Yes you read that right. One lawyer at Pfizer publicly endorsed the right of drug companies to practice off-label marketing under certain conditions.
Arnold Friede is a senior attorney at Pfizer. He has allegedly said that drug companies should be able to advertise unapproved drug uses provided that the info is "truthful and not misleading," and published in a medical journal. He made these comments at a law conference in NYC.
Of course, the FDA prohibits off-label marketing as (how they say down here in the South) "e-legal" or against federal law.
Pifzer itself has paid millions of dollars to settle off label marketing allegation investigations. In his speech at the conference, Friede said, "Peer reviewed journals would be eligible for . . . free speech protection" under a court ruling in which the WLF had sued the FDA. (source here).
What a surprise. In an era where published journals are coming under intense scrutiny for the method in which studies are published, in an era when there are allegations that drug companies are paying the authors to skew results in favor of a certain drug, ("Medical literature contains many articles expressing concern about industrial funding of clinical research") this attorney
apparently would have companies step around the FDA prohibitions?
We must be on guard, and never allow this to happen. The FDA in my view is gross underfunded. Big Pharma wields tremendous influence within the halls of Congress, outspends the FDA by a vast number when compared to the FDA's yearly budget on enforcement, and spends untold millions on industry funded clinical research. The entire process from initial studies to drug roll out needs a complete overhaul, not an end around it, as this attorney seems to suggest.
