e-journal

Cells as Drugs?: Regulating the Future of Medicine

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Regenerative Sciences, LLC, a Colorado company run by physicians, created the Regenexx-C (Cultured) (“Regenexx-C”) procedure to treat bone pain. The procedure involves harvesting a patient’s own mesenchymal stem cells (MSCs), expanding the cells ex vivo, and then injecting the resulting cellular product into the site of injury, usually an injured joint. 2 The MSCs then repair the damaged tissue.On July 23, 2012, the United States Food and Drug Administration (FDA) won a permanent injunction against Regenerative Sciences in district court, preventing the company from offering the procedure because the MSCs were adulterated and misbranded “drugs” under the Federal Food, Drug, and Cosmetic Act (FDCA). The Court of Appeals for the D.C.Circuit recently upheld the ruling. In many respects, United States v. Regenerative Sciences, LLC presented the perfect fact pattern for addressing the question of whether FDA has jurisdiction over cellular therapies. The procedure at issue involves an autologous cellular transplant,in which a patient’s own cells are used to treat his or her medical condition.The regulation of autologous transplants implicates issues of medical autonomy that the regulation of allogenic transplants, which occur between two people, does not. In fact, no one has Challenged FDA’s ability to regulate allogenic transplants. The cells used in allogenic transplants look more like traditional pharmaceuticals, which have their origin outside of the patient. In contrast, since the cells or tissues used in autologous transplants originate in the patient, patients may feel that they own the cells.Framing the issue in this way understandably generates accusations of paternalism against FDA, and also, anger among patients who want unrestricted access to the healing mechanisms of their own body parts. The underlying rationale for such regulation, however, is much more nuanced. FDA only regulates autologous cellular transplants for safety and efficacy when the cells are “more than minimally manipulated.”8 Cells are considered more than minimally manipulated when they undergo procedures that call into quest ion the chemical identity of the resulting cellular product.9 Possible changes in the product’s identity implicate new safety concerns, and placing the onus on the manufacturer to prove a product’s safety and effectiveness is a reasonable safety measure. The regulation of such therapies is consistent with FDA’s statutory authority. . The regulation of more than minimally manipulated cells is also consistent with the government policy of regulating the substances that one may put into his or her body. The intrusion on personal autonomy is no greater than that presented by any other FDA regulation. In theory, more than minimally manipulated cells no longer resemble the patient’s naturally occurring cells, and therefore, are a new substance well within FDA’s regulatory authority. Cells that are only minimally manipulated— for example, those that are only frozen—more closely resemble the patient’s actual cells, and government regulation of these cells may raise substantive due process questions. The more the final product resembles the patient’s naturally occurring cells, the greater the affront to personal autonomy. FDA avoids these issues, however, because it only regulates manufacturing procedures of minimally manipulated products so as to “prevent the . . . spread of communicable diseases” and not for safety and efficacy.10 FDA cannot, therefore, prevent a patient from accessing minimally manipulated products derived from their own cells. However, the regulation of more than minima lly manipulated autologous cellular therapies is inconsistent with a more basicphilosophical tenet of drug regulation: eliminating the information asymmetry that exists between the drug manufacturer and the consumer.11 Congress expanded FDA’s regulatory authority numerous times throughout the twentieth century in response to manufacturers selling harmful products.12 Consequently, drug and device manufacturers must publicly vet their products in carefully controlled clinical trials before FDA will consider a New Drug Application (NDA).13 FDA approval of an NDA signals to the public that a drug is safe and effective for medical use, thus significantly mitigating the information asymmetry that exists between the manufacturer and the consumer. The Regenexx-C procedure, on the other hand, occurs between a doctor and patient.
State tort law and medical licensing boards regulate the information asymmetry inherent in these relationships. Traditionally, FDA has not asserted jurisdiction over the doctor-patient relationship.14 This Note analyzes the legal issues surrounding autologous cell therapies and
concludes that, although FDA regulation of autologous tissue therapies is a legal exercise of authority and based on sound scientific principles, FDA should allow people access to these therapies because concern for patient autonomy outweighs the safety risks.15 FDA can still regulate the manufacturing process less stringently without requiring a showing of efficacy and, at the same time, allow patients access to the healing properties of their own tissues.16 Part II of this Note provides the relevant regulatory and legal background of autologous cellular therapies. This Part also analyzes the appeals court opinion that upheld FDA regulation of an autologous stem cell transplant as a drug and biological product (biologic). Part III provides an analysis of the relevant legal issues. First, the appeals court’s decision may limit FDA regulation of cellular therapies under its Commerce Clause powers. Second, because the plain language of the applicable statute permits FDA to regulate autologous cellular therapies as a drug or biologic, for medical practitioners, the relevant inquiry becomes whether a novel cellular product is minimally manipulated so as to escape stringent FDA regulation. Using
Regenexx-C as an example, this section outlines standards relevant to the minimal manipulation inquiry. Part IV recommends that FDA allow patients access to autologous cellular therapies based on theories of patient autonomy and informatio asymmetry. Part V contemplates the broader issues raised by these developments.

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Ketersediaan

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Informasi Detail

Judul Seri

Law & Medicine,

No. Panggil

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Penerbit

Boston : American Society of Law, Medicine & Ethics., 2014

Deskripsi Fisik

American Journal of Law & Medicine, 40 (2014): 298-321

Bahasa

English

ISBN/ISSN

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Klasifikasi

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Tipe Isi

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Tipe Media

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Tipe Pembawa

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Edisi

(2014) 40

Subjek

LAW & MEDICINE

Info Detail Spesifik

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Pernyataan Tanggungjawab

deliza

Versi lain/terkait

Lampiran Berkas

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