On December 27, FDA issued a draft guidance, "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices," which was jointly issued by the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine, and the Center for Devices and Radiological Health. The Guidance "updates and clarifies" FDA's current thinking and policies for providing unsolicited, off-label information to consumers, including information provided by "emerging electronic media." "Off-label" uses are unapproved or uncleared indications or conditions of use for products that are otherwise approved or cleared by FDA for other uses. Medical professionals with prescribing authority may generally prescribe any product approved by FDA for any conditions or uses, whether FDA approved or not, as part of their practice of medicine.
FDA explained that its rationale for providing the guidance is an effort to balance the desire or need of individuals to obtain additional information about approved products with the potential for a product's manufacturer to provide information that may be viewed as promotional. FDA's Guidance, however, appears motivated, at least in part by a Citizen Petition filed by seven medical product manufacturers asking FDA to clarify FDA its regulations and policies governing communication of new or off-label use of marketed products. According to the Petition, FDA's vagueness regarding permissible manufacturer speech regarding off-label use has significant consequences to manufacturers, the government, physicians, and patients., as we reported here.
As part of FDA's rationale, the Guidance stated that on the one hand, a product's manufacturer typically maintains a large database of information about their FDA-approved products, including information obtained about possible off-label uses that may over time become the medically-recognized standard of care. On the other hand, a manufacturer's statements that promote their products for off-label uses are considered potential evidence of a manufacturer's illegal intent to promote its products for those off-label uses or conditions. FDA also recognizes that the Internet with its emerging news sources, such as social media or chat rooms, provides additional opportunities for consumers to seek medical information and receive information that is both accurate and useful or biased and otherwise inaccurate from product manufacturers or third-party sources.
First, the Guidance provides a number of operational definitions. Unsolicited requests are those initiated by individuals or entities independent of a relevant firm or its representatives, whereas solicited responses have been somehow prompted by the product's manufacturer. Non-public, unsolicited requests are directed privately to the manufacturer, whereas public, unsolicited requests are potentially heard or visible to a broad audience.
With these definitions in mind, FDA permits manufacturers to provide truthful, balanced, non-misleading, and non-promotional scientific information specific to specific, unsolicited requests for information about products--even if for unapproved or uncleared indications or conditions of use--with certain parameters in mind. For non-public unsolicited requests, FDA made the following recommendations:
- 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.
- Information distributed in response to an unsolicited request should be tailored to answer only the specific answer(s) asked.
- Information distributed in response to an unsolicited request should be truthful, non-misleading , accurate, and balanced.
- Information distributed in response to an unsolicited request should be scientific in nature.
- Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments.
- Information distributed in response to unsolicited request should be accompanied by certain information including the FDA-required labeling, a statement that FDA has not approved information concerning any off-label uses included, and a list of references.
- A firm should maintain records of the requests for information and the information and any follow-up provided
- The firm should respond only when the request pertains specifically to its own named product (not a competitor's product).
- The firm's response should be limited to providing the firm's contact information (medical/scientific representatives, not sales officials) for one-on-one communication and should not include any off-label information.
- Firm representatives who respond to public responses should clearly disclose their involvement with a particular firm.
- Public responses should not be promotional in nature or tone.
In the end, FDA's Guidance only appears to scratch the surface of the eagerly-awaited social media guidance FDA promised earlier in the year. While the Guidance begins to address some of the issues requested in the Citizen Petition filed earlier this year, it is unclear whether the present recommendations will help with the need for product manufacturers to communicate with third party payers or insurance about off-label uses to help with reimbursement issues.
