2011-24316. Revised Guidance on Marketed Unapproved Drugs; Compliance Policy Guide Sec. 440.100; Marketed New Drugs Without Approved NDAs or ANDAs; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of compliance policy guide.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled “Marketed Unapproved Drugs—Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs” (CPG 440.100). CPG 440.100 describes how FDA intends to exercise its enforcement discretion with regard to drug products marketed in the United States that do not have required FDA approval for marketing. CPG 440.100 has been revised to state that the enforcement priorities and potential exercise of enforcement discretion discussed in the CPG apply only to unapproved new drug products that are being commercially used or sold as of September 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 CPG 440.100.

DATES:

Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Sakineh Walther, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5242, Silver Spring, MD 20993-0002, 301-796-3349.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a revised guidance entitled “Marketed Unapproved Drugs—Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs”. This CPG is being issued consistent with FDA's good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). This CPG is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2)). The Agency made this determination because, in light of the fact that revised CPG 440.100 establishes the date after which the enforcement priorities and potential exercise of enforcement discretion discussed in it do not apply to newly introduced unapproved drugs, 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. The potential increase in marketing of new unapproved drugs raises public health concerns; because unapproved drug products have not been approved by FDA for safety, effectiveness, and quality, patients may be at greater risk when using unapproved drug products than when using FDA-approved drug products. In light of the concerns about potential increased marketing of new unapproved drugs, FDA has determined that it is not appropriate to seek comment before implementing revised CPG 440.100. Although CPG 440.100 is immediately in effect, it remains subject to comment in accordance with the Agency's GGP regulation.

Under the Federal Food, Drug, and Cosmetic Act, drug products that require approval must obtain that approval prior to introduction into interstate commerce (see 21 U.S.C. 355). Manufacturers and distributors of products that enter the market without complying with these long-standing statutory requirements are acting in violation of the law. In June 2006, FDA announced a new drug safety initiative to remove unapproved drugs from the market. As part of the Unapproved Drugs Initiative, FDA issued a final CPG entitled “Marketed Unapproved Drugs—Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs” (CPG 440.100) (see 71 FR 33466, June 9, 2006). CPG 440.100 describes how FDA intends to exercise its enforcement discretion regarding currently marketed unapproved new drugs. CPG 440.100 describes six categories of unapproved drug products that are the Agency's highest enforcement priorities, and the circumstances in which the Agency intends to bring enforcement actions consistent with those priorities. FDA has initiated 17 actions against unapproved new drugs under the Unapproved Drugs Initiative and engaged in significant outreach to manufacturers, distributors, consumers and prescribers under this Initiative, resulting in the removal of over a thousand unapproved new drugs from the market (see http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​EnforcementActivitiesbyFDA/​SelectedEnforcementActionsonUnapprovedDrugs/​ucm238675.htm).

Despite both the long-standing statutory requirement that new drugs must obtain approval prior to marketing (21 U.S.C. 355) and FDA's outreach efforts under the Marketed Unapproved Drugs Initiative, FDA is aware that unapproved new drugs have continued to come onto the market after the issuance of the 2006 CPG. In some cases, these unapproved new drugs come onto the market to compete with other unapproved new drugs that are already on the market. In other cases, unapproved new drugs are introduced to 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, FDA 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.

To address this situation, FDA is revising CPG 440.100 to make clear that unapproved new drugs introduced onto the market after September 19, 2011 are subject to enforcement action at any time, without prior notice and without regard to the enforcement priorities set forth in CPG 440.100 for unapproved new drugs marketed prior to September 19, 2011. The revision to CPG 440.100 excludes from the enforcement priorities set forth in the guidance the manufacture and marketing of newly introduced unapproved drugs.

This guidance represents the Agency's current thinking on its enforcement priorities with respect to new drugs marketed without approved new drug applications or abbreviated new drug applications. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov.

Dated: September 16, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.