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FDA to overhaul rules on tissue research

tissue samples

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February 28, 1997
Web posted at: 11:45 p.m. EST

WASHINGTON (CNN) -- The U.S. Food and Drug Administration Friday unveiled a sweeping proposal to regulate human tissue research.

The change could affect virtually all medical procedures in the country that involve transplants, including the controversial area of reproductive tissue.

Outgoing FDA Commissioner David Kessler said the new rules are the culmination of 15 years of work aimed at eliminating inconsistencies in tissue regulation.

Many of the biological products covered under the proposed rules are new, developed within the last ten years. Among them are umbilical cord blood treatments for leukemia and tendon and ligament replacement for joint injuries.

"These are many of the products that we're going to see five, 10 years from now," said FDA spokesperson Mary Pendergast. "It's important for industry, for the FDA, so set a road map so everyone will understand as they go into the process of developing new technologies how they'll be regulated at the end of that process."

Human tissue research fast-growing area

Human semen and eggs used in fertility treatment, skin grafts and heart valves would also be affected under the proposal, part of President Clinton's reinventing government effort.

Human tissue research is one of the fastest growing areas in medicine. Under the proposed new rules, human cells or tissue would have to follow guidelines based on their potential risk of infection. The greater the risk, the more regulation is entailed.

The agency says it consulted with the bio-tech industry extensively before developing the tissue regulations, which it claims may actually speed up the process of getting promising new products into the marketplace.

Pendergast

"Before the first dollar is spent, before the first experiment is done in a test tube or in a mouse or in people, we're going to tell you what you need to do at the end of the day." Pendergast said. "There will be a level of certainty and understanding that we think will foster innovation."

The move to regulate fertility tissue is a first, the FDA said. At the moment there are no federal safety controls on fertility clinics.

Rules could take effect in 3 years

Some doctors endorse the change. "I think the people, the government as they go through the process and hear from professionals in the field, will set out rational guidelines," said Dr. Joe Massey of Reproductive Biology Associates.

The FDA will hear from the public about the proposed rules. If approved, the rules could take effect within three years.

 
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