Healthy Skepticism Library item: 9249

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Kesselheim AS, Mello MM.
Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.
Health Aff (Millwood) 2007 Mar-Apr; 26:(2):483-91
http://content.healthaffairs.org/cgi/content/full/26/2/483

Abstract:

Pharmaceutical manufacturers have long considered results collected from drugs’ clinical trials to be confidential information or trade secrets, even after submission to the Food and Drug Administration (FDA). We describe FDA policies regarding disclosure of clinical trial data and evaluate how courts have interpreted the Freedom of Information Act in cases seeking access to unreleased information. Recent examples of approved drugs later found to have dangerous side effects show the importance of complete dissemination of safety information. We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs.

Keywords:
Publication Types: Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't Review MeSH Terms: Access to Information* Biomedical Research/legislation & jurisprudence* Clinical Trials* Confidentiality/legislation & jurisprudence* Disclosure Drug Approval Drug Industry/legislation & jurisprudence Drug Toxicity* Humans Policy Making Product Surveillance, Postmarketing United States United States Food and Drug Administration