Fen Phen, Lotronex, Propulsid, Rezulin, Baycol, Vioxx, Bextra, Avandia, and Meridia – what do these pharmaceutical drugs have in common? Each was rushed to the market without adequate safety and efficacy studies, each was over-promoted by pharmaceutical representatives who had large monetary incentives to convince doctors to prescribe the drugs to patients, each ended up severely injuring or killing innocent patients, and all were eventually removed or withdrawn from the market because the risks of injury turned out to be much greater than the benefits the drugs were supposed to provide. Unfortunately, this is just a small sample of the actual number of dangerous pharmaceutical drugs that have been removed or withdrawn from the market since the late 1990s.
Now, Republican leaders of the House of Representatives Energy and Commerce Committee want to overhaul of the Food and Drug Administration by allowing faster clinical trials for new drugs, an accelerated approval process, and in some cases, waivers on post-market studies. The 393-page bill would also relax regulations on drug promotion and advertising by pharmaceutical companies.
This proposed legislation will enable pharmaceutical companies to rush drugs to market faster than ever before with even less safety and efficacy data, and that will expose patients to unnecessary risks of severe injury or death just as we’ve seen in the past. Most people do not realize that the pharmaceutical companies – not the FDA – conduct the clinical trials for their drugs and the FDA only reviews the data supplied to it by the pharmaceutical company. We have seen numerous instances where the pharmaceutical companies have withheld important data from the FDA, so this is terrible news for consumers.
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