Fox Guarding the Hen House

The Washington Post is reporting that the FDA allowed fees to be charged – as much as $25,000 – for companies to attend private meetings held with the agency.  Private meetings that “shaped the federal government’s policy for testing the safety and effectiveness of painkillers”.  It makes you wonder if such paid admission private meetings happens with pet food issues too.

The Washington Post states:

A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request.

The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.”

Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States. FDA officials who regulate painkillers sat on the steering committee of the panel, which met in private, and co-wrote papers with employees of pharmaceutical companies.

Even as the meetings were taking place, the idea of FDA officials meeting with firms that had paid big money for an invitation raised eyebrows for some. In an e-mail to organizers, an official from the National Institutes of Health worried whether the arrangements made it look as if the private meetings were a “pay to play process.”

FDA officials did not benefit financially from their participation in the meetings, the agency said. But two later went on to work as pharmaceutical consultants and more than this, the critics said, the e-mails portray an agency that, by allowing itself to get caught up in a panel that seemed to promise influence for money, had blurred the line between the regulators and the regulated.

In a statement, the FDA said “we take these concerns very seriously.” But, it said, “we are unaware of any improprieties” associated with the group.
 
Douglas Throckmorton, a deputy director of the agency, said in an interview that strict rules of transparency and funding apply to the public-private partnerships that the agency engages in and that these efforts are important for the government and the industry.

But the group in this case was not initiated by the FDA, he said, and so was a private partnership to which those rules did not apply.

The meetings, which involved about 30 to 40 people, included academics, FDA and NIH officials, and often as many as 14 representatives from pharmaceutical companies. Only the companies paid fees to attend.

The Washington Post story shares that the meetings were not organized by FDA; the meetings were organized by two university professors – “Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington.”  These two professors received “as much as $50,000 apiece for a meeting”.

The Washington Post story continues explaining that an FDA chief (of analgesic division) “touted the influence of the group” (known by the acronym IMMPACT) in a 2007 presentation.  “A 2007 ¬PowerPoint presentation he put together was called “The Impact of IMMPACT” and recognizes the group’s influence on FDA thinking. The presentation describes the committee as “a wealth of opportunity for communication” that was advancing the science and “approving new analgesic drug products.”

There’s more – please read the Washington Post story – Click Here.

Now, in light of the above information, let’s consider a couple of things in pet food…

Pet foods and animal foods are given special privileges by FDA to violate federal law.  Federal law states (Section 402 a 5 of the Food Drug and Cosmetic Act) “A food shall be deemed to be adulterated–
5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter;” 

One of the biggest pet food special privilege is FDA Compliance Policy 690.300 which states:

“POLICY: Pet food consisting of material from diseased animals or animals which have died otherwise than by slaughter, which is in violation of 402(a)(5) will not ordinarily be actionable, if it is not otherwise in violation of the law. It will be considered fit for animal consumption.”

It makes you wonder doesn’t it?  It makes you wonder who was in on that meeting when a FDA policy was developed to allow illegal ingredients in pet food.

It makes you wonder why the FDA – after six years of investigation into the deaths and illnesses of thousands of dogs – has yet to find the contaminant in the Chinese manufactured jerky treats.  It makes you wonder why the FDA has yet to respond to science hand delivered to them more than 10 months ago – that links the illegal antibiotic residues found in the Chinese dog treats to the exact symptoms suffered by so many dogs.  It makes you wonder what companies have influenced FDA’s thinking on this investigation doesn’t it?

With pet food, it is not solely FDA that takes the opinion and input of industry.  From the 2013 AAFCO Official Publication…(bold added)…

“Chairperson shall use discretion in inviting the trade to closed sessions.  A general philosophy shall be that formal representation at closed meetings shall be restricted to selections of trade organizations and that organizations such as the following should be given the opportunity to present when topics of concern to them are discussed;
American Feed Industry Association (AFIA)
Animal Health Institute (AHI)
National Cottonseed Products Association (NCPA)
National Grain and Feed Association (NGFA)
National Oilseed Processors Association (NOPA)
Pet Food Institute (PFI)”

Regulatory authorities of AAFCO and FDA just don’t understand it is a HUGE conflict of interest to allow industry private meetings and allow industry the opportunity to influence regulation.  And no one of authority (Congress) cares to force the agency to into doing its job correctly and fairly.  The fox guarding the hen house…we know what the outcome is.

Wishing you and your pet(s) the best,

Susan Thixton
TruthaboutPetFood.com
Association for Truth in Pet Food
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible

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