GOVERNMENT & POLICY OPENING DAY
Senators meet in Old Senate Chamber on first day of 110th Congress.
CONGRESSIONAL OUTLOOK 2007 Democrats pledge to tackle long-term budget challenges, INCREASE OVERSIGHT of Administration programs LOIS R. EMBER, DAVID J. HANSON, BETTE HILEMAN, CHERYL HOGUE, JEFF JOHNSON, AND SUSAN R. MORRISSEY; C&EN WASHINGTON
THE DRAMATIC SHIFT in power in the federal government—with both the House of Representatives and the Senate coming under the control of the Democrats this year—guarantees a lot of debate but does not ensure much progress. The noth Congress faces many of the same issues as the last one, especially the war in Iraq and national security problems, and these concerns will continue to dominate national debate. There are a number of science and technology issues—environmental rules, stem cell research, pharmaceutical safety, energy production—that are high priorities for the Democrats. The party, however, has only slim voting majorities, especially in the Senate, which will make controversial legislation as difficult to pass this year as it was last year.
Democrats in the House did, however, manage to push through several bills on their agenda during the much-publicized "first 100 hours" legislative blitz. These include a stem cell research bill and bills to raise the minimum wage and tighten ethics rules. As always, a big stumbling block will be passing the federal budget. The Democrats have pledged to do better at completing the budget process than did the Republicans, but money will be extremely tight this year, and most discretionary programs, including research and development, could actually see reductions in their funding. First sessions of a new Congress are always filled with anticipation as members have a clean slate to work with. But these are contentious times, and progress will be hard. The following is C&EN's annual
WWW.CEN-0NLINE.ORG
27
JANUARY 22. 2007
outlook of what to expect from Congress in the months ahead. ECONOMY & BUDGET. Democratic lead ers have already changed the budget process for this year by deciding to not vote on the nine appropriations bills that were not passed by the previous Congress. Instead, they will simply continue fiscal 2006 funding levels for the government through the rest of fiscal 2007. This giant continuing resolution, expected from the Democrats but not yet introduced, is expected to include corrections to a few department budgets, most likely those of the Department of Veterans Affairs and the Department of Justice. Although some money would be expected to be saved by this process, discretionary spending at the science funding agencies is likely to be lower than anticipated for this year. To smooth work on the budget for 2008, both the House and Senate have realigned their appropriations subcommittees so that each has the same responsibilities. The Republican-controlled House changed its appropriations subcommittees two years ago, but the Senate did not go along, resulting in an awkward misalignment of jurisdictions. In each body, there are now 12 subcommittees, each producing its own spending legislation. The Democrats also are pledging to do better than the Republicans have in balanc-
GOVERNMENT & POLICY
ing the federal budget. Although the annual deficit has been falling slightly over the past few years, long-term challenges to the budget, such as reforming Social Security, remain. The new chairman of the House Budget Committee, John M. Spratt Jr. (DS.C.), has said a cap needs to be imposed on discretionary spending. And there will be an attempt to impose a strict "pay-as-yougo" rule on the budget that will require any increases in spending, even increases in socalled entitlement costs such as Social Security and Medicare, to be offset with revenue increases. The previous Congress passed a tax reform bill at the end of December that preserved many of the tax cuts passed over the past six years, but Democrats already have a few tax issues of their own. Senate Finance Committee Chairman Max Baucus (D-Mont.), for example, has already introduced a bill that would permanently extend the highly popular research and development tax credit. His plan includes changing the formula for claiming the R&D credit, basing it on actual research spending instead of a company's gross receipts. Baucus also says he wants to repeal the unpopular alternative minimum tax, which ensnares millions of middle-class tax payers every year, increasing their tax bills. Getting rid of the tax would cost the treasury about $60 billion a year, however, and Baucus included no mechanism to make up for this loss.
Introduced by Rep. Bennie G. Thompson (D-Miss.), chairman of the House Homeland Security Committee, the House bill, H.R. 1, "Implementing the 9/11 Commission Recommendations Act of 2007," largely fulfills a key part of the Democrats' first 100-hour agenda. The bill sets a distribution formula for homeland security grants to states and localities based on terrorism risks and mandates scrutiny of all U.S.-bound air and
HOMELAND SECURITY. The Demo crat-controlled Congress got off to a roaring start in the area of homeland security with passage in the House of a bill implementing many of the outstanding reforms recommended by the 9/11 Commission. In 2004, the bipartisan commission set up to investigate CAUCUS Democratic ship cargo within three leaders hold an the 2001 terrorist attacks offered some to five years. Although 41 recommendations to improve home- organizational meeting in the great both measures have land security. The Republican-led 109th hall of the Thomas come in for much critiCongress, by some estimations, impleJefferson Building cism, the 100% cargo of the Library of mented about half of them. inspection provisions Congress. The nearly 300-page bill, containing especially have been 14 major initiatives, received overdeemed too costly and whelming acceptance during the floor not yet technically feavote on Jan. 9, passing by a vote of 299 to sible. They are likely to be hotly contested 128. Several of its provisions, however, are in the Senate. expected to face stiff opposition in the Sen The House bill contains no cost estiate. At press time, no companion Senate mates for implementing any of its meabill had been introduced, but any resulting sures. It does, however, include provisions bill is expected to differ significantly from for improving communications among first the House bill. responders during disasters, stemming the WWW.CEN-ONLINE.ORG
2 8
JANUARY 22. 2007
spread of weapons of mass destruction, and strengthening the powers of an existing civil liberties board that oversees U.S. antiterrorism efforts. In addition, H.R. 1 requires the homeland security secretary to assess yearly the vulnerability of the nation's critical infrastructure. Absent in the House bill is a key recommendation of the 9/11 Commission: Strengthening and streamlining congressional oversight of intelligence and counterterrorism efforts. Thompson has made H.R. 1 key to his agenda for his Homeland Security Committee, which, at press time, was still being organized. Thompson's spokeswoman, Dena Graziano, says the committee will hold a hearing this week "on the state of the Department of Homeland Security and, next month, will hear from Secretary Michael ChertoffonDHS's budget." The House committee "will look into rail and mass transit security," Graziano says. But oversight of DHS will be a principal committee focus, especially "the problems plaguing DHS's chemical security regulations." Late last December, DHS released draft chemical plant security regulations that largely track efforts the chemical industry has voluntarily undertaken. The rules leave vulnerability assessments to the companies, but DHS would determine whether the assessments were adequate. DHS will receive comments on the draft regulations until Feb. 7 and, by law, must issue final rules by April 4. The Senate Homeland Security Committee, chaired by Sen. Joseph I. Lieberman (I-Conn.), began "the 110th Congress developing legislation to implement the outstanding 9/11 Commission recommendations," says spokeswoman Leslie Phillips. Lieberman said at a Jan. 9 committee hearing that he planned to mark up a bill within weeks that would pass the Senate by the end of January. On the issue of plant security, Phillips says Lieberman "will oversee implementation of chemical security provisions contained in the [fiscal] 2007 DHS appropriations bill," but she could not yet offer further details. In cooperation with ranking member Sen. Susan M. Collins (R-Maine), Lieberman will focus heavily on DHS oversight, Phillips says. According to Collins spokeswoman Jen Burita, the senator's priorities include
Democrats have only slim voting majorities, which will make controversial legislation as difficult to pass this year as it was last year. "continued examination of DHS's budget, programs, and priorities," including Chertoff's reorganization efforts, and "DHS responsibilities for national pandemic planning." Also of high interest to Collins is ongoing oversight "of DHS efforts to identify vulnerabilities and threats to critical infrastructure" and of DHS's chemical plant security regulations, Burita says. Lieberman and Collins worked closely last year in developing legislation—which President George W. Bush recently signed into law—to strengthen the structure of the federal emergency management system. Both senators plan to keep a watchful eye on implementation of that law to make sure congressional intent is carried out. As in the past, DHS will also receive oversight from the appropriate House and Senate appropriations subcommittees. And as chairman of the House Oversight & Government Reform Committee, Rep. Henry A. Waxman (D-Calif.) will likely keep a keen eye on DHS's contracting efforts, which has been a particular concern of his in the past. Sen. Barbara Boxer (DCalif.), chair of the Senate Environment & Public Works Committee, is reported to have said her committee would assume
oversight of DHS's chemical plant security efforts, but committee staffers could offer no details. ENERGY. Global warming, ethanol, renewable energy, inc "ntives for coal-to-liquidfuel production, nev." °fficiency standards for appliances and vehic^s, and oil and gas drilling are just some of the t. °rgy-related issues House and Senate member say they intend to take up in the new Congress. This year and next could be pivotal for U.S. energy policy, congressional staff and Congress members say. However, they warn not to expect many blockbuster energy bills such as the Energy Policy Act of 2005. Instead, smaller and issue-specific "freestanding" legislation is more likely, which maybe passed alone or bundled with similar bills on the House and Senate floors, says Bill Wicker, Democratic Party communications director for the Senate Energy & Natural Resources Committee. However, the legislation could be farreaching with great impact. Consider that this year a national farm bill is up for reauthorization, and momentum for climatechange legislation is growing fast. The Senate—with its 5i-to-49 party split and a requirement of 60 votes to avoid a
filibuster and ensure bill passage—is likely to have the fullest legislative debate and the most give-and-take among members. Consequently, both Majority Leader Harry Reid (D-Nev.) and Senate Energy Committee Chairman Jeff Bingaman (D-N.M.) have already stressed their desire to encourage bipartisan support for legislation with hearings and public debate. Wicker expects the Senate process on energy legislation to be deliberate and discussions to be complicated as most bills vvln carry provisions affecting a wide range of inters:° and requiring approval by several c o m m i c ^ s . For instance, he notes that although the S e n ^ Agriculture, Nutrition & Forestry Committer Ws primary jurisdiction over a farm bill, the energy title in that bill would spread jurisdiction in part to Bingaman's Energy Committee, the Environment & Public Works Committee, and the Finance Committee. On Jan. 10, the Senate Energy & Natural Resources Committee and the Agriculture Committee held their first hearings, and both concerned energy. The Energy Committee held a general discussion of global oil supplies and how they may change. This was to set the stage for several energy hearings to follow.
Look CD en O O z
o U_
z Q
< h< UJ
rr O H
GO UJ
D O UJ
WWW.CEN-0NLINE.ORG
2 Q
JANUARY 22. 2007
Novel Heterocyclic Boronic Esters N
/-V"
for Drug Discovery I
.N
HO
N
B
X ^
CI
B
X
H2N
BE30
BE39
N
N
B
B
N
B
X
BE33
BE28
|^
[
N
This year and next could be pivotal for U.S. energy policy.
B J < 0 -f
LJ
o hco LiJ
D
a
BE 10
BE57
BE16
BE35
CombiPhos Catalysts, Inc. P.O. Box 220, Princeton, NJ 08542-0220 Phone: 800-659-9793 Fax: 800-659-1979 www.combiphos.com
LU
WWW.CEN-0NLINE.ORG
2 Q
JANUARY 22. 2007
GOVERNMENT & POLICY
2 o in -.-••
LlJ
y
•Jj
H-
-^ : CO
2: D: LL!
Z
< more toxic air polluE-mail to
[email protected] c UJ tion." cr He noted that "our actions with respect to other countries can be distorted by our dependence upon oil from overseas. I want us to move in a meaningful way toward alternative fuels and to place more emphasis on conservation in this country, as we have done under previous presidential leadership."
M&H Laboratories Co., Ltd.
cr
WWW.CEN-0NLINE.ORG
X2J
JANUARY 22. 2007
Boxer's committee will also scrutinize the Bush Administration's new streamlined review process for setting health-based standards for the quality of the nation's air. Announced last month, that process enhances the role of political appointees and, critics say, diminishes the role of agency scientists and its external science advisers. EPA intends to use this process for the first time as it decides whether to scrap the national standard for the allowable amount of lead in air. Boxer and six other Democrats on the Environment & Public Works Committee wrote to EPA Administrator Stephen L. Johnson on Dec. 21,2006, asking him to discard the new process. Boxer is also concerned about the lack of money to cleanup abandoned hazardous waste sites under the Superfund law. She cites internal EPA documents that indicate that the program needs $1.25 billion more than the agency has to clean up Superfund sites. Hearings on this EPA program are likely to start in the Subcommittee on Superfund & Environmental Health, now chaired by Sen. Hillary Rodham Clinton (D-N.Y.). As of mid-January, House committees had no clear schedule for legislation or oversight hearings on pollution-related matters. However, the Energy & Commerce Committee is likely to look into electronic waste recycling and disposal, perchlorate in drinking water, funding for Superfund cleanups, and EPA enforcement, a House aide tells C&EN. DRUG POLICY, A lot of Democratic effort in the 110th Congress is likely to involve some aspect of regulating pharmaceuticals—pricing, safety, importation from foreign countries, and direct-to-consumer advertising. Already, Reps. Dingell and Charles Rangel (D-N.Y.) have introduced the "Medicare Prescription Drug Price Negotiation Act" (H.R. 4), which would repeal the current provision that prohibits the secretary of Health & Human Services (HHS) from bargaining for lower drug prices for some 40 million Medicare recipients. However, the bill would prohibit the government from establishing a formulary; that is, a select list of drugs approved for reimbursement under Medicare Part D. This means the Center for Medicare & Medicaid Services (CMS) would not be able to bargain down a drug price by threatening a company that it would disallow purchases of its product under Medicare plans. The bill has already passed in the House but faces opposition in the Senate.
Senate Finance Committee Chairman Baucus plans to hold hearings on the issue before the details of a companion bill are worked out in the Senate. The American Association of Retired Persons, AFL-CIO, Consumers Union, and Families USA support H.R. 4, but CMS and some large pharmaceutical firms oppose it. CMS claims that H.R 4 would SENATE Leaders in the Senate this "require limiting acyear include (from cess to some drugs left) Republican while promoting othMinority Leader ers in exchange for Mitch McConnell (R-Ky.), Dick price discounts." The Durbin (D-IIL). Congressional BudMajority Leader get Office released a Harry Reid (DNev.), and Charles letter on Jan. 10 that Schumer(D-N.Y.). concludes the drug
price negotiations required under the bill would save little or no money. This finding is likely to influence the debate in the Senate, where there is more skepticism about the legislation. The drug pricing issue has not escaped the notice of the White House, either. President Bush has already notified Congress he will veto the pricing negotiation bill if it comes to his desk. A bill that would allow the controversial importation of pharmaceuticals was introduced in the Senate and House on Jan. 10 by a bipartisan group of legislators. The "Pharmaceutical Market Access & Drug Safety Act of 2007" would allow wholesalers, pharmacies, and individuals to import drugs approved by the Food & Drug Administration from Canada and other countries
o o
o T O
•::
oo z O
permitted by the HHS secretary. Individuals could order drugs directly from Canada if they are using an FDA-approved pharmacy. The aim of the legislation is to make drugs more affordable by putting an end to monopoly pricing, says Sen. Byron Dorgan (D-N.D.). According to the bill, drug prices in other industrialized countries are 35 to 55% lower than in the U.S. The Pharmaceutical Research & Manufacturers of America adamantly opposes the legislation. "Simply put, there is absolutely no way to guarantee the safety and efficacy of medicines imported from Canada," says PhRMA Senior Vice President Ken Johnson. "Importation schemes undermine the U.S. government's ability to assure us that our drug supply is safe and secure and can expose Americans to counterfeit drugs." Furthermore, he says, "Canadian authorities report that counterfeit drugs are being sold in their country at alarming rates." Similar legislation stalled in past Congresses, but the prospects for passage appear better this year. Democratic leaders have promised a vote on the bill in the House, and Dorgan predicts a favorable vote in the Senate. "This Congress needs to pass reimportation because prescription drugs are the foundation of modern medicine—not only for seniors, but for every American," says Rep. Rosa L. DeLauro (DConn.), who chairs the House Appropriations Subcommittee on Agriculture, Rural Development, Food & Drug Administration & Related Agencies. The drug importation bill will face
o
Look into the future of customization
en O
o z o l_l_
z Q
< < UJ
cr O I— oo LLJ
ID
O LLJ
a: WWW.CEN-0NLINE.ORG
1/1
JANUARY 22, 2007
GOVERNMENT & POLICY
i
stiff opposition from HHS and the White House. DeLauro and other lawmakers also plan to try to increase FDA funding for generic drug approval and for the agency's office that monitors the safety of drugs after they are approved. There is a large backlog of generic drug applications at the agency, and faster approval of the drugs would tend to lower prices. Over the past few years, there has been much criticism of FDA's tracking of the safety of approved drugs. For example, pharmaceutical firms that are asked to perform additional safety studies of new medicines often fail to do so. Another Democratic goal is to rein in direct-to-consumer (DTG) advertising. A Government Accountability Office report issued last December found that FDA has limited ability to curb the distribution of misleading and false DTC ads. The agency has no power to fine a company for
Register on Jan. 11, FDA recommends that annual user fee collections by the agency be increased by $87 million to $393 million. The largest part of the additional funds would be used to track the safety of medications after they are on the market. In addition, FDA proposes the creation of a separate program to collect user fees from drug companies that seek advisory reviews of their DTG television ads. The agency estimates that these fees would support 27 additional staff to carry out the reviews. Another issue that will likely be the subject of hearings this year is safety of the nation's food supply. Most observers expect that Democrats in Congress will once again try to create a single food safety agency that would have regulatory jurisdiction over all types of food. Currently, food safety functions are split primarily between USDA, which has jurisdiction over meat and poultry, and FDA, which controls
sponsoring a misleading ad. It can only send out warning letters, which are issued on average eight months after the first misleading ad appears, GAO said. DeLauro plans to reintroduce a bill from the past Congress that would ban DTG advertising of new drugs for three years. But lawmakers' efforts to limit or ban DTC advertisements and improve the safety of marketed drugs maybe shortcircuited by FDA's own proposals for the reauthorization of the Prescription Drug User Fee Act. The act must be reauthorized this year, as it is every five years. In a proposal published in the Federal
fruits, vegetables, and fish. The recent Escherichia coli contamination problems with fresh produce—primarily spinach and lettuce—have given rise to calls from many consumer and health groups for a new food administration.
HEARINGS
Democrats plan to hold more oversight hearings on Administration programs than did the previous Congress.
SCIENCE POLICY. One of the hottest issues in Congress this year is likely to be the federal support of embryonic stem cell research. Led by the Democrats' push to expand the human embryonic stem cell federal policy, congressional hearings are expected to focus on research and the potential of embryonic and adult stem cells, as well as on the impact of the recently reported isolation of stem cells from human amniotic fluid. As one of its highest priorities, the House has already passed by a vote of 253 to WWW.CEN-0NLINE.ORG
2/1
JANUARY 22. 2007
174 a bill that expands the federal policy on embryonic stem cell research. The Senate is expected to follow suit in the next few weeks. The bill passed by the House (H.R. 3) is identical to the legislation introduced and passed in the 109th Congress, then vetoed by President Bush. Authored by Reps. Diana DeGette (D-Colo.) and Michael N. Castle (R-Del), the bill would allow researchers to use federal funds to study stem cell lines derived from human embryos that were originally created for fertility treatments but which are no longer needed and are scheduled to be discarded as medical waste. It would not allow embryos to be created solely for research. The Administration has already issued a statement reaffirming Bush's position that the current policy is adequate and promising another veto if such a bill makes it to his desk. It is unclear whether the House and Senate have the necessary votes to override the President's veto. Congress will also renew its push to pass legislation, stalled in the previous Congress, that will improve U.S. competitiveness and innovation. The Senate is expected to introduce related legislation soon, and the House has already introduced a trio of bills that will serve as the cornerstone of the Democrats' Competitiveness & Innovation Agenda. Two of the House bills aim to increase the number of math and science teachers, to authorize funding increases for physical sciences at key agencies, and to provide other resources for physical science research. The third bill of the package would create an Advanced Research Projects Agency for Energy. Whenever there is a change in the majority in Congress, there are a number of shifts and adjustments that take place. The 110th Congress is no different, and one of the changes is a new name for the key House committee with jurisdiction over a wide range of science policy issues. The old Science Committee has been renamed the Science & Technology Committee, under the chairmanship of Rep. Bart Gordon (D-Tenn.). Under its revised name, the Science & Technology Committee has set out an agenda for this year that includes overseeing of the National Aeronautics & Space Administration, ensuring adequate federal support for basic research, increasing U.S. energy independence, and continuing to make sure U.S. workers are prepared to compete in the global economy. •
