Drugs

House Bill to Reform OTC Drug Monographs

A bipartisan group of House lawmakers has introduced legislation to make more over-the-counter (OTC) medications available to patients. The Over-the-Counter Monograph Safety, Innovation, and Reform Act was spearheaded by Reps. Diana DeGette (D-CO), Bob Latta (R-OH), Debbie Dingell (D-MI) and Brett Guthrie (R-KY) to reform FDA’s OTC monograph system. If passed, it would help get more safe OTC drugs approved for the market sooner, the lawmakers say, adding that it would also reduce the time it takes for drug makers to get the approval they need to update and refine existing OTC products.

The lawmakers point to a study released earlier this year that found that, on average, every dollar spent on OTC medicines saves the U.S. health care system $7.20. The savings, according to the report, come from a combination of consumers spending less on lower-priced OTC drugs and patients self-treating their ailments instead of paying to see a doctor to get a prescription.

To make more OTC products available to consumers faster, the legislation would, among other things, provide FDA with additional funding to hire more staff dedicated to its OTC-related efforts. It would also help the agency develop a new electronic infrastructure needed to speed up the agency’s review and approval process for new over-the-counter drugs.

Additionally, the bill would create a new approval pathway for drug makers to use to update an existing OTC product. “Under the current system, it can take several years for a company to get the approval it needs to update a product label with new safety information, or add a new ingredient, or make some other important change to one of its drugs,” the lawmakers say. “By creating a new path for drug makers to more quickly refine and improve their current OTC products, the legislation would encourage more innovation of those products and allow the industry to respond more quickly to any future issues that may arise.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome