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.

It seems early in the oversight of the new FDA Commissioner and Deputy Commissioner to the agency turning a corner, or maybe not.

There have been two indications of possible increased enforcement that have emerged in the past few days that lead one to at least wonder if the FDA is getting more serious about enforcement. 

First, as mentioned in the Weekly Roundup on Friday, Caraco Pharmaceuticals experienced a seizure by U.S. Marshalls of product.  This occurred after a long period of regulatory interaction.  

Second, in the same week, the FDA issued a Notice of Intent to Revokethe biologics manufacturing license to Immucor regarding a facility in Georgia, also following regulatory interactions. 

Regulatory actions take time to organize and move in the bureacratic machinery and it could be that these efforts were in the works for a while and it is perhaps too early to determine if the FDA is picking up the regulatory pace.  But if we start seeing Consent Decrees, then we may be in fact seeing a sea change in enforcement.

We have had 3 days in a row without rain.  That is most welcome.  Today, I fear, we may lose our streak.  It has heated up in Washington and so has the debate on healthcare reform.  Another public figure who favors the sentiments of the Defense of Marriage Act goes down in lusty carnal flames. They are dropping like flies.   Meanwhile, here is a little of what happened in our world this week: