Drug Companies May Now Discuss Off-Label Uses

by Teri Robert, Lead Expert

One of the problems we face when looking for Migraine and headache preventive treatments is that there is not a single medications on the market that was originally developed for this purpose. Up to now, the FDA has prohibited representatives of pharmaceutical companies from discussing off-label use (prescribing for purposes for which the medications have not been FDA approved) of medications.

There are four medications that are FDA approved for Migraine prevention:

  1. propranolol (Inderal)
  2. timolol (Blocadren)
  3. divalproex sodium (Depakote)
  4. topiramate (Topamax)

There are approximately 100 other medications in use for Migraine and headache prevention, but even if doctors asked about them, nobody affiliated with the pharmaceutical companies has been allowed to talk about them.

Now, the FDA has finalized guidelines allowing pharmaceutical companies to talk with doctors about unapproved uses of their products. The guidelines allow pharmaceutical companies to distribute copies of journal articles about unapproved uses of medications.

This is a controversial decision, eliciting contradictory comments from doctors and pharmaceutical company spokespeople. An FDA spokesperson said,

"The public health may be advanced by healthcare professionals' receipt of medical journal articles ... on unapproved new uses... Such uses may even "constitute a medically recognized standard of care."

Representative Henry Waxman, D-California, stated,

"In the final hours of this administration, political appointees at FDA have given drug companies a long-coveted parting gift... This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective."

Alan Bennett, an attorney representing the pharmaceutical company commented,

"Physicians need timely access to the latest medical information to keep abreast of the best practices in patient care."

Summary and comments

In a time when doctors offices are busier and busier, and doctors have less and less time for continuing their own education and educating patients, I consider this a good move on the part of the FDA. It's not a perfect answer, but it will at least get more information into the hands of doctors and perhaps offer them more options to discuss with their patients.

Especially given that the vast majority of medications used for Migraine and headache prevention are prescribed off-label, additional information from medical journals should be quite helpful.


Richwine, Lisa. "U.S. lets drugmakers advise doctors on unapproved uses." Reuters. January 12, 2009.

Perrone, Matthew. "FDA OKs sharing unapproved drug uses with docs." Associated Press. January 13, 2009.

Page copy protected against web site content infringement by Copyscape© Teri Robert, 2009.
Last updated January 18, 2009.

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