Patent Agent, Bawa Biotechnology Consulting LLC, Ashburn, Virginia, USA.
Curr Drug Deliv. 2011 May;8(3):227-34. doi: 10.2174/156720111795256156.
There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle nanomedicine research and development (R&D) and erode public acceptance of nanoproducts. The end-result of this could be a delay or loss of commercialized nanoproducts. Whether the FDA eventually creates new regulations, tweaks existing ones or establishes a new regulatory center to handle nanoproducts, for the time being it should at least look at nanoproducts on a case-by-case basis. The FDA should not attempt regulation of nanomedicine by applying existing statutes alone, especially where scientific evidence suggests otherwise. Incorporating nanomedicine regulation into the current regulatory scheme is a poor idea. Regulation of nanomedicine must balance innovation and R&D with the principle of ensuring maximum public health protection and safety.
纳米医学——将纳米技术应用于医疗保健的多学科领域——引起了巨大的兴奋和期待，它已经在影响制药行业。在治疗药物的设计、配方和输送方面尤其如此。目前，纳米医学正处于关键阶段。然而，这方面的监管指导普遍缺乏，制造商、政策制定者、医疗保健提供者以及公众都迫切需要明确和法律确定性。市场上有数以百计甚至数千种用于人体的纳米产品，但人们对它们的健康风险、安全数据和毒性特征知之甚少。人们对进入环境并与人类接触的纳米产品知之甚少。这些纳米产品，无论是药物、设备、生物制品还是这些产品的任何组合，都给食品和药物管理局（FDA）带来了挑战，因为监管机构正在努力积累数据并制定测试标准，以确保安全有效的纳米产品（包含纳米技术的产品）的开发。越来越多的证据表明，许多纳米产品固有地具有新颖的基于尺寸的特性和毒性特征。然而，这一科学事实被 FDA 普遍忽视，该机构继续对这一问题采取预防措施，希望能应对未来潜在的负面公众意见。结果，FDA 只是在其与纳米医学相关的监管政策方面维持现状。因此，纳米医学没有具体的法律或监督机制，FDA 继续将纳米产品视为与其散装产品基本等效（“生物等效”）。因此，目前提交给 FDA 审查的纳米产品将继续面临不确定的监管途径。这种监管上的不确定性可能会对风险投资产生负面影响，抑制纳米医学的研发（R&D），并削弱公众对纳米产品的接受度。其最终结果可能是商业化纳米产品的延迟或损失。无论 FDA 最终是创建新的法规、调整现有的法规还是建立一个新的监管中心来处理纳米产品，至少目前它应该逐案考虑纳米产品。FDA 不应该仅仅通过适用现有的法规来尝试对纳米医学进行监管，尤其是在科学证据表明并非如此的情况下。将纳米医学监管纳入现有的监管计划是一个糟糕的主意。纳米医学的监管必须在创新和研发与确保最大限度保护公众健康和安全的原则之间取得平衡。
