Biomedical Engineering Reference
In-Depth Information
generally agreed-upon methods of risk assessment for nanomaterials, so delays can be expected as
regulators and industry seek to reach agreement on what testing will suffice to support approval for
targeted applications. Such testing will likely increase the cost of product development—all consid-
erations that have affected drug and device companies having to cope with premarket approval for
products containing macro versions of substances. It can be postulated that the delay and cost will
at least initially be greater for nanomaterials, until a great deal more information is generated and
analyzed. Similar results can be anticipated for drugs and devices in the EU and elsewhere.
Another issue is whether nanomaterials, because of their characteristics and effects on biologi-
cal systems, are “new” when compared to the macro version of substances, thereby requiring pre-
market review prior to marketing where it might otherwise not be required. A positive resolution
to this question is important to the nanotechnology industry. In terms of generating support for the
products under development, and those proposed, comparison to the macro form of the substance
involved that has a solid safety record can be a great benefit, saving costly testing for the most part,
and increasing consumer and patient confidence in the known.
Conversely, if a nanosubstance is found to be different from the macro form, considerable effort
will be needed to overcome the finding. The “new” debate has been around as long as there have
been products in development that could provide risk to the public—such as sunscreens. The state-
ments made by the FDA for devices, drugs, cosmetics, and food packaging leave open the likelihood
of “newness” as a topic, as do the REACH registration provisions and TSCA chemical substances
debate involving different forms of a substance. Any situation where the similarity of a nanomate-
rial to its macro counterpart becomes a contested issue must be watched because it could change the
curve for the success of the industry.
Another area to monitor is reporting of adverse events from products in use. Reports, especially
involving some serious adverse effect, could discourage confidence, raise the specter of product
liability litigation and tougher regulation, and slow down funding/investment. In an industry try-
ing to gain a foothold, serious product problems could be crippling, given the manner in which the
substances' safety has been touted.
Somewhat mundane by comparison to the above, but important to the growth of a new industry,
are requirements that might be imposed on the design, choice of materials, manufacturing, and
quality control provisions prior to release of a product for sale. This would involve the promulga-
tion of some form of good manufacturing practices (GMPs) or quality systems regulation. Given
the wide variety of procedures for the manufacture of nanoparticles, the lack of general agreement
on acceptable methods, the concern about confidentiality in the process, and the relative lack of
expertise on the part of regulators, the institution of GMPs could command a great deal of time on
the part of the small companies presently making up the bulk of the industry.
The next problem would be inspections of the procedures put into place in reaction to the regula-
tions and the expense and possible adverse publicity if the procedures are claimed to be inadequate
or not being followed. This is another area of regulation that should be kept under close observation.
One of the most important functions of product and substance regulation is the mandatory gener-
ation of information regarding risk/benefit, or safety and effectiveness. As regulators are challenged
to get more involved in the workings of the nanotechnology industry, the lack of hard information
or procedures for addressing issues previously identified for all products will become increasingly
apparent. To date, regulators around the world have been able to address the theoretical concerns
about products by pointing to the absence of reports of adverse effects, or instances of product
failures due to lack of controls. They have also fielded safety or risk concerns by opining that the
nanoparticle forms have not been shown to present any additional documented risks to consumers
and patients. That could change as more information-gathering mechanisms are implemented, and
the manner in which regulatory bodies react could foretell the continued development or slowdown
of commercial development of pharmaceuticals and medicinal products. How regulators react, and
to what, will likely signal the emergence of any effects on the industry.
