15 November 2009
Complete abridged guide to FDA social media Guidance and regulation
11/18/09 07:32 Filed in: Social Media Regulation
While you are trying to steer around the multiple points of view about last week's FDA hearing and FDA's approach to regulating drug, biologic, and medical device promotion on the internet and in social media, below are some (mostly) indisputable facts you need to know. If you grasp the points below, you can save yourself a lot of wheel spinning.
Start here:
1. FDA will likely issue a draft guidance document following the comment period for the public hearing.
2. The ultimate draft guidance will have its own process and comment period, which will in all likelihood come well after the close of the public hearing comment period.
3. Once FDA collects comments after the comment period for any future draft guidance, it will then consider them and work on a final guidance.
4. The draft guidance will likely be able to be followed by industry even if it isn't final, because it represents FDA's current thinking, even in draft. Industry will have to follow the final guidance once finalized.
5. Any guidance document will CLARIFY how FDA believes FDA laws and regulations apply to the internet and social media. It will not CHANGE regulatory requirements. The latter would require either Congress to enact a new law or amend the Food, Drug and Cosmetic Act or would require FDA to issue a new regulation through its rulemaking procedures. The rulemaking procedures are much more burdensome and would take a much longer time than issuing a guidance. Comments and proposals should keep in mind whether or not a proposal would require a CHANGE of regulation or a CLARIFICATION of how existing regulations apply to internet and social media. All good ideas should be communicated, but should first be communicated with a goal of clarifying how they're allowable under current regulations. Only laws and regulations are legally enforceable. Guidance documents clarify how legally enforceable laws and regulations will be enforced.
6. FDA did state in its Strategic Plan on Risk Communication that certain aspects of its promotional regulations needed modernization, so there is in fact a potential for an update to regulations that would impact internet and social media promotion. (See Policy Strategy 4). Both a Guidance and new Regulations are conceivable in the coming years.
7. FDA's risk communication initiatives, steered mostly by the Commissioners office and not DDMAC, will also have a major impact on FDA's guidance, particularly around how the internet handles risk communications as well has how risk communications are perceived by the public. Integrating these two initiatives adds another wrinkle in the ability for FDA to finalize policy. Ultimately, expect some double standards in terms of what FDA can do and what industry can do.
9. Risk communication, minimization of risk, or omission of risk is FDA's most frequently cited violation for ALL media, print, broadcast, or internet.
10. At all times, any internet or social media strategy must be strategizing for outcomes that are legal, scientifically substantiated, and medically responsible, regardless of the current state of any FDA guidance. FDA, the Department of Justice, Plaintiffs lawyers and perhaps company employees/potential whistleblowers will look far deeper than what you tweeted or put on your Facebook page to see if you had any intentions to do something that was illegal. This will focus on the outcome you were trying to achieve far more so than what media you used to achieve it. So, if you are documenting social media or internet communication strategies, make sure the claims and perceptions you are trying to communicate are actually legal in addition to the methods used to get them out.
Bonus Point: The biggest and most difficult issue facing FDA and any regulatory, medical, and legal review committee at any company is the substantiation of claims. It is not the internet or social media. Whether or not a claim is presented in a way that is not misleading and is supported by FDA's substantial evidence standard is the most difficult and time-consuming issue. Claims in any media, including social media or the internet, must be truthful and substantiated on their face and be presented and stated in a way that is not misleading. When FDA says that "Its the message, not the media" this is what they're talking about.
Good luck.
John Murray
Start here:
1. FDA will likely issue a draft guidance document following the comment period for the public hearing.
2. The ultimate draft guidance will have its own process and comment period, which will in all likelihood come well after the close of the public hearing comment period.
3. Once FDA collects comments after the comment period for any future draft guidance, it will then consider them and work on a final guidance.
4. The draft guidance will likely be able to be followed by industry even if it isn't final, because it represents FDA's current thinking, even in draft. Industry will have to follow the final guidance once finalized.
5. Any guidance document will CLARIFY how FDA believes FDA laws and regulations apply to the internet and social media. It will not CHANGE regulatory requirements. The latter would require either Congress to enact a new law or amend the Food, Drug and Cosmetic Act or would require FDA to issue a new regulation through its rulemaking procedures. The rulemaking procedures are much more burdensome and would take a much longer time than issuing a guidance. Comments and proposals should keep in mind whether or not a proposal would require a CHANGE of regulation or a CLARIFICATION of how existing regulations apply to internet and social media. All good ideas should be communicated, but should first be communicated with a goal of clarifying how they're allowable under current regulations. Only laws and regulations are legally enforceable. Guidance documents clarify how legally enforceable laws and regulations will be enforced.
6. FDA did state in its Strategic Plan on Risk Communication that certain aspects of its promotional regulations needed modernization, so there is in fact a potential for an update to regulations that would impact internet and social media promotion. (See Policy Strategy 4). Both a Guidance and new Regulations are conceivable in the coming years.
7. FDA's risk communication initiatives, steered mostly by the Commissioners office and not DDMAC, will also have a major impact on FDA's guidance, particularly around how the internet handles risk communications as well has how risk communications are perceived by the public. Integrating these two initiatives adds another wrinkle in the ability for FDA to finalize policy. Ultimately, expect some double standards in terms of what FDA can do and what industry can do.
9. Risk communication, minimization of risk, or omission of risk is FDA's most frequently cited violation for ALL media, print, broadcast, or internet.
10. At all times, any internet or social media strategy must be strategizing for outcomes that are legal, scientifically substantiated, and medically responsible, regardless of the current state of any FDA guidance. FDA, the Department of Justice, Plaintiffs lawyers and perhaps company employees/potential whistleblowers will look far deeper than what you tweeted or put on your Facebook page to see if you had any intentions to do something that was illegal. This will focus on the outcome you were trying to achieve far more so than what media you used to achieve it. So, if you are documenting social media or internet communication strategies, make sure the claims and perceptions you are trying to communicate are actually legal in addition to the methods used to get them out.
Bonus Point: The biggest and most difficult issue facing FDA and any regulatory, medical, and legal review committee at any company is the substantiation of claims. It is not the internet or social media. Whether or not a claim is presented in a way that is not misleading and is supported by FDA's substantial evidence standard is the most difficult and time-consuming issue. Claims in any media, including social media or the internet, must be truthful and substantiated on their face and be presented and stated in a way that is not misleading. When FDA says that "Its the message, not the media" this is what they're talking about.
Good luck.
John Murray
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