FDA WARNING_LETTER - Acorda Therapeutics Inc. - September 09, 2011

On May 10, 2012, the FDA issued a Warning Letter to Acorda Therapeutics Inc. following an inspection from August 15 to September 9, 2011. The inspection identified significant violations of Section 505(k) of the Federal Food, Drug, and Cosmetic Act and 21 CFR §§ 314.80 and 314.81, concerning postmarketing adverse drug experience (ADE) reporting.

Repeat violations from previous inspections in 2006 and 2009 were noted, including late submission of 15-day Alert reports and failure to develop written procedures. Specific violations from the 2011 inspection included:

1. **Failure to submit serious and unexpected ADEs within 15 calendar days:** Approximately (b)(4) late ADE reports were submitted between January 22, 2010, and August 15, 2011, including deaths, irregular heartbeats, and acute fulminant hepatitis. Some reports were over 100 days late. Corrective actions, such as changing contractors, were ineffective, as (b)(4) late reports occurred after implementation. 2. **Failure to develop adequate written procedures for ADE surveillance, receipt, evaluation, and reporting:** The firm lacked procedures to ensure ADEs were detected, identified, assessed, and reported, contributing to untimely reporting.