The government is paying millions of dollars each year for
potentially dangerous drugs that are not approved by the Food and Drug
Administration (FDA). That shocking conclusion comes from a recent analysis
conducted by the Associated Press, which finds that the Federal government
spent nearly $200 million dollars on unapproved drugs between 2004 and 2007.
The analysis found that Medicaid, the nation’s low-income health insurance program, shelled out money for more than 100 different drugs that have not gone through the FDA testing normally required for the U.S. market. The FDA says these drugs are a public health problem and need to be removed from the market yet concede that there may be thousands of unapproved drugs on the market.
So how could this happen? How can one government agency be spending so much money on drugs that another government agency says could be dangerous? And why are these drugs on the market in the first place?
The answer has to do with the history of federal laws regulating pharmaceutical products. It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market, mainly for common conditions like colds and pain, were also supposed to be evaluated. But some manufacturers claimed their medications were grandfathered under earlier laws, and even under the 1962 bill. Many of these drugs remained on the market and are still there today. The FDA says it is trying to eliminate them from the market, but conflicting federal laws allow the Medicaid health program for low-income people to pay for them.
Among the unapproved drugs the AP's research identified were Carbofed, for colds and flu; Hylira, a dry skin ointment; Andehist, a decongestant; and ICAR Prenatal, a vitamin tablet.
In most cases, doctors, patients, and pharmacists are unaware that the drugs are not approved. Since the drugs have never been tested, no one knows how effective or safe they are. Additionally, no one is monitoring the effects of these drugs on the people currently taking them so major adverse events might go unnoticed.
Learn more about unapproved drugs on the FDA’s Unapproved Drugs Website. Although the FDA does not maintain a complete list of unapproved drugs still on the market, you can find out if a drug you are taking is approved by comparing it to the FDA’s list of approved drugs. If you find out that you are taking an unapproved drug, talk to your doctor about what you should do next. If you have questions about any of the drugs you are taking, ask the experts at Healia Health Communities.
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