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FDA, unapproved drugs, unapproved drugs ordered off market

FDA Cracks Down on More Unapproved Prescription Drugs

April 01, 2009 12:30 PM
by Emily Coakley
The U.S. Food and Drug Administration told nine manufacturers to stop distributing narcotic painkillers, as part of an ongoing campaign against unapproved drugs.

Action Won't Cause Shortage, FDA Says

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This week the FDA sent letters to the companies accused of selling the unapproved narcotics, all of which are in the United States.

Deborah Autor of the FDA said that patients shouldn’t worry about being able to get pain medication.

“There will be no shortage for consumers,” she said, according to U.S. News and World Report.

The major problem with unapproved drugs, according to NPR, is that “[r]egulators haven't checked that those versions work as well and are as pure as their approved competitors.”

While the FDA has taken about 500 unapproved prescription drugs off the market in the last three years, thousands remain, Autor said.

The FDA may seize products of companies that ignore the orders, according to NPR.

Background: More FDA Efforts

In September the FDA told several pharmaceutical companies to take unapproved versions of an eye solution and certain skin ointments off the market, Reuters reported.

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.

In 2007, 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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