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FDA seeks ways to streamline biologic submission process.

GAITHERSBURG -- At a meeting aimed at helping the Food and Drug Administration re-energize an increasingly sluggish pipeline for new biologic products, manufacturers and patient advocates lobbied for what would amount to a faster track for bringing such agents to the market.

Greater access to FDA reviewers and more formal guidance from the agency could help speed the development process, drug-makers and patients told the FDA.

As part of an undertaking, dubbed the "Critical Path" initiative, the FDA is seeking advice from the stakeholders in light of a significant worldwide slowdown in new drug and biologic submissions to regulatory agencies since 2000.

"Product-development science is underdeveloped," and yet there are still diseases with no treatments, Kathryn M. Carbone, M.D., associate director for research at FDA's Center for Biologics Evaluation and Research (CBER), said at the meeting.

On one front, the FDA may choose to accelerate knowledge about drug outcomes by permitting the use of new animal models. There may even be ways to refine preclinical studies in order to reduce the number of animal studies that are needed, said Joyce L. Frey, Ph.D., acting director of the Office of Cellular, Tissue, and Gene Therapies at CBER.

Agency officials are also seeking insight on clinical trial design and on the use of biomarkers and surrogate end points, Dr. Frey said.

The bottom line for many of the stakeholders in drug development--manufacturers and patients alike--is that they want more guidance from the FDA upfront, early in the drug development process, emphasized James S. Cohen, acting director of the Office of Compliance and Biologics Quality at CBER.

Giving researchers and drug manufacturers more feedback from FDA reviewers during the earlier phases of drug development and testing may help create a clearer path to product approval and help them avoid regulatory problems later, Mr. Cohen said.

At the same time, stakeholders don't want greater interaction with the FDA to come at the cost of a more rigid approval process.

There is a need for a science-based decision process at the Food and Drug Administration, but it should include flexibility, said Katherine High, M.D., a faculty member at the Children's Hospital of Philadelphia and president of the American Society of Gene Therapy.

The preliminary results of a survey of members of the American Society of Gene Therapy shows that they would also like to see more guidance documents from FDA and greater access to experienced agency reviewers, Dr. High said.

Patient advocate groups such as the Genetic Alliance threw their support behind the effort to ensure that industry receives more guidance from the FDA.

Patients would also like to see a more standardized approach from CBER and better and faster coordination between the various federal agencies, said Patrick Terry, a professional advisory board member of the Genetic Alliance.

BY MARY ELLEN SCHNEIDER

Senior Writer
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Author:Schneider, Mary Ellen
Publication:Internal Medicine News
Geographic Code:1USA
Date:Nov 15, 2004
Words:471
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