Saturday, September 08, 2012

States' Rights: Regulation Via Settlement

"I believe in states' rights.... I believe we have distorted the balance of our government today by giving powers that were never intended to be given in the Constitution to that federal establishment."

Ever since Ronald Reagan said he believed in "stats' rights" that has been the rallying cry of Republicans up to and including Romney-Ryan.

For pharmaceutical companies, however, states' rights to enforce some federal laws via litigation is a problem. Take for example, the the $181 million settlement reached August 29 between 36 attorneys general and Jannsen Pharmaceuticals (a Johnson and Johnson company). According to a Forbes contributor, this settlement "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" (see State Attorneys General Step to the Fore on Off-Label Drug "Promotion").

Relating to the distribution of off-label information/reprints about Risperdal (or any "Atypical Antipsychotic"; i.e., all of Jannsen's products that are FDA-approved formulations containing risperidone and/or paliperidone), Jannsen agreed that only Jannsen "Scientifically Trained Personnel" may distribute such materials and NOT sales or marketing personnel UNLESS Jannsen has a "pending filing with the FDA for approval of the new indication described in the reprint." "Scientifically Trained Personnel," according to the settlement are Janssen personnel who are "highly trained experts with specialized scientific and medical , usually with an advanced degree scientific degree (e.g., and MD, PhD, or PharmD)."

"While this specific agreement pertains only to antipsychotics, the principles are obviously applicable at a higher level of generality," said Arnie Friede in a interview with Pharmalot (here). And J&J/Janssen has said they won’t use sales or marketing personnel to disseminate any off-label reprints unless they’ve already submitted an application to FDA covering that particular use and they may well apply the same “rule” in the marketing of other FDA-regulated products. This restriction goes beyond a provision in the FDA Modernization Act that has since expired, which obligated companies to certify that they were conducting studies intended to support a supplemental application before disseminating an off-label reprint, even if peer reviewed, but which did not require actual submission of an sNDA."

Why did J&J/Jannsen agree to this settlement rather than fight the case in court? The Forbes writer suggests it was just a matter of money: "the cost-benefit calculus of fighting vs. settling likely led the companies to resolve the claims."

Perhaps, however, this case is not closed and the settlement could be declared null and void if the "Federealists" have their way: "Unless I’m missing something," said a commenter to the Pharmalot post, "it seems a sure bet that the industry, perhaps via its pals at Federalist Society et al, will file a preemption case that these state requirements interfere with DDMAC’s authority to regulate off-label promo and related. Indeed, I do think the case for federal preemption is considerably stronger here than for preemption of state product liability law. In the meantime, friends-on-the-court could use the case as an opportunity to open the wider issue of off-label promo (for a case down the road)."

It ain't over till the fat lady SUPREMES sings!

1 comment:

  1. Very Nice article, pharmaceutical companies seem to have been playing a game of one-upmanship, each surpassing yet a new milestone of wrongdoing — fraudulently marketing their drugs or making misleading claims about their safety — and the threat of massive payouts appears to have offered little deterrent. While the pharmaceutical industry is essential to medicine and has produced crucial drugs that have saved countless lives, eight of the 10 biggest international drug companies have recently agreed to pay millions to billions of dollars to settle charges of wrongdoing, and are currently operating under so-called corporate integrity agreements — essentially, promises not to commit the same crimes again. Some have already violated earlier agreements multiple times, however, to the tune of hundreds of millions dollars. Market Research

    ReplyDelete