FDA’s Recent Actions Against Illegal Prescription Drug Flow
Last month, US Food and Drug Administration Commissioner Margaret Hamburg announced the agency’s six-point plan for tougher enforcement of its policies and regulations as means of protecting public health. The plan, which includes actions like setting postinspection deadlines, speeding the Warning Letter process, and working more closely with FDA’s regulatory partners, was designed to “to prevent harm to the American people,” as Hamburg said in an FDA release.
The agency has been actively involved in several recent cases involving instances of illegal importation and sales, drug diversion, and misbranding of drug products. FDA’s Office of Criminal Investigations has conducted investigations and partnered with other government offices when necessary.
From the United States Attorney’s Office, District of New Hampshire
On July 27, 2009, Christopher Chase, of Lynn, Massachusetts, was sentenced to three and a half years imprisonment and three years of supervised release for his involvement in an Internet prescription drug scheme that distributed anabolic steroids, human growth hormone (HGH), insulin-like growth factor (IGF-1), and clenbuterol throughout the United States. A two-count indictment charged Chase and two codefendants with conspiracy and money laundering.
According to the indictment, Chase and his team illegally imported the drugs from overseas, primarily China, marketed them as body-building substances, and sold them without a prescription on various websites. Of course, FDA has not approved anabolic steroids, HGH, or IGF-1 for use in body-building activities, and clenbuterol is not approved for use in humans by FDA. Although some countries have approved it as a prescription-only bronchodilator, clenbuterol is known to be abused by bodybuilders for its weight-loss properties, according the the Department of Justice. The money from the sales of these drugs was sent to various merchant bank accounts that Chase had set up, and then laundered through foreign countries such as China and Moldova.
FDA’s Office of Criminal Investigations worked with US Immigration and Customs Enforcement, the US Postal Inspection Service, and the Internal Revenue Service, Criminal Investigations office on the case.
From the United States Attorney’s Office, Southern District of Florida
Last month, Arnesto Segredo was convicted of conspiring to divert the prescription HIV drug Serostim (somatropin [rDNA origin] for injection, EMD Serono, Rockland, MA) and Nutropin AQ (somatropin [rDNA origin] injection, Genentech, South San Francisco, CA), which is approved for the treatment of growth hormone deficiency, and one count of causing the diversion of these drugs in interstate commerce.
Segredo used unlicensed California-based suppliers to ship hundreds of boxes of Serostim, and some Nutropin AQ, to him in Miami from 2000–2002. He operated a prescription drug wholesaler that was not licensed to engage in the distribution of prescription drugs in Florida from 2000–2001. Segredo later ran his scheme through Genendo Purchasing Organization, a Miami-based prescription drug wholesaler that became licensed in Florida in July 2001. According to a press release from the US Attorney’s Office, a significant portion of the Serostim originated from California-based AIDS patients who sold their Serostim supplies secured from the Medi-Cal Medicaid program. The drugs were shipped from the California-based unlicensed suppliers to Segredo in Florida.
Sentencing is scheduled for October 23, 2009 in Miami. FDA’s Office of Criminal Investigations conducted the investigation.
From the United States Attorney’s Office, Northern District of New York
In a case involving the misbranding of drugs by physicians, The Plastic Surgery Group (TPSG, Albany, NY) pleaded guilty in early August to one felony count of misbranding drugs, and five physicians, the practice administrator, and the supervisory nurse of TPSG also pleaded guilty to strict-liability misdemeanor misbranding violations. In 2004, TPSG misled patients by injecting them with the unapproved product TRI-toxin (botulinum toxin type A) manufactured by Toxin Research International (Tuscon, AZ) instead of the FDA-approved brand Botox Cosmetic (botulinum toxin type A) manufactured by Allergan (Irvine, CA) patients believed they received. Patients not only believed they were getting Botox injections, but paid Botox prices for the cheaper and more dangerous unapproved drug TRI-toxin that TPSG administered.
TPSG faces a fine of up to $500,000 and an order to pay restitution to about 150 patients, who paid approximately $100,000 for the phony Botox injections. The individual defendants face up to one year in prison and fines of up to $100,000. Sentencing is scheduled to take place on Dec. 10, 2009. FDA’s Office of Criminal Investigations conducted the investigation of this case.
These cases are examples of FDA’s efforts to protect consumers by stemming the flow of illegal or adulterated substances. Increased enforcement of FDA’s regulations, especially in the face of rising of illegal activity concerning prescription drugs online, will help to protect public health. As Hamburg said, “The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible.”
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!
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.
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.
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?
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.
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”.
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.
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.