Monday, March 22, 1993
Disagreement on multiple trials
ROCKVILLE, Md. - Members of the FDA's Peripheral and Central Nervous System Drugs advisory panel on Friday debated but did not resolve the need to conduct multiple Phase III trials before approving drugs or biologic compounds.
The committee rejected suggestions that the Chiron Corp.-Berlex Laboratories' trial of Betaseron in multiple sclerosis victims could be considered as two independent trials, one Canadian and one U.S. The trial was conceived as a single, multi-center trial and was conducted by one set of investigators.
Janet Woodcock of the FDA's Center for Biologics Evaluation and Review, told the committee that the agency currently interprets the law to permit a single trial for approval of a biological agent but, with a very few exceptions, it has held that more than one trial must be conducted for a drug. This is in part because regulation of biologicals and drugs are based on separate federal statutes.
New drugs are regulated