FDA proposes change to rule on off-label drug use

The FDA has issued a proposed rule that clarifies when drugmakers are required to update their drug labels to reflect off-label use, STAT reported. 

Off-label drug use occurs when a drug is used to treat something other than what it is FDA-approved to treat. Physicians are allowed to prescribe a drug for any purpose, but courts have ruled that drugmakers can only advertise off-label uses if the information provided isn’t misleading. 

The newly proposed rule, published Sept. 23, says that the FDA won’t consider a drugmaker to have intended off-label use for a drug if it simply is aware that off-label use occurs. Instead, it would have had to make specific claims in ads, STAT reported. A drugmaker still is required to update drug labels if there is evidence it intended its drug to be used off-label. 

“Without these rules defining the limits of what it means to have an intended use, companies could find loopholes to market products for unapproved uses. We wouldn’t know if those uses are safe and effective, and FDA could do nothing about it, jeopardizing public health,” Michael Carome, MD, director of Public Citizen’s health research group, told STAT

“Intended use” has been an issue surrounding off-label drug use, as the FDA relies on intended use to decide when a drugmaker has intentionally marketed a drug for off-label use. In 2015, the FDA reversed a policy that said drugmakers could be held liable for having knowledge of an off-label use. But in 2017, the FDA inserted language into a final rule that said a drugmaker could be required to update its drug label if it was aware of an off-label use, according to STAT

The pharma industry filed a petition against the rule, arguing it gave the FDA too much leeway to gauge how a drugmaker intended its drug to be used. The FDA delayed implementing the rule. 

The FDA said the new proposed rule doesn’t change any policy or practice but provides “greater certainty and predictability” for drugmakers, STAT reported. 

A spokesperson for the Pharmaceutical Research and Manufacturers of America, the drug industry’s top lobbying group, told STAT the proposed rule is still being reviewed and declined further comment. 

“It’s a modest rule that provides much needed clarity, because this thing has been a point of legal uncertainty for many, many years. So it’s a very welcome action, and I think manufacturers will be relieved to have this clarification in place and presumably settled,” Jeffrey Shaprio, a director at Hyman Phelps & McNamara, a law firm that specializes in FDA regulatory matters, told STAT

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