1 fda: advancing its mission through innovations and improvements in communication usphs scientific...
TRANSCRIPT
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FDA: Advancing Its Mission Through Innovations and
Improvements in Communication
USPHS Scientific and Training Symposium
June 22, 2011
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Objectives
• Present overview of the Office of Special Health Issues (OSHI)
• Provide examples of how FDA works with patients and health professionals to improve its public health messaging
• Describe how FDA tailors its information to health professionals
• Describe FDA’s efforts to use social media to communicate public health messages.
FDA Organization
OSHI
Organizational StructureOffice of the Commissioner
Office of External Affairs *
Office of Public Affairs
Office of External Relations
Office of Special Health Issues
Web Staff
* Responsible for communications to the media, consumers, industry, patients, and health professionals
Office of Special Health Issues• Serves as a liaison between the FDA and the
patient and health professional communities.• Encourages and supports active participation
of these stakeholders in forming FDA regulatory policy to assure the agency’s decisions are based upon a full range of perspectives.
• Communicates important safety and regulatory information to health professionals and patients.
FDASeeksInput
Seeking Input to Improve the Public Health Message
• Working with states, health professionals, and patients to better understand how regulated products are used in the community and the potential impact of a proposed Agency action
• Incorporating these perspectives to communicate the Agency’s action
1. Pancreatic Enzyme Products (PEPs)
2. Intrauterine Device (IUD)/Intrauterine System (IUS)
3. Colchicine
FDA Approved Pancreatic Enzyme Products (PEPs)
CREON®
(Pancrelipase)Delayed-Release Capsules
PEPs Timeline
1938//
1991//
1995 2006
2007
2009
20102004
PEPs marketed before FFDCA
PEPs are new drugs and require approval – Proposed Rule
FDA Final Rule
FDA allows 4 years to gain NDA approval
FDA publishes guidance for NDA submission of PEPS
FDA adds 2 more years to gain NDA approval (2010)
Creon and Zenpep approved
Pancreaze approved
Unapproved PEPs can no longer be marketed
Unapproved PEPs
Communication Improvements• Pre-announcement:
– Hosted stakeholder calls with health professionals and patients advocacy organizations prior to the removal of unapproved products from the market
• Post-announcement:– Developed stronger relationships with the Cystic
Fibrosis Foundation, the National Pancreas Foundation and the Boomer Esiason Foundation
– After the announcement continued to work closely with patients and their advocacy groups and health professionals
Intrauterine Devices (IUDs) and Intrauterine Systems (IUS)
Unapproved IUD/IUS• FDA’s major concerns with the use of
unapproved IUD/IUS’s:
(1) Lack of safety and risk of reduced efficacy for preventing pregnancy
(2) Negative public health impact from the import of these products from unknown sources or foreign locations
– may not have been manufactured, transported or stored under appropriate conditions
(3) Billing for unapproved medical products – possibility of insurance fraud (Medicaid
fraud)
Unapproved IUDs• Issued letter to
healthcare professional organizations seeking help in communicating unapproved IUD information to their members
• Developed a consumer-friendly article
Communication Improvements
• Pre-announcement:– Sought input from women’s health professional
organizations on key messages – Coordinated effort with the State of Rhode Island
Department of Health
• Post-announcement:– Hosted a stakeholder call with relevant health
professional groups– Developed a Q&A document based on questions raised
from health professionals and consumers
Unapproved Drugs Initiative Enforcement Priorities
• Marketed Unapproved Drugs – Compliance Policy Guide (CPG) (June 2006)
• For all unapproved drugs:– Drugs with potential safety risks– Drugs that lack evidence of effectiveness– Fraudulent drugs– Unapproved drugs that directly compete with an
approved drug– Drugs from firms that are otherwise violating the Act (e.g.
GMP violations, ADE reporting violations)– Drugs with formulation changes made as a pretext to
avoid enforcement
Unapproved Drugs Initiative
FDA Expert Video Commentary Series on Medscape
http://www.medscape.com/viewarticle/737615
Colchicine (Colcrys)
• FDA approved Colcrys on July 30, 2009
• September 2010,FDA took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine
• Companies expected to stop manufacturing single-ingredient oral colchicine within 45 days and stop shipping the unapproved product in interstate commerce within 90 days
Communication Improvements• Pre-announcement
– Outreach to ACR, AAFP, ACP, and Familial Mediterranean Fever community
• educate on the unapproved drugs initiative• ensure patients and prescribers are aware of the
company’s patient assistance program– FDA Drug Info Rounds: Single-Ingredient Oral
Colchicine Video
• Post-announcement– Follow-up with medical and patient
community
Tailoring Safety Information to Health Professionals
• Explored the potential for better communication with health professionals by targeting messages to specific audiences – MedWatch Targeted Messaging Pilot
FDA’s Safety Information andAdverse Event Reporting Program
HOW FDA FINDS OUT ABOUT POST MARKETING RISK AND SAFETY ISSUES
- Reports of serious adverse events (death, life-threatening, required hospitalization, disability or permanent damage, birth defect)
- Reports of medication errors (wrong dose, wrong medication…)
- Reports of product quality issues (contamination, counterfeit, poor packaging or labeling, product mix-ups, device malfunction…)
HOW YOU FIND OUT ABOUT POST MARKETING RISK AND SAFETY ISSUES
- MedWatch Safety Alerts (MWSAs)
•receive concise, timely clinically important medical product alerts by
Email, text, Twitter, RSS Feed to your desktop, webpage
http://www.fda.gov/Safety/MedWatch/default.htm
MedWatch Targeted Messaging Pilot
• Defined criteria by which MWSAs are targeted to specific audiences
– Medical specialists likely to treat patients with the condition(s) indicated in the approved product labeling
– Medical specialists likely to treat patients who present with adverse events associated with the product
MWSA - ExampleAudience Field: Endocrinology, Cardiology
Adverse Event: Possible Cardiovascular RiskIndication: Treatment of
Type 2 Diabetes
Appropriately Targeting MWSAsMWSA Title Medical
Specialty Appropriately Targeted (≥ 66.7%)
Rosiglitazone: Ongoing Review of Cardiovascular Safety
Cardiology
Endocrinology
Yes, 75 percent
ESAs: Drug Safety Communication
Oncology Yes, 100 percent
MedWatch Targeted Messaging Pilot Summary
• MedWatch targeted MWSAs appropriately 83% of the time.
• The limitations of the pilot were a small sample size and the use of a limited number of medical specialties.
• With advancements in electronic delivery systems, the idea targeting MWSAs may be revisited in the future.
• One needs to consider the risks and benefits of receiving too many MWSAs versus not receiving all MWSAs when deciding to receive targeted MWSAs.
Social Media to Communicate Public Health Messages
• Examples of leveraging traditional media and social media to communicate health information:1. Peanut recall 2. Graphic health warnings on
cigarette labels 3. Caffeinated alcoholic beverages
4. Propoxyphene withdrawal
FDA’s Social Media Tools• YouTube channel
• Facebook page
• Flickr
• Podcasts
• Bloginars
The 2009 Peanut Recall
3,800 products recalled as of 3/30/09
Twitter - FDArecalls
FDA Product Recall Database and Widget
• Searchable Database of Recalled Products – Over 22 million page
views• Recall Widget
– 9.6 million page views– Placed on 20,000
external websites
FDA Online Video• FDA’s video on the “Do’s
and Don’ts” during the peanut recall was available on both the FDA and CDC YouTube channels.
• FDA YouTube Channel: http://www.youtube.com/user/USFoodandDrugAdmin
• CDC YouTube Channel: http://www.youtube.com/user/CDCstreaminghealth/
Bloginar: Webinar for Bloggers• The webinar held on
February 3, 2009, gave blog writers the chance to speak with FDA and CDC subject matter experts about the Salmonella Typhimurium outbreak efforts and future resources for bloggers during food safety incidents.
• Bloggers were provided with Web graphics to share with their readers.
Peanut Recall Buttons and Badges
Proposed New Warnings and Graphics for Cigarette Packs and Advertisements
Timeline for Proposed New Warnings and Graphics for Cigarette Packs and
Advertisements
11/12/2010 6/21/2011 6/22/2011 9/22/2012 10/22/2012
FDA released 36 proposed color graphic images and proposed rule
FDA announced its selection of nine cigarette health warnings
FDA’s final rule publishes in the Federal Register
Cigarettes can no longer be manufactured or advertised without the new cigarette health warnings
Cigarette manufacturers can no longer distribute cigarettes unless they display the new cigarette health warnings
Graphic Health Warnings
Graphic Health Warnings
Graphic Health Warnings
Graphic Health Warnings
Graphic Health Warnings
Graphic Health Warnings
Graphic Health Warnings
Graphic Health Warnings
Graphic Health Warnings
Graphic Health Warnings
Twitter – FDA Tobacco
FDA facebook Page
flickr: The U.S. Food and Drug Administration
FDA’s Web Content Syndication Project –
Pilot for Center for Tobacco ProductsGoal:– Make FDA’s web content available to other sites
Value: – Increases exposure to FDA’s information and
services– Allows other sites to add greater depth, value and
immediacy of information to their sites– Eliminates the need for other sites to update or
maintain FDA’s content
Syndication Storefront
Syndication Examples – Ohio.gov
Syndicated information from FDA’s website to a state website
Cigarette Labeling Button
Tobacco “News You Can Use” Widget (Spanish)
Caffeinated Alcoholic Beverages (CABs)
• Available in convenience stores in many states
• Come in large, boldly colored cans comparable in size to "tall" cans of beer
• According to data and expert opinion caffeine masks some of the sensory cues individuals rely on to determine how intoxicated they are
• Twenty-five state attorneys general had asked the FDA to investigate the drinks
FDA Media Call: Leveraging the Power of Federal and State Agencies
• On November 17, 2010, FDA’s Commissioner and Principal Deputy Commissioner held a media call to announce that warning letters were sent to four companies that manufacture CABs.
• FDA determined the caffeine added to their beverages is an “unsafe food additive” and seizure of their products is possible.
• The Federal Trade Commission (FTC), the Alcohol and Tobacco Tax and Trade Bureau (TTB), and the Centers for Disease Control and Prevention (CDC) participated on the call.
• The State Attorneys General of Washington and Iowa also participated on the call.
FDA facebook Page
CNN - FDA Commissioner Interview
The Buzz Over CABs: NM Incite Report
• Nielsen McKinsey Incite follows social media coverage.
• Gets to the heart of discussions consumers are having online about a topic.
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Withdrawal of Propoxyphene (Darvocet, Darvon)
• November 2010 - manufacturer agreed to withdraw the medication from the U.S. market at FDA’s request– FDA received new
clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities.
Propoxyphene Withdrawal Announcement
YouTube video embedded in press release
Podcast of Propoxyphene Announcement
FDA Online Video
Twitter – FDA Drug Info
Mobile Media Marketing to Communicate Public Health Messages
• Examples of leveraging mobile media to communicate health information:
MedWatch Text Messaging Pilot
MedWatch Text Messaging Pilot• 85% of U.S. adults own a mobile phone (Harris
Interactive) • More Americans have mobile phones than
computers at home (Pew Internet and American Life Foundation)
• Mobile phone’s use in the US includes low-income and other under-served populations
• The purpose of the pilot was to leverage mobile as another channel to reach healthcare professionals, patients, and other members of the public
MedWatch Text Messaging Pilot (MW Txt Msg Pilot)
• Interagency agreement with CDC• Six-month pilot, 3/10 through 9/10, to assess
efficacy including interest, value, and reach • Alerts with timely new safety information on
human drugs, biologics, medical devices, vaccines, dietary supplements, and cosmetics
• Expectation that seven to ten messages would be sent per week
• Voluntary participation
Promotion of Pilot Through Affiliate News/Weather/Sports Mobile Web Pages
• Targeted Markets:– Top 10 markets – New York City, Atlanta,
Dallas, Chicago, San Francisco, Los Angeles, Washington DC, Miami, Boston, Seattle
– 86 grass root markets– Top 8 Hispanic markets – Dallas, Miami, Los
Angeles, New York City, Atlanta, San Juan, San Francisco, Sacramento
• 2,357 signed up to participate in the pilot
Assessing the MW Txt Msg Pilot• Participants received three optional demographic
questions:1) “Gender? Reply MM=Male or FE=Female. 2) “What is your current job title? Reply HP= Health Professional;
IP=Industry Professional; CO=Consumer; OO= Other. 3) In what zip code do you currently live? Reply with the ZC, a
space, and your zip code.
• The data collected was used to assess reach and interest.
• To assess impact, at three months and six months, participants received a text message with a link to a survey that asks questions related to their user-experience
MW Txt Msg Pilot Survey Results:Promotion and Sign Up
FDA.gov38%
Email alert24%
Ad19%
Other19%
Facebook0%
Twitter0%
Communications Improvements and Innovations
• Improvements– Worked more closely with patients and health
professionals– Collaborated with Medscape
• Innovations– Increased use of social media
• Twitter, Facebook, Flickr, blogs, text messaging
– Developed creative ways to share information• Web syndication, widgets, badges, buttons
Acknowledgments• Joanne Elder, Web Staff
• Dan Luxenberg, Web Staff
• Brenda Evelyn, Acting Director, OSHI
• Heidi Marchand, HPLP Director, OSHI
• Daniello Sepe, OSHI
• Jay Wattenberg, OSHI
Contact InformationCAPT Beth Fritsch
[email protected](301) 796-8451
CDR Janelle [email protected]
(312) 596-6516
LCDR Christine [email protected]
(301) 796-8453