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Potential Changes to FDA Regulation of Homeopathic Drugs

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On April 20, 2015 the Food and Drug Administration (FDA) heard testimony regarding homeopathic drugs and the Agency’s role in the regulation thereof. These two-day long hearings come after the FDA received over 1,500 public comments about the possibility of regulating homeopathic drugs in a manner consistent with over-the-counter (OTC) drugs. A primer for the public hearing can be found in the federal register, here. Homeopathy began in the 18th century, based off of teachings from a German scientist, Samuel Hahnemann. The main concept in homeopathy is that, “like cures like” (similia similibus curentur) meaning that disease causing substances can…
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FDA Approves Bladder Control Drug for OTC Use, Highlighting Rx to OTC Switch

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On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced the approval of the first women's bladder control product available without a doctor's prescription. In the past, all bladder control drugs were only available by prescription. This product, called Oxytol for Women, will be made available without a prescription for women aged 18 years and up only. Oxytol will remain available through a prescription only for men. The full story may be accessed here. Overactive bladder, a condition where the bladder squeezes too often or without warning, affects up to 33 million Americans annually, and the majority of…
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