The New FDA Monitoring Board
Hey hey, some people are complaining about the limited scope of the new FDA monitoring board, but I'm delighted that they have done anything at all. It's not perfect, they can't stop unsafe drugs from reaching the shelves, but they will go after drugs that are already on the market. It's a start, and you've got to start somewhere.
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Safety board to check FDA-approved drugs
After a string of miscues, the FDA announced that a new federal board will follow up with safety checks of prescription drugs after they receive government approval.
By TONY PUGH
WASHINGTON - In a move designed to quiet criticism of its regulation, the Food and Drug Administration said Tuesday that it plans to establish an independent board to monitor the safety of prescription drugs now being sold to consumers.
The FDA also plans to launch a new Drug Watch Web page on which it will post and update data about the safety, risks and possible side effects of drugs that might be dangerous for patients. In addition, the agency wants to provide information sheets that inform healthcare providers and patients of all the drugs listed on the new Web page.
Health and Human Services Secretary Michael Leavitt described the moves as a new FDA effort toward transparency in regulating the prescription-drug industry.
The FDA has been battered recently for a string of miscues that raised questions about the agency's effectiveness in keeping Americans safe from the dangers of modern pharmaceuticals. It delayed issuing strong warning labels on antidepressants even though studies indicated they caused suicidal tendencies in children and teenagers. It also approved popular arthritis pain relievers Vioxx and Celebrex, even though studies linked both to heart attacks and strokes.
Beginning today, the agency will hold three days of hearings on the class of pain relievers known as Cox-2 inhibitors, which includes Celebrex and Bextra, to decide whether to keep them on the market.
Read the whole story
----------------
Safety board to check FDA-approved drugs
After a string of miscues, the FDA announced that a new federal board will follow up with safety checks of prescription drugs after they receive government approval.
By TONY PUGH
WASHINGTON - In a move designed to quiet criticism of its regulation, the Food and Drug Administration said Tuesday that it plans to establish an independent board to monitor the safety of prescription drugs now being sold to consumers.
The FDA also plans to launch a new Drug Watch Web page on which it will post and update data about the safety, risks and possible side effects of drugs that might be dangerous for patients. In addition, the agency wants to provide information sheets that inform healthcare providers and patients of all the drugs listed on the new Web page.
Health and Human Services Secretary Michael Leavitt described the moves as a new FDA effort toward transparency in regulating the prescription-drug industry.
The FDA has been battered recently for a string of miscues that raised questions about the agency's effectiveness in keeping Americans safe from the dangers of modern pharmaceuticals. It delayed issuing strong warning labels on antidepressants even though studies indicated they caused suicidal tendencies in children and teenagers. It also approved popular arthritis pain relievers Vioxx and Celebrex, even though studies linked both to heart attacks and strokes.
Beginning today, the agency will hold three days of hearings on the class of pain relievers known as Cox-2 inhibitors, which includes Celebrex and Bextra, to decide whether to keep them on the market.
Read the whole story
posted by Christine at Wednesday, February 16, 2005
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