This project, known as the FDA Sentinel Initiative, is a national electronic system that was supposed to include 25 million patients by July 2010 and 100 million by 2012. It is intended to provide a method by which the FDA, upon receiving an early signal of a possible adverse drug safety event, can go to a large outside database in order to quickly determine the signal’s validity. The Sentinel project, which isn’t actually up and running yet, will be implemented in stages. The FDA has contracted with Harvard Pilgrim Health Care to develop and test a pilot version.
"The real challenge here, although it sounds simple, is the software and the methodology. The software systems among these different databases are hugely different," Dr. Buckley observed.
Other major FDA initiatives remaining works in progress include:
FDA-TRACK. Designed to improve transparency regarding the agency’s inner workings, this performance evaluation system will publicly disclose measures of workload and success rates in meeting goals for more than 100 offices at the FDA. This should reduce backlogs and regulatory decision delays.
The Safe Use Initiative. This project is aimed at curbing injuries due to preventable medical errors. The ACR is among the medical organizations partnering with the FDA in this initiative, which is just getting started. Dr. Buckley sees this project as having a high potential for controversy as the agency tries to weigh risk versus benefit for approved drugs without as yet having any defined metrics for doing so. It’s a situation in which physicians could easily get caught in the middle of a cross fire between competing viewpoints.
She cited as an example of the problems that could arise under the Safe Use Initiative the issue of opioid abuse. Unintentional opioid overdoses now account for more fatalities than heroin and cocaine overdoses combined. Sales of oxycodone and methadone nearly quadrupled during 1997-2002. At present more than 3% of adults are on long-term opioid therapy for chronic noncancer pain.
But at the same time that prescription opioid sales were mushrooming, clinicians were being urged by pain experts as well as the AMA and other medical organizations to treat pain better. Dr. Buckley wonders if the FDA will prove capable of wisely balancing the benefit of these drugs in individuals with chronic pain versus the public risk.
The FDA’s new Office of Special Health Issues is developing a regular consumer health information page on the agency’s Web site. "The FDA Web site is still somewhat difficult to navigate, though," according to Dr. Buckley.
Risk Evaluation and Management Strategies (REMS). When sponsors bring forward a new drug for consideration for FDA marketing approval, they now have to present, in addition to efficacy and safety data, a proposal regarding how to deal with the drug’s toxicity. In the case of a low-risk drug, the remediation plan might be very simple. But for higher-toxicity drugs, the FDA now has the authority to require restrictions on distribution or use, including special provider training modules and certification requirements.
Meanwhile the FDA is awaiting a report from the IOM, due this spring, evaluating the strengths and weaknesses of the various drug safety evaluation studies the agency might require.
"The question is, will we get all this done, and when it’s done how much will it cost, and how effective will it be?" Dr. Buckley said in summing up the FDA’s ongoing efforts at organizational transformation.
She declared having no relevant financial interests.