How is FDA doing vis-à-vis the Science of Drug Safety? That was the topic of an Institute of Medicine (IOM) Drug Forum session held Wednesday to provide a review of activity since IOM, and the FDA Science Board released their reports, and the 2007 FDA Amendment Act. There is new leadership and energy at the agency around the drug safety question under Dr. Peggy Hamburg and her Deputy Dr. Josh Sharfstein and an evolving safety landscape.
For several hours, officials from the FDA, industry, and policy opinion leaders provided progress reports that showcased the work that’s underway at the FDA. Each had a resounding sentiment: much has been done, but more needs to be accomplished, and it won’t happen without substantial infusion of human and financial capital.
Indeed, much is on the FDA’s plate. Speakers echoed the importance of a life-cycle approach to evaluating drugs and medical devices – a way to monitor a product from its pre-approval through its post-marketing phases to ensure safety and efficacy. Such a holistic approach would require, among other thing,
- standardizing the collection and analysis of observational data,
- updating epidemiological approaches to go with evolving public health needs,
- ensuring interoperability and integration across federal agencies (i.e., efforts that relate to comparative effectiveness research and health information technology), and
- implementing communications channels to collect data from consumers in real-time (especially as it relates to adverse events), as well as relay back transparent, accurate, and reliable information
Several aspects of the risk management/drug safety question threaded through presentations. Such as: how much risk are we willing to accept in the area of drug safety? How does the advent of health IT and new batches of health data gathered per the Health Information Technology for Economic and Clinical Health (HITECH) Act impact what FDA needs to do to ensure drug safety? How can we tell if things are improving in terms of FDA’s ability to monitor drug safety?
The final message was from Dr. Gail Cassell, Co-chair of the Forum and Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, who ended with a reminder that FDA’s appropriated dollars are still not enough to tackle the drug safety to-do list. As an Alliance for a Stronger FDA board member I couldn’t agree more. We are conveying that message as loudly as we can, but need more voices.
This is an enormous undertaking. How do you eat an elephant? One bite at a time.
