CU urges FDA to accept Black Box Warning recommendations of Committee
February 17, 2006
Dr. Andrew C. von Eschenbach, MD
Food and Drug Administration
Parklawn Building, 5600 Fishers Lane
Rockville, MD 20857
Dear Dr. Eschenbach:
Consumers Union, the independent, non-profit publisher of Consumer Reports, urges the FDA to accept the February 9, 2006 Black Box Warning recommendations of your Drug Safety and Risk Management Advisory Committee. The Committee’s recommendations relate to warnings about possible cardiovascular events in children and young adults from the use of attention deficit and hyperactivity disorder drugs.
Frankly, recent actions of the FDA have caused great concern in the consumer community: these actions include, but are not limited to, the reported retreat on providing a new on-line warning system for adverse events, the gratuitous preamble language on the labeling rule which attempts to pre-empt stronger State labeling laws, and a FY 2007 budget request that fails to address so many unmet consumer needs. We hope therefore that you will re-assert FDA’s role as a leader in protecting the public’s health by accepting the recommendations of your Advisory Committee. Physicians and patients should be warned that there are questions about these powerful drugs, that there are risks that should be balanced with the benefits, and that these drugs should not be casually used.
The Advisory Committee was convened to consider possible future, multi-year studies on the safety of these drugs, with a number of FDA physicians expressing concerns about this class of stimulant drugs. According to press reports, the Committee surprised many of those in attendance by seeking strong action through a warning. We strongly endorse the Committee’s action. We hope you will proceed with safety studies—but in the meantime, please act to place Black Box Warnings on these products. Warnings are a form of consumer empowerment that should be encouraged—not discouraged.
Thank you for your consideration of this request.
Senior Policy Analyst