Monitoring Drug Safety
The industry and the U.S. Food and Drug Administration have come under significant scrutiny since Merck’s withdrawal of Vioxx. Six papers on the issue were published on the subject in the Dec. 1, 2004, issue of the Journal of the American Medical Association. The journal’s editors called for a new, independent office separate from the FDA to monitor drugs after they’re on the market.
Merck and the FDA have been accused of moving too slowly to stop sales of the arthritis drug Vioxx, which Merck withdrew in September after revealing it raised the risk of heart attacks and strokes. Some scientists claim that painkillers similar to Vioxx, especially Pfizer Inc.’s Bextra, also carry risks.
Dr. David Graham, associate director of science in the FDA’s Office of Drug Safety, told a Senate panel that the FDA was incapable of protecting the public and that at least five other drugs are on the market that should be looked at seriously to see whether they should remain there. He cited the acne drug Accutane, the weight-loss drug Meridia, the anticholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent.
PharmaVOICE asked: Are companies and regulators doing enough to protect consumers? What needs to be done to ensure that drugs are safe once on the market? And is a new regulatory body needed to oversee drug safety?
FDA Improvements in Drug Safety Monitoring
Safety from a Small-Company Perspective
Larry Tamura, Director Regulatory/Quality Assurance, Cornerstone BioPharma Inc.
100 People, 100 Responses
Matthew W. Reynolds, Ph.D., Senior Director, Risk Management and Safety Services, MetaWorks Inc.
Donald P. Verbarg, Director Technology Development, Fluid Air Inc.
Taking Responsibility as an Industry
Bill Quinlivan, Marketing Partner, AD-TECH Communications
Stricter Adherence to the IND Process
Jim Clifford, Group Company Chairman, CommonHealth