As if it were needed, yesterday one more example emerged yesterday to demonstrate how the FDA is failing in the all important digital space.  The National Institutes of Health announced a collaboration with the Wikimedia Foundation that has the aim to make "health and science information online more accessible and reliable."  It is indeed a visionary and laudable goal.  After all, evidence has demonstrated that health is one of the main reasons people go to the internet to seek information and that for those with chronic illnesses, it is an invaluable resource from which they not only get information, but act upon it.  

That is why other healthcare agencies in government, including HHS, CDC and now NIH have taken many steps to embrace digital communications as a means to talk to patients and to provide useful resources to help them get access to quality information that will be of help to them.  The efforts of these agencies span both a breadth and depth and convey that they understand the important role of the internet in healthcare communications.  

There are a number of angles that one can look at the FDA to see if there are indeed winds of change blowing through the agency.  Recently, we looked at the level of warning and untitled letters coming out of DDMAC as one indicator that there might be increased regulatory scrutiny now that the Bush Administration's "off-switch" for domestic agencies seems to have been turned back on.  Also recently noted was the rash of seizures that seemed to be happening at a quicker pace. 

It turns out that the FDA has more to talk about this year than last.  About 50% more.  During the first six months of 2008, the agency issued 80 press releases as compared to the first six months of 2009 when it issued 120 press releases.  And apparently, there is more to say because the agency is doing more.  

In May 2007, the FDA responded to an increasingly vocal set of critics in Congress by appointing Dr. David Acheson at FDA to "Assistant Commissioner for Food Safety" - with the media quickly dubbing him as the new "food safety czar."  During that time the FDA was quite beleaguered and there had been a number of food safety issues that had plagued the agency and the public.  The Congress was skeptical and particular members such as Congresswoman Rosa DeLauro took occasion to make the food safety czar into a punching bag.  At the time of his appointment, Dr. Acheson was quoted as saying that the primary strategy to guide future food protection efforts would be to move to a model that was preventive over one that was reactive in nature.  

Fast forward to July 8, 2009.  Two years later.  The FDA announces the appointment of Mike Taylor, a former FDA employee and a nationally recognized food safety expert, is appointed as a senior adviser to the commissioner on food safety.  Said Dr. Hamburg of the new appointment - "His expertise and leadership on food safety issues will help the agency to develop and implement the prevention based strategy we need to ensure the safety of the food we eat."  Already bloggers, among others, have dubbed him the new Food Czar.   We'll see if folks in Congress start beating this one up.

Sound familiar?  And, uh, how many Czars does it take?    Everyone wants prevention-based. Everyone is a Czar.  When do we turn the corner?

Today's WaPo editorializes under the title of "Food Fright" that what we need is strong, new legislation that will encourage a broader and stronger food safety system.  There is not shortage in Congress - there are about six new food safety bills that will address food safety on a widespread basis covering FDA and USDA that could introduce new standards of traceability and introduce some sweeping authority over organizing better oversight over industry, which could include new food fees to pay for greater enforcement (I always thought there would be some kind of FPUFA - Food Production User Fee Act).  

In addition to the proposed legislation, the FDA has been moving on several fronts with respect to food safety - most recently this week, taking regulatory action against a cheese manufacturer and issuing new regulations around eggs and salmonella.  However, it will be a combined effort of sweeping authority to actually change the status quo and new regulatory action and enforcement to allow the FDA to catch up to the demands on food safety that have made themselves present by globalization and other factors. So in the end, the proof will be in the pudding - the pudding that was recalled as unsafe before anyone got sick and died from tainted ingredients.  Otherwise, two years from now, we may pick up the paper to read about a new Czar at FDA who is going to move the system to one of prevention.  And we might yawn.

Yesterday we examined the quantitative aspect of the warning and untitled letters from FDA's DDMAC - today we are going to look at the substance of the letters to discern any lessons learned.   And just for the record, the letters from this quarter cited activities that included a wide span of communications - from the spoken word at conferences to video to mailers.  

As mentioned last week, there may be a pattern of greater enforcement emerging at FDA and there are a number of vectors by which one can try to ascertain the level of regulatory action, or lack thereof, on the part of the agency.  One such area is the issuance of Warning and Untitled letters by the Division of Drug Marketing, Advertising and Communications (DDMAC).  In this first installment, we examine solely the numbers of letters issued, followed in a future posting by looking at the substance of the enforcement.