Ethical Off-Label Drug Promotion: What Would It Look Like?

In a Forbes piece (here), former Pfizer VP of Research John LaMattina noted the "jarring" juxtaposition of two articles in the August 8th edition of the New York Times.

One article was the obituary of Dr. Frances Oldham Kelsey (see image on left, read Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide, Dies at 101), a "legend for anyone involved in regulation and approval of new drugs."

The other was an article about a court ruling opening the door for pharma to promote their new (and old) drugs off-label (read Amarin Wins Off-Label Case Against FDA; Will Promote Viscera Off Label "ASAP").

You recall that thalidomide was already on the market in Europe as a sleeping aid, when the drug company Merrill submitted it for approval to market in the U.S. by the FDA.

Dr. Kelsey felt that there was insufficient safety data to justify U.S. approval. "Much to Merrill's dismay," notes LaMattina, "Dr. Kelsey was adamant that more testing was needed and refused to recommend approval of the drug. This delay proved to be more than justified."

Jump ahead more than 50 years to the off-label court case. What does the thalidomide experience teach us about off-label promotion?

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