FDA Issues New Guidance on Medical Devices.

William Salage

On January 18, 2017, the Food and Drug Administration [FDA] announced two new draft guidance on medical product communications.[1] The purpose of the drafts is to help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products. Specifically, the drafts seeks to answer two common questions amongst the manufacturing community: (1) when off-label marketing is considered free speech; and (2) when should such communications, whether they are directed at doctors, insurers or the public be considered in violation of the law or US Food and Drug Administration (FDA) regulations.[2] The release of the memo and new guidance follows a two-day meeting in November on off-label communications in which the FDA examined the possibility for less regulation despite recent court decisions adverse to the FDA’s official position.[3]

The first draft guidance document entitled: ““Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities,” explains the FDA’s current thinking and recommendations on firms’ communication of health care economic information (HCEI) about approved drugs under section 502(a) of the FD&C Act, which was recently amended by the 21st Century Cures Act.” [4] The draft also provides the FDA’s recommendations regarding firms’ communications to payors about investigational drugs and devices that are not yet approved or cleared for any use by the FDA.

The second draft guidance entitled, “Medical Product Communications That Are Consistent With the FDA-Required Labeling,” explains the FDA’s position about firms’ medical product communications that include data and information that are not contained in their products’ FDA-required labeling, but that concern the approved or cleared uses of their products.[5]

 

[1] Food & Drug Admin., Statement from FDA Commissioner Robert Califf, M.D. announcing new draft guidances on medical product communications (2017), http://www.fda.gov/NewsEvents/ Newsroom/ PressAnnouncements/ucm537371.htm (last visited Jan. 27, 2017).

[2] Zachary Brennan, Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications, Regulatory Affairs Professionals Society (Jan. 18, 2017), http://www.raps.org/Regulatory-Focus/News/2017/01/18/26628/Truthful-and-Non-Misleading-FDA-Looks-to-Clarify-Policies-on-Medical-Product-Communications/

[3] Brennan, supra note 2; See e.g. Amarin Pharma, Inc. v. U.S. Food & Drug Admin., 119 F. Supp. 3d 196 (S.D.N.Y. 2015) (granting Amarin’s application for a preliminary injunction allowing for the company to engage in truthful and non-misleading speech promoting the off-label use of Vascepa).

[4] Food & Drug Admin., Statement from FDA Commissioner Robert Califf, M.D. announcing new draft guidances on medical product communications (2017), http://www.fda.gov/NewsEvents/ Newsroom/ PressAnnouncements/ucm537371.htm (last visited Jan. 27, 2017).

[5] Id.

Leave a Reply

Your email address will not be published. Required fields are marked *