Pharma Forum Dialogues

Two FDA Citizen Petitions Granted Regarding Manufacturer Speech

Posted by New York Pharma Forum Inc. on Aug 1, 2014 3:08:00 PM

By Al Cacozza and Sarah Blankstein, Ropes & Gray

On June 6, 2014, the Food and Drug Administration (“FDA”) issued a response granting the two pending FDA citizen petitions[1] filed by members of the Medical Information Working Group (“MIWG”), an ad hoc coalition of drug and device manufacturers to which Ropes & Gray LLP serves as one of the outside counsel. This response reflects the agency’s on-going effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical information to health care professionals (“HCPs”). This post summarizes the key aspects and implications of that response.

MIWG Citizen Petition Response

In July 2011, seven MIWG member companies filed a citizen petition requesting that FDA clarify its regulatory approach to four types of manufacturer communications about off-label uses: (1) responses to unsolicited requests; (2) scientific exchange; (3) communications witregulation-1h formulary committees and payers; and (4) the dissemination of third-party CPGs. In partial response to that petition, on December 28, 2011, FDA issued adraft guidance entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” and opened a public docket on the concept of “scientific exchange.”
In September 2013, MIWG member companies filed a second citizen petition requesting that FDA respond fully to all four requests in the July 2011 petition. The second petition further requested that FDA undertake a comprehensive review and modification of its entire regulatory approach to manufacturer communications, particularly in light of three recent cases[2] highlighting the constitutional and statutory limitations of FDA’s regulatory authority, principally the First and Fifth Amendments of the Constitution and the Federal Food, Drug, and Cosmetic Act (“FDCA”). That comprehensive review would require clarification of the scope of the definitions of the terms “labeling” and “intended use,” as well as the overall drug and medical device advertising regulations. Again, in partial response to the 2011 and 2013 petitions, on February 28, 2014, FDA issued a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices.”
risk information for approved drugs and biologics
Al Cacozza, Partner, Ropes & Gray LLP

In its June 6, 2014, response to the MIWG granting the petitions, FDA stated that it 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, by the end of the calendar year. In addition, FDA reported it plans to issue draft guidance documents that address MIWG’s remaining requests involving health care economic information by year-end. The response also provided that, “in light of the importance of the public health issues and free speech and due process principles at stake,” FDA commits to continuing the review of its regulatory regime for areas where it can refine and clarify the distinction between permissible and impermissible conduct.

risk information for approved drugs and biologics

Sarah Blankstein, Associate, Ropes & Gray LLP 


It remains to be seen whether any regulatory changes FDA is considering will result in additional flexibility or additional scrutiny over manufacturer communications regarding truthful, non-misleading information for approved or cleared products. It also remains to be seen whether FDA can square its current regulatory approach with constitutional requirements.


[1] See July 2011 Citizen PetitionFDA-2011-P-0512; September 2013 Citizen PetitionFDA-2013-P- 1079.

[2] See Sorrell v. IMS Health, Inc.,131 S. Ct. 2653 (2011); FCC v. Fox Television Stations, 132 S. Ct. 2307 (2012); United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).


For another recent post on FDA regulatory news, see FDA Releases Draft Guidance on New Risk Information for Approved Drugs

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Topics: FDA guidance