At the urging of the pharmaceutical industry, the Food and Drug Administration is moving to close a federal laboratory that has monitored the purity and effectiveness of antibiotics for 37 years.
The move won't save the government much, since most of the lab's $6 million annual budget comes from fees paid by the industry, but drug manufacturers expect to save $60 million a year in "direct and indirect costs" when the National Center for Antibiotics Analysis closes Oct. 1.
The drug industry has hailed the action as the long-overdue elimination of a "vestigal remnant" of the days when antibiotics were new and relatively untested. But consumer groups say the laboratory performs an important oversight function and that closing it could open the way for unsafe drugs to enter the marketplace.
"It's a classic example of yielding to industry pressure," said Sidney M. Wolfe of Public Citizen's Health Research Group.
The lab, at 200 C St. SW, employs about 190 persons. It has been in operation since 1945, when penicillin, the first of the infection-fighting antibiotics, became generally available. Virtually its only function is to carry out an FDA requirement that each batch of antibiotics be tested and government-certified as safe and potent.
Drug manufacturers have tried to get out from under the certification requirements since the late 1940s, and in 1980 they won a partial victory from the Carter administration, which agreed to phase out the requirement, starting with antibiotic preparations that are applied to the skin.
But when the Reagan administration came into office vowing to take an ax to unnecessary regulation, the industry decided to try to speed things up. In a March, 1981, letter to Health and Human Services Secretary Richard S. Schweiker, the Pharmaceutical Manufacturers Association called the testing procedure "costly and anachronistic in terms of current good manufacturing practices," and suggested it as a prime candidate for elimination as an "excessive and burdensome" FDA regulation.
"Based on a survey conducted by PMA in 1980, we estimate that the elimination of batch-by-batch certification of antibiotic products . . . would relieve the pharmaceutical industry of direct and indirect costs on the order of $60 million a year," PMS Vice President Bruce J. Brennan told FDA in a later letter.
In December, FDA announced that it agreed with the PMA. In May, a proposal to exempt all antibiotics from certification was published in the Federal Register, and this week the agency started making plans to close the testing laboratory.
As part of those plans, FDA has imposed a freeze on hiring, firing and promoting until Sept. 30 "as an important means of protecting the rights of employes being affected," said FDA spokesman Faye Peterson.
Wolfe suggested that the laboratory had fallen victim to its own success. "It was working," he said. "Over the years there was steady improvement in the rate in which antibiotics failed to meet standards."
FDA spokesman Christopher Smith said the laboratory had tested 18,819 batches of antibiotics in fiscal 1981 and that less than 1 percent failed to meet government standards of purity and strength.
But Wolfe's group contends that the drug manufacturers' record in product testing "is less than exemplary." A Health Research Group report quotes an official of the antibiotics lab as saying that the testing methods proposed by the drug companies "do not accurately measure what is in a drug product."