Alliance of Specialty Medicine Sends Letter to FDA Identifying Drug Compounding and Off-Label Communication Policies as Key Areas for Regulatory Relief for Physicians

Recently, the Alliance of Specialty medicine sent a letter to the Food and Drug Administration (FDA), echoing similar concerns raised by ASCRS, in response to FDA’s Request For Information (RFI) on existing regulations that could be modified, repealed, or replaced to achieve meaningful burden reduction on physicians and practices. In the letter, the Alliance expressed concerns about the final guidance on “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act,” that requires physicians to write individual prescriptions for compounded medications before they can be filled by 503A compounding pharmacies. While these medications may be filled without a prescription from an 503B outsourcing facility, they do not come in quantities appropriate for small physician practices or in formulas necessary for certain uses (i.e., in ophthalmic solutions or “eye drops”). As a result, physicians are facing difficulty accessing important compounded medications to treat patients. The Alliance urges the FDA to rescind the final guidance and work with the specialty physician community on a solution that preserves patient access to compounded drugs.

In addition, the Alliance raised concerns about the burden placed on physicians because of the FDA’s off-label communication policies that restrict access to scientific information provided by manufacturers on the safe and effective use of medical products (including drugs, devices and biologics). The Alliance urges the FDA to ensure that physicians have access to scientific information from manufacturers on the safe and effective approved and unapproved use of medical products. The Alliance requested that the FDA issue a revised draft guidance for comment, to allow for the appropriate distribution of truthful, non-misleading information. We will keep you updated.