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MONDAY, NOVEMBER 23, 2009
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Medicaid Spends Millions on Drugs FDA Never Approved

FDA loophole allows potentially-lethal drugs to stay in market

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(Newser) – Taxpayer dollars still pay for unapproved prescription drugs that have sold for decades and are linked to dozens of deaths, the AP reports. In the past 5 years, at least $200 million has been paid for drugs like cold and pain medications that were never approved by the FDA, yet are covered by Medicaid. The problem dates back to 1962, when a bill "grandfathered" drugs already on the market, allowing them to exist without FDA approval.

The FDA says such drugs account for 2% of all prescriptions, or 72 million per year. Medicaid attests to the problem, but says it needs help from Congress to take action. "I think this is something we ought to look at very hard, and we ought to fix it," said Medicaid chief Herb Kuhn. "We as Americans have a belief that all prescription drugs have been approved by the FDA," said one pharmacist. "We have a false sense of security."

The finding surprises even doctors and pharmacists, one of whom warns that patients have a
The finding surprises even doctors and pharmacists, one of whom warns that patients have a "false sense of security" about the medicine they use.   (AP Photo/Sun Herald, John Fitzhugh)
Thousands of medicines unapproved by the government are available through Medicaid.
Thousands of medicines unapproved by the government are available through Medicaid.   (AP Photo/.Bizuayehu Tesfaye)
The legal loophole results from a grandfather clause that lets Medicaid cover drugs the FDA never reviewed.
The legal loophole results from a grandfather clause that lets Medicaid cover drugs the FDA never reviewed.   (AP Photo/Mel Evans)
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petepenguin
Nov 23, 08 8:50 PM CST
Why is this not surprising. Reply
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Reader25229471
Nov 24, 08 3:13 AM CST
"FDA Crackdown" A crackdown and it only took about 50 deaths to do it ? Wow the FDA has really been streamlined during the BUSH admin. If these were Iraqi deaths then we would see some action. Reply
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