How Do Unapproved Drugs Make it to Market?

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It may come as a surprise that some of the drugs your doctor can prescribe have not been approved by the Food and Drug Administration (FDA). That means that they haven’t been evaluated for safety or efficacy, and there isn’t any evidence that they actually work.

About 500 cough, cold and allergy medications that fall into this category were removed by the agency on Wednesday, as part of the FDA’s ongoing Unapproved Drugs Initiative, an effort launched in 2006 to pull potentially unsafe drugs from the market.

How do these drugs become available in the first place? Over the past century, says Dr. Michael Levy, director of the division of new drugs and labeling compliance at the FDA, the agency has changed its regulations regarding which drugs can be legally marketed in the U.S. In the case of the prescription cold and allergy drugs removed Wednesday, many were made available prior to certain rule changes and no longer meet new requirements for safety and efficacy, he says; others are blatantly illegal, or involve cases in which manufacturers simply bypassed the FDA and went directly to market with their medications. “We see firms with New Drug Applications and approved New Drug Applications that also market products without proper FDA approval,” says Levy. “We also see firms who have as their primary business model marketing unapproved drugs.”

Some of the pulled medications were being prescribed by doctors, since they show up on drug registries and are even covered by insurance drug plans. “Part of the problem is that practitioners are largely unaware that there are unapproved products or prescription products out there,” says Dr. Charles Lee, medical officer of the FDA’s division of new drugs and labeling compliance. “These products have detailed inserts just like approved products, they are exhibited at professional societies and meetings just as approved products are, and they are picked up by pharmacy insurance benefits just as approved products are.”

That’s why the agency, since 2006, has focused on identifying classes of these unapproved medications and requiring their manufacturers to comply with current regulations for approval, or stop selling them. At the time they began, FDA officials estimated that about 2% of drugs sold fell into this category, and since then, because of actions like the current one against cold and allergy medications, they speculate the percentage has fallen to about 1% to 2% of the prescription drug market.

Still, that’s more than most people would feel comfortable with. While many of the products removed contain common cold- and allergy-fighting ingredients, the action affects only the specific brands and drugs cited by the FDA, and does not affect legally approved medications containing the same ingredients. For a list of the removed medications, see here.

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