Lawand Stem Cell research
Themain stakeholders in the dispute are the United States governmentrepresented by the Food and Drugs Authority (FDA) and RegenerativeSciences Company and proponents of stem cell research networks. TheFDA argues that stem cells used in treatment of orthopedic patientsare a biological product subject to proper manufacturing process andlicensing. My favorite stakeholders are the proponents of innovativestem cell products that offer new and better forms of medication. Thestem cell proponents use logos to argue that the MSC S is multipotenthence they can form only type of cell (Tigerstrom1). In addition,autologous stem cells are individualized and cannot be produced formass consumption, hence no need for FDA regulations. The Stem cellproponents use pathos when they argue that regulation of stem celltherapy by FDA will reduce research interest in the subject. Inaddition, stem cell therapies have saved many lives and itsregulation will result in loss of many lives (Pivarnic 16).
TheFood and Drugs Authority (FDA), Has the power and authority toregulate autologous stem cells used in treatment of patients. TheHCT/P regulation argues that cellular products created externallyusing chemicals, though originally from patient’s biologicalmaterials, fall under FDA regulated substances. The FDA regulatesdrugs that do not originate from patients and are produced bypharmaceutical companies and labs, however, the doctors who producepersonalized medical therapies cannot be clearly differentiated fromdrug manufacturers. FDA’s decisions are science based and they donot necessarily meet the patient demands. There is need for publiceducation on innovative therapies and the role of FDA in regulatingsuch scientific innovations. FDA has limited experience and knowledgein use of autologous cells treatment, which can be adopted in"clinician-centered activity in hospitals andclinics,"(Tigerstrom, 2011).
TheUnited States v. Regenerative Sciences law suits is more of a civilrights issue whose outcome will highlight what control patients haveon the use f their own tissues and cells. The FDA regulations willresults in loss of death of many patients who would have otherwisebeen saved by their autologous cells. Unconscious patients in the ICUcan be saved using autologous stem cells however, if FDA gainscontrol, patients will die, as they will be unable to make decisionsin their unconscious state (Pivarnic 16). In addition, the tong timewasted in waiting on Washington to make decision will result I manydeaths. By forcing clinics to comply with FDA, rules will enforceharsh economic and administrative burden on the clinics hencecompelling them to abandon the stem cell treatment, which is abreakthrough in medical research.
Thedecision made by the Federal trial court to mandate the Food Drugsand Authority to regulate stem cell treatment is a major setback inmedical innovation. The cells taken from a patient are re implantedto relieve pain and treat orthopedic patients. Therefore, they do notfall under the same category as manufactured drugs. New biologicaltreatment techniques using body cells should not be grouped in thesame category with manufactured drugs, as the regulating standardsare not similar. The new regulation is likely to impose financial andmanagement constraints on clinics, compelling most researcher toabandon the research. On the other hand, the regulation of stem cellsby FDA is in accordance with the law, as it will ensure that patientsreceive quality treatment. The FDA is in a tight situation because ifit fails to regulate stem cell procedures, which result in death, itwill face public ridicule and blamed for inefficiency.
Tigerstrom,Von Barbara. “The Food and Drug Administration, RegenerativeSciences, and the Regulation of Autologous Stem Cell Therapies.”TheFood and Drug Law Institute Food and Drug Law Journal.2011
Pivarnik,Greg.“Cellsas Drugs Regulating the Future of Medicine.” AmericanJournal of Law & Medicine.40.2 (2014):298-321