Crestor Safety Defense Misrepresents FDA Position, Agency Tells Company
This article was originally published in The Pink Sheet Daily
Executive Summary
An AstraZeneca “patient safety” print ad that ran in mid-November “misleadingly suggests that the agency does not believe that Crestor poses safety concerns,” the FDA ad division says in an “untitled” letter to the company. The Crestor ad asserted FDA has concluded safety concerns about rosuvastatin “have no medical or scientific basis.”
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AstraZeneca's print ad defending the safety of Crestor "misleadingly suggests" FDA has no concerns about the statin's safety, the agency's ad review division said in a Dec. 21 "untitled" 1 letter to the company. The agency takes issue with a print ad that ran in the Washington Post Nov. 23 and claimed that FDA officials believe safety concerns about rosuvastatin "have no medical or scientific basis." AstraZeneca ran the ad several days after FDA Office of Drug Safety Associate Director for Science David Graham identified Crestor as one of five drugs with unresolved safety issues during a Nov. 18 congressional hearing on Vioxx (2 (Also see "Crestor, Serevent Are Among Problem Drugs Cited By FDA Safety Reviewer" - Pink Sheet, 18 Nov, 2004.)). The ad ran under the headline, "You can be assured that at AstraZeneca, patient safety is our number one priority." Similar ads ran the same week in other national and regional newspapers, including the New York Times, Wall Street Journal, USA Today and Los Angeles Times. FDA's letter objects to a section of the ad describing the agency's position on Crestor safety. "FDA has confidence in the safety and efficacy of Crestor," the ad stated. "The scientists at the FDA who are responsible for the approval and ongoing review of Crestor have, as recently as last Friday, publicly confirmed that Crestor is safe and effective; and that the concerns that have been raised have no medical or scientific basis." The statement contains a footnote to FDA's website "accessed on 11/19/04." The ad "misleadingly suggests that the agency does not believe that Crestor poses safety concerns," the agency told AstraZeneca. "There is...no statement on the website by FDA concluding that 'the concerns [about Crestor] that have been raised have no medical or scientific basis,'" the letter states. "In fact, recent public statements made by the agency contradict that conclusion." The reference in the AstraZeneca ad appears to be a statement issued by Center for Drug Evaluation & Research Acting Director Steven Galson following Graham's congressional testimony and posted on the agency's website. In the Nov. 18 statement, Galson said Graham's testimony "does not reflect the views of the agency." "The five specific drugs that Dr. Graham identified in his oral testimony are currently approved as safe and effective for use in the U.S.," the statement reads. "FDA takes all allegations of safety risks seriously and will continue its longstanding practice of assessing the safety of all drugs using only sound science and peer-reviewed analysis and literature." The letter to AstraZeneca notes that Galson was also quoted in a Nov. 18 Washington Post article entitled "Campaign Waged Against Crestor" as saying that FDA "has been very concerned about Crestor since the day it was approved, and we've been watching it carefully." Public Citizen cited the same article in urging FDA to halt what it called AstraZeneca's "false and misleading" ad campaign on Crestor safety (3 (Also see "Public Citizen Takes Aim At Crestor DTC Ads Defending Statin's Safety" - Pink Sheet, 26 Nov, 2004.)). The agency's letter also objects to AstraZeneca's "false or misleading safety claims that minimize the risks associated with Crestor," particularly with the 40 mg dose (see 4 (Also see "AstraZeneca Ad Minimizes Risks Posed By Highest Crestor Dose, FDA Says" - Pink Sheet, 22 Dec, 2004.)). The agency requests AstraZeneca cease distribution of the ad and submit a written response by Jan. 7 "describing your intent to comply with this request, listing all violative promotional materials for Crestor the same as or similar to those described above, and explaining your plan for discontinuing use of such materials." The specific ad cited by the agency is no longer running. However, AstraZeneca is still running direct to consumer print and broadcast ads for the product that claim superiority to other statins. - Sue Sutter |