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FDA, In the News, Science Policy, Stem Cells

U.S. District Court rules that stem cells are drugs

Peter Aldhous from New Scientist reports today that the U.S. District Court in Washington, DC, has ruled that a person’s own cultured stem cells are drugs subject to regulation by the Food and Drug Administration.

This is a big deal, as it’s the cornerstone of an ongoing argument between the agency and Colorado-based Regenerative Sciences (The FDA Law Blog summarized the legal tussles nicely last October). It’s also germane to the issues surrounding Texas-based Celltex, which I’ve blogged about before.

According to Aldhous:

It’s official: stem cells are drugs. At least, that’s the opinion of the [court]… which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies.

Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice – not regulated by the US government. But if the cells are subjected to more than “minimal manipulation”, the FDA maintains that the therapy becomes a “drug”, which must be specifically approved for use.

Aldhous also quotes Regenerative Sciences’ medical director Christopher Centeno, MD, vowing to appeal the ruling, as well as Stanford’s own Christopher Scott:

“I think it’s a good ruling, and I’m glad to see that that the FDA has exercised its muscle on the case,” says Christopher Scott, who heads the Program on Stem Cells in Society at Stanford University in California.

Scott hopes that the FDA will now step up its efforts to regulate other clinics offering unproven stem cell therapies. These include Celltex of Sugar Land, Texas, which rose to prominence after Texas governor Rick Perry was injected with stem cells supplied by the company to aid his recovery from back surgery.

This is obviously not the last of the story– we’ll keep you posted.

Previously: FDA audit of Texas stem cell clinic revealed by Houston Chronicle and Stanford’s Irving Weissman on the (lost?) promise of stem cells
Photo by sideonecincy

17 Responses to “ U.S. District Court rules that stem cells are drugs ”

  1. Federal court gives FDA explicit power to regulate stem cells as drugs: start of new era? | Knoepfler Lab Stem Cell Blog Says:

    […] story has been reported in the media at New Scientist and Scope Blog. You can read over the key […]

  2. Paul Knoepfler Says:

    For more thoughts on what today’s court ruling means, check out my lab’s blog post: Hint. It’s not a witch hunt or great conspiracy, but an effort to protect the patients.

    Paul Knoepfler PhD
    Associate Professor
    UC Davis School of Medicine

  3. A new turn in FDA versus Regenerative Sciences lawsuit | Stem Cell Assays Says:

    […] Refuting potential downsides to stem cell drug court ruling (Knoepfler Lab Stem Cell Blog) U.S. District Court rules that stem cells are drugs (Scope […]

  4. Daniel Says:

    Yes it is an effort to protect the patients, but like almost all past efforts by the FDA to protect patients it will harm by delaying worthwhile treatments far more patients than it helps by preventing bad ones.

  5. Peter Says:

    Too bad. Progress will now be glacially slow. How can the FDA approval process work for individual modifications of stem cells? since each patient is unique, would a clinical trial be needed before each treatment? There needs to be a new regulatory regime for this that does not run to thousands of pages. Not likely with the current crew.
    Oh well. At least the work will get done in Asia.

  6. stonedome Says:

    what happened to NOW and “keep your government hands off of our bodies”? stunningly silent during leftist administrations

  7. David Says:

    What if a person doesn’t want the government protecting them? Isn’t that a decision for the patient?

  8. Ken Says:

    They’re not drugs, they’re taxes!

  9. Fred Says:

    This is not an effort to protect the patients. This is an effort to show everyone “who’s the man’. The FDA loves to be boss.

  10. denton Says:

    This is not about patient protection, it is about patent protection. It is an attempt on the part of the FDA to protect the value of key influence group patents that would be nearly worthless if stem cell extraction, proliferation and re-introduction were a common and simple doctor’s office procedure.

    It makes me wonder: If the FDA is looking out for the influence groups, who is looking out for the people?

  11. Kevin P. Says:

    Wow. This will greatly damage research into individualized stem cell treatments if each treatment requires FDA approval. The approval will take ten years, and the patient will likely be dead by then. The same result that we get today with life-saving pharmaceuticals – the patients are dead, but at least they were not given potentially unsafe drugs!

  12. chaz Says:

    This is wrong. The only people this ‘helps’ is the FDA employees and the Pharmaceutical companies.

    Two organizations I don’t think need that much help.

    Research will now be glacially slow.

  13. Barbara Hanson Says:

    This is an effort to protect patients? Come on. This is an effort to protect the self interests of many in the industry who refuse to listen to patients. State licensing of physicians and mandatory malpractice insurance already protects patients. We want access to our own stem cells. This should be a decision between a patient and his or her own doctor. Patients will now be forced offshore or to clinics doing treatments under the radar. I urge patients to become very vocal. Instead of protecting patients, this ruling will be a death sentence for many. Heart transplants didn’t even require this type of regulation! Doctors should be alarmed at this type of ruling as well. What type of intrusive regulatory measures will be next for them?

  14. Doug Says:

    I concur that this has probably been more about protecting the pharmaceutical powers-that-be, and potential profits, than truly helping patients. It will also create a huge opportunity for the Asian countries to develop these techniques and jump far far ahead of the US. Reminds me of Chiba City in the old William Gibson cyberpunk novels. Well, oh well, the US had it’s fleeting moment in the sun. Now it’s quickly becoming just another police state/Corporatocracy.

  15. denton Says:

    Mesenchymal stem cells generate powerful anti-inflammatory proteins, which can be extremely beneficial. There are two ways to get these proteins.

    One way is to have cells extracted from the patient’s bone marrow, proliferated, and re-introduced. This is a fairly simple procedure that major hospitals could do on an outpatient basis. The potential is that this could be a reasonably inexpensive, long lasting treatment. Plan on booking a trip to the Dominican Republic or Tel Aviv if you want this anytime soon.

    The other way is to buy the new drug that provides the proteins. The drug is covered by a patent, and many who have investigated suspect that the FDA is being guided by the patent holders who stand to make billions if this decision stands.

  16. FDA wonk Says:

    It’s disappointing to see all the posts from people who drank the Kool Aid about what this means for access to therapies without the initiative to even check the FDA site. This has NOTHING to do with slowing access to important therapies. There are literally half a dozen ways to legally obtain this product, while collecting safety data and making sure it gets to patients who want to evaluate whether this product is safe for them. . This has to do with access to the manufacturing process by FDA Inspectors. There are plenty of chances for the product to get contaminated, and this makes sure contamination controls are in place before the company profits by getting an untested product into patients bloodstreams. Insurance companies demand FDA review, too, so unless you’re an NBA player, don’t expect to be able to afford this on your own unless insurance will pay.

  17. Albert Salazar Says:

    FDA wonk, so do the medical devices, gloves, transplants, hand washing, and injections. However, all of these are part of medical board procedures. Can you imagine if they needed FDA clinical approval like a drug, medical costs would probably triple at minimum, accessibility would diminish, and many of medical procedures would end up in a baron waist-land not pursued because of cost. You know, just like what is happening with viable stem cell treatments today.


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