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FDA and off-label uses: a balancing act [Medical Marketing and Media](Medical Marketing and Media Via Acquire Media NewsEdge) AS PART of a sweeping First Amendment review of off-label information and other communi- cations made by medical product sponsors, FDA says it is planning to release by the end of the year additional guidance documents that address unsolicited requests, the distribution of scientific and medical information on unap- proved new uses, manufacturer discussions regarding scientific information, and healthcare eco- nomic information. Meanwhile, the agency's cur- rent re-examination of its off- label promotion policies in light of the First Amendment is a bal- ancing act between its rock-solid traditional enforcement posture and a diverse new electronic communications environment that defies effective regulation. The two most important influ- ences the agency is balancing may be seen in the 2012 Second Circuit Court of Appeals deci- sion in U.S. v. Caronia that senior FDA lawyers at first shrugged off but now take very seriously, and the agency's own new draft Guidance for Industry Distribut- ing Scientific and Medical Pub- lications on Unapproved New Uses-Recommended Practices. The former reasserted a Supreme Court decision that "Speech in aid of pharmaceu- tical marketing...is a form of expression protected by the Free Speech Clause of the First Amendment," and it did so in a case that was strongly on point: a drug salesman's use of speech to promote unapproved uses. The latter, published by FDA two years after Caronia, reveals hard-line adherence to FDA's traditional posture, that the 1962 efficacy amendments to the Food, Drug and Cosmetic Act require that "safety and effec- tiveness for each intended use be established before introduction of the product into interstate commerce for that use..." The draft guidance recalls that this literal interpretation was reinforced by the 1997 FDA Modernization Act, and "came from experience showing that exclusive reliance on post-hoc remedies, such as enforcement actions for false or misleading labeling, was inadequate to pro- tect the public health." Indeed, based on initial com- ments from industry on the draft guidance, which is one of sev- eral similar steps the agency's re-examination is taking down the same off-label policy road, FDA has hardened its position in several important respects, and may become even harder after it finalizes the document. A Biomet Biologics comment said it has three objections: (1) the document would make manufacturers responsible for ensuring no conflict of inter- est for article authors; (2) the perceived lack of distinction for electronic dissemination versus traditional routes; and (3) the use of broad non-descriptive terms for qualifying published studies. In another comment, Life- Cell Corp. criticized the draft guidance for not recognizing that healthcare providers have their own independent access to off-label use information and for imposing limitations on manu- facturers that "are burdensome and unpredictable. " Navidea Biopharmaceuticals in its comments pointed out that the draft guidance appears not to "take into consideration the new federal physician payment reporting program established by the Patient Protection and Affordable Care Act." Comments from Pharmaceuti- cal Research and Manufacturers of America (PhRMA) reas- serted the association's posi- tion, previously expressed in 2012 comments to an FDA open docket on scientific exchange of information on off-label uses. In those comments, PhRMA warned FDA that litigation would follow any attempt by the agency to restrict scientific speech by biopharmaceutical companies. In its latest comments, PhRMA said FDA should pro- vide guidance that is consistent with the First Amendment and "encourage and facilitate, rather than overburden, manufactur- ers' efforts to provide healthcare professionals with truthful, non- misleading information about medically accepted unapproved uses of FDA-approved drugs." PhRMA said the Constitu- tion's protection of an open and robust exchange of ideas "limits FDA's ability to regulate scien- tific speech. PhRMA respectfully submits that FDA should give additional consideration to these First Amendment limitations." Public statements by FDA leaders, including Commissioner Margaret Hamburg and drugs director Janet Woodcock, indi- cate that their re-examination is taking First Amendment con- cerns "very seriously." This is highly unusual for an agency that has long refused to even utter the words "First Amendment," much less publicly re-examine policies under which it has repeatedly and expansively curbed marketers' use of infor- mation on unapproved uses. Yet the agency's traditional stance glowers menacingly in its latest draft guidance. -James G. Dickinson The Second Circuit Court of Appeals affirmed First Amendment protections for marketers' speech (c) 2014 Haymarket Media, Inc. |