State Attorneys General Step to the Fore on Off-Label Drug “Promotion”

Cross-posted at WLF’s Forbes.com Contributor blog

With their law enforcement counterparts at the federal level raking in prodigious financial settlements, it’s no surprise that state attorneys general (“state AGs”) want a bigger piece of the action on off-label drug “promotion” regulation. The $181 million settlement reached August 29 between 36 attorneys general and a drug maker confirmed that state AGs must indeed be reckoned with on off-label issues. What will get medical product companies’ attention is not the financial settlement, though. The real eye-opener was the precision of the settlement’s conduct requirements, most notably one restraint on speech which goes beyond the dictates of federal law.

The settlement arose from “deceptive marketing” suits filed by state AGs throughout the country involving Ripersdal. Some of those suits resulted in verdicts imposing six- or seven-figure damages on the defendant, Janssen Pharmaceuticals. Janssen and its parent company, Johnson & Johnson (J&J), had appealed those verdicts, but the cost-benefit calculus of fighting vs. settling likely led the companies to resolve the claims on a global basis (much like the tobacco companies did with the state AGs).

In addition to the monetary settlement, Janssen and J&J agreed to conditions and limitations on how they share information about Ripersdal with medical professionals. As noted above and emphasized by former FDA associate chief counsel Arnie Fried in a Pharmalot interview, such behavior-changing dictates were what the AGs were really after here.

The most interesting and in our opinion problematic conditions apply to the dissemination of reprints of scientific or medical journal articles discussing off-label uses of Risperdal (see 13-14 of the settlement document).

The settlement first requires that all reprints comply with applicable FDA rules and guidances. This is straight-forward, although the profoundly vague nature of applicable FDA rules and their inconsistent enforcement make full “compliance” a slippery concept.

It next states that “Scientifically Trained Personnel” should be responsible for relevant journal reprint dissemination, but then goes on to add, “Neither Janssen Sales nor Janssen Marketing personnel shall disseminate these materials, unless Janssen has a pending filing with FDA for approval of the new indication described in the reprint.”

The state AGs are trying to make sure that the sharing of reprints describing off-label uses is part of an antiseptic “scientific exchange” rather than a sales pitch. But the way the settlement document keeps sales personnel out of it—by requiring Janssen to have a Supplemental New Drug Application (“sNDA”) on file at FDA—is to our knowledge unique.

Federal law imposes no such condition on the ability of marketing personnel to share journal reprints.  Section 401 of the Food and Drug Administration Modernization Act (“FDAMA”) stated that if a drug maker certified that it would be submitting a sNDA, dissemination of journal reprints would not be used against the company as evidence of intent to unlawfully promote an off-label use. That provision of FDAMA ceased to be law in 2006. But even if it were still in effect, it required a promise to seek an sNDA, not an affirmative act of having filed one with FDA.

Some may question the larger importance of the sNDA condition, since it was agreed to in a private settlement and involves one company and (possibly) just one drug. Such an innovation in regulation-through-settlement agreement will no doubt inspire similar or more far-reaching provisions in future state or federal settlements involving off-label speech. That outcome will add insult to the injury that we believe federal government restrictions already impose on the First Amendment rights of health care companies, providers, and patients.

The state AGs’ “successes” in their collective efforts against Janssen—money in state treasuries and otherwise unachievable regulation of speech—will encourage further “deceptive marketing” litigation against the sharing of off-label use information. The result will be even less clarity and consistency in an area of government regulation that is already entirely opaque and unpredictable. Who wins in such circumstances? Certainly not the American patient.

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