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FDA’s Campaign to Control the Practice of Medicine – Letter to the Editor

The Wall Street Journal published the following letter to the editor written by Phillips & Cohen partner Erika A. Kelton in response to an op-ed that criticized the prosecution of a doctor who was paid by a pharma company to make sales pitches. Ms. Kelton represented the whistleblower in the qui tam case against Orphan Medical.

FDA’s Campaign to Control the Practice of Medicine

Mr. Silverglate distorts both a federal appeals court ruling and the grounds for Dr. Peter Gleason’s conviction. (“A Doctor’s Posthumous Vindication,” 12/26/12) The court ruled that pharma sales representatives can’t be convicted for making truthful statements about a drug’s effectiveness in treating particular medical conditions even if the FDA hasn’t approved that use. There was nothing truthful about Gleason’s statement that “table salt is more dangerous” than Xyrem or other sales pitches he made to convince fellow doctors to prescribe Xyrem. For those sales pitches, Gleason was paid tens of thousands of dollars by Xyrem’s manufacturer, Orphan Medical—a point Mr. Silverglate omits.

The government was right to prosecute Gleason because he violated the law and people’s health and lives were at stake. Xyrem can have serious side effects, and when improperly used can induce comas and cause death, which is why it has a “black-box” warning. Orphan also was prosecuted for promoting Xyrem for dangerous, unapproved uses and pleaded guilty. Jazz Pharmaceuticals, which acquired Orphan, paid $20 million to settle civil and criminal charges. In no way did the appeals court ruling vindicate Gleason or Orphan.

Erika A. Kelton
January 3, 2013


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