FDAAA: Unintended Consequences

Abstract

Prior to the 1980s, little was known publicly about how pharmaceutical, biotechnology, or medical device companies (ie, the industry) conducted clinical trials or how they managed the dissemination of the outcome of these trials. Pressure from patient advocacy groups helped bring about the AIDS Clinical Trials Information System and Section 113 of the Food and Drug Administration Modernization Act, which provided for a clinical trials registry for serious and life-threatening conditions known as ClinicalTrials.gov. Additional interest by the International Committee of Medical Journal Editors, the World Health Organization, and others challenged the US Congress to pass the Food and Drug Administration Amendments Act (FDAAA), which was signed into law in 2007. This article explores the negative and positive unintended consequences that befell the pharmaceutical, biotechnology, and medical device industries, patient advocacy organizations, and medical/scientific journals following the implementation of FDAAA.