They additionally voted in majority against additional studies assessing the pharmacokinetics and clinical efficacy of other phenylephrine doses. As is a common dynamic between the FDA and its expert advisory committees, the agency is now expected to submit a regulatory ruling on the status of cough medicine formulas containing oral phenylephrine marketed to treat nasal congestion. Impacted drug makers may also work to update its cough medicine formulas to reflect a removal of oral phenylephrine in the meantime. ReactionsA number of regulatory figures and infectious disease experts weighed on the committee vote Tuesday, including former FDA commissioner Scott Gottlieb, MD. “In a clear statement, FDA admits how it got approved in the first place, also predicting some consequences,” Jayadevan posted.

Source: New York Times September 12, 2023 21:03 UTC