- Stakeholders from across the pharma industry are converging on the Maryland campus of the Food and Drug Administration this week as the regulator holds a two-day meeting on the sometimes controversial issues of off-label drug promotion.
- Regulators are soliciting input on how to regulate communications about off-label uses for already approved medical products and devices. Under the Food, Drug, and Cosmetic Act, the FDA has authority to police drug misbranding, including improper promotion of drugs for indications for which they are not approved.
- Yet those in the industry have argued for clearer standards which allow drug developers to communicate truthful and non-misleading information to physicians, who are currently permitted to prescribe drugs off-label if it is in the interest of the patient.
The FDA is in the midst of a comprehensive review of its regulatory approach to industry communications regarding off-label uses of approved products.This week's meeting, which got under way Wednesday, is aimed at providing input for future guidance.
While the issue does seem deep in the regulatory weeds, it's a major source of friction between the industry and the FDA, resulting in some eye-popping fines. In 2012, for example, GlaxoSmithKline was forced to pay $3 billion to resolve criminal and civil liability tied to improper marketing of the antidepressants Paxil and Wellbutrin.
According to the consumer watchdog Public Citizen, there were 105 settlements between pharma companies and state and federal governments over unlawful promotion during the last 25 years — the second most cited violation in that period.
The FDA acknowledges that truthful information about off-label uses can help health care professionals make more informed treatment decisions. And the agency allows drugmakers to reply to unsolicited requests from physicians about off-label uses of its drugs as well as promote peer-reviewed articles by third-parties discussing the same.
But the industry wants the FDA to issue clearer guidance and permit a wider range of communications.
"In this changing environment, it is important that biopharmaceutical companies be able to share appropriate science-based information with population health decision makers, yet the U.S. Food and Drug Administration’s (FDA) current federal regulations have not kept up with this new reality," industry trade organization PhRMA said in a statement.
On the other side, critics are concerned about the potential impact loosening of off-label rules might have on public health.
"Drug companies’ disputed First Amendment rights should not catalyze a major shift in the agency’s enforcement authority; any changes should be approached with an abundance of caution," wrote two law professors from the Yale Law School in a JAMA viewpoint article.
The authors argue current legal precedent could mean the FDA will slowly lose its authority to regulate off-label promotion unless it takes a stronger defense of its powers to protect public health priorities.