow the Europeans by farming out a little work, they say, products would reach the market more quickly.
At least one bill now before Congress urges the FDA to abide by the counsel of private entities at some stages of its review process. The drug and device industries are throwing their weight behind such proposals. Manufacturers warn that America will lose the race for medical advancement if the FDA doesn't pass the baton of product review, at least some of the time.
"No matter how hard the FDA struggles-and I've seen this from the inside-the technology is going to be evolving so fast, beyond its reviewers' ability to stay up with things," said James Benson, a senior vice president at the Health Industry Manufacturers Association and a former high-level FDA administrator.
So far, the agency has agreed to give privatization a trial run-but not without some qualms.
Drug and device makers would pay private firms for the contracted reviews under most proposals. The practice could lessen the FDA's workload without straining its budget or lowering approval standards. Yet, it would raise the question of whether marketing approvals are for sale.
That's not the only problem. No U.S. organization combines the FDA's knowledge of clinical trial procedures, drug chemistry and toxicity, engineering and medical materials.
"Where are we going to get the expertise to run these companies?" one technology expert asked. "You're talking about starting a whole cottage industry."
Underwriters Laboratories, the electrical safety certifier, could carry out part of a product's review, said Robert Williams, its manager of standards and research. After all, electrical medical products make up some of the 70,000 engineering evaluations it performs annually. But the Northbrook, Ill.-based company isn't equipped to oversee clinical trials.
ECRI, a respected technology assessment firm in Plymouth Meeting, Pa., will have nothing to do with contracted review, said Joel Nobel, M.D., its president. "Money," Nobel said, "is inevitably corrupting."
None of this is lost on the FDA, said Eric Rechen, a policy analyst at the agency. Nevertheless, it will launch a fairly broad pilot program before year-end as part of the Clinton administration's plan to "reinvent government."
Under the experiment, the FDA will use the recommendations of manufacturer-hired reviewers to make its final decision about some low- to moderate-risk devices. Among the 45 candidate devices: condoms, hearing aids and surgical gloves.
For these products, marketing approval rests on whether the device is judged "substantially equivalent" to already marketed products. Manufacturers will provide performance studies, and clinical trials won't be necessary, Rechen said.
The FDA held a public meeting last week to discuss its plan. Policymakers still must sort out the serious issues, such as how to certify reviewers and guard against conflicts of interest, but they hope to do so with the help of industry and consumer groups.
Meanwhile, disgruntled drug and device companies are prodding lawmakers to reshape the FDA.
Earlier this month, Rep. Ron Wyden (D-Ore.) introduced a bill that, among other reforms, would order the FDA to certify third parties to conduct chemistry, toxicology and statistical analyses of drugs.
Although the proposed legislation is extensive, it still falls short of the changes sought by industry and other interest groups. The Health Industry Manufacturers Association, for example, would like legislation that authorizes certified third parties to review marketing applications for all types of devices.
Last week a think tank tied to House Speaker Newt Gingrich (R-Ga.) called for a near dismantling of the FDA. The group, the Progress and Freedom Foundation, said the FDA should review third-party reviewers instead of the actual products.
The underlying problem is that the FDA's mission to protect consumers conflicts with manufacturers' need to market products and patients' desire for the most advanced technology.
"We could make the process a lot more efficient at the cost of some safeguards," said Lester Lave, an economics professor at Carnegie Mellon University in Pittsburgh. "Is that what we want? Somebody has to think this through fairly carefully, or we could end up with a system worse than what we have."