R-PR Accused Of Promoting Off-Label Drug Use

Franco-American drugs giant Rhone-Poulenc Rorer is being sued by fourcurrent and former employees who allege that the company forced them to promote drugs that were not approved by the US Food and Drug Administration. According to the Wall Street Journal, the plaintiffs, who are seeking more than $1 million each, claim they were told to destroy evidence of the off-label promotion and were harassed if they protested.

The lawsuit also alleges that R-PR paid indirectly for speaking engagements by physicians that focussed on off-label uses of its drugs. One of the physicians being sued, Alexander Turpie, made dozens of speeches last year in which he spoke about Lovenox (enoxaparin sodium), which is frequently used for indications which are not approved.

Unapproved Use Doesn't Surprise R-PR Lovenox brought in revenues of $400 million last year worldwide and $151 million in the USA, according to R-PR, but the WSJ estimates that 60% of these sales were generated for unapproved use. The company counters this by saying it is not surprised that enoxaparin is prescribed for other uses, given the number of articles in medical journals which have detailed its usefulness for unapproved indications.