FDA Seeks to Clean Up Unapproved Cough/Cold/Allergy Drug Market

By Kurt R. Karst –      

In a notice slated for publication in the January 7th Federal Register, FDA is seeking to end the continued marketing of many unapproved oral prescription drugs for the relief of cough, cold, or allergy.  The action will likely affect hundreds of marketed unapproved drug products evaluated under the Drug Efficacy Study Implementation (“DESI”) program –  including any Identical, Related, or Similar (“IRS”) product – that have been marketed for decades on the basis that such products are somehow shielded from obtaining approval of a marketing application.  (For background on DESI see the article here.)

FDA’s notice is broken down into two categories: (1) DESI cough, cold, or allergy dockets for which hearing requests have been withdrawn; and (2) DESI cough, cold, or allergy dockets with outstanding hearing requests.  The first category includes specific drug products identified in certain DESI proceedings noted in Docket Nos. FDA-1981-N-0361 (formerly 1981N-0391), FDA-1982-N-0225 (formerly 1982N-0078), FDA-1982-N-0310 (formerly 1982N-0311), including products IRS to them, for which all outstanding requests in response to a notice of opportunity for hearing have been withdrawn.  “Shipment in interstate commerce of the products identified in those dockets, or any [IRS] product that is not the subject of an approved new drug application (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice,” FDA states in the notice.  The second category includes drug products identified in certain DESI proceedings noted in Docket Nos. FDA-1981-N-0077 (formerly 1981N-0393), FDA-1981-N-0248 (formerly 1981N-0396), FDA-1982-N-0046 (formerly 1982N-0095), FDA-1982-N-0264 (formerly 1982N-0096), and FDA-1983-N-0137 (formerly 1983N-0095), including products IRS to them.  For the drug products identified in these dockets, FDA is offering an opportunity for firms to affirm outstanding hearing requests.  “FDA will assume that companies with outstanding hearing requests that do not respond to this notice are no longer interested in pursuing their requests, and will deem the requests withdrawn,” according to FDA. 

FDA also states in the notice the Agency plans to take swift enforcement action against companies that continue to market unapproved drug products subject to the Federal Register notice.  “Firms should be aware that, after the effective date of this notice, FDA intends to take enforcement action without further notice against any firm that manufactures or ships in interstate commerce any unapproved product covered by this notice that is not the subject of an ongoing DESI proceeding.”  Although some of the drug products identified by FDA and marketed with well-known brand names might be able to be reformulated to comply with an OTC drug monograph, FDA cautions against firms using the same brand name, or a new brand name that is substantially the same as the brand name.  “Reformulated products marketed under a name previously identified with a different active ingredient or combination of active ingredients have the potential to confuse health care practitioners and harm patients.”