Grassley Seeks Probe of Unapproved Drugs

A longtime member of Congress is asking the U.S. Department of Health and Human Services to investigate nearly $200 million the government has spent on unauthorized drugs for Medicaid enrollees since 2004. The drug purchases were discovered during an investigation conducted by the Associated Press.

Policy analysts say the lack of government approval does not by itself mean there is anything wrong with the drugs in question.

The U.S. Food and Drug Administration estimates the nearly 100 unauthorized prescription drugs “account for 2 percent of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year,” according to the report.

Sen. Charles Grassley (R-IA) has requested an investigation by the inspector general of the U.S. Department of Health and Human Services, which oversees both Medicaid and the Food and Drug Administration.

Drugs Predate FDA Mandate

According to the report, the drugs in question date back nearly half a century, before Congress passed the Drug Amendments of 1962 charging FDA with reviewing all new and experimental medications.

Thousands of prescription drugs have been taken off the market in the United States since 1962 because they lacked evidence of effectiveness or safety or lacked full disclosure and representation of known medical facts associated with their use, according to FDA.

Experts disputed the AP report’s assertion that lack of approval by FDA necessarily means a drug could pose a serious risk to Americans’ lives.

“Just because something is ‘unapproved’ by FDA doesn’t mean it is not safe or effective,” said Greg Scandlen, director of Consumers for Health Care Choices at The Heartland Institute. “If these drugs predate 1962 and are still in use, they are probably safe.”

“I suspect [the use of older drugs] is a good thing for the patients and for the taxpayers,” said John Goodman, president of the National Center for Policy Analysis. After all, he noted, “Aspirin was never approved by the FDA, and many experts think that under today’s ridiculous rules it probably couldn’t pass.”

FDA Monopoly Questioned

The $198 million spent on the unapproved medications “is a tiny amount of money in the out-of-control Medicaid budget,” said John R. Graham, director of health care policy at the Pacific Research Institute. “If the AP investigators think that Medicaid spending is going to be controlled by cutting out spending on drugs that have been around for almost half a century, before the federal government gave the FDA a monopoly on determining efficacy, then [it] is very deluded.

“Indeed,” Graham continued, “given that the AP reports no harm to patients taking these older drugs, the report invites a different suggestion: Do Americans really benefit from the massive regulatory costs imposed by the FDA’s monopoly on determining efficacy? After all, those costs have increased the price of prescription drugs significantly, and reduced the pace of introduction of new drugs, since Congress imposed them.”
Katie Flanigan ([email protected]) writes from Georgia.

For more information …

“AP IMPACT: Goverment pays for deadly, unapproved drugs,” Associated Press:

“Unapproved Drugs: Drugs Marketed in the United States that Do Not Have Required FDA Approval”:

More Choices, Better Health: Free to Choose Experimental Drugs, by Bartley J. Madden, The Heartland Institute, 2007:

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

Scroll to Top