Stem cell research is advancing rapidly; however, US administrative law (laws of regulation) and tort law (civil laws that award money damages) have lagged behind. To address this issue, Stephen R. Munzer, UCLA Law Professor and member of the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research, published a proposal in fall 2012 edition of Administrative Law Review online on January 7. It calls for a system of administrative laws dealing with the special characteristics of stem cells and creation of a special regime of product liability for their use.
Munzer notes that the science of stem cells is so advanced and fast moving that current laws have not completely addressed the legal ramifications of stem cell use or responsibility for unexpected side effects or unforeseen patient harm from their use. He explains that the potential risks and rewards of stem cell technology may differ from those of drugs, medical devices, or other biological products. His innovative proposal is to integrate regulation and liability in a dynamic model that can be adjusted as needed, based on information gathered over the time a stem cell product is used. This integrated scheme will promote safety and efficacy before and after market entry. Munzer emphasizes that effective regulation of stem cell products is intimately linked to product liability. He noted, “Some might consider this article premature because there are currently only two tissue-specific stem cell products allowed on the market by the Food and Drug Administration (FDA) for clinical treatments. But we need to take these steps now in anticipation of the speed this technology is advancing, particularly the potential clinical use of products derived from human pluripotent stem cells. If we don’t, we’ll be playing catch-up at a time when patient safety might be at risk, or when wider access to an effective treatment is needed, but not available.”
Munzer’s proposal outlines a dynamic system by which tort and regulatory law are harmonized. It provides for possible adjustments to the law as stem cell science develops. It also outlines a pathway for FDA approval and more aggressive post-approval regulatory oversight of stem cell products. The post-approval monitoring would require clinicians to routinely and systematically report to FDA stem cell effects observed during clinical practice. The clinical reports would provide sufficient data for scientists to assess ongoing safety and effectiveness of FDA-approved stem cell treatments.
Stem cell products may be classified as drugs or biologics, and use experimental delivery systems or devices; therefore, the current FDA oversight system does not easily accommodate the complexity of potential therapies. Problems may arise from pigeon-holing stem cell products into the existing FDA approval categories; therefore, Munzer outlines strategies for modification of the FDA classification system to better accommodate the differences between stem cell treatments and existing cellular therapeutics.
Currently, manufacturers must report all findings and adverse events under the current research oversight system; however, Munzer proposes a more rigorous yet flexible reporting system that would include closer follow-up after approval of a treatment to allow the FDA to make adjustments to allowable usage if needed. For example, using Munzer’s dynamic paradigm, the FDA could narrow the treatment-allowable patient population for a specific stem cell product if follow-up data indicated safety problems for some of the patients who received the treatment.
Munzer’s proposal also provides incentives for manufacturers to make sure punishment for not reporting adverse events strikes a balance that strongly encourages adherence, but that will not discourage scientists from wanting to develop future stem cell products. The FDA also would more closely monitor short- and long-term follow-up of stem cell products and devise risk-management and risk-reduction systems that rely more on information gathering than existing systems.
Munzer recommends modification of the FDA pre-market approval of stem cell products, the agency’s post-market regulation of the products, and a risk-management and risk reduction system. In addition, he proposes that the level and degree of regulation for a stem cell product should be proportionate to its potential risks. Because the proposal suggests a more aggressive role for the FDA, it also indicates that eventually there should be an assessment and reformation of the FDA if necessary. Munzer also attempts to account for the ways in which more regulation can backfire; thus, the benefits of new regulations should outweigh their costs. Under Munzer’s qualified strict liability scheme, plaintiffs could be awarded damages from more than one member of the supply chain when fault with a product cannot be attributed to one party.
To view the complete proposal, click on this link.