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  1. Labeling for CBER-Regulated Products

Advertising & Promotional Labeling Questions and Answers

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What are the general recommendations for submitting draft promotional materials?

APLB recommends that requests for advisory comments on draft materials include the following for both DTC and professional pieces:

  • Form FDA 2253 - Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (check box #13 “Part I/Draft”)
  • 2 copies of the proposed advertising or promotional labeling material
  • 2 copies of the product’s current professional labeling (for example, Approved Package Labeling (PI), Patient Package Insert (PPI), medication guide, and instructions for use)
  • Annotated references to support claims
  • Optional cover letter

Where do the regulations state the requirement for submitting prescription drug advertisements and labeling?

Under 21 C.F.R. 314.81(b)(3)(i) [(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 . . . .

Under 21 C.F.R. 601.12(f)(4): Advertisements and promotional labeling shall be submitted to CBER in accordance to the requirements set forth in § 314.81(b)(3)(i).

When do promotional materials for prescription drugs need to be submitted to APLB?

Under 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."

Final promotional materials must be submitted with Form FDA 2253 Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use (check box #13 “PartII/Final”).

For products approved under Accelerated Approval:

Unless otherwise informed by the agency, all advertising and promotional materials that are intended for dissemination or publication within 120 days following marketing approval must be submitted to the agency for review during the pre-approval review period with Form FDA 2253 [Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use] (check box #13 “Part I/Draft”). Furthermore, after 120 days following marketing approval, all advertising and promotional materials must be submitted at least 30 days prior to the intended time of initial dissemination or publication with Form FDA 2253 [Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use] (check box #13 “Part II/Final”). [21 CFR 314.550 and 21 CFR 601.45]

To whom should I send promotional materials?

Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave
WO71 - G112
Silver Spring, MD 20993-0002

Phone: 240- 402-9158
Fax: 301- 595-1302

Note: For CDER regulated products submissions should be sent to Division of Drug Marketing, Advertising and Communications (DDMAC) (see link below).

Can I use electronic submission of promotional materials?

Yes. Refer to the following Guidances for Industry:

  • Regulatory Submissions for Prescription Drug Advertising and Promotional Labeling
  • Regulatory Submissions in Electronic Format

Are submissions under 21 CFR Part 99 required?

  • No. The FDA Modernization Act of 1997, 21 U.S.C. § 360aaa, et seq. (FDAMA section 401) ceased to be effective on September 30, 2006, and the implementing regulations 21 CFR Part 99 are no longer applicable.
  • FDA has provided its current views on the dissemination of medical journal articles and medical or scientific reference publications on unapproved uses of approved drugs and approved or cleared medical devices to healthcare professionals and healthcare entities. See "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (Draft), February 2008."


What is the FDAAA required statement for DTC advertisements?

  • Section 906 of FDAAA went into effect on March 25, 2008 and amended Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA), which now mandates that published direct to consumer (DTC) advertisements for prescription drugs include the following statement printed in conspicuous text (this includes vaccine products):
  • "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088."

Do we need to submit Form FDA 3674 [Certification of Compliance, under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. § 282(j)] with promotional materials?

No. Promotional materials do not need to be submitted with FDA Form 3674. Provision 42 U.S.C. § 282(j)(5)(B), section 402(j)(5)(B) of the PHS Act, requires that a certification accompany certain human drug, biological product, and device applications and submissions to FDA using Form FDA 3674.

Does FDAAA include any new enforcement provisions?

Yes. Sec. 901 of FDAAA amended Section 303 of the FDCA to include that a person who is a holder of an approved application under section 505 for a drug subject to section 503(b) or under section 351 of the Public Health Service Act who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent violation in any 3-year period.

Biological Products Overview

What are biological products?

Pursuant to Section 351 of the Public Health Service Act, a biological product is a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment or cure of a disease or condition of human beings.

Biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. Biologics are made from a variety of natural resources—human, animal, and microorganism—and may be produced by biotechnology methods.

Most drugs consist of pure chemical substances and their structures are known. Most biologics, however, are complex mixtures that are not easily identified or characterized. Biological products differ from conventional drugs in that they tend to be heat-sensitive and susceptible to microbial contamination. This requires sterile processes to be applied from initial manufacturing steps.

What biological products are regulated by CBER?

CBER regulates a wide range of biological products, including:

  • allergenic extracts (e.g. for allergy shots and tests)
  • blood and blood components
  • plasma derivatives
  • gene therapy products
  • devices and test kits
  • human tissue and cellular products used in transplantation
  • vaccines

Do the advertising and promotional labeling regulations apply to human cells, tissues and cellular and tissue-based products (HCT/Ps)?

It depends. If an HCT/P meets the criteria described in 21 CFR 1271.10(a) so that it is regulated solely under section 361 of the PHS Act and the regulations in Part 1271 [Human Cells, Tissues, and Cellular and Tissue-Based Products], the advertising and promotional labeling regulations do not apply. However, if these criteria are not met, the HCT/P may be regulated as a drug, device and/or biological product under the FDCA, in addition to section 361 of the PHS Act and Part 1271 of the regulations. In this case, the advertising and promotional labeling regulations may apply. For example, if the HCT/P is not intended for homologous use only (as reflected by the labeling, advertising, or other indications of the manufacturer’ objective intent), it would not be regulated solely under the PHS Act and the regulations at Part 1271, and thus, the advertising and promotional labeling regulations may apply.


What are Disease Awareness and “Help-Seeking” communications?

Disease awareness communications are communications disseminated to consumers or health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device. "Help-seeking" communications are disease awareness communications directed at consumers. (See Draft Guidance for Industry: "Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms)

Can I use the FDA logo?

The FDA logo should not be used to misrepresent the agency nor to suggest that FDA endorses any private organization, product, or service. Misuse of the FDA logo may violate federal law and subject those responsible to criminal penalties.

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 . . . ."

However, any representation that implies official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding (21 CFR 807.97). Likewise, any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding (21 CFR 807.39).

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