Increased FDA Authority Over OTCs Sought in Waxman Bill

[JohnMack]

Source: The TAN Sheet Breaking News (email)

The Non-Prescription Drug Modernization Act, introduced Nov. 6, would give FDA authority 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.

Reps. Henry Waxman, D-Calif., and Tom Allen, D-Maine, and Senator Ted Kennedy, D-Mass., say the bill "would give FDA the authority to act quickly to protect consumers from unsafe or ineffective OTC drugs, by allowing the agency to revoke authorization to market such drugs without a lengthy rulemaking."

Expedited changes could be made when FDA identifies a monograph it believes should be amended because a drug may pose a significant risk, or when the agency finds that a drug under a monograph lacks evidence of effectiveness, following an advisory committee meeting. Recommendations made by a recent FDA joint advisory panel to ban certain OTC cold medicines for children under age 6 prompted the legislation, Waxman said.

The bill also would give FDA authority over OTC drug advertising, currently under the purview of the Federal Trade Commission. Civil monetary penalties for direct-to-consumer prescription drug advertising violations could apply to OTC drug advertisements as well, under the bill. The measure also would require FDA to solicit public comment seeking proposed changes to monographs, and to file a report to Congress on any findings within two years of enactment.

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