On June 6, 2014, the Food and Drug Administration (“FDA”) issued a response granting the two pending FDA citizen petitions 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
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 In addition, FDA reported it plans to issue draft guidance documents that address MIWG’s remaining requests involving health care economic information by year-end.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.
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.
For another recent post on FDA regulatory news, see FDA Releases Draft Guidance on New Risk Information for Approved Drugs