The Food and Drug Administration is bracing for change. Riding a wave of strong bipartisan support, a bill aimed at reforming the powerful regulatory agency passed Congress last week . President Clinton is expected to sign the bill into law soon, and it would take effect immediately.
Incremental rather than revolutionary, the FDA Regulatory Modernization Act of 1997 nevertheless sets an important change in tone for the agency. By rolling back some regulations and streamlining others, the bill could improve public health through quicker approvals of new products, supporters said.
"This is permission from the Congress and the administration that says to the FDA that we want you to change direction," said James Benson, executive vice president at the Health Industry Manufacturers Association, a Washington trade group for devicemakers that backed the bill. "It's not as much as we wanted, but we're pleased with what is there."
For instance, the law would lessen or repeal some planks of a 1990 law that significantly expanded the FDA's authority and gave manufacturers headaches, such as requiring them to maintain registries of patients with certain implanted devices.
Those changes are practically and symbolically important, said Benson, a career FDA employee and acting FDA commissioner from 1989 to 1990. "It's the first time there's been rollback legislation," he said.
Several provisions aim to cut the time the FDA takes to approve new products. For instance, the reform law would require FDA staff to meet with manufacturers during clinical trials of some new products and allow the agency to expand a pilot program that uses third parties as subcontractors in reviewing some low-risk devices.
The new law also promises to prevent a growing headache for hospitals. Within a few years, hospitals and nursing homes would no longer be required to submit reports to the FDA when patient deaths or serious injuries involve medical devices.
This year the General Accounting Office, Congress' investigative arm, faulted the agency for failing to implement user reporting requirements, mandated by a 1990 law.
Under the reform bill, the FDA could rely instead on a small sample of representative hospitals and nursing homes, known as sentinels, to collect data on devices involved in patient injuries or deaths.
Despite the grab bag of reforms, some FDA watchers lamented the bill as a squandered opportunity to make more fundamental change.
"Reform it isn't -- tinkering it is," said James Phelps, an attorney specializing in FDA law at Hyman, Phelps & McNamara in Washington. Phelps said the modest moves to streamline the approval of new products don't go far enough and are susceptible to bureaucratic backsliding.