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          The Office of Prescription Drug Promotion (OPDP)Center for Drug Evaluation and Research | CDER The Office of Prescription Drug Promotion (OPDP)

    
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10903 New Hampshire Ave., Building 51, Room 3203
Silver Spring, MD 20993-0002
Phone: 301-796-1200
Fax: 301-847-8444 or 301-847-8445

Mission

OPDP protects the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. This is accomplished through comprehensive surveillance, compliance, research, and education programs, and by fostering better communication of labeling and promotional information to both healthcare providers and consumers.

On December 26, 2023, FDA issued a final guidance 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.” The final guidance was issued 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, issued November 21, 2023, 88 FR 80958). This guidance is a Small Entity Compliance Guide (SECG) presented in a question-and-answer format that explains key provisions of the CCN Final Rule. The effective date of the final rule is May 20, 2024, and the compliance date is November 20, 2024.

On December 11, 2023, FDA published a revised final guidance for industry “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” The guidance updates are minor and include the following revisions:

In Section I, the term “over-the-counter animal drugs” has been replaced with the term “nonprescription animal drugs.”
	Footnotes 3 and 5 have been revised to replace the term “over-the-counter animal drugs” with the term “nonprescription animal drugs”On November 20, 2023, the U.S. Food and Drug Administration issued a final rule to amend its prescription drug advertising regulations, 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” (CCN Final Rule). The rulemaking implements a requirement of the Food, Drug, and Cosmetic Act (the FD&C Act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85), that in human prescription drug ads presented directly to consumers in television or radio format stating the name of the drug and its conditions of use, the statement relating to major side effects and contraindications (“major statement”) must be presented in a clear, conspicuous, and neutral manner. As directed by FDAAA, FDA is establishing standards to help ensure that the major statement in these advertisements is presented in the manner required. The effective date of the final rule is May 20, 2024 and the compliance date is November 20, 2024.

On October 23, 2023, FDA issued a revised draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” This draft guidance supersedes the revised draft guidance issued in 2014 entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.”

This revised draft guidance, when finalized, will provide FDA’s current thinking on common questions regarding certain communications by firms to health care providers (HCPs) of scientific information on unapproved use(s) (SIUU) of approved/cleared medical products. Specifically, this guidance relates to firms’ sharing of the following types of communications with HCPs:

Published scientific or medical journal articles (reprints)
	Published clinical reference resources, as follows: 
	Clinical practice guidelines (CPGs)
		Scientific or medical reference texts (reference texts)
		Materials from independent clinical practice resources
	Firm-generated presentations of scientific information from an accompanying published reprintFor the purposes of this guidance, these specific types of communications from firms to HCPs of scientific information on unapproved uses of certain approved/cleared medical products in combination with the disclosures recommended in this guidance are referred to as SIUU communications. Other communications by firms are not specifically addressed by this draft guidance, and the Agency does not intend to convey any views on such communications in issuing this draft guidance.

If a firm shares an SIUU communication with HCPs in a manner that is consistent with the recommendations in this guidance, FDA does not intend to use such communication standing alone as evidence of a new intended use.

**Information About What OPDP Reviewers Do**

OPDP reviewers have the responsibility for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading. They engage in a variety of tasks to perform this responsibility, including: providing written comments to pharmaceutical sponsors on proposed promotional materials to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion; reviewing complaints about alleged promotional violations; initiating compliance actions on promotional materials that are false or misleading; comparing the product labeling and promotional materials of various closely related products to ensure that the regulatory requirements are consistently and equitably applied; traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities; and acting as a liaison between OPDP and other divisions within the FDA on promotional issues.

The Bad Ad Program

FDA's Bad Ad Program is an outreach program designed to help healthcare providers recognize potentially false or misleading prescription drug promotion. The program’s goal is to raise awareness among healthcare providers including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and trainees about potentially false or misleading prescription drug promotion while also providing them with an easy way to report it to the Agency.

OPDP Submission Information

OPDP ComplaintsOPDP Resources

OPDP News
	OPDP Frequently Asked Questions (FAQs)
	For Industry: Using Social Media
	OPDP Research
	Contact OPDP
	OPDP Regulatory Information
	Truthful Prescription Drug Advertising and Promotion
	OPDP Metrics
	OPDP eCTD

                                                                                  Content current as of:
      12/26/2023Center for Drug Evaluation and Research | CDER
            
          
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER
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