Dingell Seeks Generic Epilepsy Drug Tests

The congressman who is heading a far-reaching investigation of the Food and Drug Administration said Wednesday that he has “no confidence” the agency can ensure the safety of generic drugs used to treat epilepsy and other conditions requiring precise dosages.

Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee as well as its oversight and investigations subcommittee, asked the FDA to increase its scrutiny of the nation’s leading generic drugs to include all epilepsy products and other narrow therapeutic range medications.

Subcommittee investigators said that Dingell’s comments signify a major “break of faith” with the FDA, which has been cooperating with a federal inquiry into bribery and fraud in the generics industry.

“The compliance people--the people doing the work in the field--are fine,” one subcommittee investigator said. “The real problems,” he added, involve the FDA’s Center for Drug Evaluation and Research, which handles approval and regulation of brand-name and generic drugs.

FDA officials refused to comment on Dingell’s charges.

But subcommittee investigators, after meeting Wednesday afternoon with FDA Commissioner Frank E. Young, said that Young “had indicated a favorable response” to Dingell’s request to include the additional generic products among the drugs it is testing.

“We know that Young has been concerned about these epilepsy drugs for a long time,” the subcommittee staff member said. “He’s given many speeches and said publicly many times that he was concerned about them.”

The federal inquiry, which also involves the U.S. attorney in Baltimore, began with disclosures that chemists in the FDA’s generics division had accepted bribes from industry executives in return for speeding the approval of certain generic drugs.

So far, federal officials have found no evidence that the generics scandal has resulted in unsafe products reaching consumers.

But Dingell said that he is especially worried about reports that a generic company--Pharmaceutical Basics Inc., of Chicago--substituted a cheaper raw material for a more expensive one in carbamazepine, an epilepsy drug.

After the substitution, “breakthrough” seizures were reported by a number of patients who may not have absorbed enough of the medication. Breakthrough seizures occur when a patient is on medication designed to prevent them.

At least two patients taking the firm’s carbamazepine product died, although no direct evidence links their deaths to the drug. But a report written by the FDA’s Denver district office and released by the subcommittee said that a toxicology test of one of the patients showed the level of the drug to be “subtherapeutic.” The drug has since been recalled.

“I regret the additional resource drain this imposes on FDA laboratory facilities,” Dingell wrote in a letter to Young. “However, the demonstrated failures in the generic drug approval process make essential a review of the dissolution and potency of sensitive generic drugs currently being marketed.”

For most conditions, exact dosages of drugs are not usually necessary. But some afflictions--epilepsy, asthma and certain cardiac conditions, for example--require a precise amount of medication to ensure therapeutic effectiveness.