# Presentation: 170362

## Advertising: Regulatory Primer Course Overview 

- Lesley R. Frank, Ph.D., J.D.
- FDA-DDMAC
- June 27, 2005

## Who regulates Advertising and Promotion?

- CDER’s Division of Drug Marketing, Advertising, and Communications
- CBER’s Advertising and Promotional Labeling Branch
- CVM Reviewers and CDRH Compliance Officers
- Mission: To protect the public health by assuring medical product promotion is truthful, balanced, and accurately communicated

## Functions

- Ensure compliance with FFD&C Act
- Not false
- Not misleading
- Balance between risks and benefits
- Voluntary Compliance
- Enforcement Action

## Voluntary Compliance

- Guidance documents
- Comments when requested
- Clarifications of issues and questions

## “Promotional” Labeling

- Brochures, booklets, mailing pieces, file cards, bulletins, calendars, price lists, catalogs, letters, videos, slides, exhibits, and similar pieces of printed, audio, or visual matter descriptive of a prescription drug

## Advertising

- Advertising -- published journals, magazines, and other periodicals, newspapers, broadcast through media such as television, radio, and telephone communications

## Standards for Labeling and Advertising

- May recommend and suggest the drug ONLY for those uses contained in the approved product labeling
- May not be false, lacking in fair balance, or otherwise misleading
- Prescription drugs are unique -- the law requires disclosures of the consequences of using the drug

## Basic Communication Requirements

- Accurate communication of product indication(s) including context for any claim
- Communication of most important risks in a manner reasonably comparable to benefits (presentation and language)
- Can’t omit important information (disclosure of “material” facts in light of claims made about product)

## What’s False or Misleading

- Better or more effective than indicated
- Safer (fewer side effects, lower severity, incidence)
- Comparative claims (better/safer than other products) w/o substantial evidence
- Misleading presentation of data, risk relative to benefit, etc.

## FDA Jurisdiction

- No laws/regulations prohibit DTC promotion in general or for specific prescription drug products or product classes
- Regulatory focus is on the content of the materials **NOT** their general existence

## Types of Promotion

- Help seeking (“see your doctor,” disease oriented) -- these are NOT drug ads

## Slide 12

## Types of Promotion

- Reminder -- regulations specifically exempt from disclosure requirements; includes name of product, but no representations beyond dosage form and packaging, price information
- not for products with especially serious (“boxed”) warnings

## Slide 14

## Types of Promotion

- Product claim
- claims or representations trigger requirements for accuracy and balance
- risk disclosure requirement

## Slide 16

## Slide 17

## Enforcement

## Surveillance

- Disseminated materials submitted to FDA for prescription drugs and biologics
- Post-marketing reporting requirements
- Form 2253 – human drugs/biologics
- Form 2301 – veterinary drugs
- Conference attendance
- Complaints
- Surveillance including websites, TV ads, and journal ads

## Enforcement Options

- Untitled letters
- Warning Letters
- Injunctions/consent decrees
- Seizures

## Enforcement Issues -- Efficacy

- Incomplete communication of indication
- Suggesting better efficacy than in PI
- Broadening indication or suggesting unapproved uses, special patient populations, etc.
- Misleading presentation of data (e.g., “cherry-picking” good data; suggesting clinical significance where not proven, etc.)
- Inadequate communication of limits of use, e.g., relevant patient populations
- Unsubstantiated comparative claims (not supported by substantial evidence, i.e., adequate and well-controlled head-to-head studies)

## Enforcement Issues -- Safety

- Omission, minimization or ineffective communication of important risk information
- Lack of comparable prominence given to risk information
- Risks/warnings as footnotes, small type, etc.
- Risk information in paragraphs while claims are bulleted with white space, large font size, etc.

## References	 - Statute

- Federal Food Drug and Cosmetic Act (FFD&C)
- Sections 201(m) and (n)
- Sections 502(a) and (n)
- Public Health Service Act
- Section 351

## Additional References

- Regulations
- 21 CFR Part 99 – Dissemination of Information on Unapproved/New Uses
- 21 CFR Part 201/202 – Labeling/Advertising
- 21 CFR Part 300 – NDA/IND
- 21 CFR Part 500 – Veterinary products
- 21 CFR Part 600 – BLA and Blood products
- Websites
- _[http://www.fda.gov/cder/ddmac/](http://www.fda.gov/cder/ddmac/)_
- _[http://www.fda.gov/cder/warn/index.htm](http://www.fda.gov/cder/warn/index.htm)__ _
- _[http://www.fda.gov/cber/efoi/adpromo.htm](http://www.fda.gov/cber/efoi/adpromo.htm)_