FDA WARNING_LETTER - Rablon - March 12, 2019

The FDA issued a Warning Letter to Rablon on March 8, 2019, for introducing misbranded and unapproved new drugs into interstate commerce, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

Specifically, Rablon offers an "Abortion Pill Pack" containing mifepristone and misoprostol, which the FDA deems an unapproved new drug. This product lacks FDA approval under section 505(a) and is not generally recognized as safe and effective for its labeled uses. The FDA-approved mifepristone product, Mifeprex, is subject to a Risk Evaluation and Mitigation Strategy (REMS) program due to serious risks, requiring certified prescribers and specific dispensing settings, which Rablon's product bypasses.

Furthermore, the "Abortion Pill Pack" is misbranded under sections 502(f)(1) and 502(f)(2) because it lacks adequate directions for layperson use and sufficient warnings against dangerous use. As a prescription drug, it requires professional supervision, which Rablon does not mandate, violating section 503(b)(1) and 301(k) by dispensing without a prescription.

The FDA emphasizes the inherent risks of unapproved drugs, including contamination, counterfe