What We Asked the FDA

Medic sittting on question mark. Isolated over white
Following the release of the draft guidance on “Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices” the response from within the industry has been less than satisfied which is not surprising.  But call me a glass half full kind of gal as I saw the document as an opportunity for companies to confirm their existing social media guidelines.  I do agree however that parts of the draft guidance leave much to the imagination and thus we embarked on an effort to see if we could get some more clarity.

The following is a list of questions gathered from a mix of Pharmaceutical companies, industry consultants, and 3rd parties.  Last week, I sent these questions off to Jean-Ah Kang from the FDA, in hopes of gaining some insight into the direction the FDA is heading in.

Global Websites & Wikis
1.     How do we handle global websites such as a corporate Facebook page where some responses may be off-label in the US but not for other countries?

Responding Publically and Privately to Unsolicited Questions
2.     Could you provide clarification on the term “choose” in regards to a company’s responsibility to communicate directly to off-label unsolicited requests (i.e. does this mean that a company can choose not to respond)?

3.     What Guidances, if any, are there on which unsolicited responses we choose to or not to respond to on sites outside of a pharmaceutical company’s ownership and control?  By responding, are we then assuming responsibility for responding in perpetuity?

4.     If we respond to a request on one website but not another would that be considered cherry picking?

Providing Information to Patients & Consumers
5.     Can patients and consumers receive the same information as what we would provide an HCP?

6.     Is a summary of a reprint allowable in addition to the full reprint?

Documentation Retention

7.     Is there any guidance around how long information needs to be retained?

8.     What are the requirements for logging and reporting these unsolicited Off-Label interactions (i.e. filing 2253)?

Definition of Off-label
9.     Is information that is consistent with approved use, but not contained in the labeling considered “off-label” for the purposes of the draft guidance?

Comment: In general, there is a lack of clarity in the industry regarding the degree to which information about a prescription drug that is not contained in the labeling is considered to truly be “off-label”.  It is clear that dissemination of information about a patient population or disease for which a drug is not indicated would describe an unapproved use of the drug and casino therefore would be only disseminated in the manner described in the Draft Guidance. However, as noted by the Agency, medical departments of pharmaceutical companies have a vast amount of information about its drugs that, while supportive of the approved indication(s), is not contained in the labeling. Such information may include subgroup analyses of pivotal trials and secondary endpoints of pivotal trials, etc., that are literally “off label”, but consistent with the approved use of the drug.

10.  It is a common practice for pharmaceutical companies to sponsor presentations about its drugs. While the presentations are typically provided by a healthcare professional who is paid for his/her time, the presentations are clearly promotional and as such, consistent with the labeling and balanced with respect to the drug’s risk/benefit. Generally presenters are permitted to answer unsolicited “off-label” questions posed by the audience. The Draft Guidance provides a recommendation that in such instances the speaker provide only the contact information to the Medical Department thus precluding the other audience members from hearing the off label information.  While it is clear that questions related to an unapproved use would be handled as described in the Draft Guidance, it is difficult to understand why a question such as “Were there any Asians in the trial?” or “Was the change in LDL due to particle size or number?” –not specifically contained in the labeling–would require the same handling to avoid audience exposure to the information.  Can you clarify?

We anxiously await Jean-Ah’s response and look forward to sharing her input with you all.  In the meantime, let us know if there is anything else you would have liked to see asked?

Zoe Dunn
Zoe Dunn, President and CEO of Hale Advisors, is a digital marketing and communications specialist with over twenty years of experience in the field. She has extensive experience in both the agency and commercial marketing side of the pharmaceutical, medical devices, and biotech industries.

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