FDA Announces Enforcement Plans for Marketed Unapproved Hydrocodone Drug Products; The Specter of Legislation Looms

September 28, 2007

Earlier today, FDA announced that the Agency plans to take enforcement action with respect to marketed unapproved drugs containing hydrocodone.  Hydrocodone is an opioid derived from codeine that is recognized both for its analgesic and antitussive effects, and is an active ingredient in several FDA-approved drug products.  The announced enforcement action is the first since May 2007 when FDA announced enforcement action on marketed unapproved timed-release guaifenesin drug products. 

FDA’s latest enforcement action, a notice of which will be published in the Federal Register on October 1, 2007 (a pre-publication version is available here), wraps up the Agency’s previous conclusions made under the Drug Efficacy Study Implementation (“DESI”) program for certain pre-1962 FDA-approved hydrocodone drug products, which were last addressed in 1982 Federal Register notices.  According to FDA, since 1969, when FDA first implemented an adverse event reporting system, and as of 2005, the Agency “has received more than 400 spontaneous reports of serious adverse events associated with all antitussive hydrocodone-containing products” that involve the central nervous system, the gastrointestinal tract, the cardiopulmonary system, and hypersensitivity and intentional and unintentional overdose.  In addition, “some of these [hydrocodone] products omit important labeling warnings and information or are inappropriately labeled for use in young children.”  FDA also notes additional risks, such as medication errors because of “confusion based on similarity between the proprietary names of unapproved hydrocodone-containing antitussive products and other drug products.”  

According to the FDA announcement and notice:

Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007 and must cease further shipment in interstate commerce on or before March 31, 2008.

FDA does not expect to issue Warning Letters or any other further warnings to firms marketing unapproved hydrocodone drug products prior to taking enforcement action. 

FDA’s actions are consistent with the Agency’s June 2006 Compliance Policy Guide, in which FDA announced its enforcement priorities for marketed unapproved drugs.  These enforcement priorities include taking action on drugs with potential safety risks. 

FDA’s action comes on the heels of an article on CNN.com and an editorial in the Wall Street Journal critical of the Agency’s handling of marketed unapproved drugs.  In addition, the Wall Street Journal article notes that “Congressional legislation [creating a special regulatory pathway for marketed unapproved drugs] will be introduced shortly.”  Indeed, earlier this year the Branded Pharmaceutical Association (“BPA”) announced that the organization submitted draft legislation to Congress to create a special approval pathway for what the organization terms “legacy drugs.”  The BPA has reportedly been working with certain members of Congress to get the bill introduced.  In July 2007, 11 members of the House of Representatives sent a letter to FDA Commissioner Andrew von Eschenbach asking for FDA’s “assurance that ‘Legacy Drugs’ will not be unfairly targeted before Congress has the opportunity to afford due process.”


Categories: Enforcement