FDA Completes Timed-Release Guaifenesin Enforcement Initiative; Adams Spokesperson, Mr. Mucus, Says “Thanks, FDA! But Why Didn’t You Act Sooner?”

May 29, 2007

Last Friday, FDA announced the Agency’s plans to take enforcement action against firms marketing unapproved drug products in timed-release dosage forms containing guaifenesin, a commonly used expectorant drug.  On May 29, 2007, FDA published a Federal Register notice to this effect.  FDA’s latest action is at least the fourth in 2007 –a year FDA in which the Agency has promised to be particularly aggressive in enforcement actions concerning marketed unapproved drugs.  (FDA’s  previous enforcement actions concerned the drug products ergotamine and trimethobenzamide, and the firm PharmaFab.) 

FDA first took enforcement action with respect to unapproved timed-release guaifenesin drug products in October 2002, when the Agency issued scores of Warning Letters to firms marketing unapproved products competing with Adams Respiratory Therapeutics’ FDA-approved Over-the-Counter (“OTC”) drug MUCINEX (guaifenesin) Extended-Release Tablets, also marketed under the trade name HUMIBID. (You know, the drug product in those ubiquitous “Mr. Mucus” commercials.)  However, that enforcement action was limited to single-ingredient timed-release guaifenesin drug products.  Since then, Adams has obtained FDA approval for 2 other OTC timed-released drug products containing guaifenesin – MUCINEX DM (dextromethorphan HBr; guaifenesin) Extended-Release Tablets (approved in April 2004), and MUCINEX D (guaifenesin; pseudoephedrine HCl) Extended-Release Tablets (approved in June 2004). 

Adams has been trying to get FDA to take enforcement action against firms marketing unapproved timed-release multiple-ingredient guaifenesin drug products ever since MUCINEX DM and MUCINEX D were first launched.  FDA’s delay of enforcement action until 3 years after Adams’ approvals is curious.  FDA’s Federal Register notice simply states that in accordance with the Agency’s June 2006 Compliance Policy Guide:

[t]he agency is taking action at this time against these products because the agency has approved applications to market timed-release drug products containing guaifenesin, alone and in combination with other active ingredients, for relief of cough, cold, and allergy symptoms; thus the continued marketing of unapproved timed-release guaifenesin is a direct challenge to the drug approval process.       

FDA’s “Question and Answer” document accompanying this enforcement action is no more illuminating:

Why is FDA taking this action?  When drugs lack required FDA approval, consumers and health care providers cannot be assured that those drugs are safe, effective, accurately labeled, and properly manufactured. For products in timed-release form, FDA approval is also necessary to ensure that the product is made so that the active ingredients are released at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective. FDA has stated in a regulation since 1959 that drugs in this form need to be reviewed and approved by the FDA.

Whatever reasons FDA might have had for delaying enforcement action, Adams is clearly pleased.  Adams’ President and CEO, Michael Valentino, commented in a press release that:

We are extremely pleased with the FDA announcement today. We have always believed that the FDA would take enforcement action against the unapproved prescription versions of our Mucinex DM and Mucinex D and remove them from the market in due course. Our initial review of this regulatory action is underway and we expect to be able to serve the additional market demand for our products as it develops.

Firms currently marketing unapproved timed-release guaifenesin drug products must cease manufacturing them by August 27, 2007.  The products may not shipped in interstate commerce after November 25, 2007.  In addition, FDA’s Federal Register notice “cautions firms against reformulating their products into guaifenesin-free unapproved new drugs that are marketed under the same name or substantially the same name (including a new name that contains the old name) . . . .  Depending on the circumstances, these products may be considered misbranded . . . .”

Categories: Enforcement