Comments on: FDA’s Recent Actions Against Illegal Prescription Drug Flow

By: Jack Coupal

Jack Coupal — Sun, 13 Sep 2009 23:04:50 +0000

Dan M.,

I get leery when a government official says “We don’t have enough people to do our “X” job”.

You state that the FDA Office of Criminal Investigation has 180 people. I assume that doesn’t include the boots-on-the-ground inspectors, technicians, etc. who do the actual detective work, collecting evidence. Those 180 are undoubtedly all lawyers and should be more than sufficient for putting together all cases prosecuted nationally.

FDA probably has more lawyers than pharmaceutical and device scientists and physicians combined.

As the article admits, FDA gets cooperation from DOJ, other federal, and state officials, in prosecutions.

By: Dan M

Dan M — Wed, 09 Sep 2009 19:56:01 +0000

I see the point of the last commentary. I do know that these criminal cases are ultimately prosecuted by the Department of Justice, not the FDA. Also, I venture to guess that these “good old boys” are so huge, they can survive unlike smaller companies. I do find it odd that many execs are charged with misdemeanors, not felonies. Seems like a pattern of abuse. I have only to look at the laws given to the FDA to enforce by congress. I don’t know if you’ve had a chance to look at the Food, Drug and Cosmetic Act – but it appears to me to be overly complicated, full of loopholes, vague in language and more like a “gentleman’s agreement” with industry. Lots of self-regulation.

By: anonymous

anonymous — Sat, 05 Sep 2009 03:37:06 +0000

Just a quick comment to Dan M. You have mentioned some of the larger settlements from the phamaceutical industry recently and the interesting thing is that it’s a who’s who of the biggest pharmacutical companies in the world. Also the examples you mentioned make up a small percentage of the major companies that, on a regular basis, are in court v. FDA. Doesn’t it seem strange that these companies commit violations, time after time and pay these huge fines and still remain in business and prosper? In contrast, if a smaller operation or segment of the industry finds themselves in the FDA’s crosshairs, they usually wind up out of business and facing criminal charges, which very, very rearly happens to the “good old boys”.

By: Dan M.

Dan M. — Fri, 04 Sep 2009 14:49:26 +0000

Interesting article. I have done a bit of research on FDA’s Office of Criminal Investigation. I find it strange that some of the comments suggest the FDA and the pharmaceutical companies are in a “you scratch my back and I’ll scratch yours” relationship as stated in a previous commentary. If you look some recent FDA cases – $2.3 billion fine of Pfizer, Eli Lilly $1.4 billion, Purdue $634.5 Million, Merk $4.85 Billion – I fine it hard to believe there is such a relationship. What I find fascinating (and I get this from a friend who works with FDA) is that their Crimminal Office only has 180 or so investigators!!! I can’t believe with all of the health frauds out there, that the FDA’ police force is so small.

By: anonymous

anonymous — Fri, 04 Sep 2009 00:42:00 +0000

Thank you for posting my comment. May I suggest that a bit of research using the Freedom of Information Act might shed some light on this subject?

By: anonymous

anonymous — Thu, 03 Sep 2009 21:00:53 +0000

I applaud anonymous (the first post) on being the first to shoot back with a quick, and honest, look at the ugly underbelly of the FDA / big pharma relationship. Anybody, outside of big pharma, that has had to deal with the infamous “discretionary enforcement” practices of the FDA will tell you how truly out of control they are and how it takes “you scratch my back and I’ll scratch yours” to a whole new level.

By: Alexis Pellek

Alexis Pellek — Thu, 03 Sep 2009 20:26:42 +0000

Thank you for your comment. This is not the only case involving phony Botox administration. After four people fell severely ill with botulism poisoning in 2004, FDA’s investigations found that more than 200 physicians throughout the country purchased the unapproved drug from Toxin Research International. Agents found that the company conducted seminars that discussed the use of the product in humans, despite the fact that FDA had not approved it for use in humans and that the packaging stated “For Research Purposes Only, Not For Human Use.” I think the biggest issue with the TPSG case and similar cases is the switch the physicians pulled when administering the unapproved TRI-toxin to patients who believed they were being injected with Botox. The suggestion that the doctors shouldn’t be held accountable for these actions comes as something of a surprise. What patient would be OK with such an egregious violation of trust by his or her doctor? In my opinion, FDA is protecting public health by contributing to investigations and legal proceedings against doctors who engage in this activity. And yes, as you imply, the agency is also protecting the rights of drug companies, in this case, Allergan, that have legitimate products on the market (i.e. companies that have gone through the established regulatory channels to earn the right to sell drugs in this country). Allergan issued this press release in Dec 2004 in an attempt to clear its name in the aforementioned instance of four people who contracted botulism from injecting “massive doses” of an unapproved bulk botulism product, which was linked to Toxin Research International.

By: anonymous

anonymous — Thu, 03 Sep 2009 18:45:18 +0000

In fact, the “phony” botox was a purer, safer, longer-lasting version of the “approved” product, and according to the 2004 press releases, hundreds of doctors in the U.S and abroad effectively treated thousands of patients without a single problem or complication. Identical preparations of purified botox are approved worldwide and will be approved here in the U.S in a year or so. So why have the FDA and DOJ prosecuted these cases so vigorously, using an obscure statute intended for drug manufacturers, even now, 5 years after the fact?

The FDA has no authority over and does not regulate the practice of medicine, and there is no Federal law prohibiting a physician from using an “unapproved” drug. When one looks past the FDA and media “spin”, the alleged offense being prosecuted is the MARKETING (i,e. the “Misbranding”), not the actual USE, of the product. So in fact the FDA is NOT “protecting the public health”, but apparently it IS protecting SOMETHING, and it doesn’t take a rocket scientist to figure out what that “something” is-just follow the money!