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While some in the pharmaceutical industry think there is altogether too much public focus on drug risks at the expense of drug benefits, it may be argued that, if true, that is a consequence of the way the post-marketing drug experience is set up. It's biased in favor of reporting adverse events, and has no incentives for reporting benefits.

That may be about to change. A novel reporting system, currently being tested in Arizona by the Critical Path Institute (CPI) with FDA encouragement, is using poison-center pharmacists to interview patients taking two pulmonary drugs at 55 supermarket pharmacies.

According to FDA director of drug safety Gerald J. Dal Pan, initial results appear to bridge a gap in the 300,000 annual spontaneous reports from the FDA's MedWatch program—95% of which come from drug company networks— by providing a denominator. Dal Pan says the FDA faces “quite a challenge” from the three-fold increase in MedWatch reports that has outpaced a 50% increase in scripts from 1994 to 2004.

CPI president and FDA adviser Raymond L. Woosley describes the program as one facet of his institute's activities, many of which could benefit product developers by “facilitating change on neutral ground.” For example, he said, CPI has found data showing that 65% of patients prescribed warfarin had gene variants affecting their responses. Genetically determined dosages may be achieved by using Roche's AmpliChip technology.

The pilot's methodology has enormous implications for the future if it is expanded under the new Medicare Part D requirement that pharmacies conduct Maintenance Therapy Management for Medicare drug patients.

The response in Arizona pharmacies has been so strong that CPI plans to expand the initiative to cover SSRIs and introduce it to other drug chains.

Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)


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