SR-134, As Adopted by Senate, January 29, 2008

            Senator Pappageorge offered the following resolution:

            Senate Resolution No. 134.

            A resolution to memorialize the United States Congress and United States Food and Drug Administration (FDA) to establish stricter standards for the drug approval process.

            Whereas, Americans are justifiably concerned about the safety and efficacy of the drugs and medications they take. In recent years, the FDA has received consumer reports of safety concerns and harmful side effects after the use of drugs approved by the FDA. In some cases, the FDA or manufacturer response to these reports has not been timely and consumers continue to risk harm; and         

            Whereas, The FDA is responsible for protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Accountability rests with the FDA to require stringent testing and trials before a drug can be approved for marketing; and

            Whereas, Incidents of harmful side effects raised concerns that the FDA post-marketing monitoring needs strengthening. Although American drugs are arguably the safest in the world, allegations of detrimental consequences from FDA-approved drugs show that there is room for improvement. Stricter standards for the FDA's investigation and response to consumer reports of harmful side effects should be established to enhance the safety of drugs approved by the FDA and on the market. The FDA must immediately investigate consumer reports of harmful side effects and act quickly to protect the public. In this way, Michigan's tort law and strict FDA standards will ensure that Michigan residents can have confidence in the drugs and medications they take; now, therefore, be it

            Resolved by the Senate, That we memorialize the United States Congress and United States Food and Drug Administration to establish stricter standards for the drug approval process; and be it further

            Resolved, That copies of this resolution be transmitted to the President of the United States Senate, the Speaker of the United States House of Representatives, the members of the Michigan congressional delegation, and the Commissioner of the United States Food and Drug Administration.