Tough guys at the FDA (sarcasm alert)

Seventeen days left in the Bush administration. With the fiscal crisis it isn't clear some urgent matters will be attended to right away by the Obama folks, but one can hope. Urgent matters like getting the Food and Drug Administration back on track protecting our food supply. Consider this FDA Press Release from yesterday:

FDA Prevents Two Dairies from Adulterating Animal Drugs and Food

The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M.

FDA has cited the defendants on multiple occasions, most recently following inspections of the dairies from June 24 to July 1, 2008. During these inspections the FDA investigator noted that the defendants were not keeping adequate medication records to prevent unsafe drug residues in cattle offered for slaughter, that they failed to review treatment records prior to offering an animal for slaughter, and that they were using medications for unapproved indications not specified on the drug label. Although using drugs in this "extralabel" manner is legal with a valid veterinarian-client-patient relationship, the defendants did not have such a relationship. (FDA Press Release)

So far this could have been just a technical violation. But reading further makes clear it isn't:

In tissue samples collected since 2003, FDA determined that Do-Rene and Clover Knolls Dairies offered 12 animals for slaughter with illegal drug residues. The animals included dairy cows that tested positive for illegal levels of the drugs flunixin, penicillin, neomycin and sulfadimethoxine, a drug expressly forbidden for use in lactating cows. In addition, four bob veal calves tested positive for sulfamethoxazole. (Bob veal calves are calves less than 30 days old and may be as young as two days at slaughter.) These residues may cause allergic reactions in extremely sensitive individuals, and they may contribute to forming antibiotic-resistance in bacteria.

So these dairies had multiple repeated violations known to the FDA. So what's the response? Criminal charges? Civil charges? No. An agreement that the dairies will follow the (existing) law:

Under the terms of the consent decree, the defendants and their employees cannot introduce any adulterated food into commerce, use animal drugs in an "extralabel" manner without a valid veterinarian-client-patient relationship, or use drugs in animals in which such drugs are expressly forbidden. Failure to obey the terms of the consent decree could result in civil or criminal penalties.

These guys at the Bush FDA and Justice Department are really tough.

More like this

As a former PR person, I feel sorry for the person who had to write that press release and send it out with a straight face. Ugh.

Seriously, though, I feel sorry for the remaining good people at FDA who are no doubt trying valiantly to protect us, despite their leadership. I suspect they've had Bush's last day circled on their calendars for a while now.

WHAT?!?!?!?

I say that as a Big Pharma employee who has seen a real Consent Decree in action. They shut down one of our manufacturing sites completely for about ten years--we had to keep the site up and running, but not manufacture anything out of it, for ten years. It is not a trivial expense to keep a large manufacturing facility idle for that long, and many scientists and engineers who worked at the site were effectively blacklisted for being idiots (both for the basic idiocy that brought on the decree and for putting the company at risk). As soon as employers saw the conditions under which they were last employed, they were told, "don't call us, we'll call you." About a year after the decree ended, the site was sold off to someone else for a different purpose. There's an abundance of high school science teachers in that area nowadays, because what else are you going to do with a degree you can't use professionally?

That is a real consent decree. That is what teaches executives that they need to not be idiots. That consent decree was used as a teaching tool for all our other sites about What Not To Do, and a few years later we were acing inspections flawlessly--something that almost never happens because there's always that one inspector who finds an empty paper towel holder or burned-out lightbulb. This "Oh, just be sure to do it properly from now on" crap is an effing joke.

I'm thinking here that the Southwest Regional Office is staffed by morons, because I know the Northeast Region doesn't tolerate that shit.

@Lora,

I agree this current consent decree is a joke, but I really seriously doubt this is a regional thing. You're comparing completely different FDA centers: CDER, which regulates human drugs, vs. CVM, which regulates veterinary medicines, including the use of antibiotics in feed animals.

@ qetzal:

Good point, but I know our local CVM division is also pretty diligent. They've shut a couple of local dairies down completely for single contamination incidents. Could it be that some regions simply have a better talent pool to hire from? Or that some areas have vet schools or state agriculture departments that are better than others at driving enforcement issues?

In my Canadian experience, there are a lot of good people in regulatory agencies, both plant-animal and human.

They will, off the record be most forthcoming.

However, these same people when pushed will not rock the boat...because in my opinion, they have 'cushy' jobs with no expectation or oversight (and most importantly no code of ethics)

...your only requirement is to show up, look busy and pick up a pay check at the end of the week.

There is no democracy in my country when it comes to food inspection. These are unelected all powerful officials. If the rare politician sees the truth and decides the status quo is unacceptable...the agency will deliberately embarass the politician so they get fired instead. This happened to the Minister of Agriculture in Canada last fall.

Former presidents etc. of these agencies are often hired by those they were regulating...where they can influence those they hired to replace them or those they promoted in the past.

Its quite a system.

If I complain about excessive levels of a food preservative in animals or agriculturally related foodstuffs...the answer will be that the level is under the threshold for harm.

However, the health agency always takes each food in isolation assuming that there is no additive effects from levels consumed in other foods.

Another convenient ommission is the inability to consider that foreign chemical molecules in the body interact.

However, the most surprising finding is that the human and animal-plant regulatory agencies adjust the Food and Drug Acts with impunity... without rewriting the act...

...so that consumers can never know what illegal additives have become legal and at what concentrations...it is all backroom dealings.

If you want to know why we are all touched in one way or another by cancer...you don't have to look much farther than our current health-regulatory gutless systems.

Here is one example of an unintended consequences when it comes to multiple additives in the same agricultural or food products.

If you take melamine on its own, the threshold to 'clinical' symptoms (something you can actually observe) is probably too high to ever cause a problem. OF course most physiological damage you never see...that may show up as cancer twenty years later...and conveniently untraceable for those health regulatory agencies mentioned earlier.

I'm sure that those who contaminated the grains etc. to artificially increase N or protein content are surprised that they got caught.

I believe that the addition of ever increasing levels of formaldehyde to Chinese agricultural products and foodstuffs lead directly to the problem...without the formaldehyde additions we would all be eating melamine for a very long time.

So what other food additives, like sulphytes, chemically react with melamine or formaldehyde?

Of course, our children will probably be eating melamine for a long time anyway.

@ TomDVM

I don't know about you veterinarians in north america, but here all veterinarians are bound by a professional code of ethics, that covers those working in regulatory fields and certification. Those working in agencies equivalent to the FDA here are definitely expected to work within the code of ethics, and can be deregistered if they don't.

By Attack Rate (not verified) on 03 Jan 2009 #permalink

Weirdest thing I ever heard: you break the law, and the penalty is a court order ordering you not to break the law. I though that that was kind of implicit in the law actually being - you know - *a law* in the first place.

Tangentially -- Gupta?

Gupta??

By Hank Roberts (not verified) on 06 Jan 2009 #permalink

FDA makes natural preventive illegal and promoting it a criminal activity.

Most of Natural Medicines cannot be patented and producers of those did not always had the zillions of dollars needed to get approved by the FDA like the Big Pharma have at their disposition.

Some greedy individual, when the H1N1 became the pandemic, started to sell the miracle pills pretending all kinds of non-corroborated benefits against H1N1.

The FDA reacted swiftly and started to write new law on this issue.

Sadly, the FDA flusch the baby with the water of the bath and now proscribe, even criminalized the promotion of Supplements or Naturals Products that are helpfull in reducing morbidity and mortality in H1N1 infections.

When you do not have enough money to buy the Big Pharma FDA recommended medicines, wouldnât be fair to at least allow the informations on complementary natural medicines be accessible? And let people decided?

Well the FDA in their first Legal Prescription has determined that promoting Natural Medicines constitute a criminal activity.

FDA statements;

FDA Home Page
http://www.fda.gov/

Here is a strange denonciation invitation

Report Suspected Fraudulent Products or Criminal Activity Associated with H1N1 Flu Virus (Swine Flu )
http://www.fda.gov/...

Here is an excerpt of what it said

There is no penalty for failing to report a possible violation; however, if you knowingly report false information to FDA's Office of Criminal Investigations, you may be subject to criminal or civil penalties. Please review the FDA Web Privacy Policy for more information.
Report Suspected Fraudulent Products or Criminal Activity Associated with H1N1 Flu Virus (Swine Flu )

The FDA is alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, treat or cure the 2009 H1N1 flu virus. The agency also is advising offending websites to take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.

Snowy

By Snowy Owl (not verified) on 19 Aug 2009 #permalink