The U.S. Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services that is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The agency is responsible for regulating $275 billion dollars in drug sales each year. In 2008, a WSJ.com and Harris Interactive Poll stated that, “Majorities of U.S. adults give negative ratings for the Food and Drug Administration (FDA) on a number of measures, such as ensuring new drugs come to market quickly (60% negative) and managing recalls or withdrawals when safety concerns arise (53%). The perception that the FDA does a good job ensuring the safety and efficacy of new prescription drugs (35% positive) has declined from 45 percent in 2007 and 56 percent in 2004, even though the general population considers this to be the most important task for the FDA to focus on (61%).” The poll concluded that only 26% of consumers think the FDA does a good job of ensuring the safety of drugs manufactured outside of the United States.
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Seeking Justice for Defective Drugs Through Pharmaceutical Litigation
I founded my law firm on medical malpractice litigation, and gradually moved into pharmaceutical litigation as well. Many firms abandoned this area of law because they believed that federal pre-emption would be too big of an impediment to winning a case. I realized that it was going to take diligence, but still there were many pharmaceutical products cases that needed to be brought to protect consumers from dangerous drugs. The recent 6-3 (March 4, 2009) Supreme Court ruling in Wyeth v. Levine, states that federal law does NOT pre-empt state lawsuits for inadequate drug label warnings.
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