Hill Dermaceuticals Sues FDA Following Approval of Generic Derma-Smoothe
On November 4, 2011, Hill Dermaceuticals, Inc. (Hill), a Florida-based drug manufacturer, sued the U.S. Food and Drug Administration (FDA). Hill brought suit in connection with the FDAs recent approval of three Abbreviated New Drug Applications (ANDAs) submitted by Identi Pharmaceuticals (Identi). Hill, the manufacturer of Derma-Smoothe, an FDA-approved skin treatment, alleges that FDAs recent approvals of the generic formulations of its drug violate the Federal Food, Drug and Cosmetic Act (FDCA).
Found here, Hills Complaint alleges that the FDAs approvals of Identis ANDAs were arbitrary and capricious. In short, Hill alleges that in approving the ANDAs, FDA treated Identi differently and in contravention of the FDCA by foregoing certain testing to show that the drugs are safe for consumers. Because Derma-Smoothe is a topical treatment derived from peanut oil (a major allergen), FDA required Hill to perform testing to show that the refined oils in the drug contained only trace amounts of amino acids. Still required to test every batch it produces, Hill claims that it has “invested more than $1 million to license and develop a proprietary amino-acid analysis.” Because the methods Hill uses to test its products are proprietary, Hill alleges based on information and belief that FDA has approved Identis applications without requiring such testing or verification that Identis drugs have similarly low levels of amino acid.
Further, because Hill is required to declare that Derma-Smoothe has undergone such testing on the label of each product, Hill claims that Identis products cannot be approved as a generic form of Derma-Smoothe because the drug cannot contain such a declaration in product labeling. Under FDA regulations, generic formulations of drugs undergo approval through an Abbreviated New Drug Application (ANDA). Unlike a New Drug Application (NDA), an ANDA requires the manufacturer to demonstrate that its drug is bioequivalent to a drug approved via an NDA. This showing generally requires the generic to demonstrate that it contains the same active ingredients, is used in the same manner and will bear largely the same labeling. Thus, assuming the Hill case survives a motion to dismiss filed by the FDA, the Hill case will confront the extent of the differences that are permissible in product labeling in order for the Agency to make a finding of bioequivalence under the FDCA.
Fuerst Ittleman will continue to monitor the developments of the Hill case. For more information regarding the ANDA generic drug approval process or for any questions regarding how your company can maintain FDA regulatory compliance, please contact us at email@example.com.