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New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

Jan. 20, 2017 – The FDA effectively delayed any prompt action on new guidance covering the promotion of unapproved or off-label uses yesterday by extending the comment period related to the November 2016 hearing on this topic from Jan. 9 to April 19, and by issuing a 60-plus page memorandum that outlines the agency’s position on First Amendment considerations for regulating off-label promotion.

“The FDA is now placing the Memorandum in the docket for the public hearing to provide additional background on the issues it is considering as part of its review of its rules and policies relating to firm communications regarding unapproved uses,” the FDA stated in a Jan. 19 Federal Register notice.

The January 2017 memorandum “lays out the best case possible defending the current FDA policies on off-label,” which “appears to be a statement that current policy is constitutional and FDA is prepared to continue to defend it in court,” according to Coalition for Healthcare Communication Executive Director John Kamp. “So far, that hasn’t worked.”

Indeed, the FDA spends a fair amount of space in the memorandum discussing the potential harms of FDA-approved products being prescribed for off-label uses. “The use of approved/cleared medical products for unapproved uses has been associated with harm to patients, fraud, and waste of health care resources,” the document states, adding that recent studies have found “that the majority of unapproved uses for which drugs are prescribed lack adequate evidence of effectiveness, and that the risk of adverse events is higher for unapproved versus approved uses, and even higher when the unapproved use is not supported by reliable scientific data.”

After describing the traditional route for getting additional uses approved, the agency states that “if firms promote their approved or cleared medical products for unapproved uses, these incentives and programs could be weakened.”

In addressing specific First Amendment concerns, the FDA appears to be doubling down on its current position and continues to defend the status quo, although it does acknowledge “a tension” between public health and other interests.

The timing of this memorandum and the extension of the public hearing comment period indicate that the agency would like to tee up the off-label promotion for the new administration. However, courts have not been supportive of the FDA’s position when such promotion is truthful and non-misleading.

“The FDA Memo does a straightforward job defending the existing off-label policy under the First Amendment, but the arguments haven’t worked in courts before and are unlikely to prevail any time soon,” Kamp said. “Instead, the legal and medical talent would have been better spent developing policies consistent with both the Constitution and the public health. Now as new leadership arrives at FDA I am hopeful the process will pick up speed,” he noted.