It’s all over the pharma blogs. Generic drug manufacturer Mylan (Pittsburg, PA) and FDA almost had a showdown.

The Pittsburgh Post-Gazette reported on July 26 that workers at Mylan’s Morgantown, West Virginia, plants were “routinely overriding computer-generated warnings about potential problems with the medications they were producing.” Workers in all three shifts of the plant’s operations were allegedly involved. 

The Morgantown plant produces about 19 billion doses annually, including drugs to treat diabetes, high blood pressure, depression, cancer, epilepsy, and other conditions, according to the Gazette article. Information on how long the practice of falsifying information went on has not been made available, although Mylan claims that no medications were compromised.

Mylan put out a statement the same day as the Gazette article, saying that the newspaper’s information was obtained “improperly” and from “uninformed” third parties. The Mylan statement said their quality systems were, in fact, working.

Mylan put out another statement on Monday, July 28, saying that FDA had visited the Morgantown plant on Sunday, July 27, and had determined that there “was no evidence of any data deletion” and that the “agency agreed that this was a minor Standard Operating Procedure (SOP) deviation that existed, was fully investigated, and all corrective actions were fully implemented by Mylan.”

FDA’s own July 28 statement, however, noted: “This investigation involves allegations of compliance violations that the FDA takes very seriously. The investigation is ongoing and the agency has formed no conclusions at this time,” reported the Wall Street Journal and other news outlets.

Meanwhile, the CEO of Mylan, Robert J. Coury, thanked FDA for its fast response and also thanked “all of the employees in Morgantown for their continued dedicated, hard work, and commitment to uphold one of the industry’s highest quality standards.” It was reported by the Gazette that Coury also issued a memo in June “reminding employees of the company’s policy prohibiting unauthorized employees from talking with the news media.”

So who’s telling the truth? Is Mylan another large pharma company in self-destruct mode (think Ranbaxy) and now trying to cover up its deviating tracks? Or is the media, as ex-vice-presidential candidate Sarah Palin likes to claim, just “making stuff up.”