From the Hill – Summer 2011

Budget bill cuts R&D spending

R&D funding escaped major cuts in the bill signed by President Obama on April 15 that funds the federal government for the remainder of fiscal year (FY) 2011. However, the budgets of most key R&D funding agencies suffered reductions.

In a budget that cuts spending by $38.5 billion below FY 2010 levels, R&D investment was cut by 3.5% or $5.2 billion to $144.4 billion. However, $4.7 billion of that cut comes from defense R&D programs, with most the cuts coming from demonstration, testing, and evaluation programs at the Department of Defense. Nondefense R&D received cuts of just 0.9%.

R&D spending will increase at the National Aeronautics and Space Administration (NASA) (up $605 million to $9.9 billion), but other agencies lost ground, as follows:

• National Institutes of Health, down $260 million to $30.7 billion
• National Science Foundation, down $67 million to $6.8 billion
• Department of Energy’s (DOE’s) energy programs, down $357 million to $2.1 billion
• DOE’s Office of Science, down $20 million to $4.9 billion
• Department of Agriculture, down $501 million to $2.1 billion
• Department of Homeland Security, down $175 million to $712 million

In a budget that favored basic over applied research, DOE’s Energy Efficiency and Renewable Energy (EERE) program, an applied research effort, was cut by 18.4% or $408 million to $1.8 billion. EERE had been slated for a 35% or $775 million cut in the original House-passed budget bill. DOE’s Advanced Research Projects Agency-Energy, largely an applied research program with some development spending, received $180 million in the funding bill, less than the $300 million requested by the president. These funding levels do not include a 0.2% across-the-board cut for all nondefense agencies.

The budget bill includes some controversial policy riders. One amendment inserted by Rep. Frank Wolf (R-VA), a vocal critic of Chinese policy and especially its lack of progress on human rights, prohibits the White House Office of Science and Technology Policy (OSTP) and NASA from using federal funds to “develop, design, plan, promulgate, implement, or execute a bilateral policy, program, order, or contract of any kind to participate, collaborate, or coordinate bilaterally in any way with China or any Chinese-owned company.” Wolf is concerned that the Chinese space program is being led by the People’s Liberation Army (PLA), stating that “there is no reason to believe that the PLA’s space program will be any more benign than the PLA’s recent military posture.”

At a May 4 hearing of Wolf ’s appropriations panel, however, OSTP Director John Holdren stated that the prohibition does not apply to the president’s “constitutional authority to conduct negotiations.” Holdren said that applications of the provision to administration policy would be considered on a case-by-case basis, a statement that did not satisfy Rep. John Culberson (R-TX), who warned that OSTP and NASA funding might be jeopardized by efforts to collaborate or coordinate in any way with China.

Another provision included in the bill removed gray wolves in Idaho, Montana, and parts of Oregon, Utah and Washington from protection under the Endangered Species Act. The provision was championed by western members Rep. Mike Simpson (R ID) and Sen. John Tester (D MT) and opposed by many environmental groups because it circumvented the usual delisting process. On May 4, the U.S. Fish and Wildlife Service published a rule to comply with the directive.

The budget bill did not include a provision, pushed strongly by Republicans, to strip the Environmental Protection Agency (EPA) of its authority to regulate greenhouse gas emissions.

Although the budget fights on FY 2011 have just ended, they have already begun for FY 2012. A House-passed budget resolution approved on April 15 includes cuts in discretionary spending of about $100 billion below the president’s budget request.

In an April 13 speech, the president discussed his long-term budget vision. Although he showed signs of flexibility in his desire to “keep annual domestic spending low by building on the savings that both parties agreed to,” he said he was committed to “not sacrifice the core investments that we need to grow and create jobs.” He reaffirmed his State of Union address pledge to invest in medical research, clean energy technology, new roads and airports, broadband access, education, and job training to “do what we need to do to compete.”

Court rules in favor of funding for human embryonic stem cell research

The U.S. Appeals Court for the D.C. Circuit on April 29 vacated a preliminary injunction imposed by a district court judge last summer that blocked federal funding of human embryonic stem cell research, temporarily causing a shutdown of National Institutes of Health (NIH) stem cell projects.

The injunction was issued in August 2010 by U.S. District Judge Royce C. Lamberth in response to a lawsuit involving two adult stem cell researchers who argued that the funding of embryonic stem cell research would cause them “irreparable injury” by increasing competition and therefore potentially taking funds away from their work. Lamberth agreed and deemed human embryonic stem cell research illegal under the Dickey-Wicker Amendment, an annual feature in NIH’s appropriations bill that prohibits the use of federal funds for research that destroys an embryo. NIH was forced to shut down its intramural human embryonic stem cell experiments and halt any grants or renewals that had not yet been paid out.

Judges Thomas Griffith and Douglas Ginsburg of the Appeals Court disagreed with Lamberth’s contention that the harm to stem cell researchers caused by the injunction was “speculative.” Instead, they said the harm would be “certain and substantial. … Their investments in project planning would be a loss, their expenditures for equipment a waste, and their staffs out of a job.” They also concluded that the Dickey-Wicker Amendment “is ambiguous and the NIH seems reasonably to have concluded that although Dickey-Wicker bars funding for the destructive act of deriving an ESC [embryonic stem cell] from an embryo, it does not prohibit funding a research project in which an ESC will be used.”

Although the Appeals Court has ruled on the injunction, Lamberth still must rule on the underlying lawsuit in the case, which means that for now legal questions will continue to hamper the stem cell field.

FDA’s medical device approval process scrutinized at Senate hearing

The Food and Drug Administration (FDA) has made “limited” progress in implementing recommendations made in a 2009 Government Accountability Office (GAO) report on its procedures regarding medical devices, according to testimony at an April 13 hearing of the Senate Special Committee on Aging.

Marcia Crosse, director of the GAO’s Health Care Team, outlined the preliminary findings of an ongoing GAO investigation into the FDA’s management of medical device review, postmarket monitoring, and recall processes.

“Concerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective,” Crosse said. “Gaps in FDA’s postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled.”

Of the 27 types of devices classified as high risk in the 2009 GAO report, FDA has issued new final rules on just one, Crosse said.

William Maisel, the chief scientist of the FDA Center for Devices and Radiological Health, acknowledged at the hearing that the agency is “strained” by limited funds but is working to improve adverse-event reporting. He expects the FDA to issue rules on the remaining 26 device categories by the end of 2012. The FDA has already issued strategic goals to improve its medical device approval process. It has also commissioned the Institute of Medicine to study the issue, and the results of the study are expected this summer.

Sen. Herb Kohl (D-WI), chairman of the Senate committee, said “I am encouraged by the numerous initiatives that FDA is implementing for more effective medical device approval and postmarket surveillance. Nevertheless, I’m concerned that the agency’s oversight of medical products still remains on the GAO’s ‘high risk’ list… and that is unacceptable.”

The hearing highlighted the story of Katie Korgaokar, a Denver resident who received a DePuy ASR hip implant to treat a congenital condition called Perthes disease. In 2010, the DePuy hip was recalled, and Korgaokar endured a second hip-replacement surgery in early 2011. Korgaokar was one of 96,000 patients affected by the DePuy hip recall.

“FDA has had over 20 years to tackle these high-risk devices,” Kohl said. “As we have seen with the Johnson & Johnson hip implant today, it’s high time to protect patient safety and correctly classify these devices.”

Kohl also suggested that FDA develop a “more robust postmarket surveillance program,” signaling his interest in addressing this concern in the Medical Device User Fee and Modernization Act reauthorization next year.

A recent study led by Diana Zuckerman and published in the Archives of Internal Medicine, found that “from 2005 through 2009, the 113 highest-risk device recalls involved 112.6 million recalled products.” Zuckerman testified at the hearing that “In the first six months of 2010, the FDA recalled more than 437 million additional products because of high risks, including death.”

The medical device industry is concerned that management problems at the FDA have slowed medical device innovation. In his testimony, David Nexon, senior executive vice president of the Advanced Medical Technology Association, said that there are “inefficiencies at FDA that delay patient access to new treatments and cures and erode U.S. global competitiveness in the development of medical technology.”

Hydraulic fracturing debated in House

The House Science, Space and Technology Committee held a May 5 hearing to examine whether additional studies need to be conducted to determine the safety of hydraulic fracturing (also called fracking), a method use to extract natural gas from underground.

The hearing took place in the wake of a natural-gas well eruption and leak, a report published in the Proceedings of the National Academy of Sciences stating that hydraulic fracturing can contaminate drinking water with methane, and a report from House Democrats asserting that chemicals used in hydraulic fracturing could contaminate drinking water.

Chairman Ralph Hall (R-TX), who is opposed to additional government studies, called an Environmental Protection Agency (EPA) study that is being drafted “yet another example of this administration’s desire to stop domestic energy development through regulation.”

Paul Anastas, assistant administrator of EPA’s Office of Research and Development, defended the EPA’s hydraulic fracturing study: “The study is designed to examine the conditions that may be associated with the potential contamination of drinking water resources and to identify the factors that may lead to human exposure and risks. The scope of the proposed research includes the full lifespan of water in hydraulic fracturing, from acquisition of the water, through the mixing of chemicals and actual fracturing, to the postfracturing stage, including the management of flow back and produced water and its ultimate treatment and disposal.” Anastas tried to assure the committee that the EPA would not presuppose any results of the study.

Most witnesses on the first panel were not concerned that hydraulic fracturing could be a danger because fracking has never resulted in unsafe drinking water. They said that there were enough studies for regulators to analyze and additional studies are unnecessary. In response to a question from Rep. Ben Ray Lujan (D-NM), every witness on the first panel, except for Robert Summers of the Maryland Department of the Environment, said that states should create their own standards and that it was unnecessary to create a set of nationwide baseline hydraulic fracturing safety standards.

Although Democrats, for the most part, acknowledged the need for natural gas, they also thought that studies need to be conducted to prove that natural gas extraction using hydraulic fracturing is safe. Ranking Member Eddie Bernice Johnson (D-TX) reminded members that although hydraulic fracturing has been used in the past, the technology and the drilling processes have evolved rapidly in the past few years. Although not disagreeing with Johnson, Harold Fitch, the director of the Office of Geological Survey for the Michigan Department of Environmental Quality, stated that when aquifers have been contaminated, it was because of the well construction, not because of the practice of hydraulic fracturing.

Patent reform bill moves ahead

On March 30, three weeks after the Senate passed its version of a patent reform bill by a 95 to 5 vote, House Judiciary Chairman Lamar Smith (R-TX) introduced the House version of the bill, H.R. 1249, which was similar to the Senate bill. On April 14, after the bill was amended to look even more like the Senate version, it was approved by the House Judiciary Committee 32 to 3.

Like the Senate bill, the House bill would create a first-to-file system that would align the U.S. patent system with that of other countries. Inventors would still have a one-year period from the time they publish information to file a patent without their invention being considered prior art.

Moreover, the bill would allow the U.S. Patent and Trademark Office (PTO) to set its fees and keep the income. Previously, Congress would allocate excess PTO income to other programs, rather than reinvest it in the PTO. This change in funding is anticipated to result in expedited patent reviews and shrink the patent backlog, now at about 700,000 applications. Both bills would create three or more satellite patent offices.

The House and Senate bills allow patent holders to correct misfiled patents that either inaccurately portray or omit information. They also give third parties the opportunity to petition the validity of a patent once it is awarded. The rationale for this review is to weed out weaker patents or ones that should be considered prior art.

Science and technology in brief

• Sens. Sheldon Whitehouse (D-RI) and Olympia Snowe (R-ME) introduced legislation (S. 973) to establish the National Endowment for the Oceans. The bill would establish a permanent funding source for ocean research and restoration funded primarily by interest accrued from the Oil Spill Liability Trust Fund and revenues from off-shore energy development.
• On April 7, Sen. Al Franken (D-MN) introduced legislation to improve science, technology, engineering, and mathematics (STEM) education training for teachers. The STEM Master Teacher Corps Act (S. 758) would implement a recommendation outlined in a report on STEM education by the President’s Council of Advisors on Science and Technology. It would create a mentoring program and a financial reward system for high-performing teachers and schools.
• The Senate Energy and Natural Resources Committee held a May 12 hearing on legislation to encourage the development of carbon capture and storage (CCS) technology. Committee Chairman Jeff Bingaman (D-NM) and Sen. John Barrasso (R-WY) introduced The Carbon Dioxide Capture Technology Act (S. 757), which would create incentives for development of new CCS technologies through a prize system. The senators also introduced S. 699, which would create a long-term liability program that would provide incentives for large-scale, early-mover deployment of integrated geologic CCS.
• On March 30, Sens. Charles Schumer (D-NY), Susan Collins (R-ME), and Joseph Lieberman (I-CT) introduced legislation (S. 679) to eliminate the need for Senate confirmation of almost 200 executive branch positions, including all members of the National Science Board, the four associate directors of OSTP, and the chief scientist of the National Oceanic and Atmospheric Administration. The bill to streamline the confirmation process is supported by Majority Leader Harry Reid (D-NV) and Minority Leader Mitch McConnell (R-KY).
• On May 5, director John Holdren announced that OSTP has requested that every covered agency provide its draft scientific integrity policy within 90 days. At the time of the announcement, 30 executive departments or agencies had submitted progress reports to OSTP on their scientific integrity policies, and six of them had submitted draft policies.
• The Office of Government Ethics (OGE) issued a proposed rule that would allow federal employees to serve or participate in an official capacity in nonprofit organizations, including professional scientific societies. The OGE proposal reflects a recommendation made in the OSTP Scientific Integrity Memorandum.
• EPA announced that it would delay the effective date of its new standards for major source air boilers and commercial incinerators to allow the agency to seek additional public comment. EPA will accept additional data and information on these standards until July 15, 2011.

“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.