Letter to Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Re: Overall Benefit to Risk Considerations for COX-2 Selective Nonsteroidal Anti-inflammatory Drugs and Related Agents
0214-NSAID-FDA-Hearing.pdf | 50.8 kB
February 15, 2005
The Joint Meeting will convene to discuss the overall benefit to risk considerations (including cardiovascular and gastrointestinal safety concerns) for COX-2 selective nonsteroidal anti-inflammatory drugs and related agents. As the Committees consider the safety questions specific to COX-2s, we urge the Committees and the FDA to also address the systemic problems of FDA’s drug safety system that have delayed and stifled public availability of drug safety information about NSAIDs, hampered the ability of the agency to take timely action to address public health concerns surrounding them, and suppressed internal voices within the agency who sought to bring safety issues to light.