The recently enacted spending bill, which covered FDA, contained some good news for proponents of nanotechnology as well as the promise of more to come in years ahead. The latter will be harder to deliver considering the overall budget constraints of the U.S. Making good on the promise, however, is likely key to the country’s ability to at least retain its number one position in nanotechnology if not expand this lead.
FDA’s National Center for Toxicological Research (NCTR) was approved $60 million for fiscal 2012, which was proposed by President Barack Obama and favored over the $51.5 million sought by the Republican-controlled House of Representatives. While NCTR’s latest approved budget did not increase compared to fiscal year 2011, at least it did not go down. NCTR’s duties include conducting peer-reviewed research to identify health and safety issues related to new medical products like nanomaterials.
More importantly, perhaps, than this year’s money is language inserted into the spending bill’s House-Senate conference report by Sen. Mark Pryor (D-AR) endorsing future plans by the agency to fund that even further: “The conferees support FDA in its mission to expand upon current research in nanotechnology and support the eventual development of a Nanotechnology Core Center to meet its mission.”
“Nanotechnology activities at FDA are focused on three main activities: (1) laboratory and product testing capacity; (2) scientific staff development and professional training; and (3) collaborative and interdisciplinary research to address product characterization and safety,” FDA spokeswoman Rita Chappelle told GEN. “These enterprise-wide programs are in addition to focused regulatory science research activities conducted at each of the FDA centers.”
Lynn L. Bergeson, a founding member of the law firm Bergeson & Campbell, pointed out to GEN, however, that “while the FDA speaks to its well-established experience and expertise in assessing nano-enabled products, the transparent record of this expertise is less apparent. A center expressly devoted to FDA nano research would help strengthen the reality and the perception that FDA is expert in the regulation of nanoscale materials pertinent to FDA-regulated products.”
This Year in Nanotech
During FY 2011, a Nanotechnology Core Facility overseen by NCTR and the agency’s Office of Regulatory Affairs (ORA) became operational at FDA’s Jefferson Laboratory campus in Arkansas. A similar facility at FDA’s White Oak headquarters campus, to be overseen by NCTR and several FDA centers, “is scheduled to be operational in FY 2012,” according to Chappelle.
Sally Tinkle, Ph.D., deputy director of the National Nanotechnology Coordination Office of the National Science and Technology Council, told GEN that in October NCI’s Alliance for Nanotechnology in Cancer initiated Translation of Nanotechnology In Cancer (TONIC), a public-private consortium designed to promote translational R&D opportunities for nanotechnology-based cancer solutions. Consortium members will include government agencies and biopharma companies. Last year, NCI approved a second phase of an alliance program, awarding $30 million a year over five years in multi-institution research grants.
On October 6, Pryor introduced the Nanotechnology Regulatory Science Act of 2011 (S.1662). It would direct FDA to develop safety regulations for companies using nanotech. FDA would be authorized to spend $48 million over three years: $15 million in the FY 2013, followed by $16 million and $17 million in FY 2014 and FY 2015, respectively.
Also this year, the Obama administration has issued two nanotech-related reports through the National Nanotechnology Initiative (NNI). These positioned nanotech as a top science initiative, identified goals, and called for better coordination of research, training programs, and resources. Currently, NNI coordinates the individual and cooperative nanotechnology-related activities of FDA and 24 other federal agencies.
Maintaining a Competitive Edge
Dr. Tinkle acknowledged the tight budget climate as a continuing challenge for nanotech. The Obama administration has proposed raising NNI’s budget to $2.1 billion from $1.76 billion in FY 2011. But, in the current tight budget climate and with an election looming next year for Obama, all of the House, and one-third of the Senate, any extra funds for increased nanotech R&D are uncertain at best. Unless Congress hammers out a long-term deficit plan, FDA will lose money for nanotech and everything else through the forced 7.8% sequestration required by the Budget Control Act enacted in August.
As Bergeson correctly notes, expanding NNI will be much easier said than done. “The challenges are, of course, of epic proportion,” Bergeson pointed out, such as the 17.3% drop in federal nanotech spending during FY 2010, a result of the weak economy.
Washington’s difficulty in stepping up funding for nanotech has created an opening for other nations eager to grow their own nanotech industries. According to data from Lux Research presented at a November 15 Congressional Nanotechnology Caucus briefing, European revenue from nanotech-enabled products is projected to surpass that of the U.S. by 2015, with both expected to rack up more than $1 trillion. Among individual nations, the U.S. remains at the top of corporate nanotech spending at nearly $3.5 billion as of 2010 followed by Japan (almost $3 billion) and then Germany (about $1 billion).
“The rest of the world now understands the importance of this field, and many countries are building efforts that rival what has been established by the NNI,” Chad A. Mirkin, Ph.D., director of the Northwestern University International Institute for Nanotechnology, said in a testimony July 14 to the Senate Subcommittee on Science and Space. He identified China, Great Britain, Russia, Saudi Arabia, Singapore, and Taiwan as nations where research institutes have advanced nanotech.
“If the United States does not act now and aggressively pursue the development of nanoscience and nanotechnology,” Dr. Mirkin cautioned, “we will lose our position as the global leader in this transformative field. Moreover, we will lose the opportunities it can afford us to build our economy and new manufacturing base.”
Dr. Mirkin called for expanding NNI by requiring its member agencies to assign senior executives to participate in coordination activities; by positioning the National Nanotechnology Coordination Office (NNCO) as NNI’s coordination entity; and by mandating that NNCO develop metrics for nanotechnology-specific programs using dedicated funding. He noted that 0.3% of NNI’s budget was recommended for NNCO by the President’s Council of Advisors on Science and Technology, on which he serves.
Bergeson pointed out, “The identification of research priorities and their correlation with commercialization goals is more challenging as nanotechnology matures, and the most obvious of basic research needs are filled. Coupled with the usual turf battles and the sheer complexity of managing a national nanotechnology initiative, the task Dr. Tinkle faces is indeed daunting.
“It is not the case that nano has not delivered on its enormous promise,” Bergeson continued. “The flattening of the global economy and the pressures domestically to reprioritize fiscal expenditures due to election-year pressures and the lack of a coherent Congressional commitment to nano has undermined U.S. dominance in this area,” she said.
It’s hard to have coherence when nanotech activity is spread across 25 agencies. While NNI is praised among nano professionals, its funding is far smaller than its mission. Aligning NNI’s financial backing and goals is a longer-term project, but level funding for NNI in FY 2012 is a welcome first step.
How effective will federal efforts be in maintaining U.S. leadership in nanotech, particularly in the medical field?
A Great Deal