From the Hill – Fall 2009

In a 219-212 vote on June 26, the House passed the American Clean Energy and Security Act (H.R. 2454), a bill to cap greenhouse gas emissions and transform the nation’s energy supply. The bill establishes a cap-and-trade program to reduce emissions 17% below 2005 levels by 2020 and 83% by 2050. It requires electric utilities to meet 20% of their electricity demand through renewable energy sources and energy efficiency by 2020; mandates new energy-saving standards for buildings, appliances, and industry; and authorizes billions of dollars in investments for clean energy technology, including the creation of eight clean energy innovation centers, which are partnerships of universities, nongovernmental organizations, and state institutions with a focus on energy research and commercialization.

Meanwhile, the Senate continued its own deliberations on climate change, examining familiar sticking points such as the impact of the legislation on the U.S. economy, how permits to emit greenhouse gases under a cap-and-trade system would be distributed, and how the proceeds from the auction of permits would be used.

Members of the Obama administration lent their support to efforts to enact legislation at a July 7 hearing of the Senate Committee on Environment and Public Works (EPW) and a July 22 Committee on Agriculture, Nutrition, and Forestry hearing. Officials urged the Senate to enact a bill that would reduce dependence on foreign energy, create green jobs, and protect future generations of Americans from the effects of climate change.

Members of the EPW and Agriculture Committees examined the effect of climate mitigation policy on the agricultural sector, a subject that was much discussed during the House debate. At a July 14 EPW hearing, Republican members claimed that the House bill would increase costs for farmers, but most witnesses disagreed. Bill Hohenstein of the U.S. Department of Agriculture and Bill Krupp of Environmental Defense testified that farmers, through an offset program, stand to profit from climate change legislation. Witnesses at both the July 14 EPW and the July 22 Agriculture Committee hearings said that the agriculture and forestry sectors, with proper incentives, could sequester 20% of all U.S. greenhouse gas emissions.

At a July 8 hearing, the Senate Committee on Finance examined the implications of a climate change bill on U.S. economic competitiveness. Witnesses recommended short-term options, such as free allocation of carbon permits to vulnerable industries, to address competitiveness concerns. However, witnesses emphasized that the best solution to reduce carbon emissions and protect U.S. industries would come through an international multilateral agreement. Members of the committee and witnesses expressed serious concern about measures such as border tax adjustments, which could trigger retaliation and trade sanctions from other countries. President Obama has cautioned against “protectionist” measures included in H.R. 2454, which would tax countries that do not take steps to reduce carbon emissions. However, a border tax appealed to 10 Senate Democrats who sent a letter to President Obama in early August urging the inclusion of measures to protect domestic manufacturing, including a border adjustment mechanism.

At a July 16 hearing, the EPW Committee examined competitiveness from a different angle: whether climate mitigation efforts could lead to new business ventures. John Doerr, a partner at Kleiner Perkins Caufield & Byers, a venture capital firm, testified that a cap on emissions is needed for firms to invest in new energy technologies and spur domestic production of these technologies. The current lack of a policy that would encourage these investments, he said, is “stifling American competitiveness.” Harry C. Alford, president and CEO of the National Black Chamber of Commerce, disagreed, pointing out that a recent study showed that climate legislation would cost 2.5 million jobs.

At an August 4 hearing, the Finance Committee examined how to distribute allowances and use the proceeds. Members examined which scenarios, ranging from auctioning all the permits to giving them away, would best protect consumers from price increases while ensuring that carbon reduction targets are met. Members also examined whether a “price collar”—a minimum and maximum allowance price—would provide greater cost certainty and therefore lower costs to businesses by reducing volatility.

Senate Majority Leader Harry Reid (D-NV) has asked committees with jurisdiction to report out climate bills by late September, signaling a flurry of activity to come in the fall.

NIH finalizes stem cell guidelines

On July 6, the National Institutes of Health (NIH) released its final guidelines on human stem cell research, opening the door to expanded federal funding of research involving embryonic stem cells. During the April-May public comment period, NIH received nearly 50,000 opinions on the draft guidelines that it had released in response to President Obama’s executive order lifting restrictions on stem cell funding.

Perhaps the most important change from the draft guidelines was NIH’s decision to make previously derived stem cell lines that follow the spirit of the new ethical guidelines, if not the exact documentation requirements, eligible for funding. Various scientific groups had expressed concern that because informed consent standards have changed over time, the NIH draft might have excluded stem cell lines that had been ethically derived according to prevailing research standards in place at the time.

Now, according to the final guidelines, an NIH advisory panel will evaluate older stem cell lines, and the NIH director will make the ultimate determination on whether they will qualify. The guidelines also state that NIH will develop a registry of eligible stem cell lines.

House finishes appropriations, Senate making progress

The House passed all 12 of the fiscal year (FY) 2010 appropriation bills before leaving for its August recess; the Senate has completed just four. The Energy and Water, Homeland Security, Legislative Branch, and Agriculture bills have passed both chambers, paving the way for the conference process to begin in September, the last month of FY 2009.

The Senate version of the Agriculture bill includes $1.23 billion for the Agricultural Research Service and $1.306 billion for the National Institute of Food and Agriculture, whereas the House version allocates $1.19 billion and $1.253 billion, respectively.

On the Energy bill, both chambers allocated the Department of Energy’s Office of Science $4.9 billion, up 2.6% or $126 million from FY 2009 and more than the 1% increase proposed by the president. The House would provide the Advanced Research Projects Agency-Energy (ARPA-E), the budding program intended to fund transformative energy research, with $15 million, but the Senate version makes no mention of ARPA-E.

The Senate version of the Homeland Security bill includes $994.9 million for science and technology, a 6.7% or $62.3 million increase; the House version includes a smaller increase to $968 million.

The House-passed Labor, Health and Human Services, and Education appropriations bill includes $31.3 billion for NIH, a 3.1% or $942 million increase and 1.6% or $500 million more than the president’s request. Approved by voice vote was an amendment by Rep. Darrell Issa (R-CA) to no longer fund three peer-reviewed NIH grants related to HIV/AIDS prevention, a move strongly opposed by scientific and medical organizations. The bill would also eliminate funding for grants to public and private organizations to encourage teens to abstain from premarital sex. Democrats have argued that there is little scientific evidence that the programs work. The bill renews prior restrictions on the use of funds for research that creates or destroys human embryos. The Senate Appropriations Committee approved its version of the bill, with a 1.5% increase to $30.8 billion for NIH.

National science education standards supported

The National Governors Associations (NGA) and the Council of Chief State School Officers (CCSSO) in July announced a project to establish a set of common core education standards in English and math. Meanwhile, Sen. Chris Dodd (D-CT) and Rep. Vernon Ehlers (R-MI) reintroduced legislation to promote a voluntary effort by states to adopt standards in science, technology, engineering, and math (STEM) education.

The NGA and CCSSO’s Common Core State Standards effort involves 49 states and territories. The groups plan to develop and implement “research and evidenced-based math and English internationally benchmarked standards” to better prepare students academically. With U.S. students underperforming in international assessments, the NGA and CCSSO hope the core standards will bring U.S. math and language skills up to par with countries it lags behind, as well as addressing regional disparities that exist because of the patchwork of existing state standards.

The Dodd-Ehlers Standards to Provide Educational Achievement for Kids (SPEAK) Act would create national standards for STEM fields, similar to the standards that are to be created by the NGA and the CCSSO. The legislation would amend the National Assessment of Educational Progress Authorization Act, which currently only includes math and English, to include science as part of the assessments. The bill would also direct the NGA board to develop course content for grades K-12 and would provide grants to states if they adopt the voluntary standards and alter teacher certification criteria in order to meet the standards.

Meanwhile, other bills to bolster STEM education have also been introduced. The STEM Coordination Act (H.R. 1709 and S. 1210), sponsored by House Science and Technology Committee Chairman Bart Gordon (D-TN) and Sen. Edward Kaufman (D-DE), would establish a committee within the White House Office of Science and Technology Policy’s National Science and Technology Council (NSTC) to synchronize STEM education efforts across federal agencies. The legislation, which passed the House and is now being considered by the Senate Committee on Commerce, Science, and Transportation, calls for a new NSTC STEM Committee to evaluate all federal STEM education programs every five years. The evaluation would establish long- and short-term goals, create metrics to assess the new goals, and review past efforts to determine program effectiveness. All federally sponsored STEM education activities would be inventoried.

The Enhancing Science, Technology, Engineering, and Mathematics Education Act of 2009, sponsored by Rep. Mike Honda (D-CA), would, in addition to creating an NSTC STEM Education Committee similar to the one in Gordon’s bill, direct the committee to promote efforts to improve federal and state collaboration. It would also create an Office of STEM Education within the Department of Education to coordinate and evaluate STEM education efforts within the department.

To further examine methods of collaboration and coordination, the House Research and Science Education Subcommittee held a hearing that showcased partnerships in Chicago that have improved science education. Michael Lach of the Chicago public school system said that success depended on the assistance and partnership of local community groups, colleges and universities, museums and laboratories, and the federal government. Examples of partnerships included a National Science Foundation grant to create a program at local universities to improve teacher education courses in science and mathematics; a series of course curriculum materials developed by the University of Chicago for local schools to use to enhance STEM education; and a series of after-school clubs involving local science museums and botanical gardens to enrich and retain students’ interest in key scientific disciplines.

Although Lach said that much more needs to be done, he emphasized that the success of the partnerships to date depended on a coherent strategy and centralization of the system. He stated that “systems that foster innovation and entrepreneurship push decisions and resources closest to schools and classrooms, and when they are coupled with strong accountability systems, local communities can easily gauge success.”

Biologic drug regulation examined

As part of the overall debate on health care reform, Congress is examining the regulation of generic biologic drugs. Congress wants to lower the cost of biologic drugs for patients, but not at the cost of stifling innovation by drugmakers.

Biologic drugs are the fastest-growing and most expensive element of prescription drug costs in the United States. Brand-name biologics can cost between $48,000 and $120,000 a year. Biologic drugs are made from living organisms or in living cells and are much more structurally complex and environmentally sensitive than small-molecule pharmaceuticals. A biologic drug is often unique to the specific processes used to produce it, which makes it extremely difficult to produce an exact copy of a biologic drug. Consequently, companies have begun developing “biosimilar” drugs or follow-on biologics.

At issue in the biologics debate is the length of a data-exclusivity period for developers of a drug. Data exclusivity, which is separate from patent protection, is the protection of clinical test data that is provided to the Food and Drug Administration (FDA) for the approval process. Under the 1984 Hatch-Waxman Act, generic drug applicants are not required to duplicate the clinical testing of drugs already approved by the FDA. Applicants need to show only that the generic drug is chemically the same as the original drug and can use the clinical test data from the original drug for this process once its protections expire.

Rep. Anna Eshoo (D-CA) has introduced the Pathway for Biosimilars Act (H.R. 1548), which provides 12 years of data exclusivity to brand-name biologic drug companies. The bill has 142 cosponsors. At a July 14 House Judiciary Committee hearing, representatives from the Biotechnology Industry Organization (BIO), the National Venture Capital Association, and the American Intellectual Property Law Association backed Eshoo’s bill. Witnesses testified that complexity and loopholes in the patent system require a longer data-exclusivity period as a “necessary backstop” to ensure that novel drugs are protected from competition and that innovation is encouraged. In addition, because minute differences in the structure of a biologic can sometimes cause major differences in the efficacy of the drug, BIO and other groups believe that they should not be approved without additional clinical testing.

Also present at the hearing were opponents of a long data-exclusivity period. Bruce Leicher of Momenta Pharmaceuticals testified that a longer exclusivity period will slow innovation and provide a disincentive to companies to create true generic replicas instead of mere biosimilars. Patient advocacy groups stressed that a long data-exclusivity period will hinder the creation of the generic biologic market for the creation of cheaper alternatives to name-brand drugs.

Rep. Henry Waxman (D-CA) has introduced the Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427), which calls for five years of exclusivity and is supported by the Generic Pharmaceutical Association, Consumers Union, American Association of Retired Persons, and the AFL-CIO. Waxman’s bill models the current generic pathway for small-molecule drugs, which have a five-year data-exclusivity period.

In the Senate, a long data-exclusivity period has won approval from the Health, Education, Labor and Pensions Committee. The Committee voted 16-7 to approve an amendment by Sens. Orrin Hatch (R-UT) and Mike Enzi (R-WY) that would grant 12 years of exclusivity to brand-name biologics.

The Executive Branch is examining the issue as well. The Federal Trade Commission released a report concluding that a data-exclusivity period is not necessary at all. The Obama administration has announced its support for a compromise period of 7 years.

“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.