Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer, and Sanofi-Aventis filed Citizens Petition with FDA asking for communication policy

The Citizens Petition from Allergan, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, Novo Nordisk, and Sanofi-Aventis to the FDA was filed by Ropes and Gray law firm which specializes in corporate law and litigation matters.

There's been a flurry of talk on Twitter about Face Book telling the pharmaceutical industry to unmoderate comments or take a hike. In August this will be implemented and the drug companies will then have to abide by Face Book rules and allow comments, and that will then include unregulated discussion in the comment section possibly from patients, which is a tricky area legally for drug companies as well as having a possible negative outcome considering patients can then leave comments pro or con about certain pharmaceuticals.

Prior to the Face Book regulating comments and pharma discussion there has been an ongoing discussion that the pharmaceutical companies seek out, and that is asking the FDA for regulation and guidelines in the social media sphere, what to say and what not to say and how to be held accountable for it, along the premise of being transparent. Pharma wants to know how far they can go in social media with scientific discussion, and (promotion) of products and the FDA has dragged their feet with the guidelines.

This has left patients and advocates as well as corporate representatives using Social Media (Twitter, et al)with questions as to how to address questions by patients posed toward a drug company. Currently, there are no guidelines and the companies are policing themselves with legal teams.

I have been watching AstraZeneca on Twitter, and have discussed this briefly with Tony Jewell, who tweets and edits the AstraZeneca blog. I have noticed that AstraZeneca are not listed in the group that filed the Citizen Petition with the FDA.
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Drug Wonks

Drug Wonks post:

"Think regulatory headaches about FaceBook is a hot topic?? Here are some communications issues that make social media guidance pale in comparison.

Today Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer, and Sanofi-Aventis will file a Citizen Petition with the U.S. Food and Drug Administration (FDA) asking the agency to clarify its policies on how truthful, non-misleading scientific information not included in approved product labeling can be communicated.

The petition will state that communicating accurate scientific information about new research would enhance health care quality and potentially lead to better patient outcomes, but that companies lack precise guidance on how to communicate such information.

Specifically, the companies requested that FDA issue clarifying regulations or guidances on four issues:

* “Scientific exchange”
* Sharing information with formulary committees and payers
* How to provide independent third-party clinical practice guidelines
* Responding to unsolicited requests for information

“Scientific exchange,” broadly defined, is the sharing of research and clinical information about investigational medical products or new information on approved products without representing the product as safe and effective for that use. FDA said in a 1963 regulation that it does not intend to restrict “scientific exchange.” The concept of “scientific exchange” however, is not precisely described in FDA’s regulations and therefore leaves ambiguity about the limits of what is permitted."
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Lilly Pad, A Corporate website

"Citizen Petition with FDA

July 5th, 2011 By: Greg Kueterman

"Earlier today, Lilly joined six other companies (Allergan, Johnson & Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis) in filing a “citizen petition” with the U.S. Food and Drug Administration. The purpose: to seek clarification on the agency’s policies about communicating truthful, non-misleading scientific information that is not included in product labeling.

In particular, we’re looking for more guidance in four key areas: scientific exchange, sharing information with formulary committees and payers, providing independent third-party clinical practice guidelines, and responding to unsolicited requests for information. The Pink Sheet and Drug Wonks were among the publications reporting the petition this morning.

Why now? Because there continues to be some confusion about what companies can — and cannot — say to health care professionals, payers, and patients about new scientific information. Remaining compliant with all laws and regulations governing the industry is critical, so requesting formal clarification for the entire industry seems to make the most sense. Updated guidance from the FDA will help all companies improve the flow and quality of information being used to communicate with these key audiences.

That said, we’re not asking for a change in the regulations — just clarifications that will help us communicate in a better way. These issues have needed clarification for some time — for instance, the FDA does not have a clear definition for “scientific exchange. By the way, the FDA could respond within 180 days.

This is all about clarity and transparency. It’s our job to stay within the boundaries, and clarity will help us do just that."

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Pharma Marketing Network

" If the petitioners are not satisfied with how the FDA responds to the petition, they are likely to "take the matter to court" further hamstringing the FDA efforts to issue social media guidance. The number one pharma company and one of the petitioners is already on record opposing any social media guidance on first amendment grounds (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").

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Different perspective arrives with the statements from Lilly vs John Mack's take on the matter. It leaves room to question the wording from a pharmaceutical company, which is in business to profit long before wanting open and transparent communication via social networks with patients and consumers--is it transparency pharma wants? or is it control over the FDA's regulations that in the end will ultimately benefit pharma, because after all business is business. Ropes and Gray letterhead is a good visual of that.


Hat tip to John Mack, author of Pharma Marketing , read his article here, which includes the link to pdf of the Citizens Petition.


Addendum: In the spirit of using Social Media via Twitter, I have asked AstraZeneca's Tony Jewell:

I'd like to know why AZ not part of http://tinyurl.com/3v5pygw
citizen petition.Email me w response to add to my post? thx @ TonyJewell

My previous question to Tony Jewell regarding AstraZeneca and Face Book, and whether or not the company will remain on Face Book...here's his reply:

@soulflsepulcher We're evaluating. Question isn't critical comments - but unmoderated comments on meds on company-sponsored site.