From the Hill – Winter 2008

The federal government’s fiscal year (FY) 2008 began on October 1, but most agencies are still operating under a continuing resolution extending funding at 2007 levels through December 14. Congress would like to spend $23 billion more on domestic programs than the president’s request, but President Bush has threatened—and made good on the threat—to veto any appropriations bill that exceeds his request. Efforts are under way to split the difference between the two spending goals, but it remains to be seen whether bills at that level would be acceptable to the president.

Congress finalized and the president signed a FY 2008 Department of Defense (DOD) budget with $77.8 billion for R&D, a 0.5% decline from the current year. The bill includes $13 billion for science and technology programs (down 7%) but a 3% boost for basic research to $1.6 billion. The primary reason why DOD R&D would decline for first time in more than a decade is that Congress has not yet considered a 2008 supplemental war funding package that now approaches $190 billion for the DOD portion, including $3.9 billion for R&D (nearly all for development). Because Congress is expected to approve most of the supplemental request intact in early 2008, the final DOD R&D total for 2008 is likely to be another large increase.

House and Senate appropriators were able to iron out differences in the Labor–Health and Human Services– Education appropriations bill that would have given the National Institutes of Health a 3.6% increase to $30.2 billion. But on November 13, President Bush vetoed the appropriation because it exceeded his budget request. The House attempted to override his veto two days later but fell several votes short.

Appropriators reached agreement on a Transportation/Housing and Urban Development appropriations conference report containing a 7% increase for R&D in the Department of Transportation. The House quickly approved the bill, but the Senate postponed its final vote until December.

Before the budget stalemate began, Congress had planned to add billions of dollars to the proposed budgets for federal R&D. Both the House and Senate endorsed large proposed increases for select physical sciences agencies as part of the president’s American Competitiveness Initiative and would continue to support administration plans to expand investments in new human spacecraft. But instead of cutting funding for other R&D programs as the president requested, the House and the Senate would provide increases to every major nondefense R&D funding agency and would turn proposed cuts into significant increases for the congressional priorities of biomedical research, environmental research (particularly climate change research), and energy R&D. Those proposed increases are now up in the air.

Expansion of FDA oversight power sought

In the wake of high-profile problems with drugs such as Avandia and Vioxx as well as concerns about the safety of imported food, members of Congress are continuing to push for an expansion of the Food and Drug Administration’s (FDA’s) oversight authority.

In September 2007, Congress approved and the president signed a major FDA reauthorization bill that gives the agency new powers to regulate prescription drug safety, enabling it to require pharmaceutical companies to conduct postmarket safety studies or to change the information on product labels. But senior members of Congress, including House Energy and Commerce Chairman John Dingell (D-MI) and Senate Finance Committee Ranking Member Charles Grassley (R-IA), have continued to call for an overhaul of federal drug and food safety practices.

In September, Energy and Commerce Committee Democrats proposed a bill that would impose user fees that would provide the FDA with more funding for inspecting food imports, give the agency authority to recall food products, and limit entry points for food imports to those near the FDA’s 13 inspection labs. The user-fee and port-limit proposals have drawn fire from some industry stakeholders.

In October, the committee released a report about China’s food inspection practices that Dingell said was “first-hand confirmation that food from China presents a clear and present danger to Americans under the current conditions of import.” The report indicated that China’s certification process is inconsistent. In addition, the FDA does not recognize that process, meaning that firms that don’t earn the certification can still export to the United States.

In November, a White House panel released an import safety plan that would give the FDA recall authority, though it cautioned that the U.S. government cannot “inspect its way to safety.” At the same time, the FDA announced its own food safety plan that seeks to focus its resources on the riskiest areas.

Rep. Rosa DeLauro (D-CT) and Senate Majority Whip Dick Durbin (D-IL) plan next year to take a different tactic by introducing a bill that would split the FDA into two agencies: one with jurisdiction over food and the other over drugs and medical devices.

The FDA inspects only about 1% of imported food, although it electronically scans all of it. The percentage of imported drugs that are inspected also numbers in the single digits. A recent Government Accountability Office (GAO) report discussed at a November 1 Energy and Commerce subcommittee hearing estimated that the FDA inspects approximately 7% of the foreign pharmaceutical manufacturers that export goods to the United States in a given year. Although the agency must inspect domestic drug plants every two years, there is no requirement for inspecting foreign facilities, and the FDA lacks a dedicated overseas inspection staff as well as an adequate tracking system. Causing further consternation to committee members was the fact that the GAO examined the issue and came to some similar conclusions nearly 10 years ago. Dingell called it a case of “déjà vu.”

FDA Commissioner Andrew von Eschenbach said that the agency is taking steps to improve information flow, including meeting with Chinese government officials. He has also put the brakes on a proposal, strongly criticized by some members of Congress, to close half of the agency’s inspection labs.

Another oversight issue for the FDA involves a bill passed in August by the Senate Health, Education, Labor and Pensions Committee that would authorize the agency to regulate tobacco. Eschenbach sent testimony to the House Energy and Commerce Committee opposing the legislation on the grounds that the already stretched-thin agency is geared toward promoting health, not overseeing a harmful product.

An Institute of Medicine panel came to a different conclusion, however, saying in May 2007 that the FDA is the best federal agency to deal with tobacco. The bill’s supporters include the strange bedfellows of antismoking groups and the tobacco giant Philip Morris, which, as the market leader, would stand to benefit from overarching limits on tobacco advertising.

Bill to promote electronic health records proposed

Arguing that the use of electronic health records (EHRs) is a necessary first step toward more comprehensive use of information technology (IT) in health care, the House Committee on Science and Technology on October 24 passed a bill (H.R. 2406) supporting efforts toward creating a national interoperable system for EHRs. Introduced by Chairman Bart Gordon (D-TN), the bill authorizes $8 million annually for two years to expand IT initiatives at the National Institute of Standards and Technology (NIST).

H.R. 2406 directs the National High-Performance Computing Program to coordinate federal R&D programs in health IT and requires NIST, in consultation with the National Science Foundation (NSF), to establish a university grant program for multidisciplinary research in health IT, with an emphasis on promoting collaborations with for-profit and nonprofit entities.

The bill would also require NIST to create a Healthcare Information Enterprise Integration Initiative to deal with major concerns regarding a national system of EHRs, including interoperability, privacy, security, and the specification of standards for technology. The bill would expand NIST’s authority to work with the user and technology communities to support interoperability analyses, along with the development of standards and software conformance and certification protocols. The bill requires the establishment of a Senior Interagency Council on Federal Healthcare Information Technology Infrastructure to coordinate the development and deployment of health IT systems by federal departments and agencies.

Proponents claim that a national system for health records can increase efficiency and reduce error. With current systems, the health information of one patient is often scattered among various providers, making it difficult to construct a complete medical history, especially in the case of an emergency or for elderly individuals. EHRs would make it possible to streamline administrative tasks for providers and patients and avoid adverse drug interactions arising from incomplete medical information. EHRs could also potentially halve the number of medical tests performed, because duplicate tests due to an inability to access previous results account for 49% of the clinical diagnostic tests performed. In addition, separate studies by RAND and the Center for Information Technology Leadership both say that a national network could reduce U.S. spending on health care by 5% annually.

In statements on the legislation, Gordon argued that the federal government should serve as a model in the field of health IT. However, witnesses at a hearing held by a subcommittee of the House Committee on Oversight and Government Reform argued that the federal government should do much more than act as a model; it should provide funding incentives for the adoption of health IT. Reports indicate that financing is one of the largest barriers to the implementation of EHRs, because doctors bear 80% of the cost burden in the form of equipment, software, training, and support for the systems, whereas they receive only 20% of the cost benefits.

Legislation would boost support for women in science

On September 10, 2007, Rep. Eddie Bernice Johnson (D-TX) introduced the Gender Bias Elimination Act of 2007 (H.R. 3514), which would implement many of the recommendations of the 2006 National Academies report Beyond Bias and Barriers: Fulfilling the Potential of Women in Academic Science and Engineering. The report asserted that the lack of scientific advancement by women is largely a result of the culture and structure of academic science.

Johnson’s bill takes almost verbatim the recommendations of the National Academies report, requiring federal granting agencies to provide mandatory workshops for department chairs, members of grant review boards, and agency program officers about methods to minimize gender bias. The bill also demands that agencies enforce nondiscrimination laws and conduct compliance reviews at universities as well as collect and publish data on the demographics and funding outcomes of all grant applications.

The report’s ideas were echoed in an October hearing on Women in Academic Science and Engineering held by the House Committee on Science and Technology’s Subcommittee on Research and Science Education. Chairman Brian Baird (D-WA) and Ranking Member Vernon Ehlers (R-MI), along with several witnesses, argued that not only are scientific departments often unwelcoming environments for women, but that the criteria used for advancement in these fields do not reward work such as support and mentoring of younger scientists, which is disproportionately provided by women.

Amid recommendations for reforming the scientific system, the NSF Advance program received praise at the hearing as a model for encouraging institutional transformation. The program aims to enable the full participation of women in academic science and engineering by providing grants for comprehensive programs to facilitate institution-wide change, as well as awards that support the analysis, adaptation, and dissemination of practices for increasing the representation of women in these fields.

Freeman Hrabowski, president of the University of Maryland, Baltimore County, testified that the Advance program should be expanded and the lessons learned through its grants should be applied at other institutions. Donna Shalala, president of the University of Miami and chair of the panel that produced the National Academies report, called for similar programs to be put in place at the National Institutes of Health and other funding agencies.

One recommendation of the Academies report that was not included in the legislation was allowing grant money to be applicable to dependent-care costs—an issue that Shalala continued to push for in her subcommittee testimony. Shalala also took the recommendation for compliance reviews a step further by advocating the establishment of a regulatory body that would hold universities accountable for Title IX provisions in academia as the National Collegiate Athletic Association does in athletics.

Even as Congress moves toward addressing the issues raised by the National Academies report, not all parties are in agreement as to the existence of biases against women in science. A conference held last month by the American Enterprise Institute analyzed the veracity of these biases, examining alternative explanations for the underrepresentation of women in the sciences, such as sex differences in aptitude or interest in the subjects.

Climate Change Science Program under fire

As discussions in Congress shift from debating the causes of climate change to examining solutions to address it, increasing attention is being paid to the research that supports these decisions. In particular, the Climate Change Science Program (CCSP), which funds approximately $1.5 billion in R&D in 13 government agencies, has come under scrutiny, and several efforts are under way to refocus its research portfolio to emphasize information relevant to policymakers.

A National Research Council (NRC) report, Evaluating Progress of the U.S. Climate Change Science Program: Methods and Preliminary Results, captures many of the issues raised by members of Congress and other stakeholders. The NRC report found that the research program has been successful in identifying and attributing global temperature trends and their corresponding environmental effects. But the report notes that the program has been less successful in understanding local temperature trends and regional effects of climate change and their impact on society. In addition, the report found that the CCSP has failed to sufficiently analyze adaptation plans and mitigation tactics.

Most of the witnesses at a November 14 Senate Commerce, Science and Transportation Committee hearing shared these concerns and voiced their support for the Global Change Research Improvement Act (S. 2307) introduced by Sens. John Kerry (D-MA) and Olympia Snowe (R-ME). The bill seeks to realign the research program to “a comprehensive and integrated United States observation, research, assessment, and outreach program which will assist the nation and the world to better understand, assess, predict, mitigate, and adapt to the effects of human-induced and natural processes of global change.”

The bill calls for a new strategic plan for the program and would establish a program office within the White House Office of Science and Technology Policy (OSTP) to coordinate research activities and budget proposals. S. 2307 would create within the National Oceanic and Atmospheric Administration a National Climate Service that includes a network of regional and local facilities for operational climate monitoring and prediction. The bill also directs agencies to adopt policies that ensure the integrity of scientific communications.

A related bill, the Global Climate Change Research Data and Management Act of 2007 (H.R. 906), introduced by Reps. Mark Udall (D-CO) and Bob Inglis (R-SC), is included in the House’s energy package. This bill emphasizes the need to conduct and communicate adaptation and mitigation research of interest to policymakers, and it directs the president to develop a new research plan that will be updated every five years.

A related issue that emerged during the Senate hearing was the need for a national assessment. Under the Global Change Research Act of 1990, the administration must produce a national climate change assessment every four years. The only one to be produced was completed in 2000. In lieu of a single assessment, the Bush administration decided to issue a series of 21 technical reports. Thus far, only three reports have been completed, though others are well into the review process.

In response to the delay, the Center for Biological Diversity and several other environmental groups, supported by a memorandum from Sen. Kerry and Rep. Jay Inslee (D-WA), filed suit. In August 2007, a federal court ruled that the administration had violated the Global Change Research Act by failing to produce a national assessment and ordered completion of the reports by May 2008. OSTP Director John Marburger testified at the hearing that the administration is committed to meeting the deadline. The completion of these reports will likely do little to satisfy Kerry, who believes that the series of technical reports is not comparable to a single assessment.

“From the Hill” is prepared by the Center for Science, Technology, and Congress at the American Association for the Advancement of Science (www.aaas.org/spp) in Washington, D.C., and is based on articles from the center’s bulletin Science & Technology in Congress.