As with the FDA’s previous Guidance on this topic (2009 Guidance), BIO continues to support FDA‘s clarification of its views on the dissemination of medical journal articles and medical or scientific reference publications that contain truthful and non-misleading information, including new information about the uses of approved drugs, biologics and medical devices. In addition, BIO supports FDA’s inclusion in this Revised Draft Guidance of recommendations regarding manufacturer provision of medical journals and texts, as well as Clinical Practice Guidelines (CPGs), that similarly contain truthful and non-misleading information, including new information, about the uses of approved drugs, biologics, and medical devices.
BIO agrees with FDA that the provision of truthful and non-misleading scientific and medical information to health care professionals has public health value. Information about new or potential new uses can be critical for physicians and their patients. As FDA explains in the Revised Draft Guidance, many medicines are prescribed for unapproved uses, some of which may be a part of an emerging standard of care, or may in fact already be the standard of care. Health care professionals and other relevant individuals involved in the provision of health care and health insurance should be able to receive truthful and non-misleading published informationregarding potential medical options for patients, regardless of the source of distribution of such information. On the whole, the Revised Draft Guidance provides helpful guidance for manufacturers about how FDA would view or interpret manufacturer sharing of truthful and nonmisleading information that appears in medical reference texts and CPGs concerning unapproved new uses of approved products. As explained in more detail below, however, BIO is concerned that the Revised Draft Guidance may have the effect of restricting the lawful distribution of truthful and non-misleading scientific or medical information. Accordingly, we urge FDA to ensure that the Agency’s proposed constraints in the Revised Draft Guidance are narrowly tailored to meet the Agency’s public health goals, while not unnecessarily restricting truthful and non-misleading communication.