You are a member of your local dermatologic society and attend monthly meetings in order to obtain your desired CME credits. In order to finance the meeting and encourage attendance, the society has the monthly meetings financed by a prominent drug company.
The food is excellent, conforms to pharma guidelines, and the lecture very stimulating. The drug company provides journal articles from the Journal of the American Academy of Dermatology at the meeting that document the off-label use of one of their newer biologic agents. You obtain CME credits, read the journal article, and begin prescribing the off-label medication. A fellow dermatologist tells you that the drug company is in violation of the Food and Drug Administration (FDA) rulings against promoting off-label use. He contends you might also run afoul of the regulations.
The FDA derives its authority to regulate various aspects of the pharmaceutical industry from the Food, Drug and Cosmetic Act, 21 U.S.C., section 301. For a prescription drug to be distributed by a manufacturer in interstate commerce, the manufacturer is required to demonstrate that the drug is both safe and effective for each of its intended uses.
As part of the approval process, FDA also reviews the proposed labeling for the drug, which includes all proposed claims about the drug’s risks and benefits. The FDA will only approve a company’s new drug application if the labeling conforms to the uses that the FDA has approved.
In 1962, Congress determined that a manufacturer seeking to market or promote a product for an unlabeled use must resubmit the drug for another series of clinical trials similar to those from the initial approval. Off-label uses include treating a condition not indicated on the label or treating the indicated condition but varying the dosage regimen or varying the patient population. Manufacturer promotion of off-label uses constitutes misbranding and is in violation of the FDA statutes.
Since off-label uses are presently an accepted aspect of a dermatologist’s prescribing regimen, the open dissemination of scientific and medical information regarding these treatments is of great-import. The FDA acknowledges that physicians need reliable and up-to-date information concerning off label uses. FDA recognizes that sources for such information are varied and include CME lectures and seminars. It specifically recognizes that the need for reliable information is particularly acute in the off-label treatment arena because the primary source of information usually available to physicians — the FDA approved label — is absent.
Off-label prescription practices can be problematic and have, in some circumstances, proven harmful. Therefore, the FDA, has always been concerned about drug company promotion. How far can drug companies go with off-label promotion?
It was the Washington Legal Foundation that sought to set guidelines through a lawsuit they initiated. The Washington Legal Foundation was a non-profit public interest law and policy center that defended the rights of individuals and businesses to go about their affairs without undue influence from government regulators.