Wednesday, April 08, 2009

PhRMA Says FDA Should Initiate a Public Process Rather than Regulate by Warning Letter When it Comes to the Internet

"FDA should initiate a public process, which could take the form of a meeting or draft guidance, rather than regulating by warning letter in an area where there is now a lack of clear standards," said Jeffrey K. Francer, Assistant General Counsel, PhRMA.

His comment was made during a recent 45-minute ePharma Pioneer Club conference call that I hosted. Several other ePharma Pioneer Club members, including Fabio Gratton, Jonathan Richman, Rich Meyer, and Rob Nauman were also on the call and had comments.

The subject of the call was Overcoming Barriers to Pharma's Engagement in Social Networks. I expect a podcast audio archive to be available shortly.

Meanwhile, here are the opening comments I made during the call:
As all of you probably know, the FDA just sent off 14 letters to different pharmaceutical companies about pay-per-click search engine ads that violated FDA regulations regarding fair balance. Although some of us felt in the past that these ads were perfectly kosher because of a so-called “one click rule,” it turns out that this is not the case.

Mark Senak expressed our concerns well when he said in an Advertising Age article:

"The FDA is of the mind that they don't need to issue guidance specific to digital media because their current regulations cover that," said Mark Senak, senior VP at Fleishman Hillard and author of blog Eye on FDA. "Technically that's true. However, the internet presents a lot of situations that are somewhat nuanced and would lead to question in the mind of any reasonable person. Those questions deserve some answer. Formulating policy by issuing mass warning letters is not a valid way to set that policy or express it."

I think most of us agree that there are several other ways in which pharmaceutical companies can get into trouble with the FDA when they use social media. Right now, there is NO guidance from the FDA on how they may look at social media marketing in the future. As recent FDA actions have shown, companies can be in for some bad publicity and risk losing sales if they are caught unawares. It is perfectly reasonable, therefore, for the drug industry to insist that the FDA come up with some guidelines for use of the Internet and social media.

Before the FDA goes off and creates guidelines, however, it is important that it understand the position of all stakeholders on this issue. 84% of respondents to my survey agree that before issuing any draft guidance, FDA should convene a public hearing in which ALL stakeholders – including pharma, agencies, patient advocates, healthcare professionals, web site owners, etc. – can put on record their suggestions and concerns.

Some of us have already approached the FDA on this and have been rebuffed. One goal of this conversation, therefore, could be to approach the FDA as a stronger coalition of concerned stakeholders and demand at least a private meeting.

Although it would be helpful for the FDA to release guidance for the industry on the use of social media, there is also a need to develop “best practices” that go beyond what the law requires. Some pharma companies are currently discussing this and that is perhaps what we can also do starting with this roundtable discussion.



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