Drug companies will always seek to extend the markets for their products, and regulators will always be concerned that the promotion of these products is truthful. The challenge is to maintain a balance that best protects patients. Off-label communications are on the borderline of what is permitted to provide patient value. Off-label communication is a part of the product life cycle, and policies regarding off-label uses should consider that a larger process than only an obligatory task. Let’s go through the most important considerations about communication of off-label data in Medical Affairs based on FDA draft guidance.
1. Off-label data may be communicated by Medical Affairs only in reactive manner as a reply on a unsolicited (unprompted by company) query. A solicited request is one where direct or indirect references to off-label use are first mentioned by a company or a company representative.
2. Solicited requests would render a company response to be illegal promotion.
3. Medical Affairs has to respond privately to any person making an unsolicited “public” request for off-label use. A public response on a website or in a social media forum would provide off-label information to individuals who did not request such information and, therefore, may promote a product for the off- label use.
4. This approach is different from approach to unsolicited requests in an in-person public forum, such as a meeting or a conference. In those settings, a response to an unsolicited question about off-label use may be made to the audience at large.
5. Any responses to unsolicited requests must be truthful, balanced, accurate, and not misleading. In addition, the responses should be non-promotional and scientific or medical in nature, generated by medical personnel who are independent from sales and marketing departments, responsive only to the question asked, and provided only to the person making the inquiry.
6. FDA states that unpublished data on file with the company may be disseminated and there are no restrictions on the types of data.
7. FDA advises companies to keep a written record of the nature of the request and the name, address, and affiliation of requestor; the information provided; and any follow-up inquiries, questions, and responses.
8. Disclaimers, disclosures, and attachments should accompany all off-label information, including:
– A copy of required approved labeling.
– A statement identifying the approved indications.
– A statement that the information contains references to not approved uses.
– All important safety/risk information.
– A complete list of references, including journal articles that may provide negative information about off-label uses.
9. Company policies and standard operational procedures related to medical information services and medical request resolution should be carefully considered by the responsible.
1. Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. DRAFT GUIDANCE. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf
2. Kupchyk A. FDA’s draft guidance on social media and off-label communications. Nixon Peabody LLP. http://www.nixonpeabody.com/files/142219_FDA_Health_Alert_01_26_2012.pdf
3. Kyle Sampson, J.D., and Brian J.Wesoloski, J.D. Off-Label and Pre-Approval Promotion. Hunton & Williams LLP. http://www.hunton.com/files/Publication/87a698ce-a24a-4913-bcec-71e7358dea10/Presentation/PublicationAttachment/b0b5ff9d-3de9-46ff-9624-8116942df128/ContractPharma_March_2012.pdf4. C. Lee Ventola. Off-Label Drug Information Regulation, Distribution, Evaluation, and Related Controversies. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2799128/pdf/ptj34_8p428.pdf
Written by Dr. Alexander Tolmachev.