Healthy Skepticism Library item: 7247
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Perrone M.
FDA Warns Ligand on Marketing Materials: FDA Sends Warning Letter to Ligand Citing Two Drugs Sold to Ensai
Yahoo Finance 2006 Nov 1
http://biz.yahoo.com/ap/061101/ligand_fda.html?.v=1&printer=1
Abstract:
Federal regulators warned Ligand Pharmaceuticals today that promotional materials used to market two drugs it recently sold to another company are misleading because they misstate the risks and effectiveness of the products.
In an Oct. 23 warning letter posted to its Web site today, the Food and Drug Administration states that a case study used to promote the drugs Ontak and Targretin “is false or misleading” because it minimizes the dangers and overstates the effectiveness of the drugs.
Ontak is used to treat persistent or recurrent cutaneous T-cell lymphoma, while Targretin is a treatment for cutaneous T-cell lymphoma. Ligand sold both drugs along with two others to Eisai Co. effective Oct. 25.
According to the FDA, Ligand’s marketing materials fail to mention any of the serious adverse reactions associated with Ontak, including acute hypertension, capillary leak syndrome and loss of visual acuity. Additionally, FDA says Ligand’s materials fail to mention the most serious risks connected with Targretin, which can cause birth defects if taken by pregnant women.
Federal regulators also take issue with Ligand’s claim that 60 percent of patients treated with Ontak in the case study experienced relief from their symptoms. According to FDA, the data cited by Ligand did not measure relief of the symptoms.
FDA orders Ligand to stop distributing the cited materials and requests that the company respond to the agency in writing by Nov. 6.
A spokesperson for Teaneck, N.J.-based Eisai said the company cannot comment on how Ligand marketed the drugs before it sold them.
Ligand declined to comment for this story.
Shares of Ligand Pharmaceuticals Inc. fell 10 cents Wednesday to $10.87 on the Nasdaq.
