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FDA Panel Votes to Keep Avandia on Market With More Restrictions

ABC World News (7/14, story 5, 0:25, Sawyer) reported, “A surprise decision on Avandia [rosiglitazone]. Advisers to the Food and Drug Administration recommended keeping Avandia on the market,” although most “advisers did recommend stricter warning labels and the FDA will now decide which course to take.”

The New York Times (7/15, A1, Harris) reports on its front page that the 33 panelists “took six votes on a variety of issues” and when asked what the FDA should do, “12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings.” Dr. Janet Woodcock, director of the FDA’s drug center, “said that the agency took the panel’s advice seriously and that it would consider its regulatory options.”

The Washington Post (7/15, Stein) reports that a “majority” of the panel urged to keep the drug “available, perhaps with tough new restrictions and warnings.” The votes “came after the panel concluded that there was sufficient evidence to be concerned that Avandia increases the risk of heart attacks and strokes but insufficient evidence that the drug increases the risk of death.” The panel “also voted to recommend that the FDA allow a large new international study by GlaxoSmithKline, the maker of Avandia, to proceed.” Still, the final, “mixed vote illustrated the intensity of the debate over the drug. Critics…argued that the drug was clearly dangerous and unnecessary. Others expressed concern about pulling a drug that might be useful to some diabetics, who frequently need to try more than one medication.”

USA Today (7/15, Rubin) also reports that the panel “voted 18-6 that the data raise significant concerns that Avandia carries a higher risk of those heart problems than does Actos [pioglitazone], the only other drug in its class. Nine were undecided.”

The Hill ‘s (7/15, Lillis) Healthwatch blog reports, “Sen. Tom Harkin (D-Iowa), chairman of the Senate Health Committee, is calling on the Food and Drug Administration (FDA) to reach a quick verdict on the fate of Avandia.” The Hill also notes that the panel’s “mixed verdict puts the ultimate decision in the hands of Margaret Hamburg, who heads the FDA.”

The Los Angeles Times (7/15, Zajac, Maugh) adds, “Several members of the FDA’s advisory panel expressed frustration at the lack of clear-cut data despite 18 presentations, about 500 slides and 1,000 pages of background material laid before the committee in the course of its two-day hearing.”

The Wall Street Journal (7/15, Mundy, Dooren) notes that analysts and researchers say this panel meeting may indicate that the FDA will begin demanding more safety data on new drug applications.

The Financial Times (7/15, Jack) also notes that GlaxoSmithKline confirmed the leaked emails collected for US litigation on Avandia, which said the company did not submit the results of a study from 1999 to the FDA.

NYTimes: FDA advisory panel delivers “confusing verdict” on Avandia. The New York Times (7/15, A30) editorializes, “A panel of expert advisers to the Food and Drug Administration delivered a confusing verdict on Wednesday after two days of hearings on the safety of the diabetes drug Avandia rosiglitazone]. A majority of the 33-member panel expressed concern that Avandia raises the risk of heart attacks compared with other diabetes drugs,” yet, “a majority also voted to leave the drug on the market anyway, with various degrees of restrictions or warnings.” The Times argues that while this decision may appear to be a victory for the drug manufacturer, “doctors and patients will have to think very hard before using a drug that a majority of these experts has deemed risky.”

From the American Association for Justice press release.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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