Currently, cBHRT is not on FDA’s list of difficult to compound products, falling under certain exemptions of the FD&C Act, particularly, Sections 503A and 503B. Under Section 503A, a human drug compounded for an identified individual patient based on a prescription qualifies for exemption from three sections of the FD&C Act: 1) current good manufacturing practice for drugs; 2) labeling of drugs with adequate directions for use; and 3) approval of human drug products under new drug applications or abbreviated new drug applications. One of the criteria for these exemptions is that the Secretary has not identified the drug, by regulation, as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product. However, before the Secretary may promulgate regulations to add a drug to the difficult to compound list, it must convene and consult an advisory committee on compounding of such drug(s), unless the Secretary finds that issuance of such regulations before consultation is necessary to protect the public.Continue reading
What’s New with Regenerative Medicine?
The field of regenerative medicine is ever expanding and evolving. As more viable options become available to patients, it’s important to stay abreast of regulation surrounding many of these applications.
In late 2019, the Food and Drug Administration (FDA) began informing the public of multiple reports of serious adverse events experienced by patients who were “treated” with non-FDA approved products marketed as containing exosomes. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements. At the time of the 2019 warning, there were no FDA-approved exosome products and the FDA since then has not put out any new guidance.Continue reading
Second Proposed Stem Cell Bill Goes to Florida House of Representatives
By: Matt Fischer
On November 29, 2018, Florida Representative Chuck Clemons proposed house bill 65 (“HB 65”) that would significantly tighten regulation on the use of stem cells. If the stem cell bill is signed into law, Florida will join other states (e.g. California, Texas and Washington) in passing some type of stem cell regulation. While some bills around the country have centered the regulation on informing prospective customers of the risks associated with these treatments, HB 65 takes a more stringent approach with the threat of criminal exposure and includes certain protections for providers in the form of a “right-to-try” law.
Some of the highlights of HB 65 include:Continue reading
PRP Regulation: How is Platelet-Rich Plasma Regulated by the FDA?
By: Matthew Fischer
Platelet-Rich Plasma (“PRP”) has become a popular treatment for various conditions from sports injuries to hair rejuvenation so it makes sense that PRP regulation must keep up. With PRP, both the device used to separate platelets and the subsequent use of the PRP product fall under the scope of the U.S. Food and Drug Administration (“FDA”). The common question is: what is approved by the FDA with regards to PRP? Given the increased use, it is important for health care providers to understand the FDA’s standpoint on PRP regulation.
Medical Device Regulation
Let’s start with PRP devices. Generally, the FDA provides several avenues in which a device, drug, or biologic can come to market. For medical devices, an applicant can either obtain Premarket Approval (“PMA”) or 510(k) clearance. Most PRP preparation systems have utilized the 510(k) clearance process. What is meant by 510(k) clearance? The 510(k) application process, also known as premarket notification (“PMN”), is for medical devices that are seen as lower risk which are found to be “substantially equivalent” to a previously cleared device. Under the Food, Drug and Cosmetic Act, device manufacturers are required to register and notify the FDA of the intent to market a medical device in advance.
The FDA then determines whether the device is equivalent to a device already on the market. The 510(k) clearance process is a common way for PRP devices because it is less costly and time consuming as opposed to obtaining PMA. There is one important caveat though with 510(k) clearance. Clearance does not equate to approval for treatment of any indication. It only applies to its intended use in a specific setting. For example, in past warning letters issued by the FDA, the agency has required certain manufacturers to add language to its label stating that the PRP prepared by the device had not been evaluated for any clinical indication. Continue reading
Federation's Model Telemedicine Policy is Well Timed
Many health policy experts are betting on the expanded role of telemedicine as an essential cost-saving, quality (and access) enhancing tool. Yet legal and policy issues have dogged the development of useful telemedicine guidelines, making it difficult to know what’s ok and what’s not. What sort of licensure is required for physicians practicing telemedicine? When is the physician “practicing medicine” vs. “merely consulting?” When is a physician patient relationship established? Is one even necessary? The newly developed model policy developed by the Federation of State Medical Boards should help guide states in developing specific telemedicine standards.
Phoning It In – Florida's Brand New Telemedicine Law
By: Jackie Bain
Until recently, the State of Florida has successfully avoided regulating telemedicine to account for advancements in technology. In 2003, the State issued standards for telemedicine prescribing practice for medical doctors and doctors of osteopathy, but has not formally revisited its position in light of increasingly common telemedicine practice in several states – until now.
Florida’s forestalling has officially come to an end. The State recently enacted new physician standards for telemedicine practice, and the State legislature is presently considering further regulation. These new standards do not impinge upon the prior standards for telemedicine prescribing practice, but are issued in conjunction to it. Continue reading
Major Criminal Case in Palm Beach County Directed at Hormone Business
A trial underway in West Palm Beach will have serious impact on hormone replacement therapy (HRT) businesses around the state. HRT businesses are exploding around the state and country. The underbelly of the business exists where business owners do not approach it as a medical service deserving of the same seriousness (clinically and legally) as any other healthcare service. Four of the doctors involved have already pled guilty to conspiracy charges and were placed on five years probation. One of the doctors relinquished his license.
The allegations involved in the case shed light on some of the more nefarious aspects of HRT business, which in this instance include—Continue reading