Industrial Bio-Test Laboratories has yielded to a demand by the Food and Drug Administration for a list of the products in FDA jurisdiction that it has tested in animals over the past decade, it was learned yesterday.
The agency on March 11 had geven IBT "one final opportunity" to list the products, including medicines and food additives, so that the FDA could assess the reliability of animal testing that was supposed to establish their safety.
Acting FDA Commissioner Sherwin Gardner sent the ultimatum to the Northbrook, III., firm a few hours after telling a Senate hearing that agency investigators had discovered "a number of irregularities" in an IBT animal test that purportedly proved the safety of Triclocarbon (ICC), the anti-germ chemical in virtually all deodorant soaps.
He told Sen. Edward M. Kennedy (D-Mass.), chairman of the Senate Subcommittee on Health and Scientific Research, that the investigators also had found discrepancies in IBT tests of other products, including Aprosyn, a Syntex Corp. drug prescribed for hundreds of thousands of arthritis patients.
In addition, Sandoz Pharmaceuticals of East Hanover, N.J., told the FDA on Feb. 22 that it had found discrepancies in a rat study IBT had done for it on a drug called Restoril. "Some animals died more than once and others disappeared and reappeared," the firm said in citing one example.
Over a period of months, Gardner testified, IBT had not complied with an agency request to list all of the FDA-regulated products it has tested, consenting instead to identify only the relatively few which it had authorization to do so from pharmaceutical and other manufacturers. The FDA said that up to now it knew of 15 drug manufacturers for which IBT had done testing, but did not know how many others there may be.
Kennedy, who has led an effort to assure the integrity of product testing on which public health depends, criticized the FDA for being insufficiently aggressive, and offered to issue subpoenas for the data from IBT the same day.
With that, Gardner demanded the information from IBT and warned it that the agency was prepared to request Senate subpoenas if necessary.
In a telegram three days later, on March 14, IBT President J.C. Calandro sent out a timetable for compliance by nest Friday. He made exceptions only for clients who may refuse to cooperate. But he said he would name those firms, which would enable the FDA to demand the information directly from them.
Calandro said he had been "surprised to learn of your distress," saying he thought the FDA had been getting cooperation from IBT. The firm, a Nalco Chemical Co. subsidiary, is one of the largest animal labs in the country. Its clients include, in addition to numerous manufacturers, the FDA, the Environmental Protection Agency and the National Cancer Institute.
Gardner, who said the IBT data is trade information that cannot be publicly disclosed, told IBT that its compliance proposal was acceptable even though "not fully responsive to our request for records."