Senate OKs Streamlined FDA Medical Approval

WASHINGTON — The Senate on Wednesday overwhelmingly approved a major overhaul of the Food and Drug Administration intended to streamline the regulatory approval process for new drugs and medical devices.

The bill would establish a new program to accelerate the review system for experimental medical devices, ease the way for desperately ill patients to have greater access to experimental drugs, allow wider circulation of information about unapproved uses of already licensed drugs and make it easier for food companies to add health claims to their labels.

It also would reauthorize the popular Prescription Drug User-Fee Act, a successful program that already has resulted in a speedup of the drug review process.

The vote for the bill, which the Senate debated at length during the last week, was 98 to 2.

“It’s an important step forward in ensuring a stronger and more efficient FDA,” said Sen. James M. Jeffords (R-Vt.), author of the legislation.

“This is about people’s lives,” said Sen. Judd Gregg (R-N.H.). “In many instances, this is going to save lives. In almost all instances, this will improve lives. This bill attempts to overcome the culture of overcautiousness--which has become the culture of the FDA.”

A similar bill is pending before the House Commerce Committee. Although it is uncertain when the full House would act on it, there is pressure for lawmakers to act quickly because the drug user-fee law expires on Tuesday. Under the 1992 law, drug companies pay the FDA a fee for each drug submitted for review, with the money paying for additional agency drug reviewers.

If and when FDA reform legislation clears Congress, it is not clear whether President Clinton would sign such a measure. Administration officials said they are troubled by some elements of both the Senate and House bills, though they declined to be specific.

The FDA long has struggled to achieve a balance between the need to approve new products expeditiously while ensuring that the public would not be harmed by them. Momentum to change the FDA was fueled by the Republican takeover of Congress in the 1994 election. During that campaign, GOP leaders accused several public health and safety agencies, including the FDA, of “overregulation.”

Attempts to pass a tougher bill during the last session of Congress failed, in part because many believed that it would weaken the FDA. The measure approved Wednesday is considered more moderate and reflects months of negotiations between lawmakers, the FDA and the administration.

“I won’t say this is a bill we’re completely happy with, but we’ve worked to achieve many compromises and it is palatable,” said one FDA official, who requested anonymity. “We can live with it.”

Sen. Edward M. Kennedy (D-Mass.), one of two senators to vote against the bill, held up final action for weeks over a provision that would ban the FDA from reviewing the safety of certain devices for uses not listed by the manufacturer.

Kennedy warned that this could allow the unregulated--and potentially risky--use of these devices for unapproved purposes. He vowed to continue efforts to eliminate the provision before a final version of the bill clears Congress.

Joining Kennedy in opposing the bill was Sen. Jack Reed (D-R.I.).

Although FDA critics have attacked the agency for acting too slowly, several nonpartisan studies have credited it with markedly improving its review performance, particularly the process for approving new drugs, on its own.

The agency also has streamlined its procedures for reviewing medical devices in recent years, although FDA officials have acknowledged that the agency can do even better.

The Senate measure attempts to address this deficiency by expanding a current pilot program to allow most experimental medical devices to be reviewed by outside experts chosen and paid for by the manufacturer. However, the FDA would certify these reviewers in advance and make final decisions on the devices.

Also, the outside reviewers would not be permitted to review the riskiest devices, such as heart valves and other implantable items.

The FDA “has already improved its [device] review times lately and this bill will continue to nudge them along,” said James Benson, executive vice president of the Health Industry Manufacturers Assn., the medical devices trade organization.

Benson, who headed the FDA’s devices center during the early 1990s, predicted that the program would work safely because the agency “will still maintain total control over the process.”

The bill also would:

* Permit companies to add health claims to their food labels if the benefits have been substantiated by a federal scientific body, such as the National Cancer Institute. The FDA would have 30 days to review the claim and--if it disagreed--could block it or put it on hold. Currently, such claims must go through a more lengthy FDA review procedure.

* Allow drug companies to circulate among physicians the results of studies of so-called “off-label” uses of licensed drugs. Manufacturers, for their part, must agree to study the effects of the drugs in larger numbers of patients and seek formal approval for off-label uses from the FDA.

* Give terminally ill patients access to experimental drugs that are under study, even if the patients are not part of formal clinical trials of that drug or do not qualify for the studies. Currently, AIDS and cancer patients have such access. The provision would expand the concept to other life-threatening or debilitating ailments.

The legislation would renew the Drug User-Fee Act for five years. The provision is “very important for our state’s key industries,” said Tim Ransdell, executive director of the California Institute, which watches legislation of interest to the state. “One-third of the nation’s biotech industry is housed within California’s borders, so this is an issue critically important to us.”