WASHINGTON -- The Food and Drug Administration failed to stop 'pharmaceutical cesspools' from selling suspect generic drugs, some destined for the military and children with cancer, a congressional panel charged Thursday.
Top FDA officials repeatedly rejected pleas by FDA field staff in Chicago to stop three firms from marketing generic drugs 'manufactured with apparent disregard for the public health consequences,' said Rep. John Dingell, D-Mich., head of the Subcommittee on Oversight and Investigations.
Among the problems cited were: drugs contaminated with metal; insects and other questionable sanitary conditions in areas used to make a drug syrup sold to the military to treat liver and digestive ailments; and poor stability in a drug, called vincristine sulfate, used for children with leukemia undergoing chemotherapy.
'The on-the-scene inspectors of those facilities knew that these three firms could best be described as pharmaceutical cesspools run by people who cared not a whit for the safety and efficacy of their products,' Dingell said.
Investigations into why those drugs were allowed to be sold 'make clear that a root cause of the inability of the FDA to recognize and prevent the generic drug scandal lies in the top-heavy regulatory structure of the FDA,' Dingell said in a memorandum to subcommittee members.
'With only two exceptions, FDA headquarters personnel rejected the field recommendations for meaningful action and substituted a series of ineffective warnings,' the memorandum said.
Daniel Michels, director of compliance at the FDA's Center for Drug Evaluation and Research in Rockville, Md., told the panel he was 'frankly dismayed in respect to how my organization and agency has dealt with these firms.'
Michels and Ronald Chesemore, the FDA's Associate Commissioner for Regulatory Affairs, said the FDA needs to streamline how it polices drug firms. Chesemore, who said it is possible problems like those uncovered in the Chicago area exist elsewhere in the country, said an effort to reduce the regulatory red tape would start 'next week.'
The committee's latest probe focused on:
--Alra Laboratories, Gurnee, Ill.: Sources told the subcommittee Alra sold adulterated drugs, falsified test results and stonewalled FDA inspections. The firm allegedly coated and shipped pills contaminated with metal, including remnants of a metal pipe and a steel wood pad.
--Lyphomed Division of Fujisawa Pharmaceuticals, Deerfield, Ill.: The subcommittee said evidence indicates the firm shipped non-sterile 'and otherwise dangerously violative' drugs to hospitals.
--Pharmaceutical Basics Inc., Chicago: The firm allegedly sold drugs made by its newly acquired firm, MY-K Laboratories Inc., even though its staff could not make the drugs with the formulas and production process MY-K used to win FDA approval.
Since 1988, the generic drug industry has been mired in a scandal stemming from revelations that company executives bribed FDA officials to obtain swift and unscrutinized approval for drugs. Drug makers also fraudulently substituted brand-name drugs for their own unproven formulas to subvert FDA tests and blocked the government's investigation.
'How long will this investigation last? It will last as long as necessary to clean up this cesspool,' Dingell said.
Thursday, the subcommittee focused on how the FDA's cumbersome bureaucractic structure contributed to the woes.
An FDA inspector's recommendation for civil legal action against a drug-maker must clear at least 13 levels of review before it reaches FDA lawyers who refer cases to the Justice Department. Generic drug firms and their lawyers 'know the game well,' and exploit the bureaucratic tangles, Dingell said.
FDA Commissioner David Kessler has vowed to beef up FDA enforcement, saying will add 100 new criminal investigators to the agency's staff in the next two years.
But Rep. Ron Wyden, D-Ore., questioned whether adding field staff will do anything to improve the FDA's ability to discipline wrongdoers. 'The central problem is that you did not efficiently use the people you had,' Wyden said.
Dr. Raj Bhutani, president of Alra Laboraties, and Dr. John Kapoor, former head of Lyphomed, took the Fifth Amendment in response to the subcommittee's questions.
Officials with Fujisawa Pharmaceutical, which bought Lyphomed in April 1990, and Pharmaceutical Basics Inc., which bought MY-K in July 1988, testified they had cleaned up the problems and are complying with FDA regulations.
