Prescription Drug Advertising and Promotional Labeling section of the CDER Handbook
Consumer-Directed Advertisements
Drug of Choice
Drug Name Size
FDA Approved
"New"
Package Inserts
Post-marketing Reporting
Presentation of Information
Pre-distribution Submissions
Reminder Advertisements
Miscellaneous Questions
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.
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Drug of Choice
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.
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Drug Name Size
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?
DDMAC 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.
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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 . . . ."
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How long may the word "new" be used in promotional labeling and advertisements for a newly approved product, indication, or dosage form?
DDMAC 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.
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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 can be anywhere as long as the labeling piece states clearly where
the package insert is located and as long as the package insert accompanies the piece.
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.
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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:
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(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 DDMAC?
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 DDMAC?
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 an Form FDA 2253?
Address
To whom should I send the materials?
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Drug Marketing, Advertising, and Communications
5901-B Ammendale Road
Beltsville, MD 20705-1266
Upon arrival, the material will be logged in for tracking and assigned to a reviewer in
DDMAC.
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).
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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.
BENEFITS
disadvantages
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Does FDA approve advertisements and promotional labeling before use by the company?
No, except for accelerated approval products and, 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.
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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.
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Are the advertising and labeling procedures for orphan drugs and regular NDA products the same?
Yes.
