10 Years of Eye on FDA – Looking Back

This month marks a decade of Eye on FDA. A good friend of mine was writing a personal blog, which most blogs were back then, that was well-written and funny and I thought – hey I could do that only about professionally-related issues. Well, not as well-written and not as funny as my friend’s blog, Eye on FDA has nonetheless been around to provide insights and commentary on a range of issues related primarily to FDA and the industries it regulates.

Over the years a lot of ground has been covered. Here are a few of my favorite moments looking back:

  • March 2009 – FDA’s First Words on Social Media Regulation - In a posting entitled “A Conversation with FDA/DDMAC About Pharma, Social Media and Web 2.0” a representative from OPDP (then called DDMAC) provided the agency’s first real public commentary on how FDA was thinking of approaching the use of social media by pharma. At the time the agency’s thinking was that it was the message, not the medium and that regulated industry needed to follow guidance that had been given regarding print and broadcast. It was the single most shared and read posting in the entire 10 year history of the blog.
  • January 2010 – Twitter and Congress - Following the 2008 election cycle, the Obama campaign earned a reputation for its savvy use of digital and social media in the campaign. Today, virtually every member of Congress is on Twitter and Facebook and many have blogs, but back in 2009, only about one-fourth of the Congress was there. In “Twongress – the Power of Twitter in Congress” two things happened – the first was coining the term “Twongress” which some people loved and some people hated and the second was the publication of a White Paper that compared the use of twitter between the Republicans and the Democrats in the Senate and the House. The paper got a lot of media attention and then House Minority Leader John Boehner issued a press release about the paper.
  • April 2013 – Is Digital Risker? – The lack of guidance from FDA around social media stretching out for years may have contributed to a perception that social and digital media were risker communications platforms than were traditional forms of communication among those in regulated industry. Who knew?  After working on a database of OPDP/DDMAC warning and untitled letters that spanned back through 2004 – the result was a White Paper – “Some Digital and Social Media Guidance – FDA Regulation of Pharma Communications in a Digital Era“.  One of the fields that was tracked in the data base was whether or not the communications vehicle involved in violations cited in letters were digital or not. A comparison during the years when social media was in its ascendancy (2008-2012) revealed that in fact most violations were still happening on traditional media properties and digital was not growing in proportion nor did it represent a greater proportion of Warning Letters. That is a observation that has held up over time.
  • July 2014 – FDA Issues Some Guidance on Social - Waiting since the public meeting held in November 2009 industry finally saw some guidance in the summer of 2014 with the issuance of guidance documents involving the correction of misinformation and use of platforms where there is character space limitation. “In More than 140 Characters” – an Eye on FDA Webinar to review the regulation of social media and promotion to date. The Webinar had a large number of sign ups, and all in all, the story is still unfolding.

Those are a few of my favorite moments over the course of time. For me, the blog has been a great experience. I pay more attention to what is going on and I think about it more than I probably would have otherwise. I hope it does the same for you. My aim has always been – and will continue to be – the provision of material in the way of news and thoughts that will be helpful to you in what you do. I appreciate all of the readers over the years and all of the Twitter followers at @eyeonfda. Thanks for being here!

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From HIV to Zika – The Role of Communications

The pathogen may change, but there are aspects of communications during a time of outbreak, particularly involving an emerging pathogen, that seem to be a constant.

A few short months ago no one had ever heard of the Zika virus. But this past Sunday a story about the virus was on the front page of the New York Times above the fold. The spread of the virus and its unfortunate effects have captured the attention of public health authorities such as the World Health Organization and the Centers for Disease Control and consequently, the media.

In July, 1981, the New York Times carried the story of another emerging virus that did not yet even have a name, but seemed to be affecting gay men disproportionally. First called HTLV-III and later known as HIV, awareness of that virus and its impact did not fully command public attention until 1985 when it caused the death of a high profile celebrity, Rock Hudson. While the story of the AIDS epidemic is very different on a number of levels from the unfolding Zika virus situation, when it comes to emerging pathogens and communications about them, there are consistencies that do not vary much from pathogen to pathogen. Here are a few:

  1. Misinformation and Conflicting Information Can Thrive - An environment where there is limited knowledge can be a breeding ground for misinformation. Performing a simple internet search on the terms “Zika” and “likely” will yield conflicting headlines with two polarized points of view on the matter. Issues of transmission, the affect and impact of infection, long-range outcomes and prevention matters can be fuzzy for some time. Even public health authorities can, and likely will, be in error from time to time though they remain the best and most reliable source for information.
  2. The Demand for Answers Outstrips the Ability to Provide Them – Fear of the unknown prompts a lot of questions and not getting answers leads to anger and frustration. Sometimes when there is a void, people want to fill it even if the information is not entirely accurate. It is important to define that information which is known while clearly identifying that information which is speculative or based on informed thinking. “To the best of our knowledge…” or “Based on past experience with other viruses like this” are important qualifiers to statements that are not rooted in absolute fact.
  3. Many Stakeholders Won’t Sense the Importance – Denial is always a component during a threatening situation. Many stakeholders may not want to believe, or may not connect the dots, on how and why they should be concerned and taking action. The development of a “them” and “us” mentality can be insulating. Even in an environment where the future is not well defined, preparation for dealing with some basic questions and policy is important. Schools, employers, hospital systems and doctors will all likely face questions, pressed particularly when there is a first case or transmission that is local. With Ebola, hospital systems in particular faced a multitude of questions regarding transmission and policies related to quarantine. Planning ahead of time how you will deal with the issues when you have to face them can make a big difference.
  4. Fear Results in Discrimination – Fear likely spreads more quickly than a virus. Particularly where children are concerned, people want reassurances that are absolute. It is important to communicate clearly what is known about a situation and what is not known, but also to provide distinctions between what is likely and what is possible but not likely. Since transmission of Zika has been acknowledged to have occurred outside of the mosquito vector, the stakes on this front go up. Connect the dots now to consider how events will unfold with respect to your institution.
  5. Public Health Authorities Are the Best Resource - While no one has a crystal ball into the future, public health authorities at key institutions such as the Centers for Disease Control have had a good deal of experience with emerging pathogens since the AIDS epidemic. Multi-drug resistant TB, SARS, Ebola, MERS and even other mosquito related pathogens have provided them with experience allowing them to make informed judgment calls. They are the best source of information for all stakeholders including media and hopefully will produce at some point a writer’s guide to Zika, particularly as we near the Olympic Games to be held in Brazil this year.

Media focus now would seem to primarily be on understanding the impact of the virus and the efforts to contain and combat it. Should there be a spread, that focus will widen to include aspects of the expanding experience with the infection – from individual to institutional stories. Between now and that time, stakeholders will do well to consider the various ways in which they may be called on to communicate about this outbreak and to plan not only their content but also their point of view accordingly.

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FDA Guidance Output Plans for 2016

While there has been focus on what FDA accomplished in 2015 – and there will continue to be some of that – it is also a great time to look ahead. What can we anticipate for 2016? This month several parts of the agency – CDRH, CBER and CDER unveiled plans with respect to the production of guidance documents for the coming year – in some cases notable for what is there and in others for what is not. Here is a brief overview with relevant links.

  • CDRH –  So let’s start with devices. You would think this might be simple and straightforward, but it is not. There is not one list and there is not one category. Rather, the Centers for Devices and Radiological Health (CDRH) published two lists of intended guidance documents for the year – an A list, representing priorities and a B list, representing that which will come about if there depending on time and resources. Each of these is subdivided to address the prospective issuance of Final Guidance documents and the release of Draft Guidance documents. The A and B list can be found here. Current CDRH guidance documents can be found here.
  • CBER – The Center for Biologics Evaluation and Research (CBER) has a much smaller list, divided into only three categories:  Blood and Blood Components lists a potential of six documents, mostly around the topic of preventing transmission of agents through use; Cellular Tissue and Gene Therapy lists three potential documents two of which involve adverse events; and a catchall category of Other which contains only two documents. Current CBER guidance documents can be found here.
  • CDER – The Center for Drug Evaluation and Research (CDER) had the most ambitious list numbering over 100 proposed guidance documents across 15 categories.  Most notably for our purposes in the category of Advertising, there were only four documents, one of which relates to the use of the Internet/Social Media. That one is called “Internet and Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites“.  This one is noteworthy in two respects. First, it is not the first year that this title has been on the list – it is a repeat which might indicate if we were using the CDRH method, this would be a “B-list” item. Second, in previous guidance documents issued during 2014 – and with the infamous release of the 14 Untitled letters affecting 45 brands for banner ads in 2009, FDA has actually already  indicated a good deal about the appropriate use of links. In the former, the agency outlined when use of links to risk information is appropriate where there are character space limitations. In the latter, the agency indicated an area where use of links not appropriate.  Finally with regard to the CDER list, it is s not there. In the 2009 public meeting on use of the internet and digital media for promotional purposes, FDA outlined 5 areas in which they were seeking information so that they could issue guidance. While use of links was one, so was adverse events. Nothing is indicated for 2016 in terms of guidance for that topic, or to address any of the other many holes and questions OPDP has left in the guidance process on this topic. The list of CDER guidance documents can be found here by category.

While this is the plan, as you can see from the A list and B list of CDRH and the repeated topics listed in the CDER list, the plan does not always get executed. While FDA may issue guidance on these topics, being on this list is no sure bet that we will in fact see the document issued this year. We can only watch and wait.

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Weekly Roundup 1.29.16

Well, we have gotten through the first month of the year. We had a lot of days with some pretty warm temperatures and it was evident that many of the daffodils had the idea that it might be a good idea to show up a bit early. Then came the two feet of snow, which by the looks of it could linger until August. Just goes to show you, it doesn’t always pay to be early.

In better shape now than I was before, thanks to shoveling. And then more shoveling. And then some more. And here is a bit of what happened even during the many snow days that closed down government operations, among other things.

  • Drug Approved for Liposarcoma - FDA announced approval this week of the first drug to show a survival benefit in the treatment of liposarcoma when it cannot be removed either by surgery or has become advanced and in patient who have received prior chemotherapy that contained an anthracycline drug. FDA is quoted in the release as saying that the clinical trial data indicated that the drug, Halaven increase overall survival time by approximately seven months. Liposarcoma is a specific type of soft tissue sarcoma in which cancer cells that develop in the soft tissues of the body such as muscles and tendons among others occur in fat cells almost anywhere in the body. The drug had priority review status and received orphan drug designation. The press release from the sponsor company can be found here.
  • First Untitled/Warning Letter of the Year – As noted at year end, enforcement actions as evidenced through the issuance of untitled or warning letters by FDA’s Office of Prescription Drug Promotion (OPDP) declined to a new low last year. This week a new letter was posted representing the first action from that office since August, 2015 and involved a YouTube video. There was a time when any warning or untitled letter aimed at a social media communications vehicle set off all sorts of alarms in the cautious. It tended to validate the notion that digital media was riskier than traditional communications vehicles, which has been shown not to be based in the record. In this case, FDA noted that the video in question portrayed benefits of the treatment, but did not include mention of the risk profile – a circumstance that would have resulted in a letter from FDA regardless of the medium used to convey the message. In short, it wasn’t a social media thing, it was a message thing.
  • Sanders Puts HOLD on FDA Commish – Presidential candidate Bernie Sanders announced earlier in the year that he did not intend to vote in favor of the nomination of Robert Califf for Commissioner of the Food and Drug Administration. This week he went one step further and placed a HOLD on the nomination. Other Senators – Markey and Murkowski – have also placed holds on the nomination. The reasons cited for the hold were the nominee’s past ties to the pharmaceutical industry itself and concern over the pricing of pharmaceutical products. While the hold generated some news coverage, none that I saw made mention of the fact that FDA has nothing whatever to do with the pricing of products.

That’s it for me this week. Still digging out somewhat. And that thing I said the week before last about wanting a big snow. I’m over that now. Be well everyone.

Photo Courtesy of Anne Becker

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FDA 2015 Report on New Drug Approvals – A Banner Year

Greetings from the big blizzard of 2016.

With life in the slow lane for a bit, it was a good time to catch up on reading. One of those was a recently issued FDA report on the novel new drugs that were approved in 2015. It is a very thorough and well organized report and while it is worth summarizing a few things from it here, you are encouraged to download the original here. It was a banner year in approvals on a number of accounts.

First let’s just get perspective on how this year compares in terms of numbers to previous years from this chart provided by FDA in the report.

This year was not only unique because of the high number of approvals – 45 in all, but, as reported earlier, because so many of the new drug approvals involved oncology.

However it was also noteworthy that – but because of the large number of drugs approved had a special status attached to them. This was either because they were drugs to treat orphan conditions and/or because they were breakthrough, had accelerated approval, priority review or fast track status. In fact all in all, 60 percent of the approvals that occurred this year had some type of expedited status meaning FDA approved more drugs more quickly this year than in any previous year and nearly half were for rare conditions. Moreover FDA met the PDUFA date for approval 96 percent of the time and about two-thirds of the approvals were made here in the United States before being approved in any other country.

  • 45 New Novel Drugs in 2015
  • 16 (36 percent) were First-in-Class
  • 21 (45 percent) had Orphan status
  • 14 (31 percent) had Fast Track status
  • 10 (22 percent) had Breathrough status
  • 24 (53 percent) had Priority Review
  • 6 (13 percent) were under Accelerated Approval

Need the primer on the difference between all those expedited approval terms?  Click here.

The report has a lot more information and details of interest. In addition there is a very nice table that lists each approval with links to the original FDA press release where you can learn more. It certainly will be a tough year to top – let’s see.

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