Generic Drugs Pose No Danger, FDA Chief Says : Health: The probe into disclosures of falsified test data continues. Consumers are urged to keep using medications.

The outgoing commissioner of the Food and Drug Administration told members of Congress on Friday that the agency has found no evidence so far that generic drugs currently on the market are not safe and effective. But he cautioned: “Our work is not done yet.”

Dr. Frank E. Young, who will leave his post on Dec. 18, told members of the oversight subcommittee of the House Energy and Commerce Committee that “no serious problems with the safety of generic drugs have been found to date.”

Young said he would advise consumers to continue to use generics still on the market.

“Are the drugs safe and effective? At least as far as we’ve looked, the answer is a qualified yes. But we’re not finished,” he told the subcommittee, which is investigating the FDA and its relationship with the generics industry.

“For now, if consumers are taking generic drugs, they should continue with them,” he said. “If they have questions or concerns about their generic prescriptions, they should consult their physicians or pharmacists.”

The generics industry is being investigated by the subcommittee and the U.S. attorney’s office in Baltimore. The scandal began with disclosures that chemists in the FDA’s generics division had accepted bribes in return for accelerating approval of certain generic drugs and that several companies had committed fraud in submitting data to the federal agency.

As a result, dozens of generic drug products have been recalled and serious questions have been raised about the integrity of the entire industry.

As the scandal began to grow, Young initiated his own investigation of the industry. The agency analyzed samples of 30 of the nation’s most frequently prescribed generic medications and began stepping up inspections of generic drug plants.

Young told the subcommittee that laboratory tests on the 30 drugs have shown problems “no more severe” than those found in routine checks of brand-name and generic drug firms. Only 1.1% of the samples checked were not in compliance, he said.

However, the generic drugs were tested only to determine potency and the rate at which they dissolve in the bloodstream. They were not studied to determine bioequivalence--that is, whether they work as effectively as their brand-name counterparts.

In the past, FDA officials have said that bioequivalency tests are expensive and the agency did not have enough resources to conduct them.

However, Young told the subcommittee that the FDA intends to begin limited bioequivalency testing on certain generic drugs, beginning with drugs to treat epilepsy and asthma. The therapeutic value of such drugs depends on precise dosages--unlike drugs for most conditions--and discrepancies potentially could be serious.

“We intend to use our scarce resources to do this,” Young said.

Young said the FDA is also reviewing more than 1,500 product samples retained by three major contract laboratories after they conducted bioequivalency tests for generics companies as part of the approval process. Young said that one case of fraud has been detected from 500 samples analyzed so far.

Those checks were prompted by disclosures that some generics companies had substituted brand-name drugs in place of their own generic versions when submitting samples to independent labs for bioequivalency testing before approval.

Finally, Young said, FDA inspections of more than 30 generics plants have found numerous violations of “good manufacturing practices” as well as several additional cases of fraud or misrepresentation of information submitted to the FDA. Young called the incidents “a disturbing level” of violations.

“FDA’s laboratory tests of the ‘top 30’ drugs and the contract laboratory samples provide good assurances about generic drugs,” Young said. “But the findings from FDA’s inspections of generic firms, while still incomplete, have raised questions. The FDA . . . shall continue to follow through on the inspectional findings.”

Subcommittee Chairman John D. Dingell (D-Mich.) praised Young, who is leaving the FDA after more than five years to take another position at the Department of Health and Human Services, and he warned that Young’s absence will not diminish the subcommittee’s investigation.