Much at Stake for FDA, GSK, & Actos in Avandia Decision

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Avandia, which some studies have linked to increased heart-attack risk, has sparked a battle that could redefine how the FDA responds to drug-safety concerns, particularly involving products already approved and on sale.

*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

  • In patients already being treated with these medicines
  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

What’s the problem?

July 13, 2010 – As a panel of independent medical experts convene to debate over whether the FDA should pull Avandia from the U.S. market, a new battle that could redefine how the administration responds to drug-safety concerns is arising. New FDA analyses released last week criticized the Type 2 diabetes medication, which affects roughly 23 million Americans. The pharmaceutical industry, in particular, is worried that the fallout will delay new drug approvals.

“This is a defining moment” for FDA Commissioner Peggy Hamburg and Deputy Commissioner Josh Sharfstein, said former FDA Commissioner David Kessler in an interview.

Dr. Kessler said a crucial question is: “Who at the FDA will decide what happens to Avandia?” Will it be the commissioner and her deputies, or the drug division, whose longtime chief, Janet Woodcock, has defended the drug?

The FDA’s drug division has recently been criticized for demanding too much proof of a drug’s dangers before withdrawing it, and many believe that the panel that controls Avandia’s fate will also prove pivotal in the future direction of drug safety, approvals, and withdrawals.

According to Woodcock, “There is not complete unanimity within the FDA about the interpretation of this data.” Drug withdrawal decisions, she said, are often complicated by the lack of “definitive proof” of risk with drugs that show “signals” of serious problems.

Avandia already is the target of extensive litigation. GSK faces roughly 11,000 suits in federal and state courts, most of them consolidated into a few cases. Sales of Avandia slid to about $1.2 billion in 2009, from about $2.5 billion in 2006, while sales of rival Actos topped almost $4 billion last year.

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