2023-28530. Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers; Guidance for ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of availability.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers.” We are issuing this small entity compliance guide (SECG) in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule” (CCN Final Rule). The CCN Final Rule modifies FDA regulations to reflect the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that human prescription drug advertisements presented directly to consumers (DTC) in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads) present the major statement relating to side effects and contraindications (major statement) in a clear, conspicuous, and neutral manner and establishes standards to help ensure this requirement is met. The term “drugs” in this guidance refers to prescription human drug and biological products.

DATES:

The announcement of the guidance is published in the Federal Register on December 27, 2023.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA–2009–N–0582 for “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

Submit written requests for single copies of the SECG to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993–0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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 SECG.

FOR FURTHER INFORMATION CONTACT:

Suzanna Boyle, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3214, Silver Spring, MD 20993–0002, 301–796–1200, [e-mail]; or Anne Taylor, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a guidance for industry entitled “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers.” FDA is issuing this SECG as a level 2 guidance, consistent with FDA's good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). Consistent with the GGP regulation, FDA is immediately implementing the level 2 guidance and inviting public comment (§ 10.115(g)(4)).

We are issuing this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104–121, as amended by Pub. L. 110–28) to help small businesses understand and comply with the CCN Final Rule (88 FR 80958, November 21, 2023). The CCN Final Rule modifies 21 CFR 202.1(e)(1) to reflect the requirement in section 502(n) of the FD&C Act (21 U.S.C. 352(n)) that human prescription drug advertisements presented directly to consumers (DTC) in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads) present the major statement relating to side effects and contraindications in a clear, conspicuous, and neutral manner. The CCN Final Rule also establishes standards to help ensure that this requirement is met.

This guidance addresses the content and effect of the CCN Final Rule, including identifying which drugs and advertisements are covered by the rule. The term “drugs” in this guidance refers to prescription human drug and biological products. In addition, this guidance explains when firms are expected to comply with the CCN Final Rule and how they can do so. The term “firms” in this guidance refers to manufacturers, packers, and distributors of any human prescription drug that, in any State, is distributed or offered for sale and who advertise that drug, and to all persons who they cause to issue any advertisement with respect to their human prescription drug(s), including both individuals and corporate entities.

This level 2 guidance is being issued consistent with FDA's good guidance practices regulation (§ 10.115). The SECG represents the current thinking of FDA on how small businesses can better understand and comply with the “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television or Radio Format Final Rule.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in 21 CFR 202.1 have been approved under OMB control number 0910–0686. The collections of information in 21 CFR 314.81(b)(3)(i) relating to the submission of advertisements and promotional labeling have been approved under OMB control number 0910–0001.

III. Electronic Access

Persons with access to the internet may obtain the SECG at https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA websites listed in the previous sentence to find the most current version of the guidance.

Dated: December 21, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.