FDA, unapproved drugs, unapproved drugs ordered off market

Unapproved Medication Costs Taxpayers Millions, Analysis Finds

November 24, 2008 12:30 PM
by Emily Coakley
An Associated Press review found that more than $200 million was spent on prescription drugs the Food and Drug Administration has not approved.

Unapproved Medications Continue to Be a Problem


Sen. Chuck Grassley, R-Iowa, has asked the Health and Human Services Department for an investigation after an AP analysis suggested the government is spending millions on unapproved medication.

AP found the federal health program Medicaid spent nearly $200 million on more than 100 drugs that haven't been approved by the U.S. Food and Drug Administration.

"I think this is something we ought to look at very hard, and we ought to fix it. It raises a whole set of questions, not only in terms of safety, but in the efficiency of the program — to make sure we are getting the right set of services for beneficiaries," said Herb Kuhn, Medicaid's chief, in an interview with AP. 

A mix of conflicting federal laws and a lack of a master list of unapproved medications is making it hard for the FDA to correct the problem, officials told AP.

Officials say some people have died after taking unapproved drugs. According to AP, "In a 2006 case, the agency received 21 reports of children younger than 2 who died after taking unapproved cold and allergy medications containing carbinoxamine, an allergy drug that also acts as a powerful sedative."

Background: Illegal prescriptions

The FDA has been trying to work on the unapproved medication situation. In September, officials told several pharmaceutical companies to take unapproved versions of an eye solution and certain skin ointments off the market, Reuters reports.

Akorn Inc. and Alcon Inc. make approved versions of the eye solution, but Baxter and Hospira do not, according to Reuters. In the last 40 years, the agency has received 300 reports of vision loss or other problems associated with the unapproved solutions.

The other item the FDA targeted is skin ointments made with a papaya derivative called papain. Officials said there is no evidence the papain works, and they’ve received more than three dozen reports of problems associated with using those ointments. In four cases, people had “life-threatening allergic reactions.”  

Unapproved medications make up about 2 percent of all prescriptions in the market, according to a 2007 USA Today article.

According to USA Today: “Many of them have been used since before 1962, when an amendment to the Food, Drug, and Cosmetic Act required that drugs be proven effective. (The original law, enacted in 1938, said only that drugs had to be proved safe.)”

One executive whose company’s products aren’t approved said getting FDA approval would be so expensive the company would go out of business.

“‘Unapproved’ sounds horrible. A lot of these products have been on the market for 50 years. ... They’ve been time-tested better than a lot of the new products approved by the FDA,” Paul Bagley, head of Pharmics Inc., told USA Today.

FDA officials told the newspaper that they don’t have the manpower to remove every last unapproved item from the market, so they go after the most dangerous items.

Last year, Ron Davis, then-president of the American Medical Association, told CNN many doctors don’t know the difference between approved and unapproved medications. 

“I think most doctors, maybe all doctors, assume that if a medication is on the market, it has been approved by the FDA, it must be safe and effective,” Davis said.

Reference: Determining a drug’s status; Medication Web Guide


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