FDA to Allow "Off-Label" Unapproved Drug Promotion

The FDA has "finalized" guidelines allowing drug companies to promote drugs for unapproved ("off-label") uses. The guidelines will allow companies to distribute peer-reviewed scientific literature discussing off-label uses.

Drug companies and their right-wing stalking horse, the Washington Legal Foundation, have been pushing for this move for years. They regard drug promotion as a First Amendment right. According to Reuters:

The FDA said: "public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses."

... Consumer advocate Sidney Wolfe said the guidelines were only recommendations to companies, rather than a formal regulation, and should be reversed quickly after Democrat Barack Obama becomes president next week.

Off-label use "means there isn't adequate evidence that the benefits outweigh the risks to have it approved by the FDA," said Wolfe, director of Public Citizen's Health Research Group. Companies may use off-label promotion "as a way of avoiding having the drug approved" for wider use, he said.

As PhRMA put it:

Providing the studies to doctors will help "assure that medical professionals receive timely and accurate medical information prior to the lengthy process" of securing FDA approval for wider use, said Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America. Off-label use "can save lives, especially in practice areas where there are few effective treatments."

But this new reg isn't about that. Rather, it's about trying to reduce the amount of responsibility companies have for their own drugs. For years, drug companies have been sued and prosecuted by plaintiffs lawyers and the government because of their illegal off-label promotion. The cases range from the outright dangerous (Pfizer's promotion of human growth hormone brand Genotropin as an anti-aging drug) to those that, in hindsight, seem reasonable (Pfizer's promotion of seizure med Neurontin as a painkiller).

By allowing companies to talk about off-label use, it gives their corporate defense lawyers the ability to say, look, the government approved of this type of marketing. We acted within the rules.

But the rules as described by Reuters aren't all that strict. The off-label literature must be peer-reviewed with authors' conflicts "listed." Not banned, just listed. So you can expect a new flood of drug company sponsored, peer-reviewed literature to hit the market on off-label uses.

With a lowered level of legal liability -- or none, in some cases -- the consequences for public health could be trememdous. Here's a small sample of recent off-label drug promotion controversies:

• Pfizer and Genotropin The company promoted and sold the human growth hormone drug as an anti-aging treatment for adults. Ended in criminal prosecutions.
• Johnson & Johnson and Risperdal J&J's funding of off-label studies with prominent psychiatrists has led to headlines and a lawsuit. (There's also a separate, unrelated criminal prosecution.)
• Eli Lilly and Zyprexa It's approved as an antipsychotic but is being used off-label for ADHD in kids.
• Cephalon and Actiq It's approved for cancer pain, but used for any pain. Cephalon was placed under the control of the Department of Justice because of its off-label marketing.
• Abraxis and AstraZeneca Sales reps with no clinical education in cancer held a secret meeting to discuss off-label uses of cancer drug Abraxane

There is no strong evidence that atypical antipsychotics work for any off-label conditions, but there is some medium level evidence about three off-label conditions and about harms.