FDA WARNING_LETTER - Actelion Pharmaceuticals U.S., Inc. - July 20, 2009

On September 14, 2010, the FDA issued a Warning Letter to Actelion Pharmaceuticals U.S., Inc. following an inspection from June 24 to July 20, 2009. The inspection focused on Actelion's compliance with Postmarketing Adverse Drug Experience (PADE) reporting requirements for Tracleer® (bosentan), Ventavis® (iloprost), and Zavesca® (miglustat).

The FDA found that Actelion failed to comply with postmarketing reporting requirements under 21 U.S.C. § 355(k) [Section 505(k) of the Federal Food, Drug, and Cosmetic Act (the Act)] and 21 C.F.R. Section 314.80, constituting a prohibited act under Section 301(e) of the Act [21 U.S.C. § 331(e)].

Key violations included: 1. **Failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (21 C.F.R § 314.80):** Actelion's procedures for Tracleer® and Ventavis® patient-support programs did not require expedited reporting of deaths within 15 calendar days when there was a "reasonable possibility" the drug caused