Eye on FDA’s 9th Birthday

It is hard to believe, but today – February 9, 2015 – I have passed the ninth marker of Eye on FDA. It seems like only a short time ago that I was reading a friend’s excellent and humorous blog and I thought to myself “hey – I could do something like this only make it about professional stuff…” That was in November 2005. In February 2006, I did a soft launch with an initial posting “Welcome to My Blog” followed by a more public facing launch a few weeks later.

I began the blog when it seemed that there was a pretty big state of flux respecting the agency and the medical products industry. For the previous five years, there had been more time that the agency did not have a Commissioner than time spent with one. There had been some high profile adverse events associated with products that were eventually withdrawn. Starting a blog to talk about this ever-changing environment offered me the opportunity to provide thoughts, analysis and opinion over the years.

For the sake of context, I thought it would be fun to take a look back to the world of 2006 when this blog began. It was a very different world – both from a regulatory perspective, a technological slant, and a communications one. Guidance on industry communications was limited to print and broadcast. There were no apps. There were no iPhones. Reporters were not on twitter. There was no Twitter.

Here are a few observations about then and now:

  • THENYouTube was one year old and had just been acquired by Google. By July of 2006, YouTube was getting 100,000,000 viewings of video daily and the site had 20,000,000 visits a month.
  • NOW – Over 6 billion hours of video are viewed each month and there are over 1 billion visits to the site each month. The number of people subscribing daily is up three times what it was last year.
  • THENTwitter did not exist. It would not come on line until March 2006 and would not be launched until July. There were many skeptics that a media platform that limited you to 140 characters would catch on.
  • NOW Every media outlet and nearly every journalist is on twitter. By December 2014, there were 500,000 registered Twitter users with about 284 million active users and a half a billion tweets sent each day. The Eye on FDA Twitter feed was begun in April 2008 and has about 12,000 followers.
  • THENFacebook existed in educational institutions and only became available to members of the public over the age of 13 who had an email address in September 2006. By December of 2006, there would be 12 million users and the concept of company pages emerged.
  • NOW – There are now over 1.2 billion monthly users of Facebook and there has been a proliferation of business pages sponsored by companies, including pharmaceutical companies and even government agencies such as FDA (which did not emerge until 2009).
  • THEN
    • FDA approved only 22 new drugs in 2006.
    • The agency issued a press release to announce the approval of a new laboratory test to detect human infection with an emergent strain of avian flu – a major emerging health concern at the time.
    • FDA had an Acting Commissioner at the time – Andrew C. von Eschenbach, later confirmed in late 2006, but the agency had either been without a commissioner or had someone in an acting capacity more often than not.
    • FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) issued only 22 Warning/Untitled letters – fewer than any other recent year.
  • NOW
    • FDA has also in the past year not only approved 41 new novel drugs the past year, over half of which received priority review and several under FDA’s “Breakthrough” designation and more orphan drug approvals than at any time in the agency’s history.
    • FDA has recently approved rapid tests for detecting Ebola – a major emerging health concern of our time.
    • The FDA Commissioner is Dr. Margaret Hamburg, but she will be stepping down in March after six years.
    • FDA’s Office of Prescription Drug Promotion (OPDP), the re-situated and re-named DDMAC produced the fewest number of Warning/Untitled letters  – 10 – less than half those of 2006 and only 6.4 percent of the number produced in 1998.

I have tried to provide insights and observations in this space regarding those issues that might impact the work that communicators face in medical product and foods. To that end, I have developed databases that help me draw some analysis – including

  • one on FDA Warning Letters,
  • one on Pharma activity in social media space,
  • one on FDA press releases.

There is a lot going on, worth keeping one’s eye on, that can help provide information regarding the communications parameters in which those industries regulated by the agency can operate.

There has been a constant over the past nine years – the one reliable thing is that nothing stays the same and things generally change rather quickly. It has been fascinating to watch, particularly as communications became so radically altered by communications technologies – especially on a platform like the Internet – a resource to which people turn for answers on healthcare. I have very much enjoyed watching, anticipating these changes – sometimes fast and in the case of FDA’s regulation – sometimes slow – and providing commentary in this space.

Thanks for being a reader. On to year 10.

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