As I see it

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Keep your eyes on the Democrats' government reform chairman, Henry A. Waxman, when the new Congress convenes. The California Democrat has a long-established agenda aimed at the FDA, drug advertising and marketing practices.

Wall Street's down-ranking of pharma stocks right after the elections reflected analysts' awareness of the frosty legislative climate that's coming, topped by expected Medicare price negotiations, and new measures that will seek to cool drug marketing in the name of drug safety.

One vehicle for flexing muscle over drug marketers will be the renewal of the Prescription Drug Marketing Act. You can expect carve-outs for increased post-market surveillance and electronic safety data monitoring.

Waxman, 67, is also likely to push for restrictions on DTC advertising during the first two years of a new drug's marketing.

Adding to Waxman's role will be an old FDA nemesis, Rep. John Dingell (D-MI), 80, who is poised to resume his leadership of the Energy and Commerce Committee, where he directed aggressive FDA oversight in the 1990s, most notably over the generic drug scandal.

Earlier this year, both Dingell and Waxman objected to an FDA policy statement on preemption of state tort cases as part of its prescription drug labeling rule. Dingell has questioned the FDA's reliance on non-inferiority trials in showing effectiveness in antibiotic submissions, and asked the GAO to examine the issue further. Waxman has shown an interest in reduced FDA enforcement actions, and has urged more actions against ad violations.

On the Senate side, Edward Kennedy (D-MA) will resume a role comfortable to him: chairman of the Health, Education, Labor and Pensions Committee, which has primary FDA oversight. The lawmaker has favored giving FDA more authority to police compounding.

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

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