Responding to your emails
I’ve reached nearly 30,000 views on this little blog and received 100s of emails. I am sorry to each and every one of you suffering from tinnitus, but I must be very careful in my responses. We have our current clinical results in hand and I believe we will have good news to share on our fundraising efforts soon. Our clinical results will be presented at the TRI conference in Belgium in June.
The FDA has provided a set of guidelines that dictate how I am allowed to discuss our results/information publicly. I hope this makes it clear that we take our responsibility to not make unsupported off-label claims (everything is off-label since we don’t have an approved product). I post some of the language below:
The draft guidance has a lengthy section dealing specifically with requests for off-label information encountered through what the FDA characterizes as “emerging electronic media,” such as product websites, discussion boards, chat rooms, company-controlled electronic forums, and third-party sites over which companies do not maintain control.
In these situations, the FDA apparently is concerned that companies might post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating off-label use information to individuals who have not requested that information. The FDA also is concerned about the “enduring nature” of detailed public online responses to off-label questions because specific information may become outdated. Accordingly, the draft guidance contains a number of recommendations that essentially enables a company to respond to a public request privately.
First, the FDA recommends that a company respond only when the request pertains specifically to its own named product (and is not either generic or solely about a competitor’s product). Thus, for example, if an individual poses a non-specific question such as “What drug can be used for Condition Y” in a public communication thread and a pharmaceutical company manufactures or distributes a drug that is not FDA-approved or cleared for that condition, the company should not respond to the request because the question is not specific to its drug.
Even when an unsolicited request for off-label information is posed as to a specific drug or device, the FDA also recommends that a company’s public response be limited and should not include any off-label information.
The response should convey that the question pertains to an off-label use and state that individuals can contact specifically identified medical/scientific representatives of the company or its medical affairs department for more information. Contact information for the specific individuals should be provided so that individuals can follow up independently with the company to obtain specific information about the off-label use of the product through a non-public, one-on-one communication. The company representatives who provide public responses should clearly disclose their involvement with their company. In addition, a public response should include a mechanism for providing readily accessible current FDA-required labeling, if any, for the product (such as an FDA-approved package insert, an FDA-approved patient labeling or, for new animal drugs, an FDA-approved client information sheet).