Total Injury

On Monday, the Food and Drug Administration (FDA) announced steps aimed at improving the agency's safety programs.  The three key elements in the FDA's plan to improve drug safety are:

• Strengthening the science that supports the FDA's medical product safety system, including initiatives to:
  • Develop new scientific approaches to detecting, understanding, predicting and preventing adverse events;
    
  • Develop and incorporate new quantitative tools in risk / benefit assessment; and
    
  • Conduct a pilot program to review the safety profiles of certain newly approved drugs on a regular schedule
• Improving communication and information flow among all stakeholders involved in promoting safe use of medical products by:
  • Establishing an advisory committee to help improve the agency's risk communication policies and practices; and
  • Reviewing current public communication tools and developing a comprehensive risk communication plan
• Improving management / operations to ensure implementation of necessary review, analysis, consultation and communication processes, through the use of external management consultants

The FDA has been under fire from consumer advocacy groups for years, and the outcry has increased in recent years as multiple FDA approved prescription drugs have been found to cause serious medical problems and even death.  In some of those cases, it has been revealed that information regarding these risks was available long before it was publicly acknowledged, leading to unnecessary medical complications and deaths.