Everyone Piles Up on FDA for the Election Cycle

J0316946I’ve been on the road traveling for several days and lots has been happening.  The occasion of the 100th anniversary of the FDA’s existence has sparked a great deal of commentary. 

Gang up!  Remarkably, all on the same day, Public Citizen, the Center for Science in the Public Interest and Congressman Waxman all jumped on the FDA and the Administration for not doing a good enough job protecting the public health.  This, in turn, caused the Grocery Manufacturers Association to counter.  Ouch!  Everyone’s hair is on fire, making me somewhat happy to be a head shaver…

Here is what everyone said:

Congressman Henry Waxman’s (D-CA) statement was labeled "Prescription for Harm – The Decline in FDA Enforcement Activity" was really aimed at the Bush Administration.  The complete report is available by clicking here.  The statement was based on a report by the Congressman citing these key conclusions:

  • FDA enforcement actions have declined under the Bush Administration – This appears to be true.  Enforcement actions have declined.  I can recall a few years back asking the then Deputy Commissioner for External Affairs whether or not the slow down in Warning Letters issued by the agency was a reflection of lower funding for enforcement and I got a one word answer – "No."  If not because of budget, then either the companies got wiser about avoiding them or the agency less prone to exercising their ability to issue them.  That said, fewer enforcement actions do not necessarily translate to lax enforcement, it could mean more selective enforcement.   A quantitative review without a qualitative review does not mean much here.  You really need to calculate whether or not more people have been harmed by drugs, factor in the number of people who have benefited from the drugs and several other variables to see if the enforcement pattern is more lax than before.  The FDA should be making that clear, but instead seems to not care.
  • FDA headquarters officials have routinely rejected the enforcement recommendations of career field staff – The press release states that in 138 cases over 5 years, the FDA filed to take actions recommended by staff.  However, without a comparison to other 5 year periods, it is not clear whether or not this is an increase over other administrations.  However, of course, Plan B does stand out as an example of the FDA acting politically, and that is and was unforgivable for the damage it has caused to both the agency and individuals.
  • FDA’s record keeping and case tracking practices are inadequate – This criticizes the FDA’s compliance with requirements on record keeping.  I translate this to mean transparency.  The agency is actually, for the most part, very transparent when you compare it to the EMEA in Europe.  Meetings are public, transcripts are posted, etc… However, they do appear selective some of the time in postings.  Take, for example, their failure to post Dr. Janet Woodcock’s May testimony before Congress on RU-486.  They have been inconsistent and that could lead one to conclude that they are enacting a policy of transparency by choice.  (May 17 Notice – RU-486 SAFETY – Committee on Government Reform: Subcommittee on Criminal Justice, Drug Policy, and Human Resources held a hearing entitled “RU-486–Demonstrating a Low Standard for Women’s Health?” Testimony was heard from Janet Woodcock, M.D., Deputy Commissioner, Operations, FDA, Department of Health and Human Services; and public witnesses.)

The Center for Science in the Public Interest statement threw in the kitchen sink.  They criticized the acceptance of user fees under PDUFA, the failure to learn from past drug withdrawals, alleged consumer fraud on tobacco cessation products and on the food side – failure to address obesity, heart disease, high blood pressure, labeling and food safety generally.  That is a lot.  True, the agency does have a broad mandate, but I don’t think they are responsible for America being so fat and unhealthy.  Be real.  The agency is not there to weed out every evil in the garden. 

Public Citizen had this to say – it was the exact same press release as CSPI!  These organizations must be chipping in for Communications Director salaries. 

The GMA statement rose to the defense of the agency.  At least someone did it.  But they focused on the agency’s track record respecting food safety and work on the obesity problem.  While a nice lauding of the agency, it doesn’t really address the damning scale of attack launched on the FDA. 

I am a fan of both Congressman Waxman (he used to be my Congressman and I always voted for him) and the FDA.  However, in this case, I see neither as acting fully in the best interests of the public, but rather, both acting in the best interests of politics, and I’m not sure that either is doing even that very well.

The Administration has been lax regarding drug development.  The agency, under this Administration has allowed the agency to limp along without leadership and allowed a political issue to interfere with a scientific outcome for an RX to OTC switch.  The track record of the Administration can be effectively attacked without attacking the agency itself.

But my point is that, as usual, and this is a point upon which I’ve been consistent, the FDA seems focused on doing nothing from a communications perspective to right the problems or to proactively address the situation, unless you count launching new "initiatives" that fail to relate to the public imagination and does not fall into the category of crisis communications.  Interestingly, the CSPI and Public Citizen press releases criticized the FDA in their "self-congratulatory throes" of the 100th anniversary.  That’s a laugh.  Their communications plan around their 100th anniversary is non-existent.  If you go to the Web site and view their activities, they are understated, to say the least. 

But the agency needs to make a plan.  They need to execute it.    Because in this election cycle, this is only the beginning.  And so far, they don’t seem to get that. 

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