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【drug-news】FDA对GSK在文迪雅临床研究中知情不报
Regulators say the drug maker omitted study results in reports on the diabetes pill Avandia.
WASHINGTON (AP) -- Federal regulators have issued a warning to GlaxoSmithKline for not reporting safety results on its diabetes pill Avandia, which received a prominent warning label last year.
The Food and Drug Administration said that between 2001 and 2007 the drug maker did not annually update the agency on more than 10 ongoing studies of Avandia, as required by regulations.
While the agency acknowledges information from the studies was disclosed in other notices, the omissions "are serious and may be symptomatic of underlying post-market reporting failures."
The FDA said it had no record of nine other studies until last September, when Glaxo provided a corrected version of its 2007 update on Avandia.
FDA posted the warning letter, dated March 25, to its Web site Tuesday.
Glaxo's shares fell $1.53, or 3.4% to $43.50 in late morning trading.
"We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are under way," Glaxo's Chief Medical Officer Ronald Krall said in a statement.
Avandia received a black box warning, the most serious a drug can carry, last November. The labeling alerts doctors and patients that the drug could increase the risk of heart attacks, though the evidence is inconclusive.
Glaxo has agreed to FDA's demand for a major study directly assessing Avandia's heart effects, but it won't be complete until 2014.
The labeling change followed several high-profile congressional hearings where FDA and Glaxo were criticized for not disclosing the drug's potential risks earlier.
FDA inspectors uncovered the reporting problems at Glaxo's U.S. headquarters in Research Triangle Park, N.C., during visits last August through November. The agency notes that the company tried to address inspectors' concerns in a December letter, but regulators said the response was "inadequate" because it did not explain how the company would stop the problems from happening again.
In at least two cases Glaxo said it didn't turn over studies because they were conducted at the request of European regulators, not the FDA.
The European excuse didn't satisfy FDA or consumer advocates.
"The FDA can't make regulatory decisions on a drug unless companies promptly disclose all information relating to safety - it doesn't matter who asked for it" said Dr. Sydney Wolfe of Public Citizen, a frequent critic of both the the drug industry and its regulators.
Sales of Avandia fell 22% last year to $2.4 billion for the year amid safety concerns. Glaxo's (GSK) shares have fallen nearly 20% from last year.
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作者:admin@医学,生命科学 2010-12-01 17:11
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