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FDA to Fast-Track Even More Pharmaceutical Drugs to the Market

According to a recent report from NaturalNews, the United States Food and Drug Administration (FDA) wants to expand the types of drugs eligible for its so-called “Fast Track” process, which is a shortcut method for drugs to receive accelerated approval and priority review. In particular, the FDA plans to allow certain drugs, including obesity treatments and antibiotics, to be available on the market without undergoing the normal drug review process by the FDA. The NaturalNews report points out that this is a “shortcut method for drug companies to rush potentially-deadly new drugs to market without appropriate regulatory review.”

FDA Commissioner Margaret Hamburg recently proposed these changes to a group of scientific advisers. In particular, these “fast-tracked” drugs would receive a unique type of priority approval status, which would allow doctors to prescribe them to “critical need” patients willing to bear the effects of drugs with clinical trials involving smaller samples sizes and shorter duration periods.

MedCity News reports that “[u]nder the new pathway, the FDA would allow developers of such drugs to conduct smaller, faster clinical trials, and provide a ‘special medical use’ label which would allow doctors to administer drugs to patients with critical need.” Further, MedCity News reports that “(Commissioner) Hamburg has said that the FDA needs to take into account the needs people with deadly or debilitating diseases that may be willing to take on the risks of unproven drugs.”

NaturalNews reports that the FDA has already “fast-tracked” untested and unproven cancer drugs to market with the stipulation that the drug manufacturers must perform post-approval studies to confirm safety and efficacy. However, the drug manufacturers rarely perform these required follow-up studies – and the FDA typically does not impose penalties or restrictions on the companies for failing to perform these studies. The end result is that many new drugs are administered to patients with minimal testing in terms of safety and efficacy.

 

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