Aidaccess.org – FDA Warning Letter, Mar 12, 2019

On March 8, 2019, the FDA issued a Warning Letter to Aidaccess.org for causing the introduction of misbranded and unapproved new drugs into interstate commerce, violating sections 301(a), 301(d), and 505(a) of the FD&C Act. The FDA's review of Aidaccess.org's website revealed the facilitation of sales of unapproved mifepristone and misoprostol to U.S. consumers for pregnancy termination.

The specific product identified is a "Combipack of Mifepristone Tablets IP & Misoprostol Tablets IP," manufactured by (b)(4), (b)(6), and marketed by (b)(4), (b)(6), indicated for early medical abortion up to 9 weeks. No FDA-approved applications exist for this product. This violates section 505(a) as it is an unapproved new drug, and section 301(d) for its introduction into interstate commerce.

Furthermore, the product is deemed misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as these are prescription drugs requiring professional supervision. It is also misbranded under section 502(f)(2) for failing to bear adequate warnings, bypassing the FDA-approved Risk Evaluation and Mitigation Strategy (REMS) program for Mifeprex,