OPDP Frequently Asked Questions (FAQs)
Drug of Choice
Drug Name Size
Presentation of Information
What are the general requirements for prescription drug advertisements directed toward consumers?
The same statute and regulations apply regardless of the audience targeted by a prescription drug advertisement. The Federal Food, Drug, and Cosmetic Act (the act) requires that all drug advertisements contain (among other things) information in brief summary relating to side effects, contraindications, and effectiveness. Because of this statutory wording, this requirement has become known as the brief summary. The current advertising regulations specify that this information disclosure needs to include all the risk information in a product's approved labeling. Typically, print advertisements will include a reprinting of the risk-related sections of the product's approved labeling (also called full prescribing information or the package insert). Sponsors, however, can write this risk information in language appropriate for the targeted audience; FDA encourages this approach.
In addition to the specific disclosure requirements, advertisements cannot be false or misleading or omit material facts. They also must present a fair balance between effectiveness and risk information. FDA has consistently required that appropriate communication of effectiveness information includes any significant limitations to product use.
How do prescription drug broadcast advertisements differ from print advertisements?
Current regulations specify two requirements that all prescription drug broadcast advertisements must meet. First, broadcast advertisements must include the product's most important risk-related information in the audio or audio and visual parts of the advertisement. This is sometimes called the major statement. This requirement is not addressed by the guidance. Second, broadcast advertisements must contain either a brief summary of the advertised product's risk information, or alternatively, make adequate provision for disseminating the product's approved labeling in connection with the ad. Thus, the regulations for broadcast advertisements recognize broadcast's inherent limitations by providing an alternative mechanism for meeting the act's information disclosure requirement.
What needs to be included as part of the major statement requirement?
The major statement must include all of the most important risk information related to the product. Because risks vary from product to product, the amount of information disclosed for any particular product to meet this requirement will vary as well.
How does a product's brief summary differ from its approved labeling?
The brief summary is generally shorter -- sometimes significantly so. The brief summary typically includes only the risk-related sections of the product's labeling. This is because the advertising text itself generally meets the requirement for including effectiveness information by giving the product's indication (i.e., what it is used for), and any limitations concerning how and when the product should be used. In contrast, product labeling includes non-risk-related information, including all effectiveness information (sometimes even about the clinical studies used as the basis for product approval), how it should be taken (dosage information), how the drug product is supplied (e.g., the quantity of drug in each pill), and information about how the product works in people's bodies.
Does FDA intend to do anything about the brief summary information? I've heard a lot of concerns about its value for consumers.
FDA has also heard concerns about the lack of value of the required information from some individuals and groups. It has heard from others that consumers should get full disclosure of risk information. The agency intends to address these concerns fully through the rulemaking process. In the interim, the agency encourages product sponsors to provide consumers with non-promotional, consumer-friendly information consistent with product labeling, along with the information required by the act and the regulations. As mentioned above, in the case of print advertisements, FDA encourages sponsors to write their product brief summaries in consumer-friendly language.
May the phrase "drug of choice" be used in advertising or labeling?
The phrase "drug of choice," or any similar phrase or presentation, used in an advertisement or labeling would make a superiority claim and, therefore, the advertisement or labeling would require substantial evidence to support that claim.
Does the full prescribing information or the brief summary type have to be any particular size?
No, but the regulations specify size in sections 201.10(g)(2) and 202.1(b)(2) which state:
"The established name shall be in printed letters that are at least half as large as the letters comprising the proprietary name or designation with which it is joined, and the established name shall have a prominence commensurate with the prominence with which such proprietary name or designation appears, taking into account all pertinent factors, including typography, layout, contrast and other printing features."
Does "half as large" refer to point size or actual type size?
OPDP has interpreted "half as large" to be actual size, not point size, of upper and lower case letters in the proprietary and established drug names.
May an advertisement or labeling piece include the phrase "FDA-approved"?
Yes, if the manufacturer or sponsor has received a letter stating that the product has been approved. Effective on the date of implementation, the Food and Drug Administration Modernization Act of 1997 eliminated Section 301(l) of the Federal Food, Drug, and Cosmetic Act that prohibited "The using . . . of any representation or suggestion that approval of an application with respect to such drug or device is in effect . . . ."
How long may the word "new" be used in promotional labeling and advertisements for a newly approved product, indication, or dosage form?
OPDP generally considers that "New" is an accurate description of the marketing phase for six months from the time a product is initially marketed. This should be distinguished from the time the product is cleared by FDA for marketing.
Does it matter where a package insert is placed on a labeling piece, such as on a calendar or a brochure with a pouch?
The package insert is required to accompany the labeling piece. OPDP also recommends that the labeling piece state clearly where the package insert is located.
Are package inserts required in all labeling pieces for products that are the same except for different strengths or dosages?
Yes. Even though products may be very similar, package inserts may be different for different dosage forms or different delivery systems for the same drug. The regulations would require a package insert for each dosage form and delivery system for which claims appear in the promotional labeling piece. Some drug products, however, have multi-dosage form package inserts. In those cases, the same package insert could be attached to each piece, even if the dosage forms or delivery systems were different.
Does a package insert in another language also have to be submitted in English?
Yes. Package inserts have to be submitted in English and not only in the foreign language.
Where do the regulations state the requirement for submitting prescription drug advertisements and labeling?
Under 21 C.F.R. 314.81(b)(3)(i):
Section 314.81 Postmarketing reports.
(b) Reporting requirements. The applicant shall submit to the Food and Drug Administration at the specified times two copies of the following reports:
(3) Other reporting--(i) Advertisements and promotional labeling. The applicant shall submit specimens of mailing pieces and any other labeling or advertising devised for promotion of the drug product . . . .
(See Selected Provisions of the Act and Regulations for the entire paragraph.)
When do promotional materials need to be submitted to OPDP?
Pursuant to 314.81(b)(3)(i), submissions must be made " . . . at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product."
Do all promotional materials for prescription drugs have to be submitted to OPDP?
The regulations for submitting materials apply to holders of NDAs, ANDAs, and antibiotic applications. Manufacturers of pre-1938 products and products that have declared "not new drugs" are not required to submit specimens. All products have labels and prescribing information, however, and products without approved labeling have permitted labeling. Permitted labeling indicates FDA agrees with the label or labeling and permits its use. A manufacturer of a product with permitted labeling is responsible for assuring that advertisements and promotional labeling pieces are consistent with the product labeling.
What form should applicants use to submit materials to FDA?
Form FDA 2253 Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use.
How can I obtain a Form FDA 2253?
To whom should I send the materials?
Please see draft guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs for information on how to submit. Please note that implementation for the new eCTD M1 is still pending. Please refer to the eCTD webpage for details and timing of implementation.
Who is responsible for submitting a Form FDA 2253 if the manufacturer and distributor are different companies?
Either company may submit the specimens, however, the applicant is ultimately responsible for compliance with 21 CFR 314.81(b)(3).
Can the layout or the way information is presented affect whether an advertisement or labeling piece is in compliance with the regulations?
Yes, 21 CFR 202.1(e)(7)(viii) states that an advertisement may be false, lacking in fair balance, or otherwise misleading if it:
"Fails to present information relating to side effects and contraindications with a prominence and readability reasonably comparable with the presentation of information relating to effectiveness of the drug, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis."
For example, the presentation below of the word benefits and the word disadvantages would not be considered comparable. Although the words are the same point size, the color and contrast with the background make the word benefits much more noticeable than the word disadvantages.
Does FDA "approve" advertisements and promotional labeling before use by the company?
No, except in rare instances, when FDA may require pre-approval of promotional materials as part of an enforcement action. However, DDMAC provides opinions on proposed advertisements and labeling pieces before use upon request by an applicant. Note that accelerated approval products are under a "presubmission" requirement. The accelerated approval regulations require that applicants submit to FDA copies of all promotional materials prior to the intended date of dissemination or publication.
What is a reminder advertisement?
Under 202.1(e)(2)(i), reminder advertisements are identified as an exemption to the advertisement regulations, including the provisions under 202.1(e) to provide a brief summary. Reminder advertisements " . . . call attention to the name of the drug product but do not include indications or dosage recommendations for use of the drug product. . . . and, optionally, information . . . containing no representation or suggestion relating to the advertised drug product." Reminder advertisements cannot make a representation about the product or suggest a use for the product.
What is reminder labeling?
Under 201.100(f), reminder labeling is " . . . labeling which calls attention to the name of the drug product but does not include indications or dosage recommendations for use. . . . and, optionally, information . . . containing no representation or suggestion relating to the drug product." Reminder labeling is exempted from the provisions under 201.100(d) to provide the full prescribing information.
Can a reminder advertisement compare one product to another or say one product is an alternative for another?
No. Such a comparison would imply the indication, and then the advertisement would no longer meet the exemption criteria.
Does FDA limit the amount of money that can be spent on reminder advertisements or reminder labeling pieces or regulate the types of objects (such as pens, cups, calendars, etc.) that can be used as reminder advertisements or reminder labeling pieces?
FDA regulations do not limit how much money companies may spend on reminder advertisements and labeling pieces, nor do the regulations limit the types of objects that can be used. The regulations, however, limit the type of information that can be presented in reminder advertisements and labeling pieces, and not just the written information, but information that may be portrayed though graphics, design, or some other visual representation.
Are the advertising and labeling procedures for orphan drugs and regular NDA products the same?