Senate Oks Bill To Speed Fda Review But Consumer Groups Say Haste Makes Waste When It Comes To Protecting Public Health
The Senate overwhelmingly approved legislation Wednesday that would help speed new drugs and medical devices into the marketplace.
The bill to overhaul the U.S. Food and Drug Administration review process passed 98-2. But as the legislation moved to the House today, consumer groups warned safety is being sacrificed for speed.
Sen. Judd Gregg, R-N.H., said the bill would “overcome what you might call the culture of overcautiousness, which has become, regrettably, the culture of the FDA.”
The legislation, described as the first substantial reform in the FDA in 30 years, would set up a fast track to approve drugs for people with life-threatening diseases. It would make it easier for seriously ill people to obtain experimental treatments, allow the use of private, third-party experts to speed up reviews of new medical devices and renew a program in which fees collected from prescription drugmakers are used to help streamline the application process.
The White House said the bill “represents a significant step toward accomplishing our mutual goal of assuring the agency’s optimum performance while protecting the health of the American public.”
But it also expressed concern about the FDA’s right to review lower-risk medical devices. The bill would bar the FDA from seeking reviews of uses other than those specified by the manufacturers.
Sen. Edward Kennedy, D-Mass., said that prohibition would allow makers to promote unapproved uses of new devices. He and Sen. Jack Reed, D-R.I., were the only senators to vote against the bill.
Maura Kealey of the consumer group Public Citizen warned that revamping the FDA is a mistake at a time when revelations of the health problems from the unapproved uses of diet drugs point to the need for strong federal surveillance.
“This is the worst thing to happen to public safety in a long time. It’s the first major weakening of the FDA in 91 years,” she said.
xxxx SENATE BILL In moving to make the FDA more responsive to therapies for life threatening diseases, the Senate on Wednesday approved a bill that would: Enable patients to authorize their doctors to use experimental drugs or devices, not yet approved by the FDA. Set up a registry of clinical trials to give patients and their doctors ready access to experimental treatments and drugs. Streamline the FDA’s drug- and device-reviewing process to hasten approval of new therapies.