FDA and Its Regulatory Powers Essay

Excerpt from Essay :

Administrative Law


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).

Biological Products: Stem Cells

Stem cells are components of living organisms with the amazing potential of developing into many different types of cells in their early stages of growth in the womb (NIH, 2009). They are capable of repairing damaged tissues as they divide unlimitedly as long as the organism or person lives. As each stem cell divides and forms new ones, each new cell can either remain a stem cell or become another type with a more specialized function. It can be a muscle cell, a blood or a brain cell. Stem cells from humans and animals are either embryonic stem cells or adult stem cells. In 1998, a study of mouse embryo cells led to the discovery of human embryos and that they can be grown in the laboratory. These human embryonic stem cells are used in vitro procedures for reproductive purposes and are donated for research after their use with the informed consent of the donor. Meantime, the other type, the specialized adult cells, was found to be capable of genetic programming into induced pluripotent stem cells as though they were embryonic stem cells (NIH). The FDA's Center for Biologics Evaluation and Research regulates stem cells along with tissues and cellular and tissue-based products (AABB, 2014). These products are intended as implants, transplants, for infusion or transfer into another human recipient of the donation. FDA requires strict good tissue practice, donor screening and testing to prevent contamination and spread of communicable disease. It imposes more strictly regulatory requirements for allogeneic products than for autologous products. It requires a license for their distribution. It also reviews manufacturing procedures to insure purity ad potency (AABB). The regulation of these amazing products is explosive and will affect every ill or disabled person in the world, including myself.

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…

Sources Used in Document:


AABB (2014). How are stem cells regulated? American Association of Blood Banks.

Retrieved on May 16, 2014 from http://www.aabb.org/resource/bct/therapy/facts/Pages/regulated.aspx

Cell Therapy Cluster (2014). U.S. federal appeals court decision. Retrieved on May 16,

2014 from http://www.celltherapycluster.eu/en/news/99-us-federal-appeals-court-decision-propagated-stem-cells-are-a-drug.html

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