Re 2004-N-0018From: Christophe Kopp [Christophe.Kopp@wanadoo.fr] Sent: Wednesday, September 08, 2004 3:57 AM To: fdadockets@oc.fda.gov Subject: Re 2004-N-0018 David A. Lepay Office for Science and Health Coordination Good Clinical Practice Programs (HF-34) Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Docket No. 2004N-0018: Human Subject Protection; Foreign Clinical Studies not Conducted Under an Investigational New Drug Application Dear Dr. Lepay We are opposed to the The Food and Drug Administration (FDA) replacing the requirement that foreign clinical studies not conducted under an investigational new drug application (IND) be conducted in accordance with the Declaration of Helsinki with the requirement that the studies be conducted in accordance with Good Clinical Practice (GCP). The ethical principles contained in the 2000 Declaration of Helsinki are basic standards that were produced thanks to an international and democratic process conducted by the World Medical Association. These standards go even further than the Good Clinical Practice guides (ICH). GPC guides are mainly technical things, whereas the scientific and ethical credibility of clinical trials relies on the principles of the Declaration of Helsinki. GPC guides are the by-product of an ICH process that is conducted behind closed doors by industry representatives and the big regulatory bodies. Indeed, independent organisations of health professionals or patients are not involved in the ICH process. Increasingly, new drugs are approved despite the lack of convincing comparative evaluation against reference treatments. Lack of comparison means that the public and health professionals are not in a position to know if the new drugs are more effective, safer or more convenient than existing therapies. Including patients in clinical trials and using a placebo instead of a reference treatment as comparator is ethically and scientifically unacceptable. As specified in the Declaration of Helsinki (2000) in its section 29 "The benefits, risks, burden and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic or therapeutic value (...)". Unfortunately international regulatory bodies have failed to enforce the use of a proper comparator drug in controlled trials forming the basis of marketing authorizations. Discarding the 2000 version of the Declaration of Helsinki would make the quality and relevance of clinical data for regulatory submission even poorer than it tends to be now, thus indirectly preventing real therapeutic advances to emerge. The priority mission of the FDA, as all other medicines agencies, is to serve the public's and the patients' interest, not the pharmaceutical companies's short term profitability. Yours sincerely Christophe Kopp Editor Prescrire International [Prescrire International is the English language edition based on the French journal la revue Prescrire , www.prescrire.org. Both journals are published by the non profit organization Association Mieux Prescrire. They are funded by subscribers, with no support from pharmaceutical industry or government.]