US NDMA Urges Congress To Help OTC Drug Approval

US over-the-counter medicine manufacturers, through their trade body the Nonprescription Drug Manufacturers Association, have urged Congress to support legislation that would help facilitate approval and marketing of OTC medicines.

The NDMA has testified before the House Commerce Committee's Health and Environment subcommittee in support of provisions that would: create an OTC office in the FDA's Center for Drug Evaluation and Research; allow drug review by independent organizations, including accredited foreign regulatory authorities; and establish one national system of regulation for OTC medicines.

As well as supporting existing provisions, the NDMA is seeking inclusion of a provision to HR 3199 (the Drug and Biological Products Reform Act) that would require a "substantial evidence" standard of judicial review for FDA rulemaking. The provision would require the agency to "affirmatively demonstrate" in the rulemaking record that a problem exists and that the proposed regulatory approach is a "reasonable" way to address that problem, the NDMA notes in a press release. This is the modern standard for most federal agency actions, it adds.