# Presentation: 349359

## An Overview of Direct-to-Consumer Prescription Drug Promotion

- Nancy M. Ostrove, Ph.D.
- Risk Communication Advisory Committee
- May 15, 2008

## DTC an Evergreen Issue

- May 8, 2008 Hearing
- House Energy & Commerce Subcommittee on Oversight and Investigations
- Testimony from researchers, AMA, GAO, Merck/Schering-Plough, Ortho Biotech, Pfizer
- Web cast and prepared testimony at:
- http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.050808.DTC.shtml

**Notes:**
Ruth Day, Director, Medical Cognition Laboratory , Duke Univeristy
Nancy Nielsen, President-Elect, AMA
Mollyann Brodie, VP & Director, Public Opion and Media Research, Kaiser Family Foundation
Marcia Crosse, U.S. Government Accountability Office
James Sage, Snr Dir/Team Leader, Lipitor, Pfizer Inc
Deepak Khanna, Snr VP & General Manager, Merck/Schering-Plough Pharmaceuticals
Kim Taylor, Pres, Ortho Biotech, Inc

## Regulatory Oversight

- Oversight of drug promotion is split
- 1962 Kefauver-Harris amendments to Federal Food, Drug, and Cosmetic Act (FFDC Act)
- agreement with Federal Trade Commission
- FTC has primary jurisdiction over OTC drug advertising
- FDA has primary jurisdiction over Rx drug labeling **and** advertising; also over OTC drug labeling

**Notes:**
Drugs include biologics and vaccines
FDA also has primary jurisdiction over advertising for a small category of restricted medical devices, and the labeling of all medical devices

## Background Facts - 1 

- Until FDAAA, the FFDC Act did not distinguish between advertising to health care professionals and advertising to patients or consumers
- Currently, implementing regulations (21 CFR 202.1) do not distinguish between advertising to health care professionals and advertising to patients or consumers
*That is, the underlying rules historically have been the same regardless of audience*

**Notes:**
FDAAA has changed this – already has had implications for DTC print ads (AE reporting statement in print ads) and for some over time (e.g., “clear, conspicuous and neutral” standard for major statement in broadcast ads)

## Background Facts - 2

- Promotion directed toward consumers was never prohibited – practice changed
- FFDC Act generally prohibits any require-ment for preclearance of advertising
- except in “extraordinary circumstances”
- FFDC Act requires advertisements to include “information in brief summary” about product risks and benefits

**Notes:**
FDA generally can not regulate
Where and when ads appear in periodicals or broadcast media
Non-regulatory issues such as “taste” – we are not the “good taste” police

## Classes of PromotionalMaterials - 1

- Different classes of promotional materials
- Labeling (of the promotional variety)
- brochures, mailing pieces, literature, detail aids, price lists, calendars, and “similar pieces of printed, audio, or visual matter descriptive of a drug,” and references (e.g., PDR)

## Classes of Promotional Materials - 2

- Advertisements
- in journals, magazines, newspapers, other periodicals or through broadcast media (TV, radio, telephone communications systems)
- Different types of advertisements have different regulatory implications

## Help-Seeking Advertisements

- “See your doctor,” disease oriented
**Not** drug ads
- If done properly, FDA does not regulate
-  regulated by Federal Trade Commission

## Slide 9

## Slide 10

## Reminder Advertisements

- Regulations specifically exempt from disclosure requirements
- Focus on name(s) of product
- designed to remind knowledgeable persons of existence of product
- No representations beyond dosage form and packaging, price information
- Not permitted for drugs with boxed warnings

## Reminder

## Product Claim Advertisements

- Communicate benefits **and** risks
- Require
- name(s) and amount of product in each unit
- approved use (indication)
- optionally, other **substantiated** claims
- Risk disclosure
- requirements vary for print vs broadcast

## Part of a product claim ad*

- * “brief summary” not shown

## Ad Content Requirements 

- Can’t be false or misleading
- claimed uses must be consistent with drug labeling
- claims must be substantiated
- Must present “fair balance” between benefits and risk information
- Can’t omit “material” facts
*    **Plain language meaning:  Ads must communicate an accurate and balanced picture of the product*

## Risk Disclosure Depends on Whether Ad or Labeling

- Regulatory distinctions have implications
- Advertisements vs. Labeling
- “brief summary” vs. full package insert
- Print vs. Broadcast ads
- generally, print ads require **all** product risks
- but, 2004 draft guidance offers alternatives

## Risk Disclosure Draft Guidance

- Encourages using
- approved patient “package inserts” or Medication Guides (both labeling written for patients) or
- translation of new “highlights” section of physician labeling into consumer-friendly language

**Notes:**
Implicit acknowledgment of enforcement discretion

## Example: Use of Medication Guide*

- *Type of approved patient labeling

**Notes:**
Acceptable brief summary, even though it doesn’t include every single risk.  Guidance specifics the type of risks that need to be included – most serious risks and most frequent non-serious risks.

## What About Broadcast Ads?

- Defined as ads in television, radio, and over telephone communication systems
- Changing broadcast environment changed interpretation of “adequate provision” requirement
- to give access to approved package insert
- 1999 guidance provided interpretation

**Notes:**
Where did broadcast ads come from? What changed?

## Broadcast Risk Disclosure

- Required risk disclosure is
**all** the risks OR
- the major risks (“major statement”) plus access to approved labeling (“adequate provision”)
- Need to reach diverse audience
- reference to health care provider
- print ads/brochures
- telephone contact number
- internet site

## Enforcement Options

- Letters noting violations
- no regulatory “clout”
- high level of voluntary compliance
- Warning Letters
- regulatory clout
- prelude to more serious action
- generally request corrective action
- Seizure, injunction, prosecution
- threat may result in voluntary consent decree