Nanotechnology concerns are big in D.C.

Senate bill giving FDA authority to study nanomaterials

Amy Swinderman
Register for free to listen to this article
Listen with Speechify
WASHINGTON, D.C.—Nanotechnology holds great promise for thedevelopment of new medicines and drug delivery, but federal lawmakers andregulators are concerned about the safety and efficacy of nanotechnology-basedproducts. This concern is at the center of legislation introduced Jan. 21 inthe United States Senate. 
Senate Bill 2942, the "Nanotechnology Safety Act of 2010,"introduced by Sens. Mark Pryor, D-Ark., and Benjamin L. Cardin, D-Md., seeks toauthorize a program of scientific investigation by the U.S. Food and DrugAdministration (FDA) on nanotechnology-based medical and health products, amarket that is forecasted to grow by $7.3 billion by 2014. Specifically, thebill would enable the FDA to properly study how nanomaterials are absorbed bythe human body, how nanomaterials designed to carry cancer-fighting drugstarget and kill tumors and how nanoscale texturing of bone implants can make astronger joint and reduce the threat of infection.
"Nanotechnology is one of the most important and enablingtechnologies being developed right now, and it has hundreds of promisingapplications—from new cancer treatments to improved military machinery tostain-resistant pants," Pryor said in a statement. "As these products aredeveloped and used, we must understand any potential risks to human health,safety or the environment. My legislation will help ensure public safety andconfidence in the marketplace, and it will support companies that employnanotechnology materials."
Senate Bill 2942 is not the first occasion legislators havelooked at the need to regulate nanomaterials. Similar measures, with bipartisansupport, were introduced in 2008 and 2009, but lawmakers ran out of time to acton the proposals.
The FDA has already reviewed and approved somenanotechnology-based products, but in the coming years, regulators expect tosee a significant increase in the use of nanoscale materials in drugs, devices,biologics, cosmetics and food. According to the bill's sponsors, this willrequire the FDA to devote more of its regulatory attention tonanotechnology-based products.
"Nanotechnology touches so many facets of our lives todayand will play a greater role in the future, but the benefits to industry andconsumers come with unknown risks that must be identified and managedappropriately," said Cardin in a statement. 
In 2007, the FDA's Nanotechnology Task Force published areport analyzing the FDA's scientific program and regulatory authority foraddressing nanotechnology in drugs, medical devices, biologics and foodsupplements. The report found that nanoscale materials present regulatorychallenges similar to those posed by products using other emergingtechnologies. However, these challenges may be magnified because nanotechnologycan be used to make almost any FDA-regulated product. Also, at the nanoscale,the properties of a material relevant to the safety and effectiveness of theFDA-regulated products might change, according to the bill's sponsors.
Pryor has said that the National Center for ToxicologicalResearch (NCTR) in Jefferson, Ark., and the FDA headquarters in White Oak, Md.,already have the infrastructure to perform the work, but designating funds forthe research and giving the FDA the necessary authority is required.
The bill also supports the development of best practices forcompanies who employ nanotechnology. To support these goals, the legislationauthorizes $25 million each year from 2011 through 2015.
Notably, the FDA recently announced that it in 2011, it willjoin the budget crosscut of the National Nanotechnology Initiative (NNI)—aprogram established in 2001 to coordinate federal nanotechnology research anddevelopment—for the first time. The NNI consists of the individual andcooperative nanotechnology-related activities of 25 federal agencies with arange of research and regulatory roles and responsibilities. The FDA said itwill conduct activities in environment, health and safety that support suchagency-wide priorities as laboratory and product testing capacity; scientificstaff development and training; and collaborative and interdisciplinary researchto address product characterization and safety.
Senate Bill 2942 is currently under review by the Committeeon Health, Education, Labor and Pensions.

Amy Swinderman

Subscribe to Newsletter
Subscribe to our eNewsletters

Stay connected with all of the latest from Drug Discovery News.

March 2024 Issue Front Cover

Latest Issue  

• Volume 20 • Issue 2 • March 2024

March 2024

March 2024 Issue