FDA enters consent decree of permanent injunction against Florida drug companies

FDA last month announced that the District Court for the Middle District of Florida had entered a consent decree that prohibits Hill Dermaceuticals Inc. and Hill Labs Inc. (collectively referred to as “Hill”), and individuals Jerry S. Roth and Rosario G. Ramirez from introducing adulterated drugs into interstate commerce.

The government’s complaint in this action, filed by the U.S. Department of Justice on September 27, 2011, describes numerous deviations from current good manufacturing practice (cGMP) for drugs documented during FDA inspections of Hill. The drug cGMP regulations require manufacturers to control all aspects of the processes and procedures by which they manufacture drugs to prevent the production of unsafe or ineffective drug products. The government alleges that Hill has, on more than one occasion, submitted untrue statements in support of submissions to FDA.

“Because this company continued to violate current good manufacturing practice regulations and falsify information on submissions to FDA, the agency took this action in an effort to protect consumers,” said Dara Corrigan, FDA associate commissioner for regulatory affairs.

Terms of the consent decree include provisions to prevent Hill from introducing adulterated drugs into interstate commerce. In addition, the decree includes elements of the FDA Application Integrity Policy, which is designed to ensure the authenticity of data submitted to the agency. FDA will verify the adequacy of Hill’s corrective actions.

Hill manufactures the following topical prescription drug products: DermaSmoothe/FS Scalp Oil, DermaSmoothe/FS Body Oil, and DermOtic Oil Eardrops. In addition, Hill is the contract manufacturer of the topical prescription drug products Tri-Luma Cream and Capex Shampoo for Galderma Laboratories.

FDA is not currently aware of any recent adverse events related to the use of any of Hill’s products. Any such complaints of adverse events should be reported to the agency at: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.