Energy and Commerce Subcommittee on Health Passes Schakowsky's Drug Safety Amendment
Press Release
ENERGY AND COMMERCE SUBCOMMITTEE ON HEALTH PASSES SCHAKOWSKY'S DRUG SAFETY AMENDMENT
The U.S. House Energy and Commerce Subcommittee on Health today passed Congresswoman Jan Schakowsky's (D-IL) amendment to drug safety legislation. Schakowsky's amendment will increase public awareness of the MedWatch program, one of FDA's best tools for tracking adverse effects of prescriptions drugs once they are in the consumer market.
The amendment requires that all direct-to-consumer advertising of prescription drugs on television, radio, newspapers and magazines include the following statement, "You are encouraged to report adverse effects of prescription drug medication. Log onto www.fda.gov/Medwatch or call 1-800-FDA-1088."
Congresswoman Schakowsky delivered the following remarks during the Health Subcommittee markup.
"I offer this amendment as a common sense way to improve awareness of the MedWatch program which poses great potential to improve FDA's monitoring of adverse drug events in the consumer market, but which remains widely unheard of among people who take prescription drugs and their families.
Last October, Congressman Dan Burton wrote to FDA Commissioner Andrew C. von Eschenbach to express his concerns over the lack of awareness of how to report an adverse event to FDA. He wrote that in June of 2006, a national survey by In Touch Media Group found that 9 out of 10 Americans were completely unaware of the existence of MedWatch. This lack of awareness is scary and it is unacceptable.
Back in December of 20024, Congressman Ed Markey wrote to FDA expressing his concern that the public was not aware of the Medwatch program or how to submit their own adverse reaction reports. He asked, "On average, how many adverse event reports does the FDA receive per year?" The FDA responded that an average of 300,000 adverse experience reports were received by the Center for Drug Evaluation and Research (CDER).
Ninety percent of these reports are mandatory periodic reports from pharmaceutical companies. FDA failed to mention that only 2.3% of the total amount of adverse event reports was sent from consumers.
Adverse drug and device reactions (ADRs) account for as many as 100,000 deaths annually (according to the Journal of the American Medical Association). While drugs go through clinical trials prior to approval at FDA, not all serious side effects will be apparent during those trials. Many will not materialize until many months after they've gone on the market.
While consumer reports are not intended to replace scientific review of a particular drug, they can serve as a quick signal alert to the FDA on where to direct post-marketing surveillance of those medications causing high adverse reactions in the consumer market.
That's why it's so important that information is collected from those who are taking prescription drugs - as well as their families so that the adverse events we saw with Vioxx and Avandia are not happening "in a vacuum." The FDA's own guidelines on Medwatch encourage consumers and their families to report side effects to prescription drugs to the FDA so these can be utilized in determining drug safety. But consumers are not largely aware of the Medwatch system, and doctors aren't required to submit them.
This amendment, which would supplement the additional safety measures within the REMS section, would require that all DTC ads include the following language: "You are encouraged to report adverse effects of prescription drug medication. Log onto www.fda.gov/Medwatch or call 1-800-FDA-1088."
This is a straight forward amendment that would greatly improve FDA's adverse events reporting system (MedWatch) by allowing consumers to participate in the post market surveillance of prescription drugs, a key factor for the FDA to direct scientific review and quickly determine risk factors one a drug is on the market. I urge my colleagues to support it."
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