NDMA Supports Foreign Marketing Data Usage

Use of foreign marketing, research and data to expand over-the-countermedicines monographs has the support of the USA's Nonprescription Drug Manufacturers Association, which told the Food and Drug Administration that its plans on this should be more flexible. The FDA published an Advanced Notice of Proposed Rulemaking on the subject last October.

In December 1996, comments to the Agency, the NDMA said the ANPR is a "reasonable first step in the development of a policy opening the OTC monograph system to drugs marketed in foreign countries." The FDA, it added, should administer the "material time or extent" requirement as simply and flexibly as possible, leaving a more detailed review of safety and effectiveness data to the determination of whether the drug is generally recognized as safe and effective.

In its latest Executive Newsletter, the NDMA says that the Agency should regard foreign marketing under "third-class" (pharmacy-only sales) systems on a par with general-sale OTC marketing systems for purposes of establishing eligibility for OTC monograph status in the USA.