Mylan, FDA Square Off On Quality Control Inquiry

Generic drug developer said FDA backed up company's position that employees in West Virginia didn't ignore quality control procedures, though agency disputes Mylan's claim.

NEW YORK (AP) -- Generic drug developer Mylan Inc. said Tuesday the Food and Drug Administration backed up the company's position that employees at a West Virginia facility did not ignore quality control procedures. The agency said its probe isn't finished.

Mylan said FDA investigators found that claims in a lengthy investigative piece by the Pittsburgh Post-Gazette were unfounded. The agency, though, said that was not the case and the FDA has yet to form a conclusion. Any statement implying so, is "untrue," the agency said.

"The investigation is ongoing and the agency has formed no conclusions at this time. Statements to the contrary are untrue," said Steven Solomon, the agency's assistant commissioner for compliance policy. He said the investigation involves "allegations of compliance violations that the FDA takes very seriously."

Mylan spokesman Michael Laffin said the differing statements could be the result of a timing issue in regard to the local inspector reporting back to the agency.

"Our CEO would have never gone out with a statement without being informed of a close-out on the FDA inspection," he said.

On Sunday, the Pittsburgh Post-Gazette published an article saying the company discovered workers routinely ignored warnings about potential problems in the production process at a Morgantown, W.Va. facility. Mylan shot back with a statement the same day disputing the article.

Mylan said FDA officials visited the facility Monday after the company's "proactive" contact and noted there was no evidence of any data deletion in regard to the quality controls.

"All data was reviewed and was present and accounted for; the agency agreed that this was a minor standard operating procedure deviation that existed, was fully investigated, and all corrective actions were fully implemented by Mylan," the company said in a statement.

Shares of Canonsburg, Pa.-based Mylan were up as much as 9 percent this morning after Mylan issued its statement. In afternoon trading, the stock was up 59 cents, or 4.9 percent, at $12.69. The stock has traded between $5.75 and $14.94 over the past 52 weeks.

More in Operations