Your pharmaceutical rep: How much information can he/she give about off-label use?

Key Points

Dr. Doc has an extraordinarily busy dermatology practice. In fact, he is so busy that he has little time to attend medical meetings. He depends on his pharmaceutical representatives to provide him with the latest information about off-label use of various dermatologic prescription drugs. He knows that physician off-label use of prescriptions is not only legal, but is actually encouraged by the Food and Drug Administration (FDA).

Thus, he is shocked when one pharmaceutical representative tells him that a competing pharmaceutical representative's practice of providing Dr. Doc with copies of peer-reviewed articles documenting off-label use of drugs is illegal. Is this true?

On Feb. 15, 2008, the FDA issued a draft guidance entitled, "Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices."

It supplanted previously expired policies that allowed such distribution.

Despite the fact that this new announcement was quite similar to the previously expired FDA rules, the announcement has sparked an intense debate among pharmaceutical company critics, lawmakers and some physicians on the one side, and the FDA, drug and medical device manufacturers, and other doctors on the other.

Should pharmaceutical companies be allowed to distribute peer-reviewed articles on the off-label use of retinoids, botulinum toxins or methotrexate?

Opponents of the guidance argue that allowing drug companies to disseminate information about unapproved drugs and medical device uses will open the floodgates to wider promotion of these products, and will remove incentives for drug companies to adequately research whether the new use is actually beneficial.

They argue that distribution of marketing materials, including peer-reviewed journal articles, should only be allowed for that entity for which the drug or device is labeled (approved).

Such advocates are concerned that patients' safety will be put at risk. Sidney Wolfe, M.D., director of Public Citizen's Health Research Group, has argued, "People will die if they are getting drugs that don't have clear evidence that the benefits outweigh the risks."

In contrast, supporters of the new guidance argue that it is extremely beneficial for doctors to receive reliable information so that their patients can benefit from the more rapid disclosure of this information without having to wait for FDA approval - often a very slow process.

Arguing against Dr. Wolfe is Scott Gottlieb, M.D., a former FDA deputy commissioner, who says that the consequence of rapid disclosure of these benefits could be measured in lives.

It should be noted that behind the issues of this regulation of the promotion/ dissemination of information on off-label drug uses has been the tension among three areas: 1) the protection of patient safety, 2) non-interference with a doctor's ability to practice medicine and 3) the pharmaceutical manufacturers' First Amendment freedom of speech rights.

Once the FDA approves a drug for a specific use, physicians can legally prescribe that drug for uses that are different from the original approved use. In fact, FDA policy encourages such a physician approach.

Allowing physicians to prescribe drugs for such "off-label" usage is an accepted and necessary corollary to the FDA's mission to regulate medical drugs and devices without directly interfering with the practice of medicine.

However, even though physicians may prescribe drugs for off-label usage, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved.

In general, if the manufacturer intends to promote the drug for new uses, the manufacturer must resubmit the drug's new purpose to the FDA for another designated "label" (approval).

A provision of the Food, Drug and Cosmetic Act (FDCA) requires that new pharmaceutical drugs cannot be distributed via interstate commerce, unless it has been demonstrated to the satisfaction of the FDA that such drugs are safe and effective for each of their intended uses.