FDA Sends Warning Letter to AMAG Pharmaceuticals, Inc.
The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed AMAG Pharmaceuticals, Inc.’s websites marketing its drug products, GastroMARK (an oral gastrointestinal imaging agent for delineation of the bowel) and Feraheme (an iron replacement therapy for individuals with kidney disease).
The DDMAC found the websites for both drug products misleading and in violation of FDA rules. Pursuant to a warning letter issued on October 18, 2010, it criticized AMAG for omitting the risks associated with the use of its two drug products, suggesting unapproved new uses for the products, and omitting important information about the approved indication for GastroMARK.
- Both websites present numerous efficacy claims for GastroMARK and Feraheme but fail to communicate any of the risks associated with the drugs, e.g., the GastroMARK web page omits the drug’s contraindication in patients with known or suspected intestinal perforation or obstruction;
- The GastroMARK website fails to present the complete indication for the drug, including material limitations to the indication, e.g., the GastroMARK web page fails to include that the drug is indicated only in adult patients, and that its usefulness in the lower gastrointestinal tract and retro-peritoneal region is limited by the transit time and dilution; and
- Both websites present both approved and unapproved product information for the products together, which implies that the drugs are effective for unapproved uses.
According to the FDA, “[t]hese violations are concerning from a public health perspective because they suggest that GastroMARK is useful in a broader range of patients and conditions than has been demonstrated by substantial clinical experience, and that GastroMARK and Feraheme are safer than has been demonstrated by substantial evidence or substantial clinical experience.”
As such, the DDMAC requested that AMAG immediately cease the dissemination of its promotional materials for both drugs and submit a written response to its warning letter no later than November 1, 2010.