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The problem of unapproved and off-label prescriptions.

Publication: Women's Health Activist
Publication Date: 01-MAR-09 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
UNAPPROVED DRUGS Last November, a pair of Associated Press (AP) reporters conducted an investigation which found that Medicaid paid nearly $200 million from 2004-2007 on more than 100 unapproved drugs which never went through the Food and Drug Administration's (FDA) review and approval process. (1) The drugs entered the market prior to 1962, when the FDA began requiring safety and effectiveness reviews for new drugs. Many manufacturers consider the drugs, estimated to account for around 2% of prescriptions annually, to be "grandfathered" in and not to need further review. The FDA has neither systematically reviewed nor removed these drugs from the market since implementing the new standards. Worse, AP reported that the FDA does not even keep a comprehensive list of unapproved drugs currently on the market.

As a watchdog over health claims made...

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