Magazine article Drug Topics

FDA Examines Strategies to Improve Drug Safety

Magazine article Drug Topics

FDA Examines Strategies to Improve Drug Safety

Article excerpt

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.

The agency wants to encourage medical professionals to report more adverse outcomes when they occur. Only 10% of adverse events reported come from clinicians, Gottlieb said. So the agency is trying to inspire more reporting and improve the reporting tools. The agency is far from making the reporting live and interactive, Gottlieb noted, but it is considering something similar to the Centers for Disease Control & Prevention's Morbidity and Mortality Weekly Report (MMWR). It would release reported adverse effects earlier and in a public domain. While the concern is that the public or media will misinterpret this information, Gottlieb and others feel the benefits outweigh the risks.

"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 postmarket 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. …

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