ANALYSIS-Avandia a Test for U.S. FDA on Drug Safety


* Fate of Glaxo diabetes pill under review for heart risks

* Consumer groups pressing for Avandia’s withdrawal

* Senior FDA officials have supported drug

* Outcome to signal drug safety stance of Obama appointees

* Showdown set for July 13-14 advisory panel meeting

WASHINGTON, June 29 (Reuters) – Safety questions around a GlaxoSmithKline PLC diabetes pill pose a major test for the U.S. Food and Drug Administration’s leadership and how it will handle drug risks under President Barack Obama.

The fate of Glaxo’s Avandia is the first big side-effect controversy since FDA Commissioner Dr. Margaret Hamburg and Deputy Commissioner Dr. Joshua Sharfstein, chosen by Obama, took over the agency more than a year ago.

Both are public health advocates who have championed science in the interest of patients.

Now doctors, patient advocates, drugmakers and investors are watching to see how the new FDA leaders will rule on safety concerns raised by data that paints a mixed picture of Avandia. An FDA advisory panel is due to weigh in next month.

Consumer groups, an outspoken cardiologist, at least one lawmaker and some FDA staff are pushing to get Avandia off the market. But the drug has had high-level backers at the agency since scrutiny of heart attack risks began three years ago.

“It’s clearly a challenge for Margaret Hamburg,” said Ira Loss, an analyst with Washington Analysis.

Consumer advocates criticized the FDA under President George W. Bush as being too close to drugmakers and unwilling to take strong and quick steps against medicines that drew safety complaints after they hit the market.

The Avandia case presents “a real test for the FDA to show, hopefully, that times have changed,” said Diana Zuckerman, head of the National Research Center for Women & Families.

Inside the FDA, opinions are mixed. Staff in the office that tracks side effects after a drug’s approval have argued since 2007 that Avandia increases the chances of a heart attack and offers no unique benefits to justify future sales.

Senior FDA drug officials have backed Avandia, saying diabetics risk major complications such as heart disease, blindness and amputations from their disease, and need multiple treatment options.

The pill now comes with an agency-approved warning that it may raise heart-attack risk but it says the data is “inconclusive.” […]

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