By Lisa Seachrist

Washington Editor

WASHINGTON — Having taken a rocky road through Congress, FDA reform will become law at a White House signing ceremony on Friday morning, industry sources said.

When President Clinton signs the FDA Modernization Act of 1997 into law, he will enact changes that will set the stage for fundamentally altering the ways in which biologics are regulated and the industry and the agency interact.

The FDA, however, is ultimately responsible for implementing the law, and how the agency will integrate the changes has yet to be determined.

Industry sources speculate that the president may provide a hint by taking the signing opportunity to name his nominee to fill the post of FDA commissioner. Those same sources indicate the leading candidate is University of New Mexico's vice president for health sciences, Jane Henney, who was deputy FDA commissioner for operations from 1992 to 1994. (See BioWorld Today, Oct. 31, 1997, p. 1.)

"We had some very specific goals when we started this process," said Alan Goldhammer, director of technical affairs at the Biotechnology Industry Organization. "We actually achieved those goals. Our feeling on this is very positive. We think it is going to have a significant impact on the drug development process."

First and foremost, the law will reauthorize the Prescription Drug User Fee Act (PDUFA) for another five years. Under the reauthorization provisions, the agency will work toward establishing an all-electronic method for submissions, will be compelled to complete reviews in 10 months — two months sooner than the current statutory obligation, and will communicate with sponsors when it discovers problems with the applications.

"In all, the PDUFA provisions can shave between 10 and 16 months off the total development time for a drug," Goldhammer said. "If you look at biopharmaceuticals, which typically have a shorter development time than most drugs, that could have a significant impact."

One Phase III Trial Will Support NDA

In addition to PDUFA changes, the law will change the statutory language describing clinical evidence standards for drug approval to one clinical study and confirmatory evidence. The current language calls for clinical trials to establish efficacy. Some reviewers interpreted that to mean more than one Phase III trial was needed in order to approve a drug.

The law also will establish a fast-track drug process by which the agency becomes involved in the very early development of drugs to treat serious and life-threatening conditions. The program will provide agency guidance to industry from the preclinical stage through the pivotal trial of selected drug candidates, which could significantly decrease development time for important breakthrough products.

Under the new law, manufacturers who wish to make small changes in their production processes will be able to note those changes in an annual report rather than filing all changes with the FDA. The move will significantly reduce the amount of paperwork and streamline the workload at the agency.

The law also will codify the biologics rewrite which eliminated the establishment license application and streamlined the procedure for filing a biologics license application.

"By working on this reform legislation, we got a much better feeling for agency concerns," Goldhammer said. "This legislation should provide significantly more collaboration on drug development and should speed the process." *

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