FDA Demands Pharma Firms Pull Unapproved Drugs

Apr 01, 2009
By Pharmaceutical Executive Editors
Untitled Document

On Tuesday, FDA announced that it has sent warning letters to nine pharmaceutical companies marketing 14 unapproved narcotic drugs to treat pain.

Companies receiving warning letters include Boehringer Ingelheim Roxane, Cody Laboratories, Glenmark Pharmaceuticals, Lannett Company, Lehigh Valley Technologies, Mallinckrodt Pharmaceuticals Group, Physicians Total Care, Roxane Laboratories, and Xanodyne Pharmaceuticals.

These are drugs that have been on the market for decades. However, FDA made it clear that they are not legacy drugs, nor are they grandfathered into the system. In June 2006, FDA announced a major initiative to ensure that these drugs either enter the approval system or be taken off the market.

“The term ‘legacy drugs’ doesn’t have any true meaning to us at FDA,” said
Michael Levy, director of the division of the New Drugs and Labeling Compliance,
Office of Compliance, CDER. “We consider this class of product to be marketed, unapproved drugs, and we think it’s extremely unlikely that any of these drugs are being sold legally.”

This is the ninth major action taken against manufacturers of unapproved drugs since 2006. Levy noted that there isn’t a common thread between the different violations. In some cases, the dosage level or active ingredient didn’t receive FDA clearance; in other situations the dosage form was improper.

“When we started the initiative we estimated that approximately 2 percent of prescriptions filled in the United States were marketed, unapproved drugs,” Levy told Pharm Exec on Wednesday. “So it’s a significant number of products that are out there.”

Since that time, FDA has taken approximately 500 unapproved drugs off drugstore shelves. Levy said that FDA is also contacting pharmacies and distributors, and training them to look for FDA approval labels when considering purchasing product or filling a prescription.

“We are trying to get the purchasers of these products educated about the unapproved drugs that are out there,” Levy said.

Crack in the System
Just how these drugs got into the supply chain is another question that needs answering.

Over the years, there have been many changes to the food, drug, and cosmetic act—particularly in the 1930s and 1960s—and these drugs appear to have slipped through the cracks, remaining on the market even as FDA established strong safety and efficacy guidelines.

FDA is also clear that these are not drugs that fell of the back of a truck; they are legitimate products that are registered and inspected by FDA. Part of the problem is that the drug manufacturers in question have marketed and sold the drugs just as they would an approved treatment. The companies have salespeople that market the drugs to doctors, who prescribe the treatments to patients.

In a statement on Monday, FDA said that “Consumers who rely on narcotics for pain relief continue to have access to narcotic products that the agency has evaluated and determined to be safe and effective. The FDA has determined that removal of the unapproved narcotic products will not create a shortage for consumers.”

“We are reaching out to physicians and professional societies to make them aware of this problem because we feel strongly that patients should be assured that the drugs they are taking are approved to be safe and effective and of good quality,” said Charles Lee, medical officer, Office of Compliance, CDER.

FDA is also doing extensive outreach to the pharma companies to ensure that they know how to get these drugs into the approval system, including hiring an unapproved drugs coordinator at CDER to help firms gain approval for these drugs.

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