IsRegenerative Sciences a drugmaker or a medical practice that simply uses stem cells to perform procedures? This argument has been at the heart of a simmering dispute between the Broomfield, Colorado company, which is run by two enterprising physicians - Christopher Centeno and John Schultz - and the FDA, which is seeking an injunction to cease production.
The battle began two years ago, when the FDA sent a warning letter to Regenerative Sciences, which uses cultured cells taken from patient bone marrow or fluid surrounding the joints, and which are then grown, processed and mixed with drug products outside the body before being injected back into the patient. The FDA argues the procedure actually amounted to the use of drugs that were never approved under a biologics license application or new drug application. In other words, what Regenerative was doing was unlawful. And so Regenerative filed a lawsuit against the FDA (see this).
In a more recent lawsuit filed two months ago, Regenerative sought to head off the FDA injunction by again claiming the agency, which had recently inspected Regenerative facilities and was about to issue a negative 483 inspection report, has no regulatory authority because the company is practicing medicine and is not a drugmaker (see this).
In its filing, the FDA claims Regenerative violated good manufacturing practices that "cause its cultured cell product to be adulterated, and also misbranded due to the lack of adequate directions for use and the failure to bear the 'Rx only' symbol." The agency argues the cultured cell product was not approved by the FDA, and there are well-controlled studies to demonstrate safety or efficacy "for any indication," according to an agency statement.
UPDATE: On Aug. 9, Regenerative Science issued a statement. This is an excerpt: The Regenerative lab has strictly adhered to the International Cellular Medicine Society’s (ICMS) strict, professional guidelines and has been audited three times by independent third parties with no serious safety concerns. ICMS guidelines are the best fit for autologous cell processing and provide strong patient protection. If the FDA had any valid concerns about our medical practice not using drug factory guidelines, they knew about that in Spring of 2009 and did nothing. They did nothing because there were no safety issues. Their focus on this now is litigation posturing," says Centeno.
“What we're doing in our Colorado medical practice is no different, in principle, than a fertility clinic that uses the in-vitro fertilization technique. The only difference is that we're using stem cells and fertility clinics use fertilized eggs," Schultz says in the statement.
The complaint for the injunction would permanently prevent the company, the two docs and an employee, from "adulterating and misbranding the cultured cell product while the product, or one or more of its components, is held for sale after shipment in interstate commerce." The FDA also says Regenerative Sciences agreed to cease production while the case is pending.
18 Comments
I am absolutely ignorant on this topic, so I'm wondering, can you sue the FDA???
I worry and can verify that if patients are not able to access these types of treatments here in the US, they will go to Mexico, India or China for treatment.
I know of one patient who went to India for a stem cell transplant of her own fat cells after years of misdiagnosis and exposure to harassment, fraud and unfit drug dispenses which may have precipitated serum sickness. Or, serum sickness may have been precipitated by ongoing FDA CGMP issues.
Patients contact our nonprofit and ask me for help with accessing prescription drugs from Mexico because they cannot access prescription drugs here in the US. In another instance, patients and providers are no longer able to access adulterated medicine. According to reports, the pharmaceutical company that produced the adulterated medicine is under criminal inquiry. While compounded equivalent versions are finally available, federal programs and many PBM/insurer reimbursement amounts are not high enough to cover the compliance fees, so until recently the only prescription drugs that federal programs and most insurers/PBMs reimbursed were deemed adulterated by the FDA a number of years ago. So, patients go on the Internet and order their medicine from Thailand. I don't know if the Internet sites that these patients are ordering from are regulated by anyone.
I know of a local patient who is on a taxpayer funded health insurance who found it easier to order IV supplies over Ebay.Then there are the patients who go to animal feed stores and buy human prescription drugs without a prescription. It is easier for them than dealing with 'the system' that is supposed to be designed to help patients.
FDA and USDOJ do not have adequate resources to do their job here in the US and fewer resources and a less jurisdiction to ensure US patient safety when patients travel or drugs are manufactured in certain foreign countries.
What happens when these providers are shut down here in the US and patients start going to India and Mexico for these procedures? Will the FDA and USDOJ have the resources and jurisdiction to help keep these US (or other) patients safe?
If you can sue the FDA, what does it accomplish?
Would a lawsuit like this allow Regenerative Sciences propritary information to be made public and availble in the private domain?
A lawsuit of this type is exactly what patients who are being held hostage by the FDA in this country are wanting. I applaud the defendants in this case for challenging the FDA and bringing this to a head. As co-founder of the Stem Cell Pioneers forum, I can assure you that patients that can, do go offshore for treatments as for most of them there is nothing available in the U.S. I have a terminal lung disease and have been warned many times to not go to offshore stem cell clinics as they most likely would be harmful to my health (as if doing nothing in the U.S. would not be). My treatments have stopped the progression of the disease, something no drug can do. Recently, the FDA decided not to approve the drug Daxas for patients with COPD. These kinds of decisions are indications that something is woefully wrong at the FDA. Europe approved Daxas. Now, this agency wants to declare that our own stem cells are drugs. Is there any wonder that patients are leaving the U.S. for treatment? The ICMS has guidelines in place for safe autologous stem cell treatments. There is also a patient registry. This non profit is well organized and has done its homework and yet the FDA turns a blind eye. As pointed out, fertility clinics which pretty much do the same thing as Regenerative Sciences was doing are under no such attack by the FDA. Patients are not impressed any more by nonsense media articles about stem cell therapy being snake oil. They are concerned about safety, but if they do their research, safe treatment is available - but not in the U.S. Yes, the treatment is experimental, but when faced with chronic and terminal diseases, patients are willing to get involved. The ICMS recognizing this has published a guide to offshore stem cell clinics. This helps patients make safe decisions. Many countries are also very involved in clinical studies using adult stem cells. They are doing these trials under their own country's regulatory agencies. These aren't 3rd world countries for the most part, but countries far more humanitarian and visionary than the U.S. We are mired in a mess here with the FDA trying to figure out how they can have complete authority over our stem cells and the practice of medicine. This is outrageous and it's all about the money, not the welfare of those that are sick. Thank you a million times to Regenerative Science for suing the FDA. Someone made a comment wondering if the FDA can be sued. The answer is YES! They are not acting in anyone's best interest. It's time for people to start understanding the game that is being played in the U.S. at the expense of millions of lives.
The whole point of the matter is that your own adult stem cells are not the property of the FDA, they are yours and only yours. This appears as another example of why the FDA is not doing it's job regulating the foods that are imported and overstepping their authority or stopping stem cell research and treatments within the USA.
The FDA is making it more difficult for stem cell research, so people go out of country, they are being forced to by the inept FDA rules they make up on the fly.
There are no additives added to stem cells -they are simply grown to be more effective. We have had enough of the FDA dictating to doctors, researchers and only allowing fetal stem cell research which has a high rejection factor and will prove fruitless.
What the FDA wants to do in reality is to allow drug companies to profit from this process by adding drugs -that is the only way they would be adulterated. But we know the FDA is corrupted by drug co' corporate influence for profit -not for curing disease.
Let me get this straight. I can have 2 pints of a complete stranger's blood transfused into my body when needed, but cannot have my own bone marrow or fat cells given to me for a terminal illness? Seems to me it's my own business what I do with my own stem cells and the FDA has no business interfering.
Who gave the FDA the authority over a person's own stem cells? Do they also own the veins that are taken out of peoples legs and inserted in their hearts? What in the world has become of this country? Wake up people! These are your own cells.
first let's understand that big pharma is estimated to make 300 million per day. just a guess? how many commercials on tv tell side effects of different drugs, even to the fact they might cause death. how many drugs have they ok'd that were bad for us. our political leaders ought to get more involved, maybe we can get the fda to do the right things.
I am pleasantly surprised by the comments to your well-balanced article. People have begun to accept what we at the Repair Stem Cell Institute have been saying for years, i.e. that the FDA is a puppet of Big Pharma with one purpose (despite what its public face says). No matter the cost in suffering, pain and too-early deaths, keep Adult Stem Cells from destroying their profits in a medical system where cures of chronic diseases are not permitted in the lab or the clinic. Perhaps you haven't noticed that since Salk & Sabin kayoed polio sixty years ago, no cures have come out of any USA lab….because cures reduce the profits of FDA’s masters.
The FDA does this with the support of Big-Pharma-controlled major media which spews two huge lies at us incessantly: 1-Adult stem cells are snake oil and they "prove" it by mentioning only the scam artists and the unsuccessful patients while never mentioning the world-leading doctors who actually care about human life rather than protecting Massa’s profits of $15 MILLION PER HOUR (exactly as 60 minutes did). 2-Pretend the science fiction of embryonic stem cells is the future, by publishing all kinds of experiments on rats but never on humans. Today the big push is the hoax clinical trial announced by Geron for spinal cord patients. Every newspaper in the USA participates by never mentioning 11 previous Geron hoaxes. Is there one honest medical reporter in the USA? I cannot find one, but Pharmalot gives me hope. For a complete referenced report on these ongoing lies, http://www.americanthinker.com/2010/08/playing_politics_with_stem_cel.html
It is about time someone stood up to the FDA. They have abused their authority long enough. My stem cells belong to me and I should not have to leave my country in order to use them to save my own life.
I am overjoyed that these defendents are going up against the FDA, The last time I checked Blood Transfusion, Bone Marrow, Skin Graft, Artificial Insemination and countless Heart procedures were the practice of Medicine,and all of the above have stem cells in them. an area where the FDA has no jurisdiction even though they think they do. The oversight of the practice of medicine is reserved for the States Not the Government. We should all contact our State Government's and demand that they get involved and allow us to use our own adult stem cells if we choose. If I can give a stranger my Blood or Bone Marrow to save their life, then I should be able to use them to save my own. We should not be intimidated by the FDA, they no longer work for the public their only interest is BIG PHARMA and clearly show it by approving drugs that are poisen,and very expensive. If it shows that a drug may help us they will not approve it at any cost. We should support these defendents by standing strong and telling the FDA ENOUGH NO MORE!!!!!
I believe the FDA is acting for drug company interests here to find a way for them to profit from a human body's own cells. They will add a drug to it to make more money and call it a drug. Didn't Obama say he was opening up research in the US rather than shutting it down? Totally incompetent to run a government this way and it rails against scientific proven research.
My son had autologus bone marrow stem cell treatment in March 2010 in a clinical trial in Mexico..
Brain Injury at 4 months of age, many delays but the biggest problem was the seizures..Within 3 years I am positive I easily witnessed him have over 5000 seizures..Do the math, it is more then a couple evey day..Numerous medications did nothing..And they never showed signs of slowing down only getting worse...
Within 2 weeks of stem cell treatment..80 percent of seizures stopped..Now we are 5 months post stem cell treatment and it has been 15 days with NO seizures..They are gone for the first time in 3 years..
We had EEG before treatment and have scheduled an EEG to confirm..Should be very useful evidence to someone...
Two Thumbs up for adult stem cells...
In 2009, I was a patient of the Regenerative Sciences Clinic. The Doctors and staff are top-notch, professional, and really care about their patients. You will not find a more caring nor competent clinic anywhere. I can't express how great they were.
I am VERY angry with the FDA for sticking their nose in this. They are abusing their power. It would not surprise me if this was motivated by a drug or orthopaedics company. If the wants data to make a fair assessment, they should talk with some of the clinic's patients. I can assure you that no one has contacted me. It's really no business of the FDA what I do with my own stem cells.
By the way, my hip is much better after the stem cell injections.
If the stem cells are a drug, given that there are few lots and each lot is individually prepared, then if these are drugs as defined by the FDA, then would these stem cell drugs be compounded drugs, not manufactured drugs? If I understand the difference between the two correctly, commercially manufactured drugs that have to go through FDA approved clinical trials and approval process, but compounded drugs do not. Compounded drugs DO have to meet USP standards.
MY SON HAS BEEN TO COSTA RICA THREE TIMES FOR STEM CELL THERAPY HE HAS A T10 SPINAL CORD INJURY HE HAS HAD IMPROVEMENT WITH EACH TREATMENT. I HAVE TALKED THOSE WHO ARE RECEIVING THERAPY A BASE MY COMMENTS ON WHAT THOSE INDIVIDUALS HAVE TOLD ME SOME STORIES YOU ARE AMAZING SOME ARE JUST HOPEFUL BUT TRUTHFUL
SO AS I HAVE THE MONEY MY SON WILL GO FOR MORE TREATMENTS
We have so many chilren being born in the US with SEVERE dieases that could be treated with Stem Cell, DONATED stem Cell thearpy or stem cells from their own body. I think it is sad that people are FORCED to seek treatment our of the US. You will have people running to countries like Mexico because they can not get the treatment in the United States. How can someones own stem cells be treated as a drug? I would be willing to bet that if the head of the FDA had a child who needed this type of treatment for their health we would have a rush on making it availiable to the public or they would be taking them out of the country as well.