FDA Reprimands Genentech for “Drastically Overstat[ing] the Efficacy of Tarceva”

by Jonathan J. Darrow

On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva.  Tarceva (erlotinib) was approved in 2004 for the treatment of non-small cell lung cancer, and has since been approved, in combination with Gemzar (gemcitabine), for the treatment of pancreatic cancer. Its approval letter reported a tumor response that was 9 times greater with Tarceva than with placebo (0.9% in placebo versus 8.9% in Tarceva), but relatively modest improvements in 1-year survival rates: approximately 8 of 10 patients on placebo did not survive 1 year, while about 7 of 10 patients on Tarceva did not survive (see page 6, line 102 of the approval letter).  A 2005 New York Times article was less than enthusiastic about Tarceva’s efficacy, noting that it (along with several other cancer drugs that were new at the time) “help[s] most patients only marginally . . . .”  Despite its modest efficacy, Tarceva was reported in the same New York Times article to cost almost $31,000 per year.  A number of patents are listed in the FDA’s Orange Book as covering Tarceva until 2020.

The recent untitled letter accused Genentech’s promotional materials of misleadingly indicating that Tarceva in combination with gemcitabine extended overall survival by 3.7 months in comparison with gemcitabine alone, when the actual increase in survival was only about 12 days.  The FDA characterized the discrepancy as “drastically overstat[ing] the efficacy of Tarceva.”  (The figure of 3.7 months was derived, according to the FDA, “from a retrospective, exploratory subgroup analysis that does not provide substantial evidence to support the efficacy claims cited . . . .”). In addition, the front cover of one of the promotional materials in question contained an image of an hourglass positioned on its side, presented with the claim: “Extending survival for moments that matter.”  Although the claim with its associated image may be literally true (“moments” is left undefined), the FDA characterized the image and claim as “drastically overstat[ing] the overall survival benefit for patients” because it “strongly suggests that time is standing still for the cancer patient because of Tarceva therapy.”  The FDA noted a number of other instances of misleading overstatement of efficacy or minimization of risk.

The October 3 Tarceva letter brings to 23 the total number of Drug Marketing and Advertising Warning Letters (and untitled letters) listed by the FDA’s Office of Drug Promotion as having been sent this year.

Jonathan Darrow

Jonathan Darrow

Jonathan J. Darrow was a Student Fellow during the 2012-2013 academic year. Currently, he is a faculty member at Harvard Medical School and is a member of the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham & Women's Hospital. He holds degrees in biological sciences / genetics, law, and business from Cornell, Duke, and Boston College, respectively, as well as a research doctorate in pharmaceutical policy and intellectual property theory from Harvard Law School, where he also completed the LL.M. program. He has been qualified as a patent attorney since 2002. After admission to the California bar in 2001, Dr. Darrow worked on pharmaceutical litigation matters at Wiley Rein & Fielding in Washington, DC, taught on the business law faculties of three universities (2004-2014), served as a senior law clerk for a federal appellate judge, and explored the relationship between innovation policy and global health in service to the World Trade Organization, the World Health Organization, and the World Intellectual Property Organization. He is a co-author of three textbooks, including Cyberlaw: Management & Entrepreneurship (2015) and The Legal and Ethical Environment of Business (forthcoming 2018). His scholarship on health policy and intellectual property has appeared in the British Medical Journal, the New England Journal of Medicine; the Journal of Law, Medicine & Ethics; the Stanford Technology Law Review; the Yale Journal of Health Policy Law & Ethics; and Health Affairs, among many others, and he has testified before a committee of the Massachusetts legislature on an emerging issue of law and technology. He authored Crowdsourcing Clinical Trials (Minnesota L Rev 2014) as part of his Student Fellowship.

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