Our healthcare and business law firm works with many providers and medical practices to ensure compliance with state and federal laws, rules, and regulations for given procedures, treatments, and prescriptions. A hot topic and sometimes controversial category of drug right now is weight loss drugs (also called weight management drugs). A provider should generally prescribe a drug or treatment pursuant to a patient-provider relationship when the drug is medically necessary and appropriate, but some states have laws and rules specifically governing prescribing weight loss drugs. If your state has rules or guidance on prescribing weight loss drugs, it’s important, of course, to follow that guidance. Unlike our firm’s look into Florida’s weight loss statute, blog post available here, this blog post examines what to consider when a state does not have specific weight loss rules by using Georgia as an example. If you need assistance understanding your state’s guidance on weight loss treatments or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.
If your state has no specific weight loss statute, such as the statute we previously examined in Florida, where do you turn? Below is an idea of where to start:
- Are There Relevant Statutes or Rules?
Although there is no weight loss rule, Georgia Rule and Regulations Section 360-3-.02 references weight loss. Under Rule 360-3-.02, it is unprofessional conduct for a physician to prescribe Schedule II controlled substances, except in a narrow list of situations which includes: “Weight loss management, if drug has been approved by the FDA for that indication.” The exception may not be directly relevant to most weight loss drugs because most popular ones are not controlled substances, but this exception reveals that the medical board has considered the use of weight loss (aka weight management) drugs and acknowledges their medical use.
- Has the Medical Board Published Any Statements on Weight Management Drugs?
In Georgia, the Medical Board publishes its meeting minutes and public consent orders each month. At present, our firm has not reviewed any statements from the Georgia Medical Board specifically about weight loss treatments in general or the mention of semaglutide, ozympic, or similar drugs. In this case, the rules that apply to weight loss drugs are the same as apply to other drugs. In Georgia, drugs are typically either governed by rules relating to (a) “dangerous drugs” (drugs that are not controlled substances but require a prescription) or (b) controlled substances.
- Have There Been Any Enforcement Actions Relating to Weight Loss Drugs?
In 2023, the Food and Drug Administration and Georgia Medical Board investigated a clinic that was prescribing “semaglutide sodium,” which is not an FDA approved drug. An important thing to keep in mind is that only FDA approved drugs should be used, even if they are used in an “off label” form. Although off label uses of an approved drug are generally permitted, the drug must be approved in the first place.
There are, of course, other considerations to understand your state’s view of weight management drugs. The above provides information pertaining only to Georgia as an example of state laws governing weight loss treatment. If you need assistance understanding your state’s guidance on weight loss treatments or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.