Avandia under scrutiny
Seeing that present scenario in the Food and Drug Administration, which is more about internal struggle and political maneuvering, on Tuesday a panel of outside medical experts will sit together to figure out whether the agency should pull diabetes drug Avandia from the U.S. market.
Avandia has been linked to a possibility of heart attack and it can trigger a battle on how the FDA deals with drug safety.
Avandia was criticized on Friday when the FDA released its new analyses. Avandia presently is considered the onetime blockbuster to treat Type 2 diabetes.
If the argument stays then the pharmaceutical industry fears a delay in new drugs getting approved for the market.
FDA Commissioner Margaret Hamburg and Deputy Commissioner Josh Sharfstein, said, "This is a defining moment."
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 procedure followed by the agency's drug division too demanding as some scientists and doctors have stated that it demands too much proof before withdrawing a drug.
New Zealand News
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