Regulation of the Internet and Social Media by FDA

Public Health Interests and the First Amendment

Mark Senak, J.D.

3 Essential Questions

1. Have the Internet and Social Media made the current regulatory approach obsolete?

2. Has the regulation of the Internet and social media respected the First Amendment?

3. Is there a better way?

COMMUNICATIONS AND THE CURRENT REGULATORY ENVIRONMENT

It took 25 years for TV to mainstream

                       1936 J.C. Furnas , "The Next Hundred Years.“ Television won't matter in your lifetime or mine.

1939 New York Times editorial

The problem with television is that people must sit and keep their eyes glued to the screen; the average American family hasn't time for it. Therefore the showmen are convinced that for this reason, if no other, television will never be a serious competitor of broadcasting.

Communications Has Been Revolutionized

Medium• 10 years ago, Google had 8

employees

• Facebook launched 6 years ago in 2004

• YouTube launched 5 years ago in 2005

• Twitter only launched 3 years ago in 2007

Perspective• Today Google is the primary

means of search; noun, verb and major player

• Primary referral to Web sites, over 500,000,000 users; worlds 4th largest nation

• Uploads 24 hours of video/minute; more video in 60 days than in 60 years on broadcast

• 90 million Tweets per day – 600 Tweets per second.; 1.2 Billion Tweets in January 2010. Annual growth rate over 1300%.

Web 1.0

Web 2.0

Web 3.0?

Where is FDA in Regulating Internet and Social Media?

The Problem with that?

•The world no longer communicates in mass media in a one-way exchange. •It is a two way exchange. Web 0.0

Key Characteristics of Internet and Social Media Environment

• Portable– 33% of cell phone owners now access news on their cell

phones.

• Personalized– 28% of Internet users have customized their home page to

include news from sources and on topics that particularly interest them.

• Participatory– 37% of Internet users have contributed to the creation of

news, commented about it, or disseminated it via postings on social media sites like Facebook or Twitter.

Source: Pew Internet & American Life Project

Social Media Demands A Different Regulatory Approach

• Balance of power has shifted from the communicator to the audience

• The adoption and innovation behind social media proceeds faster than the system for regulating it

• Social media – Is not DTC– Is not print– Is not broadcast

Timeline for FDA Internet and Social Media Action

• March 2009– FDA in podcast on Eye on FDA asserts “it’s not the medium, it’s the message” as

regulatory approach to social media• April 2009

– FDA issues 14 letters aimed at 45 brands for use of paid search advertisements• September 2009

– FDA announces that it will hold Part 15 meeting in November on social media• November 2009

– FDA holds two-day Part 15 meeting on social media in Washington, D.C.

• February 2010– FDA closes docket on Part 15 meeting

• July 2010– FDA issues NOV letter based on Facebook “share” function

Conclusions on Regulation of Social Media

• FDA has been applying traditional broadcast and print media mentality to new media– Square peg, round hole

• FDA has utilized a traditional process is slow and cumbersome and cannot be relevant in fast paced environment– Social media evolving and uptake much faster than broadcast

• FDA has focused on the micro at the expense of the macro– Identifying small and insignificant issues

FIRST AMENDMENT

Free Speech Fundamentals

• First Amendment protects free speech– Personal speech can only be abridged where

government has a “compelling” interest– Commercial free speech is less protected than

personal free speech; government can intervene where there is a “substantial” interest• E,g, the protection of public health• Speech can be restricted but must not by more

extensive means than necessary to achieve its goals

• In other words, when there is evidence that a harm to the consumer could occur, commercial speech can be subject to regulation.

• But is there any evidence whatsoever that practices to date by pharma in social media have created a substantial interest whereby free commercial speech could be proscribed?

Let’s See, Shall We?

• On April 2, the FDA issued 14 NOV letters to various pharmaceutical companies covering 45 brands

• The subject was paid search advertising• The issue was that an indication for the medical

product was present in the ad without the benefit of the balancing risk information– The so-called “One-Click Rule”

Paid Search Ads – The Violation

A click on the link would take you to further information, including information on risk, commonly known as the “one click rule”

•Subsequently, a search using the term “HIV treatments” yielded ads that were not for FDA approved products, but rather ads that promised cures through “natural” means.•FDA action deprived consumer of choice to elect to view the responsible full ad

Consequence

• Company advertisement through paid search immediately curtailed

• Other Internet-based activities, particularly via social media were frozen

• Wikipedia used by consumers for health information has profiles on specific drugs with errors and misinformation

• Sidewikis can be created to Websites offering misinformation– Companies, fearful of regulatory action, do not correct such

misinformation

Conclusions

• No empirical evidence exists that consumers would get scripts based on a paid ad as it existed or that consumers didn’t get risk information by clicking thru to the full information

• Speech proscribed not only without a sound public health reason– An inadvertent public health problem resulted

• FDA has focused on the micro, based on old paradigms, not the macro based on the new and how consumers use the Internet to get health care information

IS THERE A BETTER WAY?

Yes!

Recommendations

• FDA must take time to understand how the Internet is used by consumers to collect health care information– Partner with Pew – Partner with Google– Get actual information upon which to base regulatory environment

so that policy decisions are evidence based

• Encompass social media regulation into Advisory Committee structure– Guidance development is too slow, too cumbersome and not

productive for the new media environment

Conclusions

• It is “not the medium, it’s the message” does not work. – It is the medium.

• Current environment has led to absurd outcomes– FDA can tweet about a drug and mention indications, Pharmas

cannot re-tweet it.

• The proscriptions on commercial free speech are not legally justifiable because no public health interest is served

• Status quo is not sustainable

Commercial Break

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