Introduction to the FDASM

Introduction to the FDASM

PF Anderson / Perplexity PeccableEmerging Technologies Librarian for the Health Sciences

University of Michigan

Monday, December 14, 2009

What is #FDASM?



Main Questions Addressed


Question Topics1. Accountability

2. Regulatory requirements best practices

3. Corrective information

4. Links

5. Adverse event reporting

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


http://edocket.access.gpo.gov/2009/E9-22618.htm


FDASM Resources






Wordle from Transcripts


Context: General





Context: Recent FDA Warning Letters




Context: Social Media Use Examples









Context: European Precedents


In 2003, Danish journalist Frede Damgaard published information on his website about Hyben Total, a product licensed in Denmark as a treatment for a wide range of conditions—including gout, kidney and bladder disorders, sciatica, diarrhea, and diabetes. The national regulator in 1999 refused it a marketing authorization. It is still sold as a medicine in Sweden and Norway. Mr. Damgaard’s positive description of Hyben Total’s effects on the symptoms of gout and arthritis led to his being prosecuted in the Danish courts on the grounds that it constituted advertising of a medicinal product whose sale was not authorized in Denmark, thus contravening Directive 2001/83/EC.


Title VIII, Advertising, Article 86

1. For the purposes of this Title, ‘advertising of medicinal products’ shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular:

- the advertising of medicinal products to the general public,

- advertising of medicinal products to persons qualified to prescribe or supply them,

- visits by medical sales representatives to persons qualified to prescribe medicinal products,



- the supply of samples,

- the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,

- sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,

- sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.



2. The following are not covered by this Title:

- the labelling and the accompanying package leaflets, which are subject to the provisions of Title V,

- correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product,



- factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims,

- information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products.




Context: Role of the Health Care Consumer


To start and to put you in the right mood, you should know that this official meeting about

social media will take place in an office WITHOUT ANY CELL OR INTERNET ACCESS!


DTC is direct-to-consumer

DTC is currently illegal in Europe




More Questions: What are Yours?




A Big One for Us

Does the FDA plan to proactively reach out to more stakeholders -- patients, public, and physicians in particular -- during the comment period? If so, how will it do that? What can we do to help?

Important!


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?





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)?





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





4. When is the use of links appropriate?

5. Questions specific to Internet adverse event reporting





Things You Can Do NOW


Survey: What Happens Now? Questions About the FDA’s Process for Creating Social Media Guidance: <http://www.surveymonkey.com/s.aspx?sm=cTTi_2bsVngf8aiRcggYywrg_3d_3d>


http://www.surveymonkey.com/s.aspx?sm=cTTi_2bsVngf8aiRcggYywrg_3d_3d




Survey: Predicting the Future of the Drug Industry: 2010 and Beyond: <http://www.surveymonkey.com/s/3YJQ65B>


http://www.surveymonkey.com/s/3YJQ65B

http://www.surveymonkey.com/s/3YJQ65B

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

Community discussion will be held in January to help with this




What do YOU want the FDA to do?


Introduction to the FDASM

Health & Medicine

federal register

supply medicinal

medicinal

social media

medicinal

regulatory

persons qualied

corrective