Author: mhammons

The FDA recently announced (some) updated social media guidelines for pharmaceutical and medical device firms. The actual title of these guidelines are ?Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices?.

This is still considered Draft Guidance and is an update to previously released guidance. This is, however, the first time the FDA mentions ?emerging electronic media? with specific examples related to YouTube and Twitter.

The full FDA Draft Guidance can be downloaded here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf

The document is fairly short (12 pages), by government standards, and I highly recommend you read the whole thing if you are responsible for sales, marketing or customer service for pharmaceuticals or medical devices.

I will point out some important bits below, particularly, related to responses as outlined in the FDA document. This is particularly important for maintaining compliance and is a great example of why CRM systems are very important for social media interactions and staying compliant with regulations.

V. RESPONDING TO NON-PUBLIC UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION DIRECTED TO DRUG OR MEDICAL DEVICE FIRMS

1. Information distributed in response to an unsolicited request should be provided only to the individual making the request directly to the firm as a private, one-on-one communication.

2.  Information distributed in response to an unsolicited request should be tailored to answer only the specific question(s) asked.

3.  Information distributed in response to an unsolicited request should be truthful, non-misleading, accurate, and balanced.

4.  Information distributed in response to an unsolicited request should be scientific in nature.

5.  Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments.

6.. Information distributed in response to an unsolicited request should be accompanied by the following:

• A copy of the FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet)
• A prominent statement notifying the recipient that FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided
• A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product
• A prominent statement providing all important safety information including, if applicable, any boxed warning for the product
• A complete list of references for all of the information disseminated in the response (e.g., a bibliography of publications in peer-reviewed medical journals or in medical or scientific texts; citations for data on file, for summary documents, or for abstracts)

7. A firm should maintain the following records:

• The nature of the request for information, including the name, address, and affiliation of the requestor
• Records regarding the information provided to the requestor
• Any follow-up inquiries or questions from the requestor

VI. RESPONDING TO PUBLIC UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION, INCLUDING THOSE ENCOUNTERED THROUGH EMERGING ELECTRONIC MEDIA BY DRUG OR MEDICAL DEVICE FIRMS

1.  If a firm chooses to respond to public unsolicited requests for off-label information, the firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor?s product).

2.  A firm?s public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm?s contact information and should not include any off-label information.

• The firm?s public response should convey that the question pertains to an unapproved or un-cleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information.
• The firm?s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication.

The customer service module within Dynamics CRM is particularly well suited to helping your team monitor, respond, and document social media interactions. We have a lot experience helping companies maintain compliance with regulations using CRM. If you need help, just call or fill out the request below and let us know.