WASHINGTON If you can’t beat the rules, then change ‘em.
At least that seems to be the thinking behind the introduction of the Non-Prescription Drug Modernization Act on Tuesday, which would give both the Food and Drug Administration and the Secretary of Health and Human Services broad new authorities to quickly amend or appeal OTC drug monographs without being required to pursue notice and comment rulemaking as currently required under the Administrative Procedures Act.
The bill was introduced today by Reps. Henry Waxman, D-Calif., Tom Allen, D-Maine, and Sen. Ted Kennedy, D-Mass. Waxman recently criticized the FDA and industry for not immediately acting upon an FDA advisory committee panel recommendation that cough and cold products should not be marketed for children under the age of six.
Without the cooperation of industry, the FDA would need to pursue a lengthy rulemaking process to make any amendments to the monographs governing kids cough and cold medicines. That process could take years, FDA has reported. This piece of legislation would eliminate that process.
The bill also would add OTC drug advertising to FDA’s purview, moving it from the jurisdiction of the Federal Trade Commission.