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Unapproved New Drugs

The Food, Drug and Cosmetic Act (“FDCA”) prohibits the sale of unapproved new drugs in interstate commerce: “No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application [to the FDA] is effective with respect to such drug. A drug manufacturer or distributor obtains FDA approval by submitting a new drug application (NDA) or abbreviated new drug application (ANDA) in accordance with the FDCA and FDA regulations. Unbeknownst to the public, physicians, and pharmacists; thousands of unapproved drugs have been on the market for decades. Recently, the FDA has announced its intention to take enforcement action against the unapproved rugs, and hundreds of drugs have been taken off the market so far. Unapproved drugs have been sold to federally-funded healthcare programs and are currently the subject of several qui tam lawsuits.

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