Ketamine and non-label issues-Canna Law Blog™
A common question that arises in ketamine clinic transactions is whether clinics or doctors (collectively referred to as “healthcare providers” or “providers”) can use ketamine for off-label use or promotion. The short answer is yes, but pay attention to the following points, as described below. However, before reaching the answer, it is important to define the meaning of “off-label” use and whether the U.S. Food and Drug Administration (“FDA”) has jurisdiction over healthcare providers to enforce off-label promotions.
What is “non-label” use?
The term “off-label” refers to prescriptions for indications not listed on the drug label. The label must be approved by the FDA during the pre-market approval process and must contain certain information about the approved use. See, for example, Section 201.56(a)(3) of Title 21 of the Code of Federal Regulations (“The label must be based on data derived from human experience as much as possible.”). Among other things, the label was prepared after the FDA has completed clinical trials and obtained FDA approval. See, for example, Section 505(i) of Title 21 of the United States Code (Clinical trials are required before the drug is approved for marketing).
For example, when the evidence fails to prove the safety of the drug or “lack of sufficient evidence to prove that the drug will have the claimed effect”, the FDA may reject the application for the new drug. 21 USC§355(d). (“[S]”A lot of evidence” refers to evidence composed of sufficient and well-controlled investigations (including clinical studies) conducted by scientifically trained and experienced experts who should have scientifically trained experience and be able to assess the effectiveness of the drugs involved On this basis, such experts can fairly and responsibly conclude that the drug will have the effect it claims or is alleged to have [proposed] Conditions of Use…. “).
Federal Food, Drug, and Cosmetic Act (“FDCA”) (codified in 21 USC §301) Wait. ) And FDA regulations usually prohibit Vendor From marketing, advertising, or otherwise promoting drugs for unapproved or “off-label” uses. Look 21 USC§§331(a) and (d) (It is forbidden for manufacturers to introduce misbranded or unapproved drugs into interstate trade); See also, for example, 21 Code of Federal Regulations, Section 202.1(e)(4)(i)(a) (“Prescription drug advertisements…should not recommend or suggest any uses other than those accepted by this label [the] Approved new drug application… “).
Are healthcare providers prohibited from using non-standard drugs?
Although there are very strict laws and regulations for off-label promotion of drug manufacturers, healthcare providers are not subject to these restrictions (if these providers are not employed or contracted with drug manufacturers). Look Dresser, Frader J, OTC Prescriptions: Call for Strengthening Professional and Government Oversight, “Law Journal” No. 37. Code of Ethics 476 (2009) (“In accordance with its jurisdiction, FDA controls the marketing of manufacturers’ products.”). Healthcare providers have the absolute right to discuss with patients and recommend drugs for over-the-counter use. Buckman Co. v. Plaintiff’s legal action., 531 US 341, 350-51 (2001) (because FDCA does not regulate the handling of drugs, and because prescription drugs may have therapeutic uses other than FDA-approved indications, doctors can legally prescribe for off-label use) ; You can also take a look Teo W: FDA and medical practice: Look at off-label drugs, Seton Hall Legis, page 41. J, 305, 307 (2016) (FDA has always insisted that “it does not regulate medical practice between physicians and patients.” (footnote omitted)).
What are the approval conditions for ketamine?
According to the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, ketamine is a Schedule III non-narcotics controlled substance in the United States, which means that it is a legal prescription drug that has been accepted for medical use. 21 CFR§1308.13. Ketamine is commonly used as an anesthetic in surgical procedures and has been approved for the treatment of certain types of depression. Look Digital reference for prescribers (2021), https://www.pdr.net/ (Ketamine hydrochloride has been approved for inducing and maintaining anesthesia and procedural sedation, while ketamine hydrochloride has been approved for use in combination with oral antidepressants For the treatment of depression and treatment of refractory depression in adults). Therefore, use ketamine in any other situation (E.g, Analgesics) are considered off-label products. However, doctors are increasingly using ketamine to treat mood disorders, pain symptoms and other diseases.
Can the provider use and promote ketamine under any circumstances?
Although the FDA may not have jurisdiction over off-label uses by healthcare providers, this does not mean that providers can market (or “declare”) ketamine under any circumstances without fear of retaliation. Healthcare providers should pay attention to two main areas of law-claims for medical malpractice under state and federal law and claims for fraudulent business practices (under federal law, the Federal Trade Commission has the right to sue the provider).
The use and promotion of ketamine in non-“label” situations can result in malpractice claims against careless healthcare providers. Medical malpractice claims usually revolve around whether the doctor’s care meets community standards for the treatment of a particular disease. In the absence of FDA approval or a lack of extensive research to support the use of drugs for specific diseases, it may be difficult for providers to persuade a jury to ensure that their care meets community standards (click here For a summary of the basis for possible medical malpractice claims, the note states: “If it can be determined that the doctor’s off-label medical prescription deviates from acceptable and general practice standards, the plaintiff may recover from the off-medical malpractice case.” )
The second concern is whether off-label promotions are deceptive to consumers. Both state and federal laws are designed to protect consumers from false or misleading advertising. click here Provides an overview of unfair and deceptive practices and practices (UDAP) regulations in fifty states and the District of Columbia.
According to the theory of deceptive trade practices, if a health care provider makes a “claim” for a drug that is not supported by clinical evidence, it is easy to see how this will lead to deceptive trade practices when the drug does not work properly. Advertising (or worse, hurt the patient). For example, if a provider publishes on their website that ketamine injection is a “cure” or “100% effective” treatment for mental illness, it can certainly help form the basis for fraudulent claims.
Therefore, care must be taken to promote off-label use of ketamine in a non-misleading manner. The gold standard for “proof” and “claim” is a well-controlled randomized clinical trial with statistical significance (E.g, And the results can be extended to people outside the research and control groups. Of course, FDA approval requires such proof, and without FDA approval, other reliable evidence must exist to protect healthcare providers from various legal actions.