1 fda: advancing its mission through innovations and improvements in communication usphs scientific...

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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

• Twitter

• 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

Beth.Fritsch@fda.hhs.gov(301) 796-8451

CDR Janelle DerbisJanelle.Derbis@fda.hhs.gov

(312) 596-6516

LCDR Christine MerendaChristine.Merenda@fda.hhs.gov

(301) 796-8453