Failure to comply with the FDA’s new guidelines will lead to expensive and time-consuming warning letters and requests for injunctions. Moreover, if you fail to meet the guidelines, your business may be forced to shut down until the FDA approves your stem cell business. Learn what safety and manufacturing steps you must take to prevent the FDA from issuing warning letters and seeking injunctions to close down your business.
Why medical companies are developing stem cell therapies
Stem cell research offers a lot of promise for helping to cure or treat a wide range of medical problems. Stem cell therapies can help repair tissues. Stem cell therapies can replenish other cells and regenerate new cells. Stem cells can also develop into bones, blood, and even organs. Stem cell therapy has the potential to treat some diseases that don’t have current remedies. These stem cells are also being used to test new drugs to see if they work and if they’re safe. Stem cell therapies can be an effective alternative to waiting for a transplant.
While stem cells offer a great deal of promise, the Food and Drug Administration (FDA) is deeply concerned that some health providers are overpromising or misrepresenting the abilities of stem cells to act as a cure or a treatment. The FDA is especially concerned that consumers in pain and in need of cures will turn to untested and unproven stem cell therapies. In response to these concerns, the FDA is working to protect the public by investigating claims or knowledge of abuse. FDA’s stem cell experts are working to enforce its regulations when FDA becomes aware of unscrupulous providers.
Some stem cells come from human embryos. These stem cells can be programmed into any kind of cell and, theoretically, can be used to repair a body’s tissues and organs. Adult stem cells come from tissue that is fully developed. The use of these cells is generally more limited because the cells can only be turned into similar type cells – for ex., liver cells for liver. Adult stem cells can be obtained from your own body.
FDA Oversight of Stem Cells
The FDA does have the right to regulate stem cell solutions. This FDA power includes stem cells from blood and bone marrow cells. The FDA review process for most new products includes:
- Determining if the stem cell product is safe – doesn’t jeopardize a patient’s health
- Analyzing if the stem cell product is effective – does what it promises to do and that promise is to improve a person’s health
- Reviewing how the product is manufactured so that the strength and purity of the product can be assessed
- Studying the requirement that the stem cell product maker have sufficient data to help assess the quality of risks of the stem cell product. The data should come from animal studies.
Currently, FDA review is broadly limited to cell treatments for blood disorders such as leukemia and some kinds of anemia. The review also extends to treatments for victims of burn injuries.
Medical companies offering stem cell therapies should speak with an experienced FDA stem cell attorney who understands the applicable FDA regulations. Physicians and health providers who offer stem cell therapy should make sure the therapy is approved by the FDA or has FDA authority based on its being part of an IND – an Investigational New Drug application.
Stem cell makers and clinics cannot advertise that they are conducting an approved FDA trial when they are not. Health care entities can’t say that a clinical trial isn’t required – when it is.
Consumers and physicians should understand that if there isn’t an approved IND, then the FDA hasn’t reviewed whether the stem cell therapy is safe for the public. The FDA has much more information about clinical trials including the types of trials, informed consent issues, diversity testing, and Informational Review Boards on its clinical trials website.
Why the FDA is Focusing on Stem Cell Therapies that Aren’t Proven
Some of the safety concerns about untested stem cell treatments include:
- Possible blindness
- Tumor growths
- Failure of the stem cells to work as planned
- Cell movement from the original injection site which can create improper cell types or inappropriate cell multiplication
- Bad site reactions
The FDA’s concerns about stem cells applies to stem cells created/used from your own cells – in addition to stem cells from other sources.
General Advice from the FDA for anyone considering using a stem cell therapy
The FDA suggests patients:
- Ask if the FDA has analyzed or initiated enforcement action or made an Agency pronouncement about your specific treatment. A doctor, hospital, or other health provider should know where to obtain this information. If the treatment is part of a clinical investigation, they should be able to obtain the Investigational New Drug Application number from the FDA. With the number, you should be able to review the FDA’s current assessment. Patients are advised to get this information BEFORE they start any stem cell treatment – even if the treatment uses their own stem cells.
- Understand what a clinical trial is about before you sign a consent form. IND approved clinical trials do require that patients sign a written consent that identifies the IRB – Institutional Review Board – that is reviewing the medical research. The IRB’s purpose is to protect the safety and rights of human test subjects. You should know how the trial will work and what the dangers are. For example, you should know what treatments will be given, when they will be given, and what results you should reasonably expect. The entity conducting the test should have a written brochure that describes the clinical trial process. Your health provider should help you obtain this information.
- Know the risks of obtaining stem cell treatment in other countries. Different counties have their own set of regulations. The FDA doesn’t oversee foreign treatments. In many cases, determining the safety and effectiveness of foreign treatments can be quite difficult.
FDA enforcement in the stem cell industry
Even though many of the main FDA regulations by their terms apply to limited stem cell uses (mostly blood disorders), the FDA is aggressively working to protect the public by issuing warning letters to clinics that violate its standards. These standards include laboratory protocols and the proper methods for manufacturing new stem cell drugs. The FDA, according to Consumer Reports, is increasing its inspections.
The FDA is also starting to review stem cells in the same manner is it does prescription drugs.
If you are a physician or chiropractor or other healthcare practitioner using stem cell therapies, or a company putting stem cell therapies out on the market, an experienced FDA stem cell therapy lawyer can explain whether FDA has jurisdiction, what steps the FDA may take, and what penalties may apply. Current enforcement includes civil and criminal penalties.
The FDA is continuing to help balance the safety of patients and consumers with the benefits that stem cell therapies can provide the publish. Stem cells may one day help blind people see, help seniors become younger. But the promise of stem cell research must be balanced by informed consent, honesty in advertising, and patient safety.
Recent Stem Cell Therapy Enforcement Actions
Two recent cases illustrate that the FDA is taking stem cell therapy regulation to the next level.
- U.S. Stem Cell Clinic of Sunrise, Florida. In a CNN report, the FDA, in August 2017, posted a warning letter asserting that a Florida clinic, called U.S. Stem Cell Clinic of Sunrise, Florida sold stem cell treatments that were not FDA approved and were not sterile. The FDA claimed the Florida clinic was injecting the stem cells into the spines of patients – directly or intravenously. The non-sterility claim was based on an onsite inspection.
The FDA is now seeking a permanent injunction against the company, the Chief Scientific Officer, and the managing officer of U.S. Stem Cell Clinic of Sunrise, Florida because it failed to adequately respond to the warning letter and failed to comply with the law. The injunction requests that the defendants stop marketing their products until the violations are corrected and they get the required FDA approvals.
- California Stem Cell Treatment Center Inc. Marshalls were sent to a San Diego, California company called California Stem Cell Treatment Center Inc. to seize vials of a smallpox vaccine that had been mixed with stem cells. The mixture was being injected into cancer tumors. The FDA is seeking a permanent injunction against the company, two doctors, and a related company. The injunction request seeks to enjoin the marketing of the products unless FDA approval is obtained and the companies and doctors can show that the good manufacturing practice requirements are being met.
Any company that seeks to develop stem cell therapies should review what good manufacturing practices are, what liability and regulatory exposure a physician or company can have for marketing stem cell therapies, and relevant stem cell laws and regulations – with a respected FDA stem cell therapy lawyer. Failure to obtain required approvals can mean lost profits in addition to the civil and possible criminal penalties.
New FDA framework on Regenerative Medicine
In November 2017, the U.S. Food and Drug Administration introduced several documents to guide its regulatory approach to regenerative medicine which includes stem cell therapies. The documents include information on which products will be regulated as:
- Medical devices
- Biological products
The documents also discuss:
- The scientific process that should be used to determine the safety level of stem cell therapies
- The scientific requirements for showing the therapies are effective
- The enforcement actions that will be used if concerns are raised about the safety and merit of the therapies.
- How innovations can be expanded so good therapies can be developed
The framework also includes how the 21st Century Cares Act affects the development and risks of these new therapies.
- The FDA is aggressively working to protect the safety and effectiveness of stem cell treatments, products, and therapies
- The FDA has developed new polices and guidelines for assessing when violations of its regulations may occur
- The FDA is issuing warning letters and seeking permanent injunctions to stop companies from marketing therapies until they have been approved by the FDA
- The FDA has new regenerative and stem cell therapy guidelines that must be met.
Companies will need the help of experienced FDA stem cell therapy lawyers to understand these new policies and enforcement requirements.
Make the call to an experienced FDA stem call lawyer now
Stem cell therapies offer a lot of promise for helping patients with numerous medical problems. Companies that are developing these new therapies need to understand when they need to be in compliance with FDA regulations and what those regulations are.
The best way to avoid warning letters and other enforcement actions is to speak with a respected lawyer who understands the past and new FDA regulations and requirements. To learn what steps you or your company needs to satisfy the FDA, contact Cohen Healthcare Law Group. Our FDA and FTC attorneys are understand the new stem cell therapy and regenerative medicine issues.