Post-Marketing Studies For All Products Endorsed By Drug Safety Expert
This article was originally published in The Pink Sheet Daily
Executive Summary
A mechanism is needed for post-marketing testing of all new drugs, safety expert Gross says during a Drug & Device Dialogue audio conference on the COX-2 advisory committee meeting. FDA “needs more tools” to protect public health, consumer rep Levin argues.
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Post-marketing studies to collect additional safety data on all new drugs should be considered by FDA in the wake of COX-2 safety issues, drug safety expert Peter Gross (Hackensack University Medical Center) said Feb. 23. "I think a mechanism is going to have to be put in place for post-market testing for all drugs when they first come out," Gross said. "I think we need to do more post-marketing testing. It's possible to do it because there are a number of large databases," such as "some managed care organizations who have large enough databases that we could do this and I think studies have to be designed in order for us to do that," Gross said. Gross participated in a Drug & Device Dialogue audio conference sponsored by FDC Reports and Polidais LLC to discuss the outcome of the Feb. 16-18 Arthritis/Drug Safety & Risk Management joint committee meeting on COX-2s. Center for Medical Consumers Director Arthur Levin said the safety issues raised during the COX-2 committee meeting indicate that Congress needs to give FDA greater authority for mandating approval and post-marketing studies. "The meeting emphasized for me that the agency needs to have more tools in order to be effective in protecting public health," Levin said. Congress should "really hold a series of hearings to see if it's time to update the FDA in the 21st Century," he said, "to take a broader look at FDA, what statute allows it to do, and what it doesn't allow it to do, what the approval and post-marketing processes may be." The Senate Health Committee will hold hearings March 1 and 3 to examine the FDA approval and drug safety monitoring processes (see 1 (Also see "Drug Safety To Be Topic Of Senate Health Hearings March 1 & 3" - Pink Sheet, 23 Feb, 2005.) ). HHS Secretary Leavitt announced the creation of a Drug Safety Oversight Board, which would consist of members from FDA and medical experts from other HHS agencies, during a Feb. 15 meeting with FDA employees (2 (Also see "FDA Drug Safety Oversight Board Will Include VA, Other Agencies" - Pink Sheet, 15 Feb, 2005.)). However, some members of Congress have argued that this measure does not go far enough in establishing an independent drug safety office (3 (Also see "FDA Drug Safety Reform Must Come From Outside Agency – Sen. Grassley" - Pink Sheet, 16 Feb, 2005.)). "We would like to see an office separate from CDER, probably overseeing the safety of all medical products, that is, drugs, devices and dietary supplements, and report directly to the commissioner," Levin said. "We would also like to see an office that is given the authority to levy civil monetary penalties if manufacturers do not live up to certain expectations, for example, to conduct post-marketing trials. And we'd like to see an office that is adequately funded," he added. Levin said a cut in FDA's budget while simultaneously creating an independent drug safety board would send a mixed message to the public. The advisory committee concluded that there is a cardiovascular risk associated with the COX-2 class of drugs, though that risk varies somewhat by doses and drugs within that class (4 (Also see "COX-2 Cardio Risk Is Class Effect, But Varies By Drug And Dose, Cmte. Says" - Pink Sheet, 18 Feb, 2005.)). The committee recommended in favor of "black box" warnings for the COX-2s. During the dialogue, Curt Furberg (Wake Forest) suggested that FDA could follow the European contraindication in patients with a history of cardiovascular disease (5 (Also see "COX-2 Inhibitors Contraindicated For Heart Disease Patients In Europe" - Pink Sheet, 17 Feb, 2005.)). "I think we can follow the European model. That would be patients clearly at increased risk, which would be those who have a history of heart attack, other manifestations of coronary heart disease, history of stroke and you can probably add heart failure as well." Caution should be exercised in patients with elevated blood pressure, diabetes and high cholesterol, Furberg added. Cardiovascular and gastrointestinal data for non-selective NSAIDs are limited, making the risk comparison difficult. During the dialogue, gastroenterologist Byron Cryer (University of Texas Southwestern Medical School) said one area for further research would be to compare the cardiovascular and gastrointestinal risk of COX-2s to NSAIDs with proton pump inhibitors. "The study that needs to be done are additional studies of COX-2 specific inhibitors to non-selective NSAIDs plus PPIs and to study it against a variety of non-selective NSAIDs," Cryer said. Gross, Levin, Furberg and Cryer all participated in the COX-2 advisory committee; however, they participated in the Drug & Device Dialogue as experts within their respective fields, not on behalf of FDA or the committee. [Editor's Note: To order archive access to or a CD of the Drug & Device Dialogue audio conference "COX-2 Aftermath: Defining Risk," please contact FDC Reports at 1-800-332-2181 or visit 6 http://www.drugdevicedialogue.com.] - Lee Kalowski |