The meat of the memo is FDA’s identification of alternative approaches to address off-label promotion, and the outright rejection of all of the approaches. It is ironic that FDA relies on a published study to support its position, yet puts significant restrictions on the distribution of similarly credentialed literature by industry. ![]() ![]() FDA also undermines the Caronia decision for not taking into account a study published last year that purportedly shows an association between unapproved uses and adverse drug events. FDA relies on a footnote in a qui tam matter in which the Second Circuit opines about the potential use of promotional speech in an FDA enforcement action, without reference to the truthful or non-misleading nature of the speech. Caronia by claiming it does not hold that speech cannot be used as evidence of intended use if the misbranding charge is based solely on truthful, non-misleading speech regarding the unapproved use of an approved product. Consistent with earlier statements, FDA attempts to limit the Second Circuit ruling in United States v. In the Memo, FDA describes its view of case law addressing the First Amendment and FDA regulation of off-label communications. FDA touts its efforts to date as claiming “to strike a careful balance, supporting medical decision-making for patients in the absence of better options, but doing so without undermining the measures designed to incentivize the development and approval/clearance of medical products that would reduce the need to rely on unapproved use, in light of its risks.” FDA Memo, at 20. FDA spends considerable time articulating the public health interests affected by communications about unapproved uses. The 60-page document is substantively light, as there is much background and rehashing of FDA’s legal authority contained in earlier public statements and briefs. FDA announced that it had prepared a Memorandum to specifically address First Amendment considerations and FDA’s initial reaction to proposed approaches to addressing them, and asked for public comment on the Memo. 1, 2016) (emphasis added), and anyone even superficially following these issues understands the First Amendment implications involved. Note that the original Federal Register notice stated FDA solicited comments on “ongoing developments in science and technology, medicine, health care delivery, and constitutional law,” 81 Fed. According to FDA, commenters at the November 2016 hearing complained that “FDA had not sufficiently discussed the First Amendment in the notification of public hearing.” 82 Fed. On January 19, 2017, ten days after the comment period closed, FDA reopened the comment period for 90 days (until April 19, 2017). ![]() The comment period for that hearing officially closed on January 9, 2017, and although FDA has published two draft guidance documents touching on communications consistent with the approved labeling or related to healthcare economic information (to be discussed in a separate blog post), FDA punted on the critical issue of off-label promotion. Instead, two years after their self-imposed deadline, FDA convened a public meeting to solicit views on these same issues (discussed here). In 2011, FDA announced the establishment of a docket to evaluate its policies on communications and activities related to off-label uses of marketed products late in 2014, FDA committed to issuing new guidance by the end of 2014 to address “unsolicited requests, distributing scientific and medical information on unapproved new uses, and manufacturer discussions regarding scientific information more generally,” which it did not.
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