Non-Monograph Drugs Interim Marketing Preservation Urged By CHPA

FDA's proposed rule on "material time and material extent" criteria for inclusion of drug conditions in the OTC review would "effectively terminate" the monograph process, CHPA maintains in a March 22 letter to the agency.

Provisions in the proposed reg that would require post-OTC review conditions to follow the agency's suggested procedures for additional OTC conditions and would prohibit interim marketing of non-monograph products mark an "extraordinary step," the Consumer Healthcare Products Association states.

The OTC drug review was initiated in 1972 "to provide an efficient mechanism for FDA to determine the status of every OTC drug," the trade group says. "It was not meant to be limited to the currently marketed drugs which, because of resource limitations, were the first category of products deemed eligible for the review."

Through its implementation of the ongoing OTC review, FDA has "created innovative ways of distinguishing between conditions that do not present material safety and effectiveness questions and those that should be subjected to scrutiny before being incorporated into monographs," the letter notes.

In addition, the agency has "encouraged innovation" in its willingness to permit interim marketing of certain non-monograph conditions, CHPA observes.

"The proposed regulation would effectively put an end to this long-accepted approach by replacing the common sense flexibility of the OTC review with an inflexible, and unworkable scheme," CHPA stresses.

The proposed rule, published in the Federal Register Dec. 20, outlines a multi-tier process by which an OTC drug condition would be considered for inclusion in a final monograph (¹ ).

The barring of interim marketing on non-monograph conditions, which remains in the proposed reg despite industry opposition to its inclusion in FDA's October 1996 advance notice of proposed rulemaking, would mean that any "new" condition, such as a combination of ingredients or a dosage change, would require final monograph or approved NDA status.

CHPA urges FDA to reverse its position and allow interim marketing, "in appropriate circumstances, for both pre-1972 and post-1972 conditions."

The proposed change is a "significant departure from prior agency practice and is inconsistent with FDA's regulation of OTC drugs," the association says. "A drug product that is not authorized by a final monograph is not automatically a 'new drug' which must be covered by an approved NDA in order to avoid being misbranded."

If FDA opts to stay its course on the matter, it may encourage industry to file NDA deviations for proposed modifications to monograph drugs. The approval mechanism - referred to as "dNDAs" - recently was used by Pfizer to obtain clearance for a mousse version of Maximum Strength Rid lice treatment (² (Also see "Pfizer Rid Mousse Pediculicide Approved Under "NDA Deviation"" - Pink Sheet, 13 Mar, 2000.)).

Under the proposed rule, sponsors would be required to submit to the agency a "Time and Extent Application," with foreign marketing data from all countries in which the OTC condition is sold. The ANPR had limited the requirement to the 24 "tier one" countries.

If the condition is deemed eligible for consideration based on the TEA data, safety, effectiveness and compendial data would be submitted by the sponsor and other interested parties, and reviewed by FDA. If safety and effectiveness is determined, the agency then would publish a proposal to add the condition to an existing monograph or create a new monograph. Finally, based on comments on the proposal, a decision would be made on the condition.

As proposed, the procedure is unnecessarily "complicated" and "burdensome," CHPA asserts. FDA's failure to provide specific timeframes for completion of the TEA or the "notice of eligibility process," as well as the multiple step format, could result in a formula that would take "years" to complete.

The proposed reg "creates a series of procedures so protracted and unwieldy that CHPA cannot envision that the proposal will be of any practical value," the comments maintain. It would be more time-efficient for a sponsor to gain U.S. approval of a foreign drug condition by using the NDA process, CHPA adds.

The association urges FDA to employ a 90-day initial eligibility review for foreign drug conditions. "In-depth evaluation of the relevance and quality of the foreign data," including adverse event reports, "should be reserved for the agency's safety and effectiveness review in determining the OTC candidate's GRAS/E status," the association advises.