Material time/extent proposal should allow interim marketing -- European coalition.

MATERIAL TIME/EXTENT PROPOSAL SHOULD ALLOW INTERIM MARKETING OF FOREIGN PRODUCTS, the Coalition of European Sunscreen Manufacturers asserts in Dec. 26 comments to FDA. U.S. marketing of foreign products or ingredients under consideration by FDA "should be permitted while the substantive determination regarding general recognition of safety and effectiveness is conducted," the coalition of three German companies (BASF, Merck KGaA and Haarman & Reimer) maintains. The comments were submitted by the D.C. office of Akin, Gump, Strauss, Hauer & Feld.

The coalition also made comments that echo those separately submitted by BASF, as did the other two coalition member companies, both of which submitted individual comments in addition to the coalition's comments. The coalition argues that concerns about foreign population in which a substance is used being reasonably equivalent to the U.S. population are irrelevant because "similar to the United States, patterns of immigration in European countries have operated to diversify the local populations." The Nonprescription Drug Manufacturing Association has made similar comments about population diversity ("The Tan Sheet" Jan. 6, p. 15).

In the advance notice of proposed rulemaking on material time and material extent, FDA states that, contrary to practice in its review of U.S.-marketed products, "the agency believes that allowing the marketing of a new condition before the agency has evaluated its safety and effectiveness would subject the public to unnecessary risk." The ANPR was published Oct. 3 ("The Tan Sheet" Oct. 7, 1996, p. 1).

The European coalition counters: "It would seem more relevant for the FDA to determine whether any health hazard or serious risk would be present if foreign OTC products [were] eligible for interim marketing rights." The group points out that "there is a dearth of UVA blockers on the market in the United States," adding that "the risks of skin cancer in a sun worshiping culture such as the United States outweigh the risks associated with according true interim marketing to foreign sunscreen products."

"A more flexible interim marketing policy that recognizes the low level of risks of certain therapeutic categories and ingredients" such as topically applied sunscreens "would be consistent with the historical FDA approach to the OTC review," the coalition concludes. Comments submitted by Merck, as well as comments from Haarman & Reimer, concur.

The coalition also recommends a 120-day period for a "material time" and "material extent" review. Subsequent review regarding safety and efficacy should be completed within one year, the group suggests. "Expedited" consideration should be awarded to ingredients for which petitions already are pending at FDA. "Some of these petitions date back more than 10-15 years," the coalition notes. For instance, BASF has a petition pending at FDA for the sunscreen ingredient octyl triazone based on European data and another, pending since 1989, for ethoxylated ethyl-4-aminobenzoate; Haarman & Reimer has a pending request with FDA for isoamyl p-methoxycinnamate ("The Tan Sheet" Dec. 2, 1996, p. 5).