What you need to know:

The FDA’s recently issued response concerning the communication of truthful and non-misleading scientific information about off-label uses of drugs and devices has fallen short of industry expectations by failing to adequately address requests for clarification raised by petitioners.

What you need to do:

In the absence of clear guidance from the FDA, manufactures will continue to face uncertainty regarding how to ensure that their promotional policies are in line with Agency expectations, and will need to rely on a combination of Agency materials and statements, judicial opinions and information gleaned from publicly-available criminal settlement agreements to try to minimize the risk of potentially crippling government intervention. 

In a June 6 letter, the Food and Drug Administration responded to two citizen petitions asking the FDA to address the “significant lack of clarity” about the communication of truthful and non-misleading scientific information regarding unapproved new uses – commonly referred to as off-label uses – of drugs and devices.  The petitions, submitted by members of the Medical Information Working Group in July 2011 and September 2013, sought clarification in four specific areas:

  • Manufacturer responses to unsolicited requests for information from clinicians;
  • Scientific exchange (e.g.,  scientific study results, investigator conferences, etc.);
  • Interactions with formulary committees, payors and similar entities; and
  • Dissemination of third-party clinical practice guidelines to clinicians.

The Agency’s response to the petitions fails to break new ground and largely consists of references to two prior draft guidance documents (Unsolicited Requests Draft Guidance (December 2011) and Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practice (March 2014)) and a Federal Register notice seeking comment on “various issues associated with scientific exchange.”  The FDA response did announce that the Agency “plans to issue guidance that addresses unsolicited requests, distributing scientific and medical information on unapproved new uses, and manufacturer discussions regarding scientific information more generally” as well as “draft guidance documents that address [the petitioners’] remaining requests involving health care economic information” by the end of 2014.  The lack of any additional actionable guidance, however, has been broadly viewed as a disappointment across the industry as manufacturers continue to confront the challenge of developing guidelines and policies for disseminating truthful and clinically relevant information without risking criminal prosecution, administrative action or other government intervention. 

Although guidance documents “provide industry with the FDA’s current thinking on a particular topic or certain issues,” and FDA personnel “generally follow” final guidance documents when deciding “whether or not to take action with respect to certain industry activities,” the FDA’s response falls well short of new or revised regulations as requested by the petitioners.

The FDA’s response also acknowledged “the evolving legal landscape in the area of the First Amendment,” but did not signal any change in policy or practice in light of two recent court rulings:  the US Supreme Court’s 2011 decision in Sorrell v. IMS Health (holding that the First Amendment prohibits restrictions on the sale, disclosure or use of physician prescribing records) and the Second Circuit’s US v. Caronia decision in 2012 (holding that the First Amendment protects truthful promotion of off-label uses of drugs or devices, but does not protect misleading or false discussion of off-label uses).  In the wake of these significant decisions, manufacturers have hoped that the FDA would clarify its approach to policing off-label communication so that they are able to appropriately communicate relevant clinical information and ensure that promotional policies are in line with Agency expectations.  The lack of additional guidance from the FDA in this area is likely a signal that the Agency will simply defer to the courts going forward. 

In the absence of meaningful guidance from the FDA, manufacturers are left with the imprecise task of harmonizing Agency materials and statements with judicial opinions and information gleaned from publicly-available criminal settlement agreement documents.  Manufacturers will likely continue to implement conservative policies rather than risk potentially crippling government intervention, leaving a significant gap between actual practice and Constitutionally-protected communication of clinically relevant information regarding unapproved uses.