# Presentation: 564306

##   Risk Communication

-   Risk Communication

## Existing Risk Communication Programs

- Center for Biologics Evaluation and Research
- Lorrie McNeill
- Center for Drug Evaluation and Research
- Paul Seligman, M.D., M.P.H.
- Center for Devices and Radiological Health
- Lynne Rice
- Center for Food Safety and Applied Nutrition
- Marjorie Davidson, Ph.D.
- Center for Veterinary Medicine
- Laura Bradbard
- Office of the Commissioner
- Nancy M. Ostrove, Ph.D.

##   Risk Communication

-   Risk Communication

## Center for Biologics Evaluation and Research (CBER)

- Lorrie McNeill
- Director, Office of Communication, Training and Manufacturers Assistance
- CBER

## Public Health Notifications

- CBER has issued three to date:
- Biomedical Tissue Services
- Donor Referral Services
- Rotateq Rotavirus Vaccine & Intussusception
- Early information, provided to health care professionals and patients to make informed healthcare decisions
- Posted on CBER’s web site, distributed via listserv and MedWatch

## Interdisciplinary Safety Teams

- Three teams – Tissue, Blood, Vaccines
- Established to enhance collaboration, evaluation and response to complex, emerging safety issues
- Composed of experts from multiple disciplines – product manufacturing, safety, clinical, compliance and communications

## Safety Teams (continued)

- Teams provide for greater information sharing across the organization
- Integrated approach to early detection, analysis, action and communication
- Assist in identifying and implementing long term priorities, innovative practices and collaborations, quality communications

## Risk Assessment of Potential Risk of Variant CJD From Plasma-Derived Products

- FDA developed a computer model and RA document to evaluate the potential risk of products transmitting vCJD
- Engaged stakeholder community (hemophilia treatment centers and patient groups) to discuss results and provide input on communication
- Brought issue before TSE advisory committee
- Disseminated information via CBER web site

## CBER Web Site

- Key communication tool
- Product approval information, FAQs on new products, safety issues, product shortages
- Information developed for specific target audiences (consumers, health care professionals, regulated industry)
- _[www.fda.gov/cber](http://www.fda.gov/cber)_

## 
        Risk Communication

-         Risk Communication

## CDER Safety Communication Program

- Paul S. Seligman, MD
- Associate Director for Safety Policy
- and Communication
- Center for Drug Evaluation and Research

## 75,000 listserv subscribers
160 healthcare professional and consumer groups who participate in partner program 

- 75,000 listserv subscribers
- 160 healthcare professional and consumer groups who participate in partner program

## Slide 13

## FDA Early Communication

- FDA Early Communication

## FDA Public Health Advisory

## FDA Healthcare Professional Sheet

## Recommendation 6.2
A cohesive risk communication plan should be developed that includes, at a minimum:
A review of all Center risk communication activities
Evaluation and revision of communication tools for clarity
Consistency and priority setting to ensure efficient use of resources

- A cohesive risk communication plan should be developed that includes, at a minimum:
- A review of all Center risk communication activities
- Evaluation and revision of communication tools for clarity
- Consistency and priority setting to ensure efficient use of resources

- IOM Report

##   Risk Communication

-   Risk Communication

## Center for Devices and Radiological Health(CDRH)

**Lynne Rice, Director**
**Office of Communication, Education, and Radiation Programs**
**CDRH**

## Websites

- Medical Device Safety
- Recalls
- MedSun
- Lasik Eye Surgery
- Tanning
- Heart Health
- Radiological Health
- _[www.fda.gov/cdrh](http://www.fda.gov/cdrh)_

## Slide 21

## Slide 22

## Slide 23

## Slide 24

## Slide 25

## Notifications

**	****An important message to the public about a risk associated with the use of a medical product**
**Public Health Notifications**
- For the Health Care Community
**Advice for Patients**
- For Consumers

## Newsletters

**FDA and You**
- News for Health Educators and Students
- Contact lenses
- Tanning
- Medications
**Maturity Health Matters**
- Health News for Older Adults, their families and caregivers
- Artificial Joints
- Blood Glucose
- Food Safety

## Slide 29

## Video Broadcast

_***Monthly video news show for health professionals***_
- Drugs, devices and biologics safety
- Distribution:
- Video webcast
- Video podcast
- YouTube/Google Video
- Broadcast to 4,500 hospitals/nursing homes

## Slide 31

## CDRH Risk Communication Improvement Initiatives

- Product Safety Networks
- Collaboration across functional and product expertise about product safety
- Risk Communication Steering Committee
- Evaluating our communication products and processes

##   Risk Communication

-   Risk Communication

## Center For Food Safety and Applied Nutrition

- Risk Communication Advisory Committee Meeting
- February 28, 2008
- Marjorie Davidson, PhD
- Education Team Leader

## Wide Range of Issues

- Microbiological, chemical and physical contaminants in food
- Nutrition/Obesity
- Food Defense
- Dietary Supplements
- Allergens

## Methods of Communication 

- Media Outreach (all kinds)
- Education Conferences
- Toll Free Hotline 1-800-SAFEFOOD
- E-Mail Inquiries
- Constituent Updates
- EdNet Listserve

## Methods cont’d

- Advisories
- -mercury in fish and shellfish
- -acrylamide in food
- -listeria and refrigerated ready to eat foods
- Product Labeling
- -safe food handling information for shell eggs
- -warning labels in unpasteurised fruit and vegetable juices
- Recalls
- Public Education Campaigns

## Recalls

- Spinach contaminated with *E. coli*
- Peanut butter contaminated with Salmonella
- Melamine in pet food
- Veggie Booty Snack Food contaminated with Salmonella
- Botulism poisoning in Castleberry brand canned foods
*Vibrio parahaemolyticus* in oysters harvest from Hood Canal in Washington          State

## Food 

**U.S****. ****Food**** ****and**** ****Drug**** ****Administration**

**Food**** **
**Protection**** ****Plan**

## ResponseRisk Communication to Stakeholders

- Design and conduct consumer communications and behavior response studies
- Use study information to update Food Protection Risk Communication Plan with strategies to effectively communicate with consumers
- Website for food protection information

## Nutrition LabelHealth Education Program

**http://www.cfsan.fda.gov**

- Make Your Calories Count
-   	Web-based Learning Tool on Using the Label for Healthful Food Choices

**http://www.cfsan.fda.gov**

## SPOT THE BLOCKLabel Education Program for Tweens

## SPOT THE BLOCK

- On air spots with
-  Cartoon Network
- Community
- Outreach programs
- In summer

## SPOT THE BLOCKweb site

## Critical Components of Risk Communication Programs

- Based on Research
-  Work as much as possible with Partners

## Risk Communication with Partners

- American Dietetic Association
- American Egg Board
- American Meat Institute
- Assoc. of Food and Drug Officials
- Cartoon Network
- Centers for Disease Control and Prevention
- Consumer Federation of America
- Environmental Protection Agency
- Food Marketing Institute

## Risk Communication with Partnerscont’d

- Food Temperature Indicator Assoc.
- Institute of Food Technologists
- International Food Information Council
- National Assoc. of State Depts. Of Agriculture
- National Chicken Council
- National Science Teachers Association
- National Turkey Federation
- Produce Marketing Association

## Risk Communication with Partners cont’d

- NSF International
- Produce Marketing Association
- School Nutrition Association
- The Soap and Detergent Association
- United Fresh Produce Association
- World Health Organization

##   Risk Communication

-   Risk Communication

## Communicating The Cloning Risk Assessment Message

- FDA Center for Veterinary Medicine
- Laura Bradbard
- Office of Communication

## 1997 What Hath Dolly Wrought?

- Media attention to cloning reached new heights in February when Scotland’s Roslin Institute announced they had successfully created Dolly, a clone from a somatic cell derived from cultured mammary gland cells of an adult sheep.

## March/April 1998

- CVM publishes an article in the** ***FDA Veterinarian– *
*             **BIOTECHNOLOGY: *
*    **PUTTING CLONES IN CONTEXT*

## By 2001, it had become apparent that animal cloning may become a commercial venture to help improve the quality of herds.

## FDA requested that livestock producers
and researchers keep animal clones
or their offspring out of the food supply.

- and researchers keep animal clones
- or their offspring out of the food supply.

## Evaluation

- CVM contracted with the National Academy of Sciences to identify and evaluate science-based concerns associated with animal cloning.

- The NAS Expert Committee on Defining Science-Based Concerns Associated with the Products of Animal Biotechnology assembled experts to discuss this issue and to elicit safety information from the scientific community.

## August 2002

- CVM announces that the NAS/NRC REPORT ON ANIMAL BIOTECHNOLOGY has been released.

## CVM Update

- CVM announces the upcoming public meeting on early stage draft risk assessment.
- The Center also contacted companies known to be developing agricultural clones to inform them that the Center is considering this issue, and to encourage their contributions to this public meeting.

## 2002 

- CVM and the Pew Initiative on Food and Biotechnology cosponsor a symposium entitled "Animal Cloning and the Production of Food Products-Perspectives from the Food Chain."

## September/October 2003 

**FDA Veterinarian newsletter**
**and FDA Consumer magazine **
**featured an article:**
**Cloning: **
**Revolution or Evolution in**
**Animal Production?**

## October 31, 2003

- FDA Issues Draft Executive Summary of its Assessment of Safety of Animal Cloning
- This risk assessment will be discussed publicly at a meeting of FDA's Veterinary Medicine Advisory Committee (VMAC) November 4th.

## December 28, 2006 FDA Issues Draft Documents on the Safety of Animal Clones

- Draft risk assessment
- Proposed risk management plan
- Draft guidance for industry

## Public Comment Period

- FDA requests public comments on the
-    cloning documents.
- At the request of members of the public, the initial 90 day comment period was extended for an additional 60 days, and closed on June 3, 2007.

## Public Responses

- FDA received approximately 30,500 comments.
- Approximately 17,500 of these were form letters.
- 13,000 were “directed text” comments.
- 100 were substantive, providing detailed analyses, recommendations, or opinions either supporting or opposing the agency’s draft documents or cloning in general.

## January 15, 2008

**FDA Issues Final Documents on the Safety of Food from Animal Clones**
- The agency concludes that meat and milk from clones of cattle, swine, and goats, and the offspring of all clones, are as safe to eat as food from conventionally bred animals

## Additional information released to enhance public understanding:

**Myths about Cloning**
**A Primer on Cloning and Its Use in Livestock Operations**
**Consumer Update: Animal Cloning and Food Safety**

## Transcripts Were Made Available Online for:

- Cloning Press Conference held at the HHS building to announce the findings.
- Media Telecon for reporters to ask questions about the announcement.
- Stakeholders Telecon for industry and consumers.

## FAQs were also provided online

- FAQs About Cloning for Consumers
- FAQs About Cloning for Livestock Managers

## 
Over 1500 news stories were produced about cloning in the days and weeks that followed the announcement.

- Over 1500 news stories were produced about cloning in the days and weeks that followed the announcement.

- Media

##   Risk Communication

-   Risk Communication

## Risk Communication in the Office of the Commissioner

- Focused programs/activities
- Cross-agency activities

## Office of Women’s Health

- Health Information campaigns
- Take Time to Care about
- diabetes, safe medication use, non-prescription drugs, generic drugs, buying over the internet
- and much more
- “My Medicines” brochure
- Tested brochures
-  many in English and Spanish
- some in other languages as well

## Slide 73

## Office of Special Health Issues

- Outreach to health care professional and patient communities
- stakeholder teleconferences to actively communicate important risk information
- rapid targeted communication of risk and benefit news through electronic list serves
- community-focused web sites to provide access to pages of particular interest

## Office of Scientific & Medical Programs

- Ongoing relationships between MedWatch and electronic content providers
- ePocrates, Medscape/WebMD & others
- Encouraging and facilitating HCP use of electronic resources
- guidance on electronic communication of product safety information
- letter to health care orgs to encourage HCPs to use FDA electronic tools

## FDA Website

- Integrated consumer health info page
- GovDelivery
-  >doubled subscriptions in <3 months
- 500-600 on avg signing up daily
- Incremental site improvement
- redesign entire site by end of 2008
- new Web governance to improve coordination of cross-agency response and information

**Notes:**
Critical feedback, usability test results

## Redesigned FDA Home Page

- Planning for March launch
- to improve information access
- “evolutionary” approach
- Elevation and co-location of risk and safety reporting information
- higher on page to improve access
- adjacent to product approvals

## Slide 78

## Slide 79

##   Risk Communication

-   Risk Communication