Pediatric Provision Moves OTC Monograph Reform To Subcommittee Vote
This article was originally published in The Pink Sheet
An updated draft includes a provision requiring FDA to report annually to the Energy and Commerce Committee and to the Senate HELP Committee on the agency's evaluation of the cough and cold monograph to determine whether to impose more stringent limits on formulations allowed for use by children under age 6.
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"If the system is broken … my gosh, does it take 45 years for the FDA to say, 'we need help'?" US Rep. Joe Barton, R-TX, asks at House health subcommittee hearing on proposal to streamline the OTC monograph program and establish a user fee program to support FDA's work.
FDA officials emphasize that without legislation from Congress, the OTC monograph program is not changing, and without a user fee program, the agency couldn’t implement changes.
One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.