Sales reps could be effectively barred from circulatingjournal article reprints discussing off-label uses under FDA’s draft guidanceon “Good reprint practices,” and the agency considers the policy to beeffective already, even in its draft form.
DDMAC director Tom Abrams said in an email to MM&M thedraft guidance “reflects the agency’s current thinking.” Reps “may disseminatepeer-reviewed reprints but cannot promote their drug products for unapproveduses.” Furthermore, “this material should be distributed separately frommaterial that is promotional in nature, should not be the subject of detailingdiscussions, and should not be distributed in promotional exhibit halls or atpromotional speakers’ programs.”
That’s a lot of asterisks for a rep to wriggle around.
While initial press reports, parroting Rep. Henry Waxman’spre-emptive strike on the guidance, suggested that it represents aliberalization of agency policy on reprints, it actually limits distribution ofjournal articles sharply—more than companies felt comfortable doing in the absence of a stated safe harbor, experts in food and druglaw say.
“This is a very limited proposal that virtually only allows[manufacturers] to do what the First Amendment demands they be able to do underthe Washington Legal Foundation case,” said Coalition for HealthcareCommunications head John Kamp, referring to court decisions, from 1998-2000, inwhich WLF argued companies have a right to distribute articles on off-labeluses.
Decisions in 1998 and 1999 favored the WLF’s position, butin 2000, a federal appeals court, while sanctioning the reasoning of theearlier decisions, ruled them moot because the FDA said it did not prosecutecompanies for distributing such articles. The FDA later reaffirmed that policybut added that it would include distribution of journal articles on off-labeluses as evidence of intent to promote products off-label in larger cases.
The draft guidance represents a step forward, said Kamp.“For the last 10 years, in the absence of FDA authority, the policy has beenhijacked by HHS-OIG and investigators have been pretty much making it up asthey go along,” said Kamp. “This limits the ability of HHS and stateinvestigators under the False Claims Act to essentially make up new policyabout what off-label means. This puts that authority in the hands of the FDA.”
“It’s a safe harbor, but with a really big dragon at themouth of it,” said Coleen Klasmeier, a partner at law firm Sidley Austin and aformer special assistant to the chief counsel at FDA. “It’s good in the sensethat the FDA is saying, in a somewhat authoritative context, that there is apublic health upside to the distribution of off-label information.”
Klasmeier said that’s consistent with prior safe harbors affirming the rights of companies to engage in scientificexchange with respect to off-label uses, to respond to unsolicited requests forinformation on off-label uses from physicians and to sponsor medical education,even if content includes discussion of off-label uses. But Klasmeier worriesthat the draft guidance does not acknowledge those safe harbors. “One of myconcerns is that prosecutors will read this and interpret it as the only wayfor manufacturers to do off-label information. It also doesn’t do anything torecognize, apart from those safe harbors, the First Amendment right to engagein truthful and non-misleading speech, as the WLF case held.”
Perhaps most worryingly, Klasmeier said, wording in thedraft guidance could be read to suggest that if a manufacturer following thepolicy engages, separately, in any violative promotion, “that safe harborconduct suddenly becomes fair game.”
From the April 01, 2008 Issue of MM+M - Medical Marketing and Media
