FDA: New Unapproved Drugs Subject to 'Immediate' Enforcement; No Public Input for CPG Revision

Staff Writers
October 31, 2011 at 08:00 PM EST
The FDA Sept. 19 revised a compliance policy guide (CPG) to specify that any unapproved new drugs introduced into the market after that date will be subject to immediate enforcement action — despite the enforcement priorities and provisions for agency enforcement discretion set forth in the CPG.

The June 2006 version of CPG §440.100, "Guidance for FDA Staff and Industry, Marketed Unapproved Drugs — Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs" (App. IV; see "FDA Push Targets Drugs Lacking Required Approvals, August 2006, p. 8), identified six categories of unapproved drug products as the ones to which the FDA gives higher enforcement priority:

  • drugs with potential safety risks;

  • drugs that lack effectiveness;

  • so-called "health fraud drugs," i.e., those vulnerable to deceptive promotion, advertisement, distribution or sale;

  • drugs that present "direct challenges" to the new drug approval and over-the-counter (OTC) monograph systems, including unapproved drugs that directly compete with an approved drug, and drugs marketed in violation of a final and effective OTC drug monograph;

  • unapproved new drugs that also violate the Federal Food, Drug and Cosmetic Act in other ways; and

  • drugs that are reformulated to evade an enforcement action.

Unapproved Drugs Initiative

The original CPG was issued as part of the launch of the agency's Unapproved Drugs Initiative, a safety-related enforcement initiative to remove unapproved drugs from the market. Since June 2006, the FDA has initiated 17 actions against unapproved new drugs under the initiative (see, e.g., "Unapproved Drug Initiative Targets Prescription Cough, Cold Meds; Hundreds Ordered Off the Market,"). At least one of the actions has been the subject of extensive litigation (see "Court Dismisses Challenge to Enforcement Taken Against Narcotic Under Unapproved Drug Initiative;" "Court Grants FDA's Motion To Dismiss in Dispute Over Enforcement Action Against Unapproved Drug").

In the revised CPG §440.100 and in a Federal Register notice announcing its availability (76 Fed. Reg. 58398, Sept. 21, 2011), the agency said that the enforcement priorities and potential exercise of enforcement discretion discussed in the CPG "apply only to unapproved drug products that are being commercially used or sold as of Sept. 19, 2011. All unapproved new 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 in the CPG.

New Drugs on the Market

In issuing the revised CPG, the FDA said that it was "aware that unapproved drugs have continued to come onto the market after the issuance of the 2006 CPG." In some cases, according to the agency, such drugs are marketed to compete against other unapproved new drugs; in other cases, the drugs come onto the market "when a manufacturer perceives that there may be an 'opportunity' to gain a share of the market after actions taken by FDA, including enforcement actions that remove similar unapproved new drugs from the market."

In either case, the agency said, it "must expend additional scarce resources to address unapproved products in situations where manufacturers and distributors have had ample notice that the products they are introducing onto the market cannot be legally marketed without approval."

No Prior Public Comment

The FDA also said that it is implementing the revision to the CPG without prior public comment because "prior public participation is not feasible or appropriate. ... Delayed implementation of revised CPG 440.100 would provide an incentive for manufacturers to rush new unapproved drugs to market during the comment and finalization period, in order to be subject to enforcement priorities that may be perceived as more advantageous to extended marketing of illegal, unapproved drug products."

In light of the public health concerns about the potential for safety problems with such an increase in the marketing of unapproved drugs, the agency said, the FDA concluded that seeking comment before implementing the new version of CPG §440.100 was "not appropriate."

Even though the new version is effective immediately, the agency added, it "remains subject to comment in accordance with the agency's [good guidance practices] regulation," 21 C.F.R. §10.115.


To Find Out More

The revised CPG is available online at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf.

A copy of the revised CPG is included in this month's updated pages for the FDA Enforcement Manual.


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