FDA Ramps Up Enforcement on Marketed Unapproved Human Drugs – Revised CPG Says New Products Will be Subject to Immediate Enforcement Action

By Kurt R. Karst –      

On September 19th, FDA announced the issuance of a revised version of the Agency’s June 2006 final guidance document/Compliance Policy Guide (“CPG”) (FDA Docket No. 2003D-0478), titled “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs.”  The revised guidance is further evidence of FDA’s stepped-up enforcement efforts under the so-called “Unapproved Drugs Initiative.”

FDA’s June 2006 CPG articulated the Agency’s risk-based enforcement approach to taking enforcement action with respect to the manufacture and distribution of marketed unapproved drugs.  Under that policy, FDA gives higher priority to enforcement action against unapproved drugs in certain categories, including drugs that present direct challenges to the “new drug” approval and over-the-counter drug monograph systems (e.g., when a drug is approved under an NDA and other companies market the same product without approval). (An article we authored that appeared in RAPS Focus a couple of years ago discussing the world of marketed unapproved drugs is available here.)

The revised CPG, which is issued for immediate implementation, says that FDA’s risk-based enforcement approach continues to apply, but only to unapproved drug products on the market as of September 19, 2011:

The enforcement priorities and potential exercise of enforcement discretion discussed in this guidance apply only to unapproved drug products that are being commercially used or sold as of September 19, 2011. All unapproved drugs introduced onto the market after that date are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities set forth below. In light of the notice provided by this guidance, we believe it is inappropriate to exercise enforcement discretion with respect to unapproved drugs that a company (including a manufacturer or distributor) begins marketing after September 19, 2011.

FDA’s announcement states that although the June 2006 CPG has “established an orderly approach for removing unapproved new drugs from the market,” such products “continue to come onto the market illegally,” because of, among other things, “competition with other unapproved drugs that are already on the market, and not yet subject to a public FDA announcement regarding future enforcement actions,” and “increased market share opportunity is perceived following FDA actions that removed another unapproved drug from the market.”

Will there be a sudden wave of enforcement actions in the coming months as FDA seeks to implement the revised CPG?  Stay tuned. 

FDA’s announcement follows a major enforcement action from earlier this year on marketed unapproved cough, cold, and allergy drug products, which spawned two lawsuits against FDA (see our previous post here).  FDA is also embroiled in litigation concerning marketed unapproved Morphine Sulfate Oral Solution (see our previous post here).