The FDA's regulatory approach to stem cell therapy and biological products

Administrative Law

REGULATING STEM CELL THERAPY

Administrative Agency: Food and Drug Administration

Article 1 Section 1 of the federal Constitution creates administrative agencies, which are law-making entities but with limited powers (USLegal, 2014). The rules and regulations created by an administrative agency are lawfully enforceable. It assists in the faster management of cases and is, therefore, a big help to U.S. courts. The administrative process is also a valuable resource for other important case. Members of an administrative agency are necessarily experts in their field (USLegal)..

One such agency is the Food and Drug Administration or FDA, which is under the U.S. Department of Health and Human Services or HHS (USgov, 2014). It is charged with the mandate to protect the health of the public by insuring the safety, efficacy and security of human veterinary drugs, biological products, medical devices, food supply for the country, cosmetics and radiation production. It likewise disseminates accurate and updated science-based information on health to the public (USgov).

II. Description of the Proposed Change

In February 1997, FDA announced its risk-based approach on all the products under its control and supervision (Lazarus, 2007). It recommended that the level and type of regulation should align with the product risk and that similar products shall be treated alike. Its proposed regulatory framework aimed at preventing the risk of using contaminated tissues to avoid spread; assuring proper and contamination-free handling or processing; and guarantee clinical safety and effectiveness, especially for tissues, which are highly processed for natural purposes, with non-tissue components, or may inflict systemic effects (Lazarus).

What drummed up public controversy was the intense perception of stem cells grown in the laboratory were not drugs but clear and simple human cellular and tissue products (Cell Therapy Cluster, 2014). The controversy developed from violations of the two statutes regulated by the FDA, namely the Federal Food, Drug and Cosmetic Act and the Public Health Service Act, intended to insure the safety of drugs and biological products. They require details on the amount of substances are manufactured ad labeled. Products, which do nt meet these strict requirements are considered adulterated or misbranded. Any act leading or contributing to adulteration or misbranding violates federal law and a ground for an injunction by the FDA. This led to a case filed by the FDA against the three doctors of the Regenerative Sciences LLC, which marketed "Cultured Renenexx Procedure" as a medical therapy at their clinic. The doctors extracted a sample of the patient's bone marrow or fluid and isolated mesenchymal stem cells or MSCs and placed in a solution to culture them. Other substances were added to enhance the intended differentiation of the cells. When they were numerous enough, they were combined with an antibiotic, doxycycline, to prevent infection and then re-injected into the same time where they were taken. The doctors asserted that their procedure was an alternative to surgery for orthopedic and other diseased conditions, such as arthritis and musculoskeletal and spinal injuries. In August 2010, the FDA filed for a permanent injunction against the company, which it said used the mixture as both a drug and a biological product it considered adulterated and misbranded. As such, it violated the two statues. The district court found that the appellants violated the statutes and also entered a permanent injunction to prevent them from committing the violations further. On February 4 this year, the Court of Appeals for the District of Columbia Circuit agreed with the FDA's arguments and supported its position that stem cells grown in laboratories are to be considered drugs (Cell Therapy Cluster).

III. Public Comments

Some professional groups believe that the FDA was always within its mandate of regulating medical products by guarding against risks imposed by mass production (Freeman & Fuerst, 2010). In almost all cases, it gets things rights. But its creation of 21 CFR 1271 and classified autologous tissue as drugs, it went too far. The extra step would not redound to too much public benefit and would even discourage medical innovation (Freeman & Fuerst). Public comments to the then proposed regulation ranged from objections to the language as too technical; NIH funding of stem cells would violate DHHS law; the guidelines are too restrictive; the guidelines have not been widely disseminated; embryos may eventually be "created" for research purposes; a black market for human embryos may be formed and individuals may be forced to donate them; the sale of fetal tissues may be transformed into a business for profit; more strict informed consent arrangement; and identifiers should be removed (NIH, 2014).

Perhaps out of excitement over the incredible potentials of stem cell therapy, medical corporations have sidestepped the authority of the FDA. They argue that their biological products cannot be considered either biological products or drugs. But it is always better to stay safe. Moreover, current knowledge about MSCs is still new and experimental and thus can incur unexpected risks. Ignoring FDA guidelines can be hazardous and expose patients to serious contaminations, injuries, or even death.

IV. Deadline

The deadline for this proposed regulation was October 21, 2013.

V. Legal Theories

Principles of human subjects research, which emanated from the 1949 Nuremberg Trial, apply to all kinds of research, which involve human subjects (Dane, 2007), living or in the womb, directly or indirectly involved in the study. These principles should also be observed in stem-cell research -- and use. These are respect for persons and their autonomy, justice, beneficence and non-maleficence, trust, fidelity and scientific integrity,

Respect for persons and their autonomy means donors cannot be coerced or cajoled into donating or be bribed for something that is part of them. They should be made fully aware of the meaning and consequences of a request for a donation and must freely agree to it. Justice means weighing the benefits and the risks on both sides before a deal is implemented. The donor's rights must be fully recognized. Beneficence and on-maleficence means that the action should not only inflict no harm but will also result in some benefit to the donor from the recipient. Trust means opening up in total honesty without any hidden motives. And fidelity and scientific integrity impose the responsibility on researchers not only to add something of value to existing knowledge but also to recognize all possible ethical implications to every consequence in the exercise of the new knowledge.

But all of the 5 principles or ethical-legal theories, in my opinion, the most important is justice. Justice is inherent in the other four and implies that all sides are taken in total openness and good faith. Nothing beneficial, respectful, faithful or worthy of trust can be achieved without justice.