Why the FDA needs to accept PhRMA’s Social Proposal

by Josh Bernoff

The pharmaceutical industry and the FDA are in a strange position.  

People are discussing drugs and treatments all over net, from WebMD to the American Cancer Society’s Cancer Survivors’ Network.

But pharmaceutical companies can’t encourage or participate in this activity in any way. In one case in my research, a pharma company employee begged me to take down a reference to a site her company had sponsored – the logo was right there on the site – even though the company had provided an unrestricted grant and did not influence content in any way.

This level of hypocrisy is absurd, and serves no one.   Now PhRMA – the pharmaceutical industry organization – is proposing the creation of a logo that could be placed on social sites to indicate where information that meets the FDA’s guidelines for fair balance, non-promotion of off-label uses, reporting of adverse effects, and other regulations would be strictly followed.

This is an ideal way out of the current state. The logo should be prominent. Furthermore, I think pharma companies should moderate and appropriately respond to social activity, including blocking off-label suggestions and following up on adverse effects. This works now for GSK’s alli community , which exists only because alli is an over-the-counter drug and therefore is not subjected to the same level of scrutiny by the FDA.

Sure it’s expensive to do this moderation, but alli shows it can be done, and effectively. Pharma companies are enthusiastic about social media but terrified by the lack of FDA rules, which means they never know if they’ll be cited for inappropriate behavior.   It’s time for the FDA to indicate what behavior is appropriate, including moderation and the logo linking to fair-balance information. Then people who need information about medications will be able to benefit from peer content. It’s a lot better idea than leaving all that peer content on unregulated sites, and allowing pharma only with ads with pages of small print disclaimers. How 20^th century!

Comments

[Andy Nash]

Have you seen Beth Simone Novack's book Wiki Government? She also has lots of good ideas for helping government agencies make better use of Web 2.0.

[John Mack]

An FDA logo on drug ads would only be appropriate, IMHO, if the link associate with it lead back to a page on FDA.GOV where the consumers can find links to ALL relevant documents related to the drug, including patient-friendly labeling, emerging safety information, dear doctor letters, MedWatch adverse even form, etc. In other words, if it has FDA logo it should link to information FDA maintains and updates in a timely fashion.

[John Murray]

FDA will never allow the use of its logo or likeness for information that it does not "appprove." FDA's questions to PhRMA and others proposing similar ideas highlighted its concern that the use of its logo would convey too much to the audience of an advertisement. While the information on websites and company ads must comply with FDA regulations, they are not approved by FDA, except for the Prescribing Information or package insert or Medication Guides. Nonetheless its a good idea in the right direction, but this use of FDA's name or logo will have to address the limitations of FDA's actual oversight and approval of the content a consumer will then see. That is, if all this info was actually approved by FDA, then there wouldn't be any warning letters. The information is FDA-regulated but not FDA approved, and a lay person would easily misunderstand this distinction. More work needs to be done on this promising concept.

[angkasuwan]

fda is a strong recognizable brand. might as well go with it.

[Brian Hayashi]

While not nearly as Byzantine as the FDA, governments could benefit from the same clarity around the issue of state and local tax. US governments and business entities would both benefit were there greater clarity on what is and is not appropriate, rather than fighting things out in local courts, which in turn fails to create any sort of binding precedent other than establishing lobbying as a successful career path.

The current tussle between cities and OTAs underscores the stakes involved, and loads unnecessary risks into the OTA's heretofore successful merchant model. My concern is that this level of risk creates a chilling effect for innovation, which is exactly what cities need to bring more people into their communities.

Secretary of Commerce Gary Locke has a unique vantage point, not only because of his current position but because of his participation in early discussions of the fair disposition of online tax.

http://govinfo.library.unt.edu/ecommerce/bios.htm