Specialty physicians frequently rely on unapproved uses of FDA-approved medical products to treat patients with complex health conditions and diseases. In fact, “off-label” uses of medications and devices may be the standard of care or recommended in peer-reviewed guidelines for certain health issues. A newly revised draft guidance document includes a series of frequently asked questions on how “firms” may share information with healthcare professionals on these unapproved uses of FDA-approved products. In its response, the Alliance highlights its position statement on physician-directed applications of FDA-approved products and urges the Agency to ensure access to scientific information from firms is not disrupted by the final guidance.  The full letter to the FDA can be accessed by clicking the link below.

Alliance Comments to FDA on Off-Label