Never express yourself more clearly than you are able to think.
–Niels Bohr
Think regulatory headaches about Facebook is a hot topic? Here are some communications issues that make social media guidance pale in comparison.
Yesterday Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer and sanofi-aventis will file a Citizen Petition with the U.S. Food and Drug Administration (FDA) asking the agency to clarify its policies on how truthful, non-misleading scientific information not included in approved product labeling can be communicated.
The petition will state that communicating accurate scientific information about new research would enhance health care quality and potentially lead to better patient outcomes, but that companies lack precise guidance on how to communicate such information.
Specifically, the companies requested that the FDA issue clarifying regulations or guidance on four issues:
* “Scientific exchange”
* Sharing information with formulary committees and payers
* How to provide independent third-party clinical practice guidelines
* Responding to unsolicited requests for information
“Scientific exchange,” broadly defined, is the sharing of research and clinical information about investigational medical products or new information on approved products without representing the product as safe and effective for that use. The FDA said in a 1963 regulation that it does not intend to restrict “scientific exchange.” The concept of “scientific exchange,” however, is not precisely described in the FDA’s regulations and therefore leaves ambiguity about the limits of what is permitted.
Managed care formulary committees and other payers make important coverage and reimbursement determinations based on clinical evidence and other data. The FDA has not issued a formal policy with respect to what information manufacturers can provide to formulary committees about new uses of approved medical products so that patients can be promptly reimbursed.
Third-party clinical practice guidelines are produced by leading medical organizations or the government to inform and guide diagnosis, management and treatment decisions. These guidelines are based on the most up-to-date clinical evidence and data and are intended to guide health care professionals in improving quality of care and optimizing clinical outcomes. There is no formal FDA policy on when and how it is appropriate for companies to disseminate third-party guidelines that mention off-label uses of their products.
“Unsolicited requests” are unprompted questions from physicians or patients about the off-label uses of medical products. For years the FDA has not taken enforcement action when companies respond to unsolicited requests for off-label information in a balanced and scientific manner. However, there is no written regulation or policy providing a comprehensive description of FDA’s policies on unsolicited requests.
The absence of alternatives clears the mind marvelously.
–Henry Kissinger