No decision yet for reform bill S 830

Much to the disappointment of the FDA, the Pharmaceutical Research and Manufacturers of America and numerous patient advocacy groups, legislators failed to debate or pass the FDA reform bill (S 830) before Congress' summer recess. At press time, discussions were expected to be resumed after the August recess.

The FDA reform bill contains several provisions that directly affect pharmaceutical companies and their ability to bring new drugs to market. One of the most important provisions in the bill is the re-authorization of the Prescription Drug User Fee Act.

User Fee Act

The Prescription Drug User Fee Act, which was jointly developed by Congress, the FDA and industry professionals in 1992, imposes fees on the pharmaceutical industry for the review of new drug applications.

The act expires on Sept. 30, however, and needs to be quickly reauthorized in order for the FDA to continue employing its reviewers and speedily processing new drug approvals.

A renewed version of the act, popularly known as the Prescription Drug User Fee Act II, would raise reviewer fees by at least 21% over the next five years - an increase that could translate to as much as $550 million in user fees. This would allow the FDA to install a paperless, more efficient electronic system for drug applications. And, if the FDA met its performance goals, the renewed act would hasten the drug approval process by as much as 16 months.

The FDA had originally pressured Congress to pass FDA reform before Aug. 1 because the FDA is required to give its employees 60 days notice of termination of employment.

But in late July, the agency admitted it could use approximately $24 million in carry-over funds to shoulder the burden of operating costs for three to six months if the act expired.

The carry-over funds had been set aside for two reasons: to fund review processes of drug applications submitted prior to Sept. 30 that were carried over into the 1998 fiscal year and to cover costs associated with termination of the program, including payments for severances, leases and other contract terminations.

The availability of the funds relieved some of Congress's immediate pressure to pass the bill. However, the funds cannot sufficiently cover new drug applications submitted after Sept. 30th.

As a result, pharmaceutical companies may scurry to submit new drug applications before the deadline or they may wait until the program is officially re-authorized.

Crunch time

At press time, Congress had 30 days to pass both Senate and House versions of the bill and package them as unified legislation before the drug user fee program expired.

The Senate had already resolved the majority of reform issues and passed S 830 at the committee level with a 14-4 vote; the House had yet to introduce legislation. According to Ann Oman, assistant vice president of communications at PhRMA, the delay in passing the bill was more a result of other priorities taking precedence in Congress than flaws in the bill. "We expected it to be on the floor, but everyone was so tied up in the budget deal that it just didn't get there," she said. "For [PhRMA], it's an obvious priority but the budget deal seemed to beall-consuming."

Budget issues for the FDA were settled much earlier in the summer. Legislators from both parties proposed maintaining current funding levels for the agency.

Other issues in S 830 (which Oman predicted would be the model for the final bill presented to President Clinton for approval) that legislators have settled include: provisions for expedited access, which permits manufacturers to provide investigational products to patients for life-threatening or seriously debilitating illnesses; fast-track approval, which expedites the development and approval of new drugs to treat serious and life-threatening illnesses; pediatric indications, which encourage drug sponsors to test more drugs for use by children; an information program, which directs the Secretary of Health and Human Services to create a program to disseminate information about ongoing research to patients and the general public; and the number of required clinical investigations, which grants the FDA the discretion to determine if one or more clinical trials is required to prove efficacy.

Still contested at press time, however, was the non-drug issue of uniform safety regulations for cosmetics.

Will FDA reform pass?

Will Congress pass the FDA reform bill? Probably. It enjoys strong bipartisan and public support. The National Health Council, a group comprised of 40 patient organizations, has urged Congress to pass it, as have the Arthritis Foundation, the American Liver Foundation and the National Multiple Sclerosis Society. It would also cost taxpayers nothing and yet still raise the FDA's budget by nearly $600 million.

Oman and other industry experts are optimistic about success, but they are less upbeat that it will happen before the drug user fee program expires.

"From what we've heard it will be introduced after the recess," Oman said. "But it may not pass by the Sept. 30th deadline. We've heard the FDA may give out pink slips by Sept. 15, but we've also heard that they may have enough money to go a little longer than that."

She continued: "The FDA may lose some people. These reviewers are highly qualified people who probably have other options. It's a shame that it had to go to the wire like this." PR