For the past few years, drugmakers have grappled with the Internet and how to promote their medicines to an increasingly interactive public. Although the FDA held a widely attended meeting in 2009 and indicated that a draft guidance would soon be forthcoming, the agency has yet to do issue a document. Consequently, a vacuum has been created, but industry is growing frustrated. We spoke with Tom Abrams, who heads the FDA Office of Prescription Drug Promotion about the effort to assemble a draft guidance and what to expect. This is an excerpted version...
Pharmalot: Can you describe for us the extent to which social media is still a priority in terms of issuing guidance, and not just the technical term ‘issuing a guidance,’ but really helping industry to understand what the FDA eventually will do?
Abrams: The development and issuance of guidance for social media is among the highest of FDA’s priorities. It’s very important because we want good information to be provided to consumers and healthcare professionals, information that will be useful for public health concerning prescription drugs and medical conditions. So as a result, we have committed and extensive amount of resources, both in time and human resources to develop a guidance. We have done a lot of work and not done this development in a vacuum. We have reached out to our stakeholders. We had a public meeting, where 70 presentations took place and then there were submissions of comments to the docket. And we have not stopped there. We have met with stakeholders, industry groups, different technology companies to learn and inform us. So we have identified relevant issues, including responding to unsolicited requests for off-label information. using vehicles that have space limitations for promotion prescription drugs, appropriate use of links, fulfilling the regulatory post-marketing submission requirements of all promotion materials and correcting misinformation on independent third-party web sites.
Pharmalot: Okay, can we back up for one second? In terms of timing, there’s been so much pent up interest about when we’re going to get a guidance. So what can you tell us about that timing now? And there was a lot of anticipation just a couple of years ago after that public meeting, and as recently as 2011, that we’d see something already. So what’s changed that we haven’t yet seen a guidance?
Abrams: I think we’ve been consistent in so far as the amount of resources that we have applied to this effort over the past several years. If anything, we increased our resource allocation to this effort. What has changed is what we have accomplished. And what we accomplished is that we developed what issues are the most relevant for our stakeholders to have clarification on. All the guidances are based on current regulations, but we want to identify those issues that benefit industry and then eventually the American public so they can get good information about prescription drugs.
And we’re developing content for those issues. It takes time because we follow good guidance practices and we want guidances that are well vetted and really address relevant issues, and stay relevant for a time period. It would be easier to come out with a guidance in a shorter time that may not be relevant as technology changes. One thing we know is that we can’t predict it, but we know technology is going to keep changing quicker and quicker. So we want this guidance to be applicable, regardless of which technology platform comes in the future or changes that existing platforms may make in the future.
Pharmalot: So what can you say about when we’ll see a guidance?
Abrams: It’s hard to anticipate the time, because there are many steps involved. A lot of people are involved. We are working closely together with four medical centers in FDA because we want this to be applicable across all the medical products we have responsibility for. We’re working very closely with our lawyers to make sure that the guidances we issue will be based on sound legal principles, as well as sound policy principles. So getting input from our stakeholders –and not doing this in a vacuum – does take time. It’s a lot of investment time on FDA’s part, but it’s worth it because we’re very committed to investing that time and the human resources to get this right. It’s too important an area not to complete a thorough evaluation and not to produce the best guidance we can produce.
Pharmalot. Okay, I see that by law, it’s supposed to be out by July 2014. Does that jive with your understanding?
Abrams: Yeah, there’s a provision. Section 1121 in FDASIA that provides a timeframe as far as guidance development and that would be July 2014.
Pharmalot: So are you willing to say the FDA will make that?
Abrams: Our intention is to make that.
Pharmalot: Any chance you can make it sooner?
Abrams: We are striving to make it as soon as possible. I’ll be honest with you. As soon as we’re able to issue these – we’re not waiting for a deadline or we’re not waiting for an event to occur. We are working very, very thoroughly and very hard – people are putting in extra hours. .. And as soon as we can issue these, we will issue them. We are as anxious to issue them as industry is anxious to receive them. So we’re not waiting for a deadline or a timeframe. As soon as they are ready and we are happy they are good products that are well vetted and will remain relevant for a good time period, we will issue guidance.
Pharmalot: Recently, the issue of liking something on a Facebook page came up (back story). Can you explain what the issue is with this?
Abrams: I’m limited to what I can say about that. It was issued by a district office; it wasn’t issued by the Office of Prescription Drug Promotion. And if you read the letter and it’s very long, because there were so many violations. I know there was mention that the company liked and also linked to their web site misleading information that somebody else put out. So what we do, what we evaluate in a situation like that we look at the content and ask if the content is of promotional intent? If it is, is it being controlled or influenced or disseminated further by the company.
I found the action by that company unusual because the question we get from our stakeholders – companies – is not should we support or further disseminate misleading information that somebody else put out. The question we get is when we see information on a third party web site, what is the best practices that we can correct about their own product? How can we correct misinformation? That’s the question, that’s the issue that we get questions about from pharmaceutical companies. When they see misinformation about their own drug products on independent , third-party web sites, what’s the best practice for correcting that information?
Pharmalot: When we talk about space limitations, is 140 characters just too problematic or is it possible to incorporate the information you mentioned?
Abrams: Well, I think a couple of things. You’re speaking about Twitter, obviously. Google has search terms with some number of characters. The issue is can you fit things appropriately within space limitations. And I believe that you can fit them appropriately and meet regulatory requirements. So I think you can promote your drug using a space limited venue, such as 140 characters. I do think you can promote your drug that way, yes.
Pharmalot: What about the one-click rule? What can you say about that now, given the confusion and uncertainty? Can you give us some idea of what to expect? What direction are you headed?
Abrams: One of the issues we’re developing is how to promote and fulfill regulatory requirements in venues with space limitations. People have referred to a one-click rule, but there was not a one-click rule from FDA. That is something some people from outside the agency described. Our objective is that when you present claim information, it should be balanced with appropriate material, such as risk information. It should not just say all good things about a product and leave out the risk. Prescription drugs are wonderful. They do wonderful things for people – curing disease, prolonging life. However, people have to be aware and use them cautiously because of the risk associated with their use. That is our purpose in having balanced presentation. We want the drugs to be used in a safe and effective manner.
I know there was a lot press when we issued the sponsored link letters. There were 14 letters citing different companies. What wasn’t picked up was that we did a thorough evalution of many different web sites and many companies and products were compliant and did it right. Even though we cited however many products, most were compliant. So there are ways of being complaint and that’s what we’re articulating – that there are ways of being compliant when you have space limitations. And one thing I have to say about guidances, we will have suggested approaches about how to fulfill the regulatory requirements and something like space limitations, but companies can use other approaches so long as they satisfy it.
Pharmalot: You mentioned correcting information placed on a third-party web site. What points are you looking at more specifically?
Abrams: That would be what happens when a company sees misinformation about their product? What’s the appropriate manner for correcting that information? How do you fulfill the submission requirements? The regulations require that you submit promotional material as that time of initial use. How do you do that? What are the best practices when you have interactive media, such as a chat room or a Facebook page? And then appropriate use of links.
Pharmalot: You’ve already issued pre-dissemination review guidance for DTC on television in order to evaluate overall impressions. Do you see that approach being used for social media?
Abrams: The TV pre-dissemination guidance … is a requirement that TV ads have to be submitted for review 45 days in advance. I don’t see that requirement being held to social media… It’s not in the law. However, if a company wishes to get an advisory opinion voluntarily, they can submit materials to us.
Pharmalot: This reminds me of the cliché about the horse already being out of the barn. If it’s not required, what if any issues do foresee by not doing so? …Is there something that could or should be done to avoid a worst-case scenario?
Abrams: … We receive 82,000 pieces of promotional material a year. We have a voluntary compliance program and one thing to emphasize is that we devote more resources into compliance than enforcement. We’d rather prevent a misleading message. Our objective is to work with industry and educate them… But we do have a risk-based approach to enforcement and when we see a violation out there, we will take action as soon as we can… Our OPDP definition of serious violations is 'what is the possible negative impact on public health?'.. In this way, if something out there can be negative, we want to act against and get rid of it and maybe correct it as well.
Pharmalot: What’s the likelihood we’ll have to have an updated guidance very quickly?
Abrams: Well, two things. We issue a draft guidance and have an open docket phase and receive comments. We’re trying to make this reflect issues and not so dependent on specific platforms. So we want them to be, I don’t want to say timeless, but not quickly outdated. Our hope is that, as technology evolves, these guidances will still be applicable. If there are new issues, however, that come up, we’ll issue another guidance. Or will make necessary revisions. ..It’s the message we look at, not the medium. If you look at our letters, you just don’t see TV ads cited or YouTube. You’ll see sales rep activity, journal ads, patient brochures, exhibit hall activity, DVDs given to consumers, a video posted on CNN.com. We look across the marketplace. It’s not the specific media.