FDA examines strategies to improve drug safety

October 23, 2006

While the Food & Drug Administration has always been deeply concerned with drug safety, the organization is taking new and improved measures to pay closer attention to this issue, said Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs at FDA.

"Clearly we're thinking more about [drug safety] now than we were in the past," Gottlieb told an estimated gathering of 150 pharmacists at an ASHP luncheon held last month in Bethesda, Md. "It would be a lie to say otherwise."

Adding thousands more patients or extending a drug review by another six months won't necessarily make a difference in drug safety, added Gottlieb. So the FDA has devised other strategies, including better tools for clinician reporting, better data analysis within the agency, and earlier public reporting of adverse outcome.

"It's important to get information out to pharmacists and physicians sooner because it sensitizes them to 'this is something we should watch for,'" said Ernie Anderson, a pharmacist at Lahey Clinic in Burlington, Mass., who also attended the ASHP luncheon. "If you get the information out there, people will be on the lookout for a particular issue with a particular drug."

The agency is also attempting to improve the ways it receives post-market information and how it then analyzes these data. The agency has partnered with large health systems and Medicare to receive more epidemiological data. Gottlieb admits that epidemiological data don't have all the answers to improving drug safety. "Certainly the kinds of side effects that have emerged with some drugs in recent years aren't the kinds of things you could potentially tell from epidemiological data." With these data potentially in the public domain, the FDA is developing scientific guidelines on how to use data appropriately while making clear some of its shortcomings.

FDA also wants to improve its analytical tools by using information technology more effectively. Gottlieb used the example of the agency's Adverse Event Reporting System (AERS), a computerized information database that compiles problems about drugs and therapeutic biological products as reported by manufacturers, consumers, or clinicians. The system is rudimentary. It cannot compare similar reports to one another, search other databases for information, or review medical literature, Gottlieb said. So a medical reviewer, who receives very little contextual information about the event, has to do all the research by hand.

"I think there are 14-year-olds using IT more effectively than that system," Gottlieb observed. "Clearly, with better software, we can improve that. Medical reviewers should be able to come in and have a lot of information about that event before they even start analyzing it." The agency is developing software for AERS II.

Finally, the FDA is also working to expand its risk-communication department. It wants to continue presenting interim drug information to the public when there is a concern or possible correlation between drug and adverse outcome. But because the agency doesn't want the information misinterpreted, it is finalizing guidelines on how it will present this information to the public.

"As an agency, we need to be more transparent," Gottlieb contended. "We need to do it in a way that people understand the difference between the final word and interim information. That has been a real challenge for the agency over the past few years."

THE AUTHOR is a writer based in the Washington, D.C., area.