Manufacturer's drug interaction and postmarketing adverse event data: What are appropriate uses?

• Published in: Drug safety 2001, Vol.24 (9), p.637-643
• Main Authors: KRAFT, Walter K, WALDMAN, Scott A
• Format: Article
• Language: English
• Subjects: Access to Information - legislation & jurisprudence; Biological and medical sciences; Clinical trial. Drug monitoring; drug interaction; Drug Interactions; General pharmacology; Humans; Medical sciences; Pharmacology. Drug treatments; postmarketing surveillance; Product Surveillance, Postmarketing - methods; Risk Management; safety regulations; United States; United States Food and Drug Administration
• ISSN: 0114-5916
• DOI: 10.2165/00002018-200124090-00001

Governmental agencies overseeing pharmaceutical products use a risk/benefit approach to analyse data and make regulatory decisions. Comprehensive public dissemination of the safety profile of pharmaceutical products is part of an overall strategy for reducing risk associated with the use of any medical product. In the US, reports of postmarketing surveillance of approved drugs are in the public domain. Some, but not all, of the information in drug interaction studies is available to the public through the Freedom of Information Act (FOIA). However, there are concerns over the misuse of these data for commercial or other gain. The need to protect intellectual property and foster innovation in drug development, and concerns of legal liability are often cited as reasons to limit full public access to data from drug development studies. In contrast, intellectual freedom. public safety, and a mandate for transparent decision-making processes by regulatory agencies are issues that support open access to these data. Ultimately. concern for the public safety justifies open access to postmarketing surveillance data, and to a lesser degree, data regarding drug interactions in marketed products, and should outweigh the potential loss of competitive advantage by pharmaceutical companies.