Data confidentiality assured by current FDA rules, agency says in denying WLF petition.
This article was originally published in The Gray Sheet
Executive Summary
CONFIDENTIAL DATA PROTECTION AT FDA ASSURED THROUGH EXISTING RULES, the agency says in its Aug. 8 denial of a citizen's petition submitted by the Washington Legal Foundation earlier this year. Responding to WLF's assertion that unauthorized leaks of confidential data are "increasingly common," FDA states that "existing laws, regulations and offices sufficiently address concerns involving unauthorized disclosures of information."