The FDA recently published guidelines on cell and tissue-based products, establishing clear boundaries around what it deems to be a safety risk and stating they intend to enforce these guidelines. The FDA maintains that a doctor cannot manufacture a device or drug, prescribe it to a patient, and ignore all laws governing the medical device and pharmaceutical industry simply because they’re an MD. The FDA asserts that rules that govern device and drug manufacturing apply to all companies and individuals, including clinicians. Let’s take a closer look at the recently published FDA guidelines.
Clinicians can prescribe a drug off-label, but cannot create their own drug and prescribe it. Likewise, clinicians can use a cleared FDA device off-label, but cannot make their own device outside of FDA oversight and then use it to make a biologic that they prescribe to a paying patient. The Agency has clearly stated such practices represent a safety risk to patients.
The Agency maintains that such laws apply to all device manufacturers. A recent FDA Warning Letter cautioned against, “Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, namely, your SVF product, including procedures for validation of all aseptic and sterilization processes.” Simply put, open test tubes and a laminar hood do not represent current good manufacturing practice (CGMP) and current good tissue practice (CGTP).
In November 2017, the FDA released “Guidances Related to the Regulation of Regenerative Medicine Products and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”. The guidances say a tissue will be regulated as a drug if it:
1) Meets the definition of an HCT/P and
2) The processing is more than minimal manipulation,
3) Does not meet the definition of homologous use, and
4) Does not meet the same surgical procedure exception.