Drug Firm Agrees to Pay $10 Million in Fraud Case : Health: Warner-Lambert admits it withheld data about Dilantin problems from FDA. Former executive is indicted.

WASHINGTON —  A former drug company executive was indicted Tuesday and the company agreed to pay $10 million in fines after admitting that it fraudulently withheld information from the Food and Drug Administration about persistent problems with a widely used anti-epilepsy drug.

New Jersey-based Warner-Lambert Co. admitted in its guilty plea that it committed a felony by failing to report problems with Dilantin, the epilepsy medication, in the early 1990s. The government filings state that Warner-Lambert also hid problems with three other drugs no longer manufactured by the company that were used for treatment of Parkinson’s disease and thyroid conditions.

The company’s former vice president for quality assurance, Allan H. Doane, faces a maximum sentence of 19 years in prison and $1.25 million in fines for several charges, including conspiracy and causing the shipment of adulterated Dilantin.

The company admitted that it failed to inform the FDA about “stability” problems with Dilantin--that is, a tendency of the drug to break down chemically, leading to inconsistent strength and absorption from dose to dose.

“We have no evidence of actual harm as a result of these stability failures,” said Lynne A. Battaglia, U.S. attorney for the district of Maryland. “But the fact that it was unreported created a risk of harm to consumers. . . . We are here to enforce protections for consumers.”

Warner-Lambert spokesman Jennifer Mann said: “Our company’s products were and continue to be safe and effective,” and noted that the guilty plea covers incidents that occurred between 1990 and 1992. “We’ve cooperated fully with this investigation, and we regret that these violations took place.”

Mann also said Doane, who retired in 1992, “served Warner-Lambert well for over 30 years,” and that the company would pay his legal fees.

Doane could not be reached for comment Tuesday.

The company’s guilty plea was entered before U.S. District Judge Deborah K. Chasanow in Greenbelt, Md.

According to government papers filed in the case, company officials were aware for several years prior to 1991 that batches of some of their products, including Dilantin, failed to meet federal quality standards. On Oct. 1, 1991, company employees suggested notifying the FDA about the problems with Dilantin, but corporate officials did not do so--even though they were preparing a letter to the FDA at the time describing problems with other Warner-Lambert drugs. The FDA only learned of the problems with Dilantin in 1992 while investigating stability failures in three other Warner-Lambert drugs: the anti-Parkinson’s medication Parsidol and two thyroid drugs, Euthroid and Proloid.

In 1993, the company agreed to a civil injunction ordering it to stop manufacturing many of its products temporarily, including Benadryl and Rolaids, while it brought its manufacturing procedures into line with FDA rules. The agreement, or “consent decree,” allowed the company to continue making Dilantin and other drugs for which there were no suitable substitutes. Warner-Lambert no longer makes Parsidol, Euthroid and Proloid.