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QUALITY: These Statements Have Not Been Evaluated by the FDA

Can we interest you in some unapproved drugs?

Medicaid is interested. So is the FDA. And Senator Chuck Grassley (R-IA). It seems that from 2004 to 2007, Medicaid spent nearly $198 million paying for prescription drugs that had not gone through FDA safety and effectiveness reviews, according to analysis of federal data by the Associated Press.

Bringing in the bigger picture, the AP notes:

At a time when families, businesses and government are struggling with health care costs and 46 million people are uninsured, payments for questionable medications amount to an unplugged leak in the system.

 The FDA estimates that unapproved drugs account for 2 percent of all prescriptions, or about 72 million scripts per year. (Informative FDA video with great sound track here) Many of these drugs provide little or no benefit to the patient. Some are potentially harmful, even deadly, contributing to the some 1.5 million Americans, killed sickened or harmed by preventable medication errors each year.

How did we get here?

In 1962 Congress passed a law requiring the FDA to test the safety and effectiveness of all new drugs entering the market. But today's class of unapproved drugs were already on the market, and were "grandfathered" in, allowing their continued sale today.

The concern over unapproved drugs spiked in the 1980s, when E-Ferol, a high potency vitamin E injection, was linked to the deaths of some 40 premature babies. Since then the FDA has taken steps to remove unapproved drugs from the market and encourage their manufacturers to adhere to FDA guidelines. Critics, as the AP notes, suggest this case-by-case basis is not enough. Senator Grassley has long been outspoken on the issue, last year asking the Office of the Inspector General of HHS to investigate.

Does the FDA have bigger fish to fry? Maybe. But the AP's findings provide further evidence of the lack of knowledge and coordination that exists in our fragmented system. Weeding out old cough remedies from the 1920s is just one of the benefits from the clinical and comparative effectiveness data that a more integrated health care system would provide. (And of course some of these old cheap drugs, once properly reviewed, could turn out to be better options than their expensive new cousins) After all, when you're recovering from the hantavirus, you'd like to know what's snake oil and what's safe.