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As expected, must-pass legislation to reauthorize the Prescription Drug User Fee Act (PDUFA IV) has provided a vehicle to renew numerous programs and to establish new policies to ensure the safe use of medications. The measure implements a user-fee agreement issued in January 2007 as well as a similar user-fee plan for medical devices. It also continues incentives for sponsors to study pediatric uses of drugs and devices and gives FDA authority to require postapproval studies. Manufacturers will have to disclose more information about ongoing clinical trials and research results and must revise product labels within a set time frame. There is more funding for FDA oversight of postmarket drug use and for agency information systems. And manufacturers of more risky medications will have to adopt a range of pharmacovigilance activities to ensure appropriate product use.

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In this issue, a longtime contributor to this magazine, former FDA official, and generally thoughtful, knowledgeable person concludes his excellent three-part series on drug safety with a look at how risk is communicated to patients and doctors. It's a fine, detailed, subtle piece of work, and I recommend it to you. (See "Failure to Communicate".)

Pfizer Fires Three?

Pharma giant's house gets a little cleaner after whistle-blower's accusations

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The US healthcare system may be broken, as such sages as Michael Moore suggest, but it's not likely to be fixed as long as our domestic debate remains stuck on the cost of prescription drugs. Meanwhile, obesity and diabetes are becoming national epidemics. Talk about sicko.

The Oprah Moment

In the wake of a high-profile death from counterfeit drugs, the industry reacts

All hell broke loose on May 21 when the New England Journal of Medicine released Cleveland Clinic cardiologist Dr. Steven Nissen's meta-analysis of 42 studies of Avandia, showing a 43 percent increased risk of heart attack.

The Acomplia story isn't ending. It's just beginning. Get ready to see what happens when a much-desired drug is marketed by people accountable to no one.