Reassessing Safety for Nanotechnology Combination Products: What Do 'Biosimilars' Add to Regulatory Challenges for the FDA?

Abstract:     
Amidst sweeping changes to the United States health care system ushered in by the Patient Protection and Affordable Care Act (ACA), the Food and Drug Administration continues to struggle to apply emerging technological innovations to often centuries-old product categorizations. The ACA’s introduction of a “biosimilar” pathway to market for biological products, modeled on abbreviated pathways to market for drugs and medical devices, further complicates the assessment of “safety” and measures of equivalence and similarly that allow products to hit the market faster. One area where this is particularly acute is that of nanobiotechnology, which has enabled a set of products that drift uncomfortably at the interface of drugs, medical devices, and biologics, blending unique and novel biological properties at the nanoscale that integrate chemical, mechanical and biological aspects into a wide range of consumer medical and health care products.

This article will argue that the creation of the biosimilar pathway will prove to be the straw that breaks the camel’s back unless the FDA develops new dynamic models to properly assess and regulate nanomedical combination products. This article will examine the existing frameworks of FDA oversight for medical and health care products, highlight nanotechnology (and nanobiotechnology and nanomedicine) specifically as an area where products are currently straddling traditional boundaries between FDA product categories, discuss recent FDA initiatives and agency procedures regarding nanotechnology, and will suggest an approach for the FDA to respond to nanobiotechnology, including more effective federal coordination; reorganization of the FDA either through Congressional action or Commissioner action in order to properly classify, assess, monitor, and regulate emerging nanomedical technologies and products; and changes to FDA policy regarding data requirements and post-market reporting from industry to address concerns about the scope of “safety” in the context of nanomedical products.

Number of Pages in PDF File: 56

Keywords: nanotechnology, Food and Drug Administration, drugs, devices, biologics, health care reform

Accepted Paper Series