We came across this article and interview recently between PhRMA‘s Assistant General Counsel, Jeff Francer and a writer from The RPM Report. Since the article is composed largely of a statement from the FDA‘s Division of Drug and Marketing, Advertising, and Communications (DDMAC) and an interview between RPM and PhRMA’s Assistant General Counsel, Jeff Francer, we felt it was best to post the comment and Q&A in their entirety.
FDA has delayed issuing guidance for rules of the road when it comes to the promotion of drugs on the internet and through social media platforms. The drug industry’s trade group says if FDA can promote medicines on Twitter, why can’t the manufacturers do the same?
When asked about the delay, FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) gives the following statement, reported first by the Eye on FDA blog:
Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities. Despite our limited resources and increasing workload, we remain committed to this area in terms of both time and human resources.
It is difficult to provide a timeframe for the issuance of our guidances due to the extensive work and review process, or “Good Guidance Practices” (GGPs), which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA’s current thinking on a topic.
Taking into consideration the input from within and outside FDA, including testimony and comments from the Part 15 hearing, we have identified the following issues that are important to address: Responding to unsolicited requests; Fulfilling regulatory requirements when using tools associated with space limitations; Fulfilling post-marketing submission requirements; On-line communications for which manufacturers, packers, or distributors are accountable; Use of links on the Internet; and Correcting misinformation.
We are developing multiple draft guidances to address these topics to benefit industry and the public by ensuring that these draft guidances are meaningful and well thought out when they are issued.
We asked PhRMA’s Assistant General Counsel Jeff Francer for his thoughts on the delay and the impact the guidance(s) will have on promotion practices.
The RPM Report: On a scale of 1 to 10, 1 being the least enthusiastic and 10 being the most enthusiastic, how enthusiastic are companies for internet/social media guidances to come out from FDA?
Jeff Francer: With all due respect to your scale, this one goes to 11. In this day and age when so much critical information is exchanged online, the FDA’s guidance about the communication about medicines is essential. FDA has quite an active presence on Facebook and Twitter and I think that it shows that it’s possible to use these media responsibly and clearly FDA thinks there is a public value for communications about medical treatments online.
The RPM Report: Has the delay been frustrating or is this something where you are happy for FDA to takes its time?
Jeff Francer: Don’t forget, we had a similar public meeting on the internet in 1996. So there is clearly some history to DDMAC considering this issue. Obviously, we know FDA needs time to tackle a complex issue and I think it’s fair to say that everyone in our industry wants FDA to get it right. But the agency held a public meeting in 2009 and earlier in the mid-90s, and it’s surprising that nothing has emerged.
The RPM Report: Do you expect something to come out this year?
Jeff Francer: We took FDA at its word that they would come out with guidance last year. And then we took the agency at its word that the guidance would come out in the first quarter of this year, and we’re very hopeful that we have guidance some time this year.
The RPM Report: How fast would companies be able to launch marketing campaigns around the guidance(s) once out and what kind of role will PhRMA be playing in translating them for the industry?
Jeff Francer: It’s impossible to know and it depends on what FDA says in the guidance. Companies want to be very responsible online and I think that’s why you see that, for example, FDA is more active on Facebook than biopharmaceutical companies. Depending on what type of guidance, it will take time for companies to digest the guidance and implement it as they will.
By way of example, we at PhRMA made a proposal about how to indicate risks in small spaces with the use of a universal symbol. If the FDA were to say that is one way to use media like Twitter and microblogs, it would take time for companies to digest that guidance and determine how to implement it.
The RPM Report: How do you react to the argument that the icon is tantamount to saying, “all drugs have risks but we’re not going to tell you what they are?”
Jeff Francer: I would take issue with that characterization. Anyone who watches a consumer television ad clearly couldn’t come back with the conclusion that companies aren’t communicating risks. Companies do want to communicate risks and do it in a way that is appropriate for the medium. Clearly, in 140 characters, for example (the limit on Twitter and mobile phone texting), it’s impossible to discuss all the benefits of a medicine or all the risks of a medicine. But there has to be a way to use the media responsibly. And the FDA is a great example. The FDA is tweeting about drug approvals practically every week.
The RPM Report: How many people could be reached through social media education campaigns?
Jeff Francer: We don’t know. The most recent numbers from the Pew Internet in American Life project show 80% of internet users have looked online for health information and that correlates to approximately 60% of the US population. So clearly, the internet is having a major impact on how people are learning about healthcare.
The RPM Report: Will drug promotion campaigns happen primarily on Facebook and Twitter?
Jeff Francer: Five years ago I would never have predicted that Facebook and Twitter would have come so far and their penetration of how we spend our time. I don’t think FDA should come up with standards that are appropriate for only one or two websites because clearly the internet and social media will change. It’s important to have principles. Frankly, that’s why PhRMA tries to put forward a set of principle s and some tools that could be used no matter what the medium.
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