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March 18, 2005

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In this Issue


Senate Budget Resolution Takes on Medicaid, Medicare and More


Senate Pushes Back on Bush Ag Budget Cuts, but House Cuts More


House Committee Launches NIH Reauthorization Process


GAO Questions FDA Enforcement of BSE Feed Rule


Japan, Canada Beef Trade Developments


Japanese Say R-CALF Actions Will Slow Reopening Market


Ag Groups Push To Repeal Cuba Trade Rules


Senate Committee Holds Crawford Nomination Hearing


Take Us Out To The Ballgame?
House Government Reform Committee Takes On National Pastime



FOIA Compliance Bills Introduced, Hearing Held


Bills Introduced to Award Congressional Gold Medal to Dr. Michael E. DeBakey


Michael D. Griffin Nominated for NASA Administrator


Bill Setting Up Single Food Safety Agency to be Revealed April 6


New Bills

 

 


Senate Budget Resolution Takes on Medicaid, Medicare and More

Despite approval on Thursday of the FY2006 Budget Resolutions in the Senate (51-49) and House (218-214), hopes of coming to an agreement on a single resolution could be unlikely.

In a surprise move, the Senate rebutted the White House's proposed cuts to the Medicaid budget. Sen. Gordon Smith’s (R-OR) amendment deleting the Administration’s proposed $14 billion reductions in Medicaid over the next five years passed by 52 – 48, with seven Republicans joining with the Senate's 44 Democrats and one independent. In contrast, the House's Budget Resolution provides for up to $20 billion in decreases in Medicaid.

Medicaid looks to be a deal-breaker for the Senate and House to agree on a single Budget Resolution. The White House praised the House Resolution, with party leaders expressing disappointment in Smith’s amendment. Smith had been under intense pressure from Republican party leaders to change or withdraw the measure.

While Medicaid provides the biggest obstacle to agreement, other differences in the resolutions include a Senate passed amendment by Sen. Arlen Specter (R-PA) increasing funding for National Institutes of Health (NIH). The language provides for an increase in funding from $28.6 billion, or 2.7% higher than FY2004, to $29.4 billion or 5.3% higher than FY2004. The proposed White House budget calls for only a 2.7% increase for NIH in FY2005, which does not keep pace with the rate of biomedical inflation, projected to be 3.5% in 2005.

Tackling the issue of influenza vaccines, Sen. Hillary Clinton (D-NY) offered an amendment that establishes a reserve fund for influenza vaccine shortage prevention provided separate legislation on this issue passes out of the Senate HELP Committee. The "Flu Vaccine Shortage Prevention" amendment creates a reserve fund that would support legislation to increase participation of manufacturers in the production of influenza vaccine and increase research in new technologies for development of influenza vaccine. The amendment also seeks to support efforts to enhance the U.S.'s ability to track and respond to domestic influenza outbreaks as well as pandemic containment efforts. Finally, the amendment addresses the threat of bioterrorism by encouraging technology, tracking and response efforts consistent with those undertaken to prevent future flu vaccine shortages.

At the same time, the Senate voted down an amendment by Sens. Olympia Snowe (R-ME) and Ron Wyden (D-OR) that would have given the Secretary of Health and Human Services (HHS) the specific authority to negotiate lower prices for drug purchases through Medicare.

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Senate Pushes Back on Bush Ag Budget Cuts, but House Cuts More

In an escalating war over FY2006 budget cutting, the Senate this week approved its budget resolution paring back White House ag budget cuts to $2.8 billion over five years. The House, not happy with the overall Senate budget action due to spending reinstatement, would trim $5.3 billion from ag over the same period.

While ag groups opposed to the cuts see the Senate action as good news, they say more work needs to be done to preserve 2002 Farm Bill programs. For FY2006, the House budget resolution means $797 million in cuts may have to be found. President Bush requested cuts totaling what the White House said amount to $7.5 billion over five years, but which the Congressional Budget Office (CBO) calculated would actually cost $9.1 billion. Senate Agriculture Committee Chairman Saxby Chambliss (R-GA) said the Senate resolution will allow him to find cuts in ag spending without changing current Farm Bill programs. The outlook in the House, however, is not as clear.

The budget resolutions set overall spending limits for the federal government, and for FY2006 that amount hits about $2.6 trillion. Once agreed to, that spending limit creates the specific amount the respective appropriations committees can allocate among departments and agencies. Both budget resolutions now move to conference committee.

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House Committee Launches NIH Reauthorization Process

The House Energy and Commerce subcommittee on health met March 17 to begin what is expected to be a lengthy process of developing legislation to reauthorize the programs of the National Institutes of Health (NIH). Subcommittee Chair Nathan Deal (R-GA) noted NIH reauthorization has been pending “longer than most of us have been serving in Congress.” He argued for moving ahead with reauthorization and urged members of Congress and outside stakeholders to put aside differences and “pet projects” and not allow “one minor set of issues” to prevent this being accomplished.

Committee Chair Joe Barton (R-TX) echoed these sentiments and laid out several concerns about NIH, including that its organizational structure is so large and complicated that it cannot operate efficiently. He noted Congress was partly at fault for the proliferation of institutes and centers of NIH, along with interest groups who pushed for targeted programs.

Barton laid out three actions he believes Congress needs to take to improve the effective operation of NIH: Increase the authority of the NIH director to allow for more flexibility in the allocation and/or transfer of funds among Institutes and Centers and use funds to support cross-cutting research and management projects; align the NIH budget authorities better, including considering “budget clusters” to allow more spending flexibility; and, create more transparent reporting system to replace specific disease-related reports from NIH to Congress with more comprehensive, broad research area reports.

Ranking subcommittee member Rep. Sherrod Brown (D-OH) highlighted the challenges facing NIH in terms of diseases and conditions yet to be cured as well as emerging conditions. He urged legislative activity be directed at streamlining communication between NIH and Congress and ensuring adequate funding for NIH given that the current Administration budget proposal does not provide for an increase in NIH funding for the next fiscal year. He further urged for legislation to define NIH priorities more effectively and working with NIH to achieve a better understanding not only of what resources are needed, but what are the tangible benefits of the NIH funding.

Dr. Elias Zerhouni, NIH Director, testified NIH must adapt to the changing nature of science and needs of public health. He noted investigator-initiated research will always be the mainstay of the enterprise, but ideas coming from individual researchers are only one part of a process to identify and pursue new, high-priority scientific opportunities. He discussed his new approach to priority setting that will complement existing processes and involve a newly established Office of Portfolio Analysis and Strategic Initiatives that will take a “global view of what we fund.” Zerhouni also discussed his “Roadmap for Medical Research,” highlighting several components. For example, by FY2006 Molecular Libraries Screening Centers will identify molecules that have potential as biochemical probes. An Imaging Probe Development Center will also be operating.

Zerhouni said the “Roadmap” has played a significant role in “shifting the culture of NIH from single-purpose research funded by individual Institutes and Centers to research that will benefit all endeavors.” As an example, he cited the Strategic Plan for Obesity, a trans-NIH initiative to bring together the work and resources of multiple components of NIH to address a public health crisis. He also mentioned the Neuroscience Blueprint, which is a coordinated effort in brain research.

The subcommittee and committee are expected to hold several additional hearings as they work to develop and pass NIH legislation with bipartisan support.

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GAO Questions FDA Enforcement of BSE Feed Rule

In its third investigation in five years of how FDA enforces its BSE feed rule, the Government Accountability Office (GAO) this week said while the agency has improved, it needs to develop a system to identify feed companies, transporters, on-farm mixers and “other feed industry businesses” subject to the feed ban but not yet inspected by FDA.

GAO, the investigatory arm of Congress, said “program weaknesses” limit the effectiveness of the feed rule, “plac(ing) U.S. cattle at risk of spreading BSE.” The report, done at the request of Sens. Tom Harkin (D-IA), Richard Durbin (D-IL) and Thad Cochran (R-MS), carries nine recommendations for improved enforcement by the agency.

Those recommendations include the identification of additional companies subject to the rule; requiring companies using prohibited protein material to notify FDA; developing guidance for inspectors to systematically test to verify cattle feeds don’t contain restricted material, and equipment and truck cleanout are effective; collecting feed tests from states; developing a design for FDA inspectors to routinely sample finished feed and ingredients; requiring the “do not feed to cattle or other ruminants” statement on feeds/ingredients for export; ensuring USDA and states are alerted if problems with compliance arise; modifying inspection forms to reflect questions on transportation cleanout, and ensuring inspection results are “reported in a complete and accurate context.”

FDA said it has considered, implemented or agrees with five of the nine recommendations, but considers four others – primarily related to testing -- to be impractical or have no material benefit to risk mitigation. FDA said tests will only confirm the presence of animal material, not illegal ingredient use since the rule has exemptions for some ruminant products, such as milk.

The American Feed Industry Association (AFIA), while supporting FDA’s risk-based priority inspection system, said the testing by USDA of over 275,000 animals with no BSE positives found demonstrates the feed rule is working. AFIA also said analysis of enforcement and compliance must include voluntary actions by industry to reinforce the feed rule. AFIA cited its Feed Certification Institute (FCI) and Safe Feed/Safe Food programs as effective independent auditing systems designed to ensure broad industry compliance with the FDA feed rule.

The National Cattlemen’s Beef Association (NCBA) said while the GAO report “provides FDA and industry many important observations … it is important to note that the GAO never verified the potential risk reduction significance of any of the additional measures” recommended to FDA.

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Japan, Canada Beef Trade Developments

Don’t look for an open U.S. border until some time in 2006, say Canadian beef industry officials, so some Canadian cattlemen will sue the U.S. USDA says it will appeal the recent federal court ruling halting reopening of the Canadian border, and Japanese officials say they’re not stalling on renewed U.S. beef trade, with one minister saying he’s just about had it with U.S. pressure.

An official of the Canadian Cattlemen’s Association (CCA) says he doesn’t expect the U.S./Canada border to reopen until some time in 2006, and blames R-CALF legal actions for the delay. Dennis Laycraft of CCA said, “You could easily get into nine months to a year and a half…in terms of the likely time frame around these court proceeding,” according to reports.

Some Canadian ranchers are ready to file a suit worth at least $300 million against the U.S. over U.S. inaction on resuming animal and beef trade with Canada. The suit, to be brought under NAFTA, is likely to be filed by Canadian Cattlemen for Fair Trade (CCFT) representing 500 ranch families. CCFT was to have filed a notice of arbitration in Washington, DC on March 16 using Chapter 11 of NAFTA, which allows suits brought by investors if they believe their investment has been hurt by law or regulation.

USDA announced the Department of Justice filed a request with the U.S. Court of Appeals for the 9th Circuit asking the court to overturn the U.S. district court decision temporarily enjoining USDA from reopening the Canadian border on March 7. USDA said its rulemaking is the product of a multi-year scientific process providing protection to human and animal health.

In Japan, where Secretary of State Condoleezza Rice will press the beef issue this weekend, Prime Minister Junichiro Koizumi reportedly denied yet again his country is stalling on resuming beef trade with the U.S. His remarks were in response to congressional resolutions introduced over the last couple of weeks threatening U.S. sanctions against his country if trade doesn’t resume soon. “If the beef is safe, we want to eat it, whether it is raised in America or wherever,” he said.

Meanwhile, Hiroyuki Hosoda, Japan’s chief cabinet secretary, told the Wall Street Journal he’s just about had it with U.S. pressure. “We are aware of political moves on the U.S. side, but the U.S. has also banned imports of Japanese beef due to BSE,” he said. “It is not easy to make progress on the issue of food safety in this way.”

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Japanese Say R-CALF Actions Will Slow Reopening Market

R-CALF ran a half-page ad in the March 15 Washington Post thanking the Senate for passing a resolution of disapproval on the USDA rulemaking on imports of Canadian live cattle and urging the House to do the same. Reports have surfaced that one Japanese official told R-CALF its actions on the USDA rulemaking are delaying resuming beef trade between Japan and the U.S.

According to a published report by Jim Wiesemeyer of Informa Economics, Washington, D.C., quoting an unnamed Japanese official, the Senate’s action and R-CALF’s lobbying gave rise to a consumer campaign in Japan against normalizing beef trade. According to this official, saying Canadian beef may be unsafe, as R-CALF has alleged, creates questions about the safety of U.S. beef since Japan views the U.S. and Canada as one integrated market.

R-CALF head Bill Bullard told Dow Jones the Japanese opinions make no sense and are at odds with previous statements concerning production practices and protocols for processing beef. He also said the R-CALF group who met with the Japanese official did not know he was a government representative, and assumed his opinions were not the official Japanese position.

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Ag Groups Push To Repeal Cuba Trade Rules

The House Agriculture Committee this week heard from a number of ag groups who, eager to increase trade with Cuba, urged the ag panel to take action to reverse a new Treasury Department rule they say makes it almost impossible to trade with Cuba. At the same time, 33 U.S. companies and groups formally petitioned Treasury to allow existing contracts with Cuba to proceed under terms in place before the rulemaking.

The rule, designed to tighten financial requirements on trade with Cuba, went into effect February 22, redefining the term “payment of cash in advance” to mean sellers must receive payment before shipments leave the U.S. or move through a third nation letter of credit. Previously goods could be shipped and payment received before the shipment was unloaded in Cuba. While there’s a 30-day transition period in the rule, there is also a penalty provision if goods aren’t delivered by March 24.

Rep. Bob Goodlatte (R-VA), chair of the House Agriculture Committee, said “I find it disturbing the Treasury Department’s Office of Foreign Asset Control is placing…unnecessary barriers to agricultural trade with Cuba.”

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Senate Committee Holds Crawford Nomination Hearing

The Senate Committee on Health, Education, Labor, Pensions (HELP) held a March 17 hearing to consider the nomination of Dr. Lester M. Crawford to be commissioner of Food Drug Administration (FDA). Members participating in the hearing included Committee Chair Sen. Mike Enzi (R-WY), ranking Democrat Sen. Ted Kennedy (D-MA), and Sens. Jeff Sessions (R-AL), Johnny Isaakson (R-GA), Mike DeWine (R-OH), Orrin Hatch (R-UT), Chris Dodd (D-CT), Tom Harkin (D-IA), Barbara Mikulski (D-MD), Patty Murray (D-WA), Hillary Clinton (D-NY) and Jim Jeffords (I-VT).

Enzi noted FDA has been through a difficult period and faces drug safety improvements, the flu vaccine shortage, the need to rebuild the domestic vaccine industry, and food safety and security. He said the Committee received more than 100 letters of support for Crawford’s nomination and one letter raising concerns, referring to a joint letter from Consumers Union, Consumer Federation of America, and the U.S. Public Interest Research Group. The letter calls for “substantive rather than symbolic drug safety reform,” including public disclosure of all clinical trial results, more independence for the Office of Drug Safety, and greater authority for FDA to require post-market studies and label changes.

Kennedy said Crawford, as acting FDA commissioner, has led the agency in “troubled times” and FDA must change from an “atmosphere that stifles debate,” a phrase quoted from the New England Journal of Medicine. He said Crawford must present a clear plan for change to be confirmed.

Plan B Over-the-Counter Application
Murray, Mikulski, and Clinton asked Crawford for a private briefing prior to any further Committee or Senate action on his nomination. They want Crawford to provide a progress report on the Plan B over-the-counter application, demonstrate FDA’s decision is being driven by science, not politics, and explain specifically why, as he stated, this application is “unique” and “difficult” and thus is taking a longer than “usual” to be completed. Clinton repeatedly asked Crawford to confirm that Plan B is for prevention, not termination of pregnancy. When Crawford replied he wanted to confer with FDA experts, Clinton stated, “but experts at FDA have already made their recommendation.” She asked Crawford to commit he would not allow “this dangerous slide into politics from science” to continue. Kennedy and Jeffords supported the Plan B concerns.

Enzi promised to schedule a meeting so Crawford could brief interested committee members and staff regarding Plan B, providing information to the extent legally allowable.

Drug Safety
Kennedy and Mikulski discussed with Crawford the need for change at the FDA, with Kennedy pointing to comments made to the Committee by Dr. Sandra Kweder, acknowledging “lapses” and mistakes in FDA’s actions regarding VIOXX. In response to the question of what he planned to do about this, Crawford pointed to an IOM study saying he will evaluate the “culture” of the agency and make recommendations; his goal of greater transparency in agency decision-making; a new system for engaging scientific debate within the agency, including ensuring that minority opinions are weighed appropriately; a change in the agency process of disclosing the backgrounds, and possible conflicts of interest, of advisory committee members; the new independent Drug Safety Board (Crawford said that that Board’s deliberations will be made public immediately); and more timely public communication of safety concerns via the new Drug Watch web page.

When questioned about the Office of Drug Safety (ODS), Crawford stated a new office director will be named soon and that it is his intent to keep the Office in the Center for Drug Evaluation and Research. Mikulski insisted ODS should be in the Office of the Commissioner to assure the office is independent of inherent conflicts within the center, with those who approve products being reluctant to take action against them. Dodd agreed, noting the 2002 report of the HHS Inspector General indicating 1/5 of reviewers said they felt “pressured” to approve applications and 1/3 of FDA reviewers were not convinced that agency did a good job in evaluating drug safety. He asked Crawford whether the agency’s reputation was tarnished. Crawford responded “no” and he is committed to not “have this happen again.” He will work with Congress and is open to suggestions, including the appropriate location for ODS within FDA.

Enzi and Isaakson noted testimony from non-FDA witnesses at an earlier hearing regarding keeping deliberations about safety and benefit together to ensure the balance between benefit and risk is at the forefront of decision-making. Isaakson emphasized the importance of institutionalizing electronic collection of drug use information from multiple sources to ensure information from as many users as possible can be evaluated together. He also sympathized with FDA’s difficult task of balancing the public’s desire for fast access to new therapies against risks associated with all products.

Additional Issues
Enzi - PDUFA, confirming the benefits of user fees in getting products to patients expeditiously

DeWine - Need for a process to expedite pediatric device development akin to the pediatric drugs initiatives, status of FDA’s regulation on labeling for salt content of food products labeled “healthy,” and ensuring an expedited process for approving pediatric AIDS drugs

Harkin - Implementation of the Dietary Supplement Health and Education Act (DSHEA), status of the dietary supplement GMPs regulation, and status of restaurant ”labeling” for nutrition information

Dodd - FDA should help get rid of “bad” snacks sold in school vending machines

Sessions - Reducing review and approval times for generic drugs and vaccine availability hindered by out of control lawsuits

Hatch - Plans to continue assuring the security of the food supply against bioterrorism threats and standards for quality and safety of cord blood

Jeffords - More funds from PDUFA for drug safety, including post-market monitoring (Crawford responded he thought this could be on the table in the next PDUFA reauthorization), mandatory public disclosure of clinical trials and results, and prescription drug importation (Crawford said while the Administration’s position is that this cannot be done safely, FDA is open to working with Congress)

The hearing record is expected be complete by April 4, with Enzi planning to move the nomination by April 13. Grassley, however, stated he remains concerned and could hold up the nomination if he does not receive answers to multiple drug safety questions and requested documents.

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Take Us Out To The Ballgame?
House Government Reform Committee Takes On National Pastime

In a marathon 11-hour hearing March 17 before a packed audience of hundreds of reporters and baseball fans, the House Government Reform Committee heard testimony from Major League Baseball (MLB) officials, MLB current and retired players (mostly testifying under subpoena), sports and addiction physicians, the National Institute on Drug Abuse, parents of teens who had used steroids, and Baseball Hall-of-Famer Sen. Jim Bunning (R-KY). The topic: abuse of anabolic steroids by baseball players and the league’s recently adopted policy on steroid use, was a headline-grabber that had the unusual effect of bringing the members of the committee together in a bipartisan fashion to attack MLB. Fans of the game lined the hallways and headlines in papers across the country tell the story.

On a serious note, the issue of anabolic steroids turned the discussion in an interesting direction. Lat year Congress passed and the President signed into law the Anabolic Steroid Control Act of 2004, to clarify so-called anabolic steroid precursors are also steroids under the Controlled Substances Act. The legislation includes a long list of chemicals that, in addition to substances already listed as anabolic steroids, are subject to a number of regulations, including they cannot be sold over the counter. The rationale for the legislation was that many of these substances were not considered “steroid” and were being obtained and used by young people. Many sports organizations, including the Olympics, have policies banning the use of anabolic steroids; those policies would now be expanded to include the steroid precursors listed by the new law. MLB came late to instituting penalties for using these substances, though whether they are truly “banned” was the subject of dissension at the hearing.

A key point raised by several witnesses, including the physician who now serves as medical advisor to MLB and previously was affiliated with the National Football League, was that the major problem is not the use of specific banned substances themselves, but the use of “legal” products that include these substances as “contaminants.” Several members of the Committee picked up on this, with Rep. Henry Waxman (D-CA) raising questions about “legal dietary supplements” containing substances that otherwise are “banned.” Since Waxman has been a proponent of stronger regulation of dietary supplements, he is likely to continue pursuing this “crossover” concept of products regulated as supplements having the same or similar adverse effects and potential for abuse as products regulated as anabolic steroids.

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FOIA Compliance Bills Introduced, Hearing Held


Three bills have recently been introduced in Congress, designed to increase compliance with the Freedom of Information Act (FOIA). Concerns have been raised about the responsiveness and timeliness of the responses to FOIA requests by a number of government departments and agencies.

Sens. John Cornyn (R-TX) and Patrick Leahy (D-VT) introduced S. 589 and S. 394. On the House side, Rep. Lamar Smith (R-TX) introduced companion legislation to H.R. 867. One bill (S. 589) proposes the establishment of a Commission on Freedom of Information Act Processing Delays to identify ways to reduce delays in the processing of FOIA requests. The other bills, S. 394/H.R. 867, are designed to improve compliance with FOIA by creating disciplinary action, time limits, and an Internet- or telephone-tracking system for FOIA requests.

According to Leahy, since FOIA was updated in 1996 to address digital communications, there has been a concern that homeland security legislation will trump citizens' rights with regard to access to information.

A March 16 hearing was held on these bills by a subcommittee of the Senate Judiciary Committee. Witness testimony is available here: http://judiciary.senate.gov/hearing.cfm?id=1417

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Bills Introduced to Award Congressional Gold Medal to Dr. Michael E. DeBakey

On March 16, 2005 Sen. Kay Bailey Hutchison (R-TX) along with two cosponsors, Sens. John Cornyn (TX) and William Frist (TN), introduced S. 641 to award the Congressional Gold Medal to renowned cardiologist Dr. Michael E. DeBakey. Rep. John Culberson (R-TX) also introduced the bill in the House.

Born September 7, 1908 in Louisiana, at the age of 23 and still a medical student DeBakey reported a major invention, a roller pump for blood transfusions, which later became a major component of the heart-lung machine used in the first successful open-heart operation.

During WWII he joined the Surgeon General's staff, rising to the rank of Colonel and Chief of the Surgical Consultants Division. His recommendations for the proper staged management of war wounds led to the development of mobile army surgical hospitals or MASH units, and earned DeBakey the Legion of Merit in 1945.

Joining the Baylor University College of Medicine in 1948, five years later he performed the first successful procedures to treat patients who suffered aneurysms leading to severe strokes, and he later developed a series of innovative surgical techniques for the treatment of aneurysms.

Then in 1964, DeBakey performed the first successful coronary bypass. Two years later, he made medical history again when he was the first to successfully use a partial artificial heart to solve the problems of a patient who could not be weaned from a heart-lung machine following open-heart surgery. In 1968 he supervised the first successful multi-organ transplant, in which a heart, both kidneys, and lung were transplanted from a single donor into four separate recipients.

He was awarded the Presidential Medal of Freedom with Distinction by President Lyndon B. Johnson and President Ronald Reagan conferred on him the National Medal of Science.

Today, DeBakey works with NASA engineers, refining existing technology to create the DeBakey Ventricular Assist Device, one-tenth the size of current versions, which may eliminate the need for heart transplantation in some patients.

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Michael D. Griffin Nominated for NASA Administrator

President Bush nominated Michael D. Griffin to be the administrator of the National Aeronautics and Space Administration (NASA). Griffin is currently the Space Department Head of Johns Hopkins University Applied Physics Laboratory. Prior to that he was president and chief operating officer of In-Q-Tel, Inc.

In a written statement, House Science Committee Chair Sherwood Boehlert (R-NY) praised Griffin’s nomination.

"We are extremely pleased that the President has nominated Mike Griffin to be NASA Administrator" Boehlert said in the statement. "Dr. Griffin has long been a resource to the Science Committee, both as a public witness and in providing private counsel. He has broad expertise, knows NASA inside and out, and is an imaginative and creative thinker and leader. He is also known for his candor and directness. We look very forward to working with Dr. Griffin at this critical time for NASA."

Griffin has a doctorate degree in aerospace engineering and five master's degrees: aerospace science, electrical engineering, applied physics, civil engineering and business administration.

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Bill Setting Up Single Food Safety Agency to be Revealed April 6

Long-time advocates of a single federal food safety agency Sen. Richard Durbin (D-IL) and Rep. Rosa DeLauro (D-CT) will introduce legislation April 6 to create such an agency, reports indicate. The bill would create out of 12 separate federal agencies with food safety responsibility a single independent agency. The new bill will differ from last year’s version in response to concerns from industry and consumer groups.

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New Bills

A number of new bills have been introduced. Click here to send a request for a copy of the text or more information about the bill.


S.604
Sen. Larry Craig (R-ID) introduced a bill to expand Medicare coverage of medical nutrition therapy services.

S.628
A bill proposed by Sen. Richard Lugar (R-IN) would increase planning and funding for Department of Health and Human Services health promotion programs. Additional funding is also provided for the Centers for Disease Control and the National Institutes of Health.

S.634
Sen. Saxby Chambliss (R-GA) offered legislation to allow payment terms for sales of agricultural commodities and products to Cuba.

S.641
Sens. Kay Bailey Hutchison, John Cornyn (R-TX) and Bill Frist (R-TN) offered a bill to award a congressional gold medal to Michael Ellis DeBakey, M.D.

S.658
Sen. Sam Brownback (R-KS) and 28 co-sponsors offered a bill to prohibit human cloning.

H.CON.RES.97
A resolution offered by Rep. Susan Davis (D-CA) would express the sense of the Congress that safe and effective radioprotectant drugs should be procured and stockpiled by the federal government as soon as possible.

H.R.1291
Rep. Darrell Issa (R-CA) introduced a bill to require the Secretaries of Health and Human Services, Defense, and Homeland Security to carry out activities toward bringing to market effective medical countermeasures to radiation from a nuclear or radiological attack.

H.R.1297
A bill offered by Rep. Dan Burton (R-IN) would amend the National Vaccine Injury Compensation Program.

H.R.1351
Rep. Earl Pomeroy (D-ND) offered a bill to encourage owners and operators of privately held farm, ranch, and forest land to voluntarily make their land available for access by the public.

H.R.1357
Rep. Dave Weldon (R-FL) and 103 co-sponsors offered a bill to prohibit human cloning.

H.R.1375
Rep. John Culberson (R-TX) offered a bill to award a congressional gold medal to Michael Ellis DeBakey, M.D.

H.R.1382
Rep. Jeff Flake (R-AZ) introduced legislation to provide for a one-year delay in the implementation of the voluntary prescription drug benefit program, and to provide for a one-year extension of the Medicare prescription drug discount card and transitional assistance program and of the coverage of prescription drugs under the Medicaid Program.

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