Impending FDA Regulations for Regenerative Therapies

Regenerative Therapies – what does the future hold?

The Food and Drug Administration, or FDA, is responsible for monitoring almost all of the components related to human health. This includes medical equipment, medical procedures, medication, food, food processing equipment, and much more. Many of the products on the medical market today have been FDA approved. The approval process can take years, as it involves research and clinical trials. The field of regenerative medicine has seen a rapid increase in interest and practice recently due to constantly changing laws and FDA approval. The FDA website provides information about the current status of guidelines, as well as recommendations for best practices. Read on to learn about regulations that have already occurred, what they are doing present-day to regulate these therapies, and what the future holds.

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Previous FDA Regulations and Laws

Current regenerative medicine practices include stem cell therapy, platelet-rich plasma (PRP) therapy, and gene therapy. These therapies seek to use a patient’s own cells to enhance healing properties that already exist naturally within the body. FDA regulations on these therapies are frequently changing, so they publish new information often.

In 2017, the FDA came out with four guidance documents regarding regenerative medicine. A guidance document is the FDA’s way of taking an official stance on a matter. These documents are used to provide a reference for the general public and industry professionals about what the future holds as well as regulatory techniques that could be used. Guidance documents are also used as a way for the FDA to provide recommendations for practices.

The content of a guidance document varies depending on the subject matter. Each document clearly states that the information is “nonbinding”, as these documents’ intended purpose is to guide industry professionals rather than enforce regulations. It should be noted, however, that FDA approval is much more likely to be obtained if these recommendations are followed.

The FDA has recently used a guidance document to announce a designation for regenerative therapy. Once certain criteria are met, treatment can be considered Regenerative Medicine Advanced Therapy (RMAT). Having the RMAT title could allow certain privileges such as a faster path to FDA approval. It is expressed that this title should be applied predominantly to the treatment of rare and serious conditions. Some of the criteria for achieving this designation include what the drug is being used for, if and how it has been tested, and the market’s need for the treatment. Creating this designation is important because it impacts the future of regenerative medicine in two important ways:

  • A Clear Path to FDA Approval: the process of obtaining FDA approval for regenerative medicine has been relatively unclear for years. Now that there is a clear plan, the public can become aware of treatments that may benefit them. This development also impacts clinics across the country; now that there is a more clear path to approval, clinics can begin or continue to practice accordingly.
  • Increased Access to Therapies: the FDA’s release of this designation means that there will be even more new research and clinical trials taking place in the near future. The more research is taking place, the more we are able to understand regenerative medicine. A greater understanding of regenerative medicine leads to more precise treatments and legitimacy. Increased research could also lead to new treatments and even cures for many diseases.

The public availability of these guidance documents is a crucial aspect of the process. FDA regulations are notoriously rigid, so providing practitioners with a clear-cut path to follow implies that the FDA is willing to begin acknowledging regenerative medicine as a legitimate form of medicine.

On December 13, 2016, the 21st Century Cures Act became law. The act sought to change the notoriously rigid FDA approval pathway. The goal of changing the approval process was to pave the way for new drugs and treatments to come to market more quickly. The field of regenerative medicine benefited greatly from this act, as many of the treatments and research in the field began to come to fruition. Clinics that have been researching regenerative medicine and performing clinical trials now have the opportunity to seek FDA approval much more quickly.

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Current Classification of Medical Devices

Another guidance document that the FDA released in 2017 provided a more technical approach: the document contains recommendations for how equipment should be used. This document includes a reference to the classifications of medical devices and how these classifications are determined. All medical devices are divided into Class I, Class II, and Class III:

  • Class I: this classification refers to medical devices that present a low risk to the patient. These include everything from bandages to surgical trays.
  • Class II: moderate to high-risk medical devices. Some examples of Class II devices include acupuncture needles and motorized wheelchairs.
  • Class III: this classification poses the highest risk to patients. These devices include implantable pacemakers and implantable birth control, for example.

This is a useful document for practitioners of regenerative medicine, as it offers information about how to ensure that the equipment being used is compliant. Most medical devices fall under the Class II. In the field of regenerative medicine, much of the medical equipment that is being used has been FDA approved; however, it is worth noting that FDA approval is contingent on the intended use. For example, a surgical needle may be FDA approved, but not approved for the use of injecting stem cells or platelet-rich plasma. The intended use may also change the classification depending on the risk it poses.

What’s Next for Regenerative Medicine

On January 15th of 2019, the FDA released a statement by the commissioner and director of the Center for Biologics Evaluation and Research. The statement contained predictions of how long it will take to approve a certain number of regenerative therapies – stating that by 2020, there will be approximately 200 new therapies in the stages of receiving approval.

The statement also announced that the FDA plans to hire more employees who will be in charge of reviewing clinical trials, research, and new medical devices. This will allow regulations and approvals of regenerative therapies to move forward much more quickly. The FDA also plans to move forward with RMAT regulations in the hopes that more treatments can become approved soon. The statement also included the promise of certain new guidance documents, which will include recommendations for developing products.

The future of regenerative medicine is directly correlated to the FDA and its willingness to regulate the field. Thankfully, many regenerative medicines have already yielded positive results, so the FDA is doing what they can to provide an environment in which these practices can continue. The faster that the FDA can get regenerative medicine practices and products approved, the more likely it is that cures can be found and people with chronic pain or illness can be treated.

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Ben Green

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