EUROPEAN/U.S. PHYTOMEDICINES COALITION SEEKING OTC ENTRY TO U.S. MARKET

Executive Summary

EUROPEAN/U.S. PHYTOMEDICINES COALITION SEEKING OTC ENTRY TO U.S. MARKET for plant-based pharmaceuticals based on demonstrated safety-in-use data from the marketing of these products in Western Europe. A petition filed by the European-American Phytomedicines Coalition proposes that phytomedicines marketed in Western Europe for a "material time" and to a "material extent" be considered by FDA for marketing as over-the-counter drugs. The petition suggests general guidelines that define material time and extent as at least five years on the market and retail sales of 10 mil. dosage units. Demonstration of safety-in-use should also include market authorization in one or more drug export country listed in the 1986 Drug Export Amendments Act, the petition suggests. EAPC Coalition members "would like to have their products regulated as drugs because they have dealt in that milieu and this is something they're most comfortable in," EAPC counsel Robert Pinco (Washington, D.C. office of Baker & Hostetler) told FDA representatives at a Sept. 30 OTC "feedback" meeting. The meeting was called to discuss the petition, filed July 24. Pinco estimated that the coalition would bring 10-15 substances to FDA as candidates for review "in the next few years" if the agency granted its petition. The number of submissions would be limited because of safety, efficacy and statistical data requirements and because some phytomedicines marketed abroad "make broader claims than we know could be available in the United States," he noted. EAPC members are Dr. William Schwabe GmbH, Madaus AG, Indena SpA, the French Institut Henri Beaufor, Boehringer-Ingelheim of Germany, Bioforce (the Netherlands, Switzerland and the U.S), Lichtwer Pharma GmbH, R.P. Scherer, the Israel-based firm Botanicare Natural Products and U.S.-based Murdock International. Pinco outlined the challenges the coalition will face if the agency decides to consider phytomedicines based on foreign safety- in-use data. The challenges are to convince FDA that "more health- oriented claims...fit into the OTC review," that a new category should be created and that these claims "are self- diagnosable," Pinco said. Health claims that companies can make for OTC garlic tablets, for instance, include, depending on the country, helping to "maintain a healthy heart and circulation," aiding in the prevention of arteriosclerosis or helping to lower cholesterol, a Lichtwer representative noted. Lichtwer's U.S. subsidiary markets Kwai garlic tablets domestically as a dietary supplement. FDA's OTC Drug Policy Staff Director Michael Kennedy said he thought the issue of health claims may be discussed by the OTC drugs advisory committee, which is scheduled to meet for the first time on Dec. 15-16 ("The Pink Sheet" Sept. 21, p. 9). Kennedy noted that the agency is evaluating a proposal that would spin off a category of "fiber laxatives" with ingredients such as psyllium from the OTC laxative products. Under the proposal, these fiber products would be allowed to make cholesterol-lowering claims. He stressed that these products "need something showing efficacy" before such claims can be considered. Whether a phytomedicine ingredient is sold exclusively as a drug or marketed both as a food product and a drug might depend on the ingredient, Baker & Hostetler's Mark Yacura said. Garlic, for instance, could be regulated as a food or a drug based on label claims. However, valerian, which is marketed as a sleep aid in Europe, only may be suitable for U.S. consideration as a drug because "it may not be very safe to have people taking valerian ...when it's not really properly labeled...and driving around in automobiles," Yacura said. Yacura also conceded that the five year, 10 mil. dosage units parameters outlined in the EAPC petition were "somewhat arbitrary," but said the coalition felt that the time and dosage guidelines "would give a very strong marketing history of the product" and "should give FDA some comfort level as to safety through use." Examples of phytomedicines given in EAPC's petition for consideration as Category I OTCs are valerian as a sleep aid and chamomile as a topical anti-inflammatory. The European Scientific Cooperative for Phytotherapy (ESCOP), an umbrella trade organization, is compiling data for proposals to the European Community Commission for European monographs on phytomedicine ingredients. In March, ESCOP offered proposals for 10 ingredients: marigold flower, peppermint oil, dandelion leaf and root, bearberry leaf, garlic bulb, hawthorn, hops, passiflora and ispaghula. Actions of the herbs listed in the proposals include laxative, sedative, "improvement of cardiac function," anti-inflammatory, wound healing and antiseptic. Five additional ingredients were proposed in October 1990. A petition similar to EAPC's is pending at the FDA concerning OTC sunscreens. European sunscreen manufacturers E. Merck, Givaudan, Haarmann & Reimer and L'Oreal filed a petition in July 1990 asking that the sunscreen rulemaking be reopened to accept European safety and efficacy data.