Senate Committee Approves Legislation to Modernize OTC Drug Approvals

  • by AGD Washington Advocacy Representative
  • May 10, 2018

The Senate HELP Committee has favorably reported S. 2315, the Over the Counter Drug Safety, Innovation, and Reform Act. The legislation, introduced by Senators Johnny Isakson and Bob Casey, would streamline and modernize the current process for approving over the counter (OTC) drugs.

Under the current system, OTC “monograph” drugs are limited to one active ingredient per product. This bill would change that by allowing manufacturers to combine two or more preapproved non-prescription drugs into a single dose and streamline the approval process for drugs with more than one active ingredient by allowing the FDA Commissioner to approve monograph drug submissions by administrative order.

Impact on General Dentistry: Streamlining the approval process will, among other things, allow for the FDA’s approval of non-narcotic pain relievers with a combination of two or more active ingredients, which is particularly important in the context of preventing opioid abuse.