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FDA Chief Says Agency Needs More Power to Punish Cheating on Drug Tests

November 17, 1989

WASHINGTON (AP) _ The Food and Drug Administration chief told Congress on Friday the agency needs more authority to punish generic drug companies that cheat on safety tests and misrepresent data to win product approvals.

FDA Commissioner Frank Young also gave a qualified endorsement to generic drugs, saying the agency’s investigation of the 30 top-selling generics provides ″good assurances″ about their overall safety.

″Are the generic drugs on the market safe and effective? The answer appears to be a qualified yes ... our job is not done though, and we will keep that qualification until we are done,″ Young told a House subcommittee.

He added: ″Patients using generic drugs should continue using them.″

Young, testifying before the Energy and Commerce investigations subcommittee, said he will work with lawmakers to beef up FDA’s ability to remove problem generics from the market quicker and to take stronger action against the companies that violate FDA rules.

He noted that problems have been found with certain manufacturers, including several that switched their products for brand-name drugs in tests required to win FDA approval.

So far, he said, none of these cases, nor instances of company executives attempting to bribe FDA employees, have compromised the safety of any generic drugs that were sold to the public.

As a result of the FDA’s investigation, generic drug companies have recalled a total of 83 drugs because of problems ranging from manufacturing deficiencies to cheating on safety tests.

In addition, the FDA has started the lengthy process of withdrawing drug approvals for five generic drug makers.

The FDA began investigating after the subcommittee turned up evidence of fraud. So far three former FDA employees have been convicted of receiving illegal gratuities and three generic drug manufacturing executives have been convicted on bribery charges. The investigations by FDA, the subcommittee and the U.S. attorney’s office are continuing and more charges are expected.

The FDA does not have broad authority to recall drugs. In most cases, the agency relies on companies to comply with FDA requests for recalls.

Several subcommittee members brought up the possibility of giving FDA authority to bar future drug approvals from companies that are shown to have committed criminal acts to win previous approvals.

Asked if he felt FDA needed that authority, Young said, ″I absolutely do.″

Young is leaving after more than five years as head of the FDA next month to take another position within the Public Health Service, which is part of the Department of Health and Human Services.

In an interview during a break in the hearing, Young denied speculation that he is being forced out because of the generic drug scandal.

″If I left last March, they would say it was because of the Chilean grapes,″ imports of which were halted temporarily after a poisoning threat, he said. ″If I leave now, it’s the generic drugs.

″There’s always some problem at FDA,″ he said, adding that ″there’s no way to dismount from the tiger″ without stirring speculation.

At the hearing, Rep. John Dingell, D-Mich., subcommittee chairman, praised Young’s efforts to clean house at the FDA, and warned the generic drug industry that, although Young is leaving, the subcommittee will continue its investigation and ″will make sure that a flood light is in place.″

An interim report on the FDA’s investigation into generic drugs submitted to the subcommittee said that among 11 generic drug firms suspected of wrongdoing, inspections found problems at nine of the companies, including fraudulent drug approval applications, ″cutting corners″ in the manufacturing process and other manufacturing deficiencies.

The FDA wants to withdraw drug approvals for four of those companies - Bolar Pharmaceuticals of Copiague, N.Y.; Par Pharmaceuticals of Spring Valley, N.Y.; Superpharm Corp. of Central Islip, N.Y.; and Vitarine Pharmaceuticals of Springfield Gardens, N.Y.

Among 20 other companies inspected later, one firm, Quantum Pharmics of Amityville, N.Y., was found to have falsified records for a number of its products and manufacturing deficiencies were found at other companies. The FDA wants to withdraw drug approvals for 11 Quantum products.

Tests on more than 2,500 samples of the 30 top-selling generic drugs are nearly complete and so far have found that nearly 99 percent of the drugs sampled comply with FDA standards.

Young said this is consistent with the rates routinely found for brand-name and generic drugs.

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