AAAS Policy Alert -- March 27, 2012

IN THIS ISSUE

BUDGET NEWS

House to Vote on FY 2013 Budget Plan Amid Competing Proposals. This week the House is expected to vote on the FY 2013 budget resolution introduced by Rep. Paul Ryan (R-WI) and approved by the House Budget Committee on March 21. That budget, which if passed would serve as an overall spending blueprint for the House, would reduce baseline discretionary spending by $352 billion below the President's FY 2013 budget projections over the next decade, and $19 billion below the President's budget in FY 2013. It would leave in place most of the cuts under the automatic sequestration except for those in FY 2013. Instead, it would require six House committees - including Energy & Commerce and Agriculture - to find more than $330 billion in additional savings over the next 10 years. The Office of Management and Budget has responded that the House budget would ultimately lead to $1 trillion less in nondefense spending over the next decade, which would likely have severe consequences for federal support for R&D.

Meanwhile, Democratic Members of the House will be offering multiple alternatives to the Ryan budget. Rep. Chris Van Hollen (D-MD) will propose a budget that adheres to the higher spending levels agreed to in the Budget Control Act and which uses mandatory cuts and revenue increases to avoid the sequester. The Congressional Black Caucus and the Progressive Caucus are also expected to release plans that call for far higher spending than the President's budget.

For a full breakdown of the President's FY 2013 research and development budget proposals, with the latest estimates, please visit the AAAS R&D Budget and Policy website.

OTHER CONGRESSIONAL NEWS

Bipartisan Congressional Call to Increase NIH Budget. Rep. Brian Bilbray (R-CA), in partnership with Rep. Ed Markey (D-MA), crafted a letter (PDF file) signed by 153 Members of Congress that calls for an increase of $2 billion over the President's proposed budget for the National Institutes of Health (NIH) in FY 2013. The letter was sent to the chairs and ranking members of both the House Appropriations Committee and the Labor-HHS Appropriations Subcommittee and urged that the NIH budget be increased to $32 billion, saying that the level was "vital" in order to "maintain international leadership in science and biomedical research."

Science and Technology Hearings This Week. The House Science, Space, and Technology Committee has a full slate of hearings this week to address a range of critical S&T issues including: Fostering Innovation; the International Space Station; NOAA Procurement of Weather Data; and Public Access to Scholarly Research Publications. Meanwhile, the Senate Commerce, Science, and Transportation Committee will conduct a hearing this week on the subject of science and standards of forensics.

EXECUTIVE BRANCH

NIH Gives Timetable for Producing Policies for Research Using Chimpanzees. NIH says it will need more than a year to develop new policies to allow use of chimpanzees in biomedical research "only under stringent conditions," as suggested by the Institute of Medicine (IOM) and National Research Council of the National Academies. The plan and timetable for implementing the IOM report are discussed in a comprehensive article in Genetic Engineering & Biotechnology News. See the NIH Working Group on the Use of Chimpanzees in NIH-Supported Research website for further details, including a new FAQ section.

FDA Public Meeting to Reconsider Regulations for Clinical Trials. The Food and Drug Administration will hold a two-day public hearing on April 23-24 to "obtain input from interested persons on FDA's scope and direction in modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated products." The FDA announcement acknowledges "concerns within the clinical trial community that certain regulations and policies applicable to the conduct of clinical trials may result in inefficiencies or increased cost and may not facilitate the use of innovative methods and technological advances to improve clinical trial quality." Registration to attend the hearing at the FDA's White Oak Campus must be completed by April 2. Further details are found here (PDF file).
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New Behavioral and Social Science Research Methods Website Created by NIH. A new website providing a centralized source of behavioral and social science research methods has been created by the Office of Behavioral and Social Sciences Research at the NIH and the New England Research Institute. According to a NIH press release, e-Source is focused on public health issues and is designed to "provide authoritative answers to methodological questions and set quality standards for the research community." This website includes a discussion forum, 20 chapters about topics such as emerging issues and qualitative methods, and is also intended to provide information to biological scientists to promote collaborations with behavioral and social scientists.

DOE Slows Plan for Neutrino Experiment in SD Mine. In FY 2012 the Department of Energy received $4 million for the construction of the Long Baseline Neutrino Experiment (LBNE), an experiment that would detect neutrinos generated at Fermilab by a detector to be built in the Homestake Mine in South Dakota, as well as "funds to support pumping water from the mine to preserve the investments there in the Lux dark matter and Majorana demonstrator experiments... ." Now, the Director of DOE's Office of Science, William Brinkman, has written to Fermilab director Pier Oddone to challenge Fermilab to lead the development of "an affordable and phased approach" to achieve the goals of the LBNE while lowering the cost from the projected $1.5 billion (additional details found here).

U.S. Adopts UN Chemical Classification System. The U.S. will now use warning labels and standardized language developed through the United Nations in order to communicate hazardous chemical information. Last week, the Occupational Safety and Health Administration (OSHA) released a regulation (PDF file) stating that the U.S. will now adopt the Globally Harmonized System of Classification and Labeling of Chemicals. According to a C&EN article, chemical manufacturers and importers will use pictograms to illustrate potential hazards, and companies will use standardized language in material data safety sheets. By adopting this classification system, it is hoped that safety information will be communicated more effectively and efficiently.

ELSEWHERE

Anti-Evolution Bills Advance in Tennessee and Oklahoma. Bills that challenge evolution and climate education have progressed in the Tennessee and Oklahoma legislatures. Both are so-called "academic freedom" bills; they feature language encouraging teachers to help their students critique the "scientific strengths and scientific weaknesses" of theories, making special mention of topics that include evolution and climate change. In Oklahoma, HB 1551 passed the House and has been assigned to the Senate Education Committee. In Tennessee, SB 893 passed the Senate on March 19. Its House counterpart, HB 368, passed last year. AAAS has sent letters to Oklahoma and Tennessee legislators detailing its concerns with the bills.

Supreme Court Rules Against Patent Claims for Dosage Methods. On March 20 the U.S. Supreme Court handed down a unanimous ruling in the case of Mayo Collaborative Services v. Prometheus Laboratories, Inc., a dispute over patent infringement (decision found here (PDF file)). The Court found invalid Prometheus's patent claims on methods to optimize drug dosage because they "cover a law of nature." The Supreme Court has consistently ruled that laws of nature are outside the scope of patentability, generally finding that claims covering natural laws would inhibit innovation. The ruling has already raised fears in the biotechnology industry that it will have negative effects on innovations related to personalized medicine. A general review of the case can be found here.

Research Advocacy Group Documents NIH Support by State. United for Medical Research has released an update (PDF file) to its 2011 report, An Economic Engine (PDF), on the National Institutes of Health (NIH). The update features data on the number of jobs supported in each state by NIH funding. According to the update, the total number of jobs supported in the 50 states plus DC is over 430,000.

IOM Report Outlines Links from Omics Research to Practice. The Institute of Medicine has released the report Evolution of Translational Omics: Lessons Learned and the Path Forward, which analyzes the process for translating research in genomics, proteomics, and other molecular biosciences (collectively referred to as omics) into practice. The report defines responsibilities and best practices for investigators, research institutions, funders, regulators, and journals involved in developing and disseminating clinical omics-based technologies. The report also emphasizes the critical importance of effective oversight by institutions to "ensure the integrity of the scientific process," even suggesting that "In certain instances, an outside body should be asked to investigate when an institution might appear too conflicted."

A Call for Presidential Science Debate. Two founding members of the board of Science Debate 2012, Lawrence Krauss, a physicist at Arizona State University, and Shawn Lawrence Otto, have called for the 2012 presidential candidates to engage in a nationally televised debate on urgent policy questions involving science and technology. They urge readers to support the effort and submit potential questions to the Science Debate 2012 website. Barack Obama and John McCain declined to participate in a presidential science debate in 2008, but their campaign staffs did respond to questions online (responses found here). The AAAS will be tracking the presidential candidates' positions on science, technology, and innovation issues at: this website.

Bayer Must Give Compulsory License for Cancer Drug in India. According to an article in Chemical and Engineering News, for the first time, India's patent controller authorized an Indian company to receive a compulsory license for a patented drug. Citing the high cost ($5,600 per month) and the ineffective distribution of the patented cancer drug Nexavair across India, the patent controller ruled that Natco Pharma will pay a 6% royalty to Bayer and provide Nexavair to 600 patients per year, free of charge. The controller estimated that 29,000 Indians could benefit from the drug, and Natco plans to sell the drug at $175 per month.

People in the News.
- The National Science Board has announced that Leon Lederman, Nobel laureate in physics and former director of Fermilab, is the 2012 recipient of the NSB's Vannevar Bush Award. The award is given each year "to truly exceptional, lifelong leaders in science and technology who have made substantial contributions to the welfare of the nation through public service activities in science, technology and public policy."
- President Obama has nominated Jim Yong Kim to head the World Bank. Kim, President of Dartmouth College, is a physician and global health expert. He previously oversaw the HIV/AIDS programs at the World Health Organization and was a co-founder of Partners in Health, a nonprofit global healthcare organization (more details here).

Archived issues of AAAS Policy Alert can be found at http://www.aaas.org/spp/policyalert.

Publisher: Alan I. Leshner
Editor: Steve Nelson
Contributors: Joanne Carney, Ed Derrick, Mark Frankel, Erin Heath, Matt Hourihan, Earl Lane, Anne Poduska, Deborah Runkle, Gretchen Seiler, Ric Weibl

NOTE: The AAAS Policy Alert is a newsletter provided to AAAS Members to inform them of developments in science and technology policy that may be of interest. Information in the Policy Alert is gathered from published news reports, unpublished documents, and personal communications. Although the information contained in this newsletter is regarded as reliable, it is provided only for the convenience and private use of our members. Comments and suggestions regarding the Policy Alert are welcome. Please write to alert@aaas.org.

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