FDA Is Cracking Down on Unapproved Rx Drugs


The Food and Drug Administration announced that it is renewing efforts to ensure that all drugs currently sold by prescription either go through its formal approval process or be taken off the market.

The agency has periodically targeted some of these products using its existing authority. Now, the FDA has issued more formal guidance that spells out for manufacturers how it will prioritize enforcement, and what route they can take to prove safety and efficacy of their products.

There are many reasons why unapproved products are on the market, said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, at a press briefing sponsored by the agency.

Most were marketed before passage of the 1962 Food, Drug, and Cosmetic Act, which required formal proof of safety and efficacy. Or their makers may simply have begun selling the products without seeking the agency's approval, he said, noting that the FDA will issue a new drug code number for a product even if it was never approved.

Many of the unapproved drugs are listed in the Physicians' Desk Reference. Some are advertised in medical journals. Those initially flagged for attention include products that are potentially hazardous, lack evidence of effectiveness, or appear fraudulent. If the manufacturers don't seek approval, they will be subject to enforcement action, Dr. Galson said. But in most cases, the FDA will not remove a drug from the market if it has been shown to have some medical utility. Examples include some manufacturers' levothyroxine and phenobarbital products.

The agency estimates that less than 2% of prescription drugs have not received its imprimatur. That still means potentially thousands of products that aren't approved.

Many of the drugs are cough and cold preparations that include pheniramine maleate and dexbrompheniramine maleate, or single-ingredient narcotics such as codeine phosphate and oxycodone HCl. Sedatives like chloral hydrate are also unapproved.

The agency recently announced that it is requiring makers of carbinoxamine-containing products to seek approval by late September. Any unapproved products still on the shelves at that date will be ordered off the market, said Deborah M. Autor, FDA associate director for compliance policy.

The FDA said it was targeting carbinoxamine because of safety concerns, including 21 deaths since 1983 in children under age 2 that may be related to the ingredient. Carbinoxamine is used in cough and cold treatments, mostly for children.

Physicians, pharmacists, and patients can go to the FDA's Web site (

Next Article: