Update from Washington: FDAMA

June 1, 1998
Peggy Machak

Pharmaceutical Representative

Last November, President Clinton formally signed into law the Food and Drug Administration Modernization Act, sweeping bipartisan congressional legislation focused on reforming the agency's regulation of food, drugs, medical devices and cosmetics. Overall, the new law is considered a triumph by both the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization because it embraces many of the FDA legislative reform recommendations the industries had proposed to streamline the drug regulatory process.

Last November, President Clinton formally signed into law the Food and Drug Administration Modernization Act, sweeping bipartisan congressional legislation focused on reforming the agency's regulation of food, drugs, medical devices and cosmetics. Overall, the new law is considered a triumph by both the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization because it embraces many of the FDA legislative reform recommendations the industries had proposed to streamline the drug regulatory process.

The Modernization Act renews the 1992 Prescription Drug User Fee Act for another five years. The reauthorized Prescription Drug User Fee Act further increases user fees and is expected to generate an estimated $600 million over the next five years, according to Jeff Trewhitt, a spokesperson for PhRMA. It also promises to shave another 10 to 16 months off the overall drug discovery, development and review process, which can sometimes take as long as 15 years.

"This time it's going to be more than just chipping away time from the final review of a new drug application," said Trewhitt. "It's also going to be a matter of chipping away time from the required three-phase clinical testing period."

Reform provisions

In an effort to get new medicines to critically ill patients as quickly as possible, the Modernization Act also improves and expands the fast track drug approval process to include drugs for all types of life-threatening diseases. It also reduces the priority review time from six months to four months. "This is a major victory for the industry," said Trewhitt.

The new law abolishes the long-standing prohibition on information dissemination by drug manufacturers regarding the off-label uses of their drug products, as well. Companies can now disseminate reprints of peer-reviewed journal articles explaining off-label indications, although they must agree to submit a supplemental new drug application to the FDA within a three-year time frame after conducting additional clinical trials to establish the safety and efficacy of the products' unapproved uses.

In addition, the provision allows drug companies to provide economic information about their products to formulary committees, managed care organizations and other large-scale buyers of health care products to help them with purchasing decisions. It restricts such information, however, if it has the potential to affect prescribing choices among individual medical practitioners.

Instituting the law

Although it is difficult to assess how the law will ultimately impact the industry's sales forces, Trewhitt said it will definitely benefit the industry in general -and more importantly, the patients -because medications will be approved more quickly and efficiently.

"The modernization law takes much of what we've already been doing administratively and codifies it," agreed one FDA source. "And to the extent that there will be more early collaboration between FDA and sponsors, the hope is that this will streamline development as well."

But turning proposals into law is only half the battle, according to Trewhitt. "The second half of this battle, which is equally important, is implementation, and it's a Herculean task," he said

The FDA will be issuing rules, regulations and guidances to institute the various provisions of the Modernization Act through 2001. In doing so, it must also meet a host of statutory deadlines that have been spelled out in a quantifiable, measurable timetable, including several deadlines covering major drug provisions that must be met by November.

Trewhitt said PhRMA has already submitted several formal recommendations to the agency's public comment docket for implementation of key provisions.

One recommendation, for example, addresses possible rules and regulations for a provision that offers an additional six months of product exclusivity to drug companies willing to perform clinical trials on the appropriate dosage levels of medications for pediatric populations.

"We will be working very closely with the FDA to make sure the statutory deadlines are met rationally and responsibly, and really uphold the spirit of the law as passed by Congress," said Trewhitt. "It's the top priority of the pharmaceutical industry this year, and I suspect it will be next year, as well." PR

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