The Regulatory Approval Issues That Nanotechnology Presents

Nanotechnology will present a host of complicated issues related to regulatory approval. Nanomaterials and devices will primarily be used to develop more advanced versions of a number of existing products. There will be many uncertainties and questions associated with what amounts of additional data will be required to obtain regulatory approval. For example, the novel drug delivery techniques resulting from nanotechnology will present challenging data issues. As discussed in Chapter 1, examples of drug delivery mechanisms include the use of nanostructures that release traditional antibiotics only when near an infection, coatings that prevent digestive enzymes from breaking down the drug in the stomach, and implantable devices that can periodically dispense medicines, such as insulin or morphine. When a new drug delivery system is used in conjunction with a drug that has NDA approval, the FDA will be forced to make difficult decisions about the risks of the new therapy and the data that will be required to market it. Lawyer Jonathan Kahan summarized the regulatory dilemma at an FDA workshop in 2003:

[T]he question is when you modify the drug formulation to optimize delivery with the device,... are you now about to reinvent the wheel and have to start over____That is not something that most device companies want to do. They do not want to reinvent the drug wheel. And so the question is: Is a new NDA required for the drug if you have a different mechanism that the mechanism that was described in the NDA-approved label____And query whether a device company using the 505(b)(2) process can—with a different, let's say, route of administration and a clear drug product—can they rely on 505(b)(2) without a drug manufacturer even on the horizon to get their product through? A real tough issue. I don't have the answer. It is something that a lot of companies are looking at...

Complicated data issues could arise in conjunction with an array of different medical products that could be enhanced by nanotechnology. A number of companies are developing tissue engineering and cell therapies.64 Some of these companies will receive FDA approval to market their products in the near future. If nanomaterials are later developed that can be integrated into such therapies to increase their effectiveness and reduce immune reaction risks, there will be complex questions associated with what levels of new data are required to continue marketing the improved therapies. Similarly, when approved diagnostic devices are made less invasive by reducing some of their dimensions to the nanoscale, manufacturers will have to negotiate what additional data are needed to demonstrate safety and efficacy.

The uncertainties and costs associated with obtaining regulatory approval for integrating nanotechnology into existing products is magnified by the substantial scientific uncertainties surrounding the insertion of nanomaterials in the human body. As discussed in Chapter 4, there are a variety of unknown health risks associated with nanomaterials. Dr. Vicki Colvin maintains, "Nanomaterials are valuable in many technologies because they interact quite differently with the body than larger materials."65 Further, many start-ups in the field may overlook the immunological complications associated with different types of nanomaterials. James Baker, a leader in the nanomedical field, notes: "Most of the people proposing this stuff are not biologists and they think they can stick anything in the body if it's small enough."66

The ad hoc process of determining the amount of data needed to market a nanotech product could thwart development of the field. Even though the integration of nanotechnology may only slightly alter an existing product and should have no adverse effects, a company might be required to "reinvent the wheel" and start full-blown clinical trials all over again. If a company is not prepared for these stringent data requirements, it might be forced to abandon the entire project. Ultimately, the enormous uncertainties could dissuade industry from embarking on nanomedical research and development efforts.

In the very long run, the introduction of nanorobots could present tremendous regulatory uncertainties. Reviewers will evaluate data for the safety and efficacy of a whole new type of therapy. The agency will have to consider the risks associated with "old nanorobots" being left in the body if they fail, in vivo replication, and untested interactions between different nanorobots or nanorobots and drugs. There will also be complicated manufacturing issues. For example, the FDA must ensure that the quality assurance within the manufacturing process is adequate to reduce the possibility of dysfunctional nanorobots as well as the environmental risks associated with nanorobots. As one scientist warns, "A true glitch will come from some direction that nobody anticipated."67

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