FDA Announces Major Enforcement Action on Marketed Unapproved Prescription Cough, Cold, and Allergy Drug Products

By Kurt R. Karst –      

FDA’s Unapproved Drugs Initiative, which began in June 2006 when the Agency issued its final version of “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100,” took a major step with the Agency’s March 2, 2011 announcement that FDA plans to take enforcement action against what appears to be hundreds of allegedly “unapproved and misbranded oral drug products that are labeled for prescription use and offered for relief of symptoms of cold, cough, or allergy and persons who manufacture or cause the manufacture of such products.”  FDA’s announcement, which specifically covers oral extended-release, tannate, and immediate-release drug products, comes just one day after FDA denied (here, here, and here) three citizen petitions concerning marketed unapproved tannate-containing drug products and Generally Recognized as Safe and Effective (“GRASE”) status.  The announcement also comes about two months after FDA issued a Federal Register notice in January 2011 intended to finalize certain Drug Efficacy Study Implementation ("DESI") proceedings related to cough, cold, or allergy drug products (see our previous post here).

FDA’s Federal Register notice on today’s announced enforcement action is scheduled for publication on March 3rd, and separately discusses the legal status of the affected oral extended-release, tannate, and immediate-release cough, cold, or allergy drug products.  FDA states in the notice that the Agency plans to take enforcement action under two tracks.  (In a separate Federal Register notice scheduled for publication on March 3rd, FDA announced the closure of the remaining DESI dockets that were the subject of a January notice.  FDA also commented on the regulatory status of dihydrocodeine bitartrate in a separate letter.)

First, FDA plans to take enforcement action against any drug product covered by the notice that was not listed with FDA pursuant to FDC Act § 510 before March 2, 2011, and is manufactured, shipped, or otherwise introduced or delivered for introduction into interstate commerce by any person on or after March 3, 2011.  In addition, FDA says that the Agency plans to take enforcement action against any drug product covered by the notice that is listed with FDA in full compliance with FDC Act § 510 “but is not being commercially used or sold in the United States on March 2, 2011 and that is manufactured, shipped, or otherwise introduced or delivered for introduction into interstate commerce by any person on or after [March 3, 2011].”

Second, for drug products covered by the March 3rd notice that are commercially used or sold in the U.S., that have a National Drug Code number listed with FDA, and are in full compliance with FDC Act § 510 before March 2, 2011 – termed as “currently marketed and listed” drugs in the notice – FDA says that the Agency intends to exercise its enforcement discretion in the following manner:

FDA intends to initiate enforcement action against any currently marketed and listed product covered by this notice that is manufactured on or after [June 1, 2011] or that is shipped on or after August 30, 2011.  Further, FDA intends to take enforcement action against any person who manufactures or ships such products after these dates. 

And for anyone under the impression that the submission of a marketing application might save them from enforcement action, FDA notes that “[a]ny person who has submitted or submits an application for a drug product covered by this notice but has not received approval must comply with this notice.”

FDA’s March notice is reportedly the 17th action on a drug class the Agency has taken as part of the Unapproved Drugs Initiative.  In addition to action related to marketed unapproved cold, cough, or allergy drug products, FDA also recently initiated a seizure action concerning Auralgan Otic Solution, a marketed unapproved prescription drug used to treat pain and inflammation associated with ear infections.  In that case, the manufactuer is reportedly holding firm that its drug product is GRASE.   Finally, FDA is fighting, in the U.S. Court of Appeals for the Tenth Circuit, an appeal of a Wyoming district court decision concerning the “new drug” status of marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL drug products.