Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-Labeling for Products That Contain Acetaminophen; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use—Labeling for Products That Contain Acetaminophen.” The draft guidance is intended to inform manufacturers of certain over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products that contain acetaminophen of the circumstances in which FDA intends to exercise enforcement discretion with regard to the liver warning required in the labeling.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 4, 2012.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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:

Tina Walther, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5108, Silver Spring, MD 20993-0002, 301-796-5086.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use—Labeling for Products That Contain Acetaminophen.” In the Federal Register of December 26, 2006 (71 FR 77314), FDA published a proposed rule on organ-specific warnings and related labeling for OTC IAAA drug products. In the Federal Register of April 29, 2009 (74 FR 19385), FDA published the final rule (2009 final rule). In the Federal Register of November 25, 2009 (74 FR 61512), FDA published a technical amendment to clarify several provisions in response to industry feedback. The 2009 final rule, as amended, changed some of the labeling requirements for OTC IAAA drug products to inform consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs. It went into effect April 29, 2010.

The labeling for OTC IAAA products that contain acetaminophen and are labeled for adults only, must include the following liver warning:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount [optional: “For this product”] • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product.

Although the currently proposed total daily dose of acetaminophen is 4,000 milligrams (mg), some OTC IAAA products that contain acetaminophen have directions for use that provide a maximum daily dose of acetaminophen for the product that is less than 4,000 mg. For example, for some OTC IAAA drug products that contain both acetaminophen and one or more other active ingredients, the maximum number of daily dosage units might be limited by an active ingredient other than acetaminophen, which could result in a maximum daily dose of acetaminophen that is less than 4,000 mg for that product. The optional statement, “for this product,” in the first bullet of the liver warning is intended to address these situations, by clarifying that the maximum number of daily dosage units for a product might not reflect the maximum daily dose of acetaminophen.

However, the Agency understands that in certain circumstances, despite this optional statement, the wording of the first bulleted warning might be interpreted as indicating that severe liver damage is associated with a total daily dose of acetaminophen that is less than 4,000 mg. This suggestion is not the intent of the requirement that the liver warning be included in the labeling. To address this potential confusion, the Agency intends to exercise enforcement discretion with respect to the liver warning required in the circumstances described in this draft guidance.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on this topic. 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. 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.