Washington Editor

WASHINGTON - The FDA on Tuesday disclosed a series of new initiatives aimed at improving the agency's drug safety oversight, a direct response to last fall's Institute of Medicine report issued amid congressional clamor on the matter that continues to this day.

Principally, the FDA is setting out to transform its safety system by strengthening the science that underlies such work, enhancing communication efforts and improving its internal operations and management. FDA Commissioner Andrew von Eschenbach, called the broad plan part of an "ongoing commitment" to constantly upgrade its processes.

"FDA must change to continuously adapt and continuously be able to achieve progress in our ability to determine the safety and the effectiveness of those products that we regulate," he said at a press conference, "and that is especially important with regard to drugs."

Among efforts related to the science of safety, the agency plans to upgrade its risk-benefit analysis methods through a number of ideas. That includes a pilot program to systematically assess new molecular entities' safety profiles through the use of routine post-approval evaluations for about 18 months after they reach the market.

The FDA's Center for Drug Evaluation and Research will carry out this task, said its director, Steven Galson. The first such regular post-approval review would begin this year and likely center on a drug currently in the regulatory process, he said.

"From these assessments, medical professionals and the public will learn what we have gleaned from adverse event reports, usage patterns and new studies that have been conducted since the drug's approval," Galson explained. "We'll also report on whether changes should be made to the label, to our initial assessment of the benefit-risk balance or whether additional steps need to be taken to maximize benefits and minimize risks."

In addition, the agency plans to strengthen its safety surveillance tools by accessing a wider post-approval data pool, such as a newly signed agreement with the Veterans Health Administration to share information on product safety, efficacy and use. The FDA also has begun work on upgrading its Adverse Event Reporting System.

The agency also continues to push its Critical Path Initiative to develop tests and biomarkers that predict or prevent toxicity, organ damage and adverse events, in addition to tailoring patient-specific therapies in order to reduce unnecessarily broad drug use.

"Scientific advances are creating the foundations of a new science of safety that will help us build safety into products, such as drugs," said Janet Woodcock, the FDA's deputy commissioner and chief medical officer, "and also more rapidly and predictably detect problems once those products are out in medical use."

To improve communication, the agency plans to publish a newsletter on post-approval safety findings through its website, which will have information on emerging safety issues, and create a new advisory committee on risk communications, among other things.

To improve internal operations and management at the FDA, Galson said management at the Center for Drug Evaluation and Research will address tension between pre- and post-approval reviewers. That includes involving safety personnel in new drug reviews and conducting regular meetings between safety and new drug divisions. Additional process improvement efforts include creating an electronic post-approval drug safety tracking system and applying a quality systems approach to improve adverse event detection.

In the background of all those plans is the renewal process of the Prescription Drug User Fee Act, which currently is written to fund some of the enhancements but still awaits congressional vetting, as well as proposed legislation related to drug safety. The latter includes a bill from Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) disliked by many in the drug industry.

Still, the FDA's brass believes the agency's approach complements a wider goal. "These initiatives will not just be a plan," von Eschenbach concluded, "but they will be a pathway to the future of enhanced drug safety."