Some staffers at the division of the Food and Drug Administration responsible for policing drug manufacturers are unhappy about the prospect of a move to new quarters.
Already beset by budget and staffing problems and criticized in Congress for a sharp drop in enforcement actions, the Drug Compliance Division's 100-plus staffers have been told to give up their current quarters in Rockville for a Bethesda office building about two miles away, a move many of them say will isolate the division and disrupt enforcement efforts.
"Morale has never been lower in compliance areas," one employe complained. Another warned that the move "will have a devastating effect on the everyday communication needed for compliance work" and "will delay decisions on drug product seizures, firm injunctions, prosecutions and regulatory letters."
Not so, argues Gerald Meyer, the FDA's associate commissioner for management and operation. "This is a phony rap," he said. "It won't really affect their ability to carry out their work."
Dr. Sidney Wolfe, director of the non-profit Health Research Group, said 42 division employes responded to a survey he distributed seeking comments on the proposed move. Nearly all of them said they were concerned about their lack of easy access to medical and scientific personnel, legal staff and administrative records, Wolfe said.
In a July 14 letter, Rep. Henry A. Waxman (D-Calif.) asked Dr. Edward N. Brandt Jr., assistant secretary of Health and Human Services for health, to reconsider the proposed move, saying that drug enforcement could be "seriously undermined" and result in "long-lasting morale problems."
One employe responded to Wolfe's questionnaire by saying, "The regulatory arm of this agency is being severed." Told of the remark, an FDA spokesman countered, "No, the regulatory octopus is just having one of its arms lengthened by a couple of miles."***
HOMES FOR ORPHANS. . . The FDA approved a drug recently that might have changed the course of history if it had been available in the 18th century.
Historians now suspect that porphyria, a blood disease that sometimes causes psychiatric disturbances, may have been responsible for King George III's erratic behavior toward his rebel colony in the New World. If so, the mad king could have been treated with Hematin, an "orphan" drug developed by Abbott Laboratories in Chicago.
Orphan drugs are used for diseases that are so rare that the potential market is too small for pharmaceutical companies to justify the development costs. But after passage of the Orphan Drug Act of 1983, which provides tax incentives for companies that do the research on such drugs, the FDA has found firms to do work on 23 orphan drugs and so far has approved six of the drugs for clinical use.***
TRACKING QUACKS . . . Quack medical devices and food supplements seem to spring up almost faster than the FDA can control them.
Recently, New Zealand green-lipped mussels, sold as an arthritis cure, have surfaced in California. The agency has put out an all-points bulletin with the Customs Service to stop the mussels at the border.***
THE BETTER TO FEED THEM WITH . . . At the FDA, it pays to use the suggestion box.
A better rat feeder won FDA employe John Hunziker of Jefferson, Ark., $4,958--the biggest award the FDA has ever made for an employe suggestion. His redesigned rodent cage saved the agency's National Center for Toxicological Research an estimated $150,000 in its first year.