FDA announced on Mar. 2, 2011, that it is taking action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products, according to an agency release and press briefing.

FDA’s Office of Compliance Director Deborah M. Author explained in a press briefing that the legal requirements for evaluating and approving prescription drugs have changed over the past century, including the enactment of the Food, Drug, & Cosmetic Act, and that, still, many drugs have remained on or entered the market illegally.

This class of drugs is of particular concern because many of these products are labeled as “timed release,” which are complicated to manufacture. It is important, said Author, that FDA review these types of drugs to ensure that the release of the active ingredient is occurring at the right time and in the right dosage. This class of drugs is also important because many of the products are labeled for children age 2 and under. In 2008, the agency called for the relabeling of over-the-counter cough, cold, and allergy medications for children under age 2 because of potential serious side effects.

According to the agency press release, “Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter.” 

The action, which is part of FDA’s 2006 unapproved drugs initiative, calls for companies that have previously listed products subject to FDA’s action to stop manufacturing the products within 90 days and to stop shipping the products within 180 days.  In addition, companies that have not previously listed products subject to today’s action with FDA are asked to stop manufacturing and shipping their products immediately. The overall initiative has prompted the removal of 550 unapproved products from the market in the past five years. This latest action affects 500 unapproved prescription products.