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Drug Dangers

Janicek Law > Drug Dangers

FDA responds to Big Pharma’s Citizen Petition

Big Pharma asked the U.S. Food and Drug Administration to overhaul a newly finalized regulation that gives the agency wide latitude to police off-label promotion. Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation Organization and a drug maker coalition known as the Medical Information Working Group, filed the petition on February 8, 2018.  The petition claims the rule contains unconstitutional policy changes. These organizations represent many drug makers, and their petition challenges the FDA's new rule for evaluating “intended use” of prescription drugs and medical devices.  An important concept, intended use helps the FDA assess whether companies are intentionally marketing products for unapproved uses. The...

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Brief Considerations of America’s Opioid Use

In the 1990’s, pharmaceutical companies began the wide scale advancement of their agenda to push long term use of opioid prescriptions for a wide range of ailments. They based their beliefs on limited scientific data which led them to believe patients would not develop long term addictions to the medications. The effects swept the country as patients were prescribed medicine that wasn’t even effective against some chronic pains. The medical field was under the false premise that there “was virtually no dose-ceiling” and the patients should be prescribed to the point when they reached pain relief. Under this mantra, patients...

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