Not With A Bang, But A Whimper . . . FDA Capitulates On Off-Label Regulation

As some may know, this immortal phrase comes from one of the best known poems in the history of the English language: it is the last line of The Hollow Men by T.S. Eliot (1925) and is seen as reflecting the author’s view of Europe in the aftermath of the Treaty of Versailles and the spiritual death of those who survived World War I.

Admittedly, it is not often cited in connection with the regulation of pharmaceuticals and biomedical products. But it seems apt to do so, in light of a recent admission offered by the FDA’s Director of the Center for Drug Evaluation and Research (CDER) Janet Woodcock.

Woodcock, a long time, highly respected agency senior official, has acknowledged for some time that she has accepted the implication of recent Federal court rulings on the primacy of the First Amendment, and in particular the 2012 decision of the U.S. Court of Appeals in Caronia and subsequent U.S. District Court rulings in cases that followed the Caronia reasoning. Notably, at a conference in 2014, Woodcock and then FDA general counsel Elizabeth Dickinson said that they were taking the commercial speech rights of companies “very seriously” and “carefully evaluating our policies.”

Earlier this fall, the industry Pink Sheet reported Woodcock’s musings at a discussion sponsored by the Alliance for a Stronger FDA as she elaborated on the marked decline in untitled and warning letters issued by the agency for advertising and promotional missteps. Woodcock reportedly said that she is “very wary of wading into the First Amendment” unless perceived violations involve “egregious” behavior “where [patient] health and safety might be involved.” Instead, Woodcock suggested that industry competitors effectively take on the role of private sector enforcement agent by bringing legal complaints when they see rivals pushing the envelope.

What can we say about this remarkably candid admission?

First, Woodcock has made clear what observers have thought for some time; the agency is reluctant to test their luck in the Federal courts following the Caronia ruling and risk losing entirely its regulatory prerogative over company communications that is administered through its Office of Prescription Drug Promotion (OPDP). This leaves open the core question of whether companies are free to discuss with physicians and patients truthful scientific and medical information outside of limited scientific exchange? Apparently, there will not be a showdown at the Supreme Court. Better to retain a degree of ambiguous authority, than to be left with nothing.

Second, while the FDA reserves the right to challenge companies that are marketing unapproved products or making blatantly false promotional claims, if a company has credible clinical data supporting the use of an approved product for an unapproved indication, the agency will not likely take action absent an apparent health or safety risk. How will the agency decide whether the information in question is truthful? Former FDA chief counsel and GSK general counsel Daniel Troy suggested at a panel last month that the agency could do well to consider this question more thoroughly in the context of the science of consumer understanding, and develop a more sophisticated perspective on the subject.

Read more of this Forbes article by John Osborn by clicking here.