FDA’s new draft guidance (see earlier story) on how medical product companies can disseminate scientific or medical journal articles that discuss unapproved new uses unfortunately sets “hurdles” that will “effectively put an end to any meaningful dissemination of peer reviewed information on off-label uses,” according to attorney Arnold I. Friede (Sandler, Travis & Rosenberg). He told FDA Webview
3/5 that the guidance “speaks for itself in terms of how difficult it is to meet FDA’s stated conditions. And even a good faith, but ultimately unsuccessful effort, to disseminate off label information in conformity with the draft guidance, may backfire, as FDA may conclude that such failure to comply is evidence of an intended off-label use.”

According to Friede, most large pharmaceutical companies are subject to HHS Corporate Integrity Agreements (CIA) resulting from settlements related to off-label promotion. “Many if not most of these CIA’s already regulate the dissemination of off-label information. In theory, then, a company subject to such a CIA will to have a run a dual gauntlet — compliance with the CIA and, to the extent it is more onerous than the CIA, compliance with the draft guidance.”

Meanwhile, attorneys from Ropes & Gray said in an analysis that the guidance shows some additional regulatory flexibility by permitting the distribution of clinical practice guidelines, but other key changes suggest FDA is looking to restrict certain reprint distribution practices. For example, they said the previous reprint guidance permitted distribution of reprints and texts that “address adequate and well-controlled clinical investigations,” including historically controlled studies, pharmacokinetic (PK) and pharmacodynamic (PD) studies and meta-analyses of a specific clinical hypothesis without any distinction between medical device and drug reprint practices. “The revised reprints guidance,” they explained, “draws such a distinction.

“Drug reprints,” they continued, “are limited to information that addresses adequate and well-controlled studies, whereas device reprints also can discuss ‘significant investigations other than adequate and well-controlled studies, such as meta-analyses, if they are testing a specific clinical hypothesis’ and ‘significant non-clinical research (such as well-designed bench or animal studies).’ As currently written, the revised reprints guidance implies that drug manufacturers cannot distribute reprints discussing meta-analyses, PK or PD studies and other significant non-clinical research.”