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Executive Summary

FORMER FDAer PINELLA HAS NOT BEEN CHARGED BY GOVERNMENT of any wrongdoing associated with the generic drug industry investigations. In referring to a civil case brought by Mylan, "The Pink Sheet" incorrectly included Salvatore Pinella among a list of former FDAers who have pleaded guilty to accepting illegal gratuities (Dec. 6, T&G-10). "Mr. Pinella was not charged or indicted in any wrongdoing in this matter," Pinella's Rockville, Md. attorney Michael Bell said in a letter to "The Pink Sheet." Bell stated: "I personally can verify that no 'deals' were struck with anyone, prosecutors or otherwise, in order to avoid prosecution." "Not only was Mr. Pinella never charged," the letter continues, "I know of no charges that were ever even contemplated against him, and we have been assured by Mr. Gary Jordan of the [Maryland] U.S. Attorney's Office that the matter is closed." Bell noted that his client was a witness during the government's investigation of FDA's generic drug approval processes. "Mr. Pinella was simply a cooperative witness for the government in an investigation into the practices of the generic drug industry," Bell said. The U.S. Attorney's Office confirms that it does not plan to charge Pinella with any wrongdoing in the generic drugs investigation. Pinella is named as a defendant in Mylan's civil suit against other generic-drug companies, their executives and consultants, and former FDAers. Pinella was not originally named in the case when it was filed by Mylan in June 1989 but is named as a defendant in a Dec. 8, 1992 court order dismissing the case ("The Pink Sheet" Dec. 14, 1992, T&G-7). That order was overturned by an appeals court earlier this year.

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