INTERNATIONAL HARMONIZATION: CARCINOGENICITY TESTING AND ADR REPORTS

INTERNATIONAL HARMONIZATION: CARCINOGENICITY TESTING AND ADR REPORTS are two areas where FDA is hopeful of reaching agreement with EC nations and Japan at the second round of the International Conference on Harmonization (ICH), FDA Policy Development and Coordination Staff Acting Director David Adams told the New York Pharma Forum on Dec. 2. ICH II is scheduled for Oct. 27-29, 1993 in Orlando, Fla. Three working groups on safety, efficacy and product quality were established with representatives from the drug regulatory bodies of the U.S., Japan and European Community during the first round of ICH in Brussels in 1991. Agreements were reached during ICH I in the area of preclinical toxicity studies, which has been published in the U.S. ("The Pink Sheet" April 20, In Brief), and in the areas of stability testing standards and efficacy studies in geriatric populations, Adams noted. "We hope to see significant agreements in ICH II in all three working groups," Adams said. From the safety working group, Adams said FDA is looking for an agreement on carcinogenicity studies, which, he noted, "are expensive and take time and the industry would be well-served by harmonization of these sorts of standards so you don't have to duplicate expensive studies of this type." In the area of safety reporting, Adams said FDA has "high hopes... that we can move towards harmonization of these sorts of reporting systems." Acknowledging FDA's "tentative" early efforts on behalf of international harmonization, Adams characterized ICH "as an anchor for the U.S. involvement" in the harmonization process. He noted that ICH "stands out as one of the few significant harmonization efforts in the history of our government." Initially, Adams said that FDAers found the harmonization process "difficult" given the agency's lack of experience in international standard-making. In addition, Adams pointed out that FDA's harmonization efforts are hampered by legal requirements determined by Congress and by a lack of resources. FDA's ability to share information with foreign governments also is limited by the Freedom of Information laws, he observed. FDA published a proposal to amend FoI to allow the agency to share information with the regulatory bodies of foreign governments in June ("The Pink Sheet" June 29, T&G-8). FDA's internal International Harmonization Task Force has prepared a report outlining the agency's position on harmonization that will be released "in the very near future," Adams announced. Reportedly, the task force report will be released at the Food & Drug Law Institute's annual meeting the week of Dec. 7. Adams said the report will spell out FDA's three harmonization goals: (1) to provide input into international standard setting activities; (2) to accept standards and programs of other countries when they are equivalent to FDA's; and (3) to share scientific information in order to expedite product approvals and to protect the public health. Kazutaka Ichikawa, counselor for Japan's Pharmaceutical Affairs Bureau of the Ministry of Health & Welfare, noted that international harmonization is one of the bureau's top priorities. However, he emphasized that negotiators must approach the process using good science. Ichikawa suggested that a cautious approach to harmonization that does not compromise safety and efficacy standards "is necessary in order to gain the understanding and support of the general public in each of the relevant countries" participating in the harmonization effort.