fda social media guidelines - introduction

Introduction to the FDASM

PF Anderson, Emerging Technologies Librarian for the Health Sciences, University of Michigan

School of Dentistry Bootcamp, February 10, 2010

What is #FDASM?

FDA’s Stated PurposeThis hearing is intended to provide an opportunity for broad public participation and comment concerning Internet promotion of FDA-regulated medical products, including human and animal prescription drugs and biologics and medical devices. Please note that this hearing does not address nonprescription drug promotion. FDA is particularly interested in hearing views from the public as to how expanding Web 2.0 technologies may be used to promote medical products to both health care professionals and consumers in a truthful, nonmisleading, and balanced manner. In addition, FDA is seeking public comment on Internet adverse event reporting.

FDA’s Purpose: Main PointsInternet promotion of FDA-regulated medical products

human/animal prescription drugs biologics medical devices

does NOT address nonprescription drug promotion

Web 2.0 use to promote medical products

to both health care professionals and consumers in a truthful, nonmisleading, and balanced manner

Internet adverse event reporting

Our Question

Who, What, Where, WhyWho

is allowed to say What

to Whom

regarding health information

Where in online spaces and social media?

Are Why & When & How part of the question/answer?

Main Questions Addressed

1. Accountability

2. Regulatory requirements best practices

3. Corrective information

4. Links

5. Adverse event reporting

1. For what online communications are manufacturers, packers, or distributors accountable?

FROM: Federal Register Notice of Public Hearing: http://edocket.access.gpo.gov/2009/E9-22618.htm

2. How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?

FROM: Federal Register Notice of Public Hearing: http://edocket.access.gpo.gov/2009/E9-22618.htm

3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?

FROM: Federal Register Notice of Public Hearing: http://edocket.access.gpo.gov/2009/E9-22618.htm

4. When is the use of links appropriate?

5. Questions specific to Internet adverse event reporting

FROM: Federal Register Notice of Public Hearing: http://edocket.access.gpo.gov/2009/E9-22618.htm

FDASM Resources

Wordle from Transcripts

Highlights from November Forum

1. Outbound Links

Who is responsible if the target link changes content or location?

Who should be required to use in-between page warning consumer they are leaving the site? What about groups that don’t have the skills or resources necessary to do so?

2. Semi-private conversations

Social media allows conversations and questions between private individuals in public spaces.

3. Spurious content

Who decides what is good and what is not?

Who should be held accountable for the quality of the information provided?

What should be asked of those who provide questionable content?

4. Off-Label Use

When is emerging research beneficial or dangerous to a healthcare consumer?

Who decides?

Should conversations on off-label use be supported, discouraged or managed?

5. European Precedents

Title VIII, Advertising, Article 86 (Denmark)”Directive 2001/83/EC on the Community code relating to medicinal products for human use” in conflict with “The European Convention for the protection of human rights and fundamental freedoms”

The European Court of Justice: Third-party statements about medicines may be advertising: http://www.dkma.dk/1024/visUKLSArtikelBred.asp?artikelID=15472&print=true

Digital Economy Bill (in progress, UK)

Clause 11

Maybe, instead of banning all kinds of opinions on particular product, one should think of a better way to distinguish independent journalism from mere marketing strategies. The question is how?

Context: Social Media Use Examples

Things You Can Do NOW

Think about your concerns and hopes for the forthcoming guidelines. Register your comments NOW.

FDA will have a second 90-day comment period after the initial guidelines are proposed.

What do YOU want the FDA to do?