On May 22, 2012, the U.S. Food and Drug Administration (“FDA”) announced that U.S. Marshals, acting at the requests of the Agency, had seized certain products deemed to be unapproved new drugs. HybriSil (methylprednisolone acetate 1% in silicone gel), the drug at issue was being marketed without FDA approval and therefore in violation of the Federal Food, Drug and Cosmetic Act (“FFDCA”). In particular, the seizure came as a result of two inspections conducted by the Agency, where the firm was found to be selling the product in violation of a number of FDCA provisions.
Crescendo Therapeutics, LLC, the firm marketing the product, was first warned of the violations after the FDA conducted an inspection of its facilities back in 2011. Thereafter, on November 17, 2011, the FDA issued a Warning Letter to the company, detailing the deficiencies found, including: marketing an unapproved new drug, misbranding, and failing to develop written procedures for reporting of post-marketing adverse drug experiences (“PADE”). The Warning Letter may be accessed here. According to the FDA, Crescendo failed to take the necessary corrective actions that resulted in the November 2011 Letter.
Pursuant to the discovery of deficiencies, the FDA may conduct further inspections to ensure compliance with FDA regulations and that all corrective measures have been taken. This is exactly how the persisting deficiencies were discovered here, as the FDA conducted another inspection of Crescendo’s facilities in January 2012. Since the follow-up inspection uncovered the same sort of deficiencies that were discovered during the initial inspection of Crescendo’s facilities, further action was taken. Inasmuch as the recent seizure may not have been pursued if the Company had taken all necessary corrective actions in the first place, this situation highlights the importance of taking FDA warning letters seriously, as failure to comply with regulatory requirements may result in enforcement action.