US NDMA Reviews FDA OTC MaPPs Plan

The US Nonprescription Drug Manufacturers Association has described as "very encouraging" proposals by the Food and Drug Administration to make the review, approval and post-approval oversight of over-the-counter versions of prescription products more consistent and transparent.

The improvements are to be made through the development of a new Review Management manual of policies and procedures, establishing a team review approach, under an international draft plan at the FDA. The agency's OTC and new drug approval divisions responsible for the prescription version of the drug would share responsibility for OTC reviews. The plan would also mean that approval of OTC applications that are not first in a product class might forego advisory committee presentation, and that OTCs could be introduced initially without US prescription experience.

In its suggestions for further improvements, the NDMA has told the FDA of its concern that more and more, minor matters are delaying product approvals. It calls for "efforts to be made to resolve outstanding labeling issues prior to issuance of an action letter, in order to achieve direct approval and thus avoid an approvable stage."