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Around the nation: FDA postpones debate over first OTC birth control pill


FDA postponed its Nov. 18 advisory meeting to evaluate whether HRA Pharma's birth control pill will be authorized for over-the-counter (OTC) use, in today's bite-sized hospital and health industry news from the District of Columbia, Maryland, and Ohio.

  • District of Columbia: Three of the largest manufacturers of amoxicillin—Hikma Pharmaceuticals, Teva Pharmaceutical Industries, and Sandoz, the generics division of Novartis—are currently experiencing supply issues. The manufacturers have reported shortages of various doses of amoxicillin. The shortages were primarily reported in the drug's liquid form, which is used to treat bacterial infections in young children, according to the University of Utah's drug information service—a platform that tracks medication shortages. On Tuesday, the university's drug tracker listed shortages in 14 of Hikma Pharmaceuticals' amoxicillin products, nine from Teva, and 16 from Sandoz. An FDA spokesperson said that while the agency was aware "of some intermittent supply interruptions of amoxicillin products in the U.S, and are currently working with the approved manufacturers," it does not currently consider amoxicillin to be in shortage since at least one manufacturer is capable of fully supplying market demand. (Weixel, The Hill, 10/26)
  • Maryland: FDA postponed its Nov. 18 advisory meeting to evaluate whether HRA Pharma's birth control pill Opill will be authorized for OTC use. According to a statement from HRA Pharma's parent company, Perrigo, the meeting was delayed "to review additional information requested related to the Opill Rx-to-OTC switch." The agency has not yet set an exact date for the meeting. If the drug is authorized for OTC use, it would become the first birth control drug to be sold without a prescription. Prior to the Supreme Court decision to overturn Roe v. Wade, the American Medical Association (AMA) encouraged FDA to authorize the sale of OTC oral contraceptives. "Expanding OTC access would make it easier for patients to properly use oral contraceptives, leading to fewer unplanned pregnancies," AMA said. (Twenter, Becker’s Hospital Review, 10/26)
  • Ohio: Bob Evans Foods has recalled roughly 7,600 pounds of Italian pork sausage that is potentially "contaminated with extraneous materials, specifically thin blue rubber," according to a Department of Agriculture (USDA) alert. The USDA Food Safety and Inspection Service has advised consumers to avoid consuming the sausage products, adding that they should be "thrown away or returned to the place of purchase." The recall has been classified as a "class II recall" with a "low risk" by USDA. Under this classification, there is a "remote probability of adverse health consequences from the use of the product," according to USDA. The alert said there "have been no confirmed reports of adverse reactions due to consumption of these products" but said anyone "concerned about an injury or illness should contact a health care provider." (Tyko, Axios, 10/26)

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