Print
Email
Print Edition Stories
MHT's Marc Songini: Technology to keep seniors healthy
MHT's Efrain Viscarolasaga: Tech companies may have to wait for stimulus funds
MHT's Marc Songini: Mass. bio firms prep for lifting of stem cell ban
Federal regulators have taken Millennium Pharmaceuticals Inc. to task over an advertisement for the company’s multiple-myeloma drug Velcade, calling the promotion “false or misleading because it overstates” the product’s efficacy.
The promotional materials in question were mailed to doctors ahead of the 2008 meeting of the American Society of Clinical Oncology in Chicago. Typically, such so-called “reminder labeling” is not regulated by the U.S. Food and Drug Administration.
But the FDA wrote that the mailer, which was designed to get doctors to visit the Velcade booth at the ASCO conference in exchange for a Millennium donation to a cancer charity, did not qualify as reminder labeling.
Millennium, based in Cambridge, is owned by Japanese drug maker Takeda Pharmaceutical Co. Ltd.
According to the FDA, reminder labeling calls attention to the name of a drug but makes no claims about its efficacy.
However, in the Millennium case, the mailer made several specific statements, including “Achieve a Complete Response” and “Your Complete Response Matters,” which the FDA says is common parlance in oncology circles for total disappearance of detectable signs of cancer.
The FDA said the implication was that Velcade would help patients achieve a “complete response.”
In fact, Velcade’s success rate in eradicating all detectable signs of the disease in the company’s phase 3 trial was only 30 percent, at most, the FDA said.
In a June 18 letter to Millennium, the FDA asked the company to stop disseminating the mailer and to send by July 6 a response to the FDA outlining the company’s steps to spike the mailer.
RSS Feeds
Comments
Please Login/Register to post comments.
No comments have been added or approved.