Guest Commentary

By Seth Goldberg and Rachel Tennis, Steptoe & Johnson LLP*

The Food and Drug Administration Safety and Innovation Act awaits signature by the President after passing the Senate on June 26.  The central purpose of the Act is to extend and expand the FDA’s authority to impose “user fees” on prescription drug and medical device manufacturers seeking product approval.  The fees, which will fund the FDA review process, are intended to help bring new products to market more quickly, according to the bill’s sponsors.

In a further nod to promoting innovation, Congress included a provision, Section 1126, directed at expanding FDA’s scientific expertise.  Significant efforts by FDA to address nanoscale materials in the regulatory process date back to 2006, when the agency formed its Nanotechnology Task Force.  The Task Force’s 2007 report evaluated the state of scientific knowledge and made initial policy recommendations.  Since then, FDA has issued draft guidance to help industry determine when the application of nanotechnology in a product might have regulatory implications.  It released a general draft guidance document in June 2011, and additional draft guidance documents for two specific classes of products—cosmetics and food products—in April 2012.  Comments on the product-specific draft guidance must be submitted by July 24, 2012.

Once signed into law, Section 1126 of the Food and Drug Administration Safety Act will provide the Secretary of Health and Human Services with a new mandate to step up its efforts to expand scientific knowledge.  This provision closely resembles a bill introduced in the Senate last fall.  Senate Bill 1662, the Nanotechnology Regulatory Science Act of 2011, proposed to amend the Federal Food, Drug, and Cosmetic Act to establish a new “nanotechnology regulatory science program” within FDA.  Although the new legislation does not explicitly create a separate program, it does require the FDA to look into a number of issues to inform the regulatory process, including:

  • the potential toxicology of some substances in nanoform; the potential benefit of new therapies derived from nanotechnology;
  • the effects of nanomaterials on biological systems;
  • and the interaction of nanomaterials with biological systems.

Section 1126 also empowers HHS to engage in collaborative efforts.  FDA, along with 25 other federal agencies, already participates in the National Nanotechnology Initiative, which coordinates federal nanotechnology research and development.  The new legislation authorizes FDA to work with other federal agencies to develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems.  In addition, the Secretary may “encourage” FDA to participate in international and national “consensus standards activities.”   This portion of the statute is permissive, not directive.  Where sufficient information about risk becomes available, consistency across regulatory regimes can benefit both industry and consumers.  By decreasing uncertainty and minimizing the regulatory burden, consistency can increase the chances that products containing beneficial nanotechnology applications will be brought to market.

At the same time that it engages with other regulatory authorities, FDA should continue to communicate directly with individual producers.  Current FDA draft guidance encourages industry members to consult with the agency during product development.  Consultation allows the agency to consider whether or not particle size is a significant risk factor with respect to a given product, and reduces the likelihood of erroneous determinations based on generalized concerns.  Producers, in turn, are able to develop testing plans that take the agency’s views into account early on.

Section 1126 represents a new push for regulatory consistency that will encourage FDA to allow more rapid commercialization of nanotechnology.  When combined with the agency’s current practice of consulting directly with producers, efficient data-gathering on a national level and increased international cooperation will contribute to the development of an efficient, science-based regulatory policy.

*Mr. Goldberg and Ms. Tennis authored an April 27, 2012 WLF Legal Opinion Letter, Federal Agencies Signal Shifts In Regulating Manufactured Nanomaterials.