Introduction to the FDASM PF AndersonEmerging Technologies Librarian for the Health SciencesUniversity of Michigan

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 productsHuman/animal prescription drugsBiologicsDoes NOT address non-prescription

drugs

Web 2.0 use to promote medical products

To both consumers and health care professionalsIn a truthful, non-misleading, and

balanced manner

Internet adverse event reporting

Questions

The FDA’s Questions1. Accountability

2. Regulatory requirements best practices

3. Corrective information

4. Links

5. Adverse event reporting

SimplifiedWho

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?

FDA #11. 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

FDA #22. 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

FDA #33. 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

FDA #4 & #54. 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

Context: Social Media Use Examples

Insurers Pay FB Funny Money to Oppose HC Reform

Oncology on Canvas

Social Media Use in Healthcare Communities

Highlights from November Forum

Wordle from Transcripts

1. Outbound LinksWho 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 (questions & answers) 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 UseWhen 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 PrecedentsTitle 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 a particular product, one should think of a better way to distinguish independent journalism from mere marketing strategies. The question is how?

Comments

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.

Closing Thoughts“The FDA needs to find a narrow winding road up

a steep mountain that leads to real evidence based medicine.

Too much regulation creates an atmosphere of fear, government distrust and reactionary thinking.

Too little regulation leads to graft, greed, corruption and disinformation.

Evidence based medicine means doing the right things for the right reasons.” Dr. Ren Stonecutter, at the Second Life Public

Forum on the FDASM, January 30, 2010.

What do YOU want the FDA to do?