Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.
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.
Kesselheim
Aaron S
AS
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts, USA. akesselheim@partners.org
Mello
Michelle M
MM
D022126:Access to Information; D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D030881:Disclosure; D017277:Drug Approval; D004345:Drug Industry / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011050:Policy Making; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration