Monday, February 18, 2008

Tell the FDA "No" to Off-Label Marketing

Last Friday, the U.S. Food and Drug Administration (FDA) gave draft guidance that people concerned about patient safety should be outraged about: broadening the marketing of drugs beyond what the drug has already approved by the FDA. The FDA will accept comments from the public on the proposal and take it up for final consideration in 60 days.

The press covered the story, but considering that it was published over the weekend, the story may have slipped by many readers. The New York Times gave perhaps the most comprehensive overview. But The Wall Street Journal also gave a slightly more business-oriented review.

Today, doctors are already free (as they always have been) to prescribe drugs for a purpose other than what the label specifies. But what we're talking about here is enabling drug companies to sell and market drugs for purposes which have not undergone clinical trials.

The FDA's move already is raising objections from a wide cross-section of interesting allies. California Representative Henry Waxman wrote to the FDA urging it to hold off on issuing these guidelines, which he argued would create a "large loophole" in the laws against off-label promotion. "It's a conflict of interest for the company to be promoting sales when they haven't been able to establish that a drug is safe and effective through the rigorous FDA process," Mr. Waxman said.

The blogosphere has cried foul, and you should too. Consider the following perspectives:

BrandWeekNRx's Dr. Peter Rost, and author of the book "The Killer Drug" wrote:

"Once this is allowed, the door is completely open for drug companies to promote their drugs for anything their heart desire. ... Clearly they [the FDA] are interested in helping someone, and that doesn't appear to be the public."

Merrill Goozner, and author of the book "The $800 Million Pill" elaborated further:

"Note what isn't in the policy: It doesn't say that the studies of unapproved uses must be from randomized controlled clinical trials, which is the gold standard of medical research. All the proposed guidance says is that the studies should be 'adequate and well-controlled clinical investigations that are considered scientifically sound by experts with scientific training.'"

Considering the already sad state of affairs involving the FDA, with everything from not inspecting foreign chemical manufacturers involved in drugs which have killed Americans, to hastily approving drugs which have later been proven unsafe, the latest guidance couldn't be more ill-timed, but the FDA moved ahead on this nevertheless. The Federal Register has more details, but the basics are as follows:

Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to

Tell the FDA that this guidance is ill-timed and should NOT be implemented at this time. The benefits seem questionable at best, except for the drug industry. Considering the potential problems, this guidance seems rushed and should not be implemented at this time.


Jenny said...


I could not find proposal listed on the web site.

Any clue where it is?

Scott S said...

Try and see if there might be more detail there. Sometimes, the addresses are inconsistent with the info. as published in the Federal Register.

Scott K. Johnson said...

Yikes! That is scary man!

Bernard said...

Give the recent high court decision that says device makers aren't liable for issues because FDA has already tested these devices, this sounds like a REALLY bad idea.