FDA Seeks to Rid the Market of Unapproved Cough, Cold, and Allergy Drugs

Jan 25, 2011   

On January, 7, 2011, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register, informing companies of its efforts to step up enforcement against unapproved cold and cough drugs. The targets of these enforcement efforts are unapproved drugs being marketed for the treatment of cough, cold, and allergies. Previously exempted from certain market approval requirements under the Drug Efficacy Study Implementation (DESI) program, these products are now considered new drugs by the FDA.

When the Food Drug and Cosmetic Act (FD&C Act) was enacted, new drugs required approval before they could be legally marketed and sold. Generally, the FD&C Act requires new drugs to be approved for safety, which may be established by the submission of a new drug application (NDA), unless otherwise eligible for an over the counter (OTC) monograph. However, because of their similarities to approved prescription drugs and OTC drugs, several unapproved drugs were temporarily exempted from this process through the DESI program. Under this program, the FDA allowed these products to be marketed and sold until final DESI determinations were made.

With the recent notice published by the FDA, the Agency has announced changes that will affect all orally administered DESI cough, cold, or allergy drugs. First, the FDA announced that any interstate shipment of products with outstanding hearing requests that were withdrawn is now unlawful. Second, the FDA announced that it will consider any pending hearing requests withdrawn, unless companies specifically respond with the intention of pursuing their request. While the FDA specifically names certain firms in the notice, the enforcement efforts also apply to products that are identical, related, or similar (IRS) to those in the DESI program. Additionally, the Agency warns that no further notice will be given prior to commencing enforcement actions.

While this recent roundup of unapproved new drugs signals heightened enforcement by the FDA, these efforts are decades in the making. As illustrated in the Notice, the hearings for most of these drugs had either been withdrawn or pending since the 1980s. While we previously reported the FDAs intentions to step up enforcement in 2011, this recent action shows that the Agency is ready to clear out old matters, one industry at a time.

For more information on FDA enforcement measures or compliance, please contact us at contact@fidjlaw.com.