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MEDICAL PRIVACY LAWS SHOULD NOT REQUIRE PATIENT CONSENT FOR POST-MARKETING REGISTRIES -- PhRMA; LIMITS ON RIGHTS TO RECORDS IN CLINICALS SUGGESTED

Executive Summary

Medical privacy legislation should not require sponsors to obtain patient consent for post-marketing registries when subjects are not identifiable, Glaxo Wellcome VP-Worldwide Clinical Research Richard Kent maintained at a Feb. 4 HHS hearing on medical privacy. Kent cited as an example Glaxo Wellcome's registry for the anti-convulsant Lamictal, which was established to determine whether the drug is teratogenic in humans.

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