New year, new administration, new FDA

The new year brought a new U.S. administration, and it wasn't long before word was out: Dr. Margaret Hamburg, former New York City Health Commissioner, would lead the agency; Dr. Joshua Sharfstein, Baltimore Health Commissioner, would be her deputy numero uno. Even more quickly off the mark was Congress, which wasted no time pushing for FDA to regulate tobacco.

It wasn't long before Hamburg, Sharfstein, & Co. got their prescriptions for change. The ex-editor of the New England Journal of Medicine wrote hers in the Washington Post. The Government Accountability Office issued a report smacking the agency for its failings--a 'high-risk problem' is what GAO called FDA--and offered new agency leadership a priority to-do list. A Harris Interactive poll gave the agency some idea of the American public's point of view.

Hamburg took note. She promised vigilance--on alerting docs and the public to safety concerns, on protecting pharma's ability to innovate, on improving adverse-event reporting, on post-marketing safety studies. She seemed to be seeking a balance between the industry's needs and the public's, to want to step up safety and enforcement without crushing pharma with regulation.

One of the first big moves was a crackdown on Internet search ads, with 13 companies getting warning letters about their quick-hit brand advertising on Google and the like. That FDA decision touched off an outcry, and the agency said it would come up with some rules governing online marketing and social media; public hearings took place last month. Another change: Updated and overhauled safety communications, with changes patterned on a 2006 report from the Institute of Medicine.

But the fight for change is far from over; in late October, the GAO took FDA to task for failing to act when post-marketing safety studies don't come in on time--and even when the data doesn't pan out as promised. AstraZeneca chief David Brennan recently said FDA needs more money and funding for "a full set of teeth." There's plenty of work still ahead.

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