NIH Official Educates PETA About the Applicability of Animal Research

Under the Freedom of Information Act (FOIA), NABR has obtained a response from the National Institutes of Health (NIH) to PETA regarding their recent letter which alleges the use of animals in federally-funded research is “misleading.”

PETA’s letter, dated April 5, expressed concern about applicability of animal research to humans and stated that “the U.S. Food and Drug Administration reports a 92 percent failure rate of clinical trials for new pharmaceutical drugs following preclinical success in animals.” The letter also referenced a recent PETA report that claims to highlight ways to reduce the federal budget by slashing animal research funding.

In the NIH’s response to PETA, Michael Lauer, M.D., Deputy Director for Extramural Research at the NIH, declared the importance of research with animals and explained that numerous medical advancements have resulted from research with animals including vaccines, blood transfusions, treatments for breast cancer and epilepsy, in vitro fertilization, organ transplants, and more.

Lauer specifically stated that “research using animal models continues to make significant contributions to human and animal health. Although research based on animal models needs to improve and has limitations, it is not justification for eliminating powerful tools that have arguably saved millions of Americans…In our view there is no consensus that animal models should be eliminated—rather, we want to build on prior successes and learn from prior failures.”

NIH’s response to PETA also described the strict federal and institutional regulations in place to ensure that animals are used only when necessary and that the well-being of animals is maximized.

Click here to read PETA’s letter and report. Click here to read NIH’s response.

$2 Billion Increase for NIH in Omnibus Spending Bill

House and Senate leadership reached an agreement around 2:00 A.M. Monday morning on a spending bill that would fund the federal government for the remainder of FY 2017, which ends September 30, 2017. The spending bill contains an increase of $2 billion for the National Institutes of Health (NIH), which is 6.2 percent above the funding level provided in FY 2016. In total, the U.S. Department of Health and Human Services (HHS) would receive $2.8 billion more in funding than the amount that was allocated for FY 2016.

Also in the spending bill is $153.4 billion for programs at the U.S. Department of Agriculture and U.S. Food and Drug Administration, a $12.8 increase from FY 2016 levels.

Of interest to the animal research community is a provision that would prohibit any federal funds from being used to carry out activities related to the issuance or renewal of licenses under the USDA’s Animal Welfare Act to Class B dealers who sell dogs and cats for research, experiments, teaching or testing. The provision repeats a similar provision included in spending bills last year. The prohibition on funding does not apply to all Class B license activities.

Senate Labor-HHS-Education Appropriations Chairman Roy Blunt (R-MO) praised the omnibus spending bill and lauded the importance of funding medical research by stating in a press release: “The funding provided in this bill reflects the priorities of the American people, and puts us on track to maintain a robust, sustained federal commitment to medical research. I urge my colleagues to support this bipartisan bill, and I’ll continue working to ensure NIH has the resources it needs to give hope to more families battling cancer, Alzheimer’s disease, and other chronic diseases.”

The agreement comes just a few days after legislators scrambled to avoid a government shutdown. Funding for FY 2016 expired in December, and the continuing resolution that was keeping the government operating throughout the past several months expired on Friday, April 28. To prevent a shutdown, Congress approved a one week extension, which expires this Friday, May 5 at midnight. The deal reached last night by House and Senate leadership has been reported as a bipartisan agreement.

The spending bill is expected to pass both the House and Senate before Friday’s midnight deadline. To read the full 1665-page text of the bill, click here. Stay tuned for more Updates from NABR about the spending bill and NIH funding.

FDA Commissioner Nomination Moves through Senate HELP Committee

The nomination of Scott Gottlieb, President Donald Trump’s pick to head the U.S. Food and Drug Administration (FDA), was voted out of the Senate Health, Labor, Education and Pensions (HELP) Committee yesterday morning by a vote of 14-9. The vote was scheduled to occur on Wednesday morning but it was postponed for 24 hours due to Senator Patty Murray (D-WA) and other committee Democrats expressing concern over Gottlieb’s financial holdings.

Gottlieb is a physician and managing director of T.R. Winston & Co., a Los Angeles-based bank focused on healthcare. He is also a clinical assistant professor at New York University’s School of Medicine, a resident fellow at the American Enterprise Institute, and is on the product investment board of GlaxoSmithKline. Gottlieb served as FDA’s deputy commissioner for medical and scientific affairs under President George W. Bush.

As NABR reported earlier this month, Gottlieb was vetted by the Senate HELP Committee on April 5. Gottlieb’s nomination now advances to the full Senate for confirmation but a date for that vote has not yet been scheduled.

Government Shutdown Unlikely Due to Short Term Extension

Congress must approve a spending bill or short-term extension by today, Friday, April 28, at midnight or the current stopgap spending bill will expire and the government will be forced to shut down. Previously there was a holdup amongst Democrats on the spending bill because President Donald Trump wanted to include funding for the construction of a wall on the United States-Mexico border. However, Trump has now stated that he will approve a spending bill without this language and that funding for the wall is an issue that will be revisited at a later date.

Republicans, who have a majority in both the House and the Senate, have maintained that a government shutdown is unlikely. According to NPR, the heads of the House and Senate Appropriations Committees have endorsed the idea of passing a short-term spending bill that would extend government funding until May 5 and give policymakers more time for negotiations.

As of this afternoon, Democrats are threatening to oppose the one week extension bill if Congress passes a healthcare bill before the weekend. If the short term spending bill passes tomorrow, Congress will need to vote on another spending bill or extension by May 5 to once again avoid a government shutdown.

BREAKING NEWS: Governor Sonny Perdue Confirmed as Agriculture Secretary

This afternoon Governor Sonny Perdue was confirmed by the Senate to be U.S. Secretary of Agriculture by a vote of 87-11-1. Prior to the full Senate’s vote, Perdue was vetted by the Senate Agriculture Committee on March 30. His confirmation passed through the committee with only Senator Kirsten Gillibrand voting no. Perdue has been a relatively uncontroversial Cabinet pick with Republicans and Democrats being on board with his confirmation.

As Agriculture Secretary, Perdue will head a department that oversees a broad area of programs from crop insurance to nutrition, forestry, rural development, and international trade. The U.S. Department of Agriculture (USDA) also houses the Animal and Plant Health Inspection Service (APHIS) which is responsible for enforcing the Animal Welfare Act (AWA), the federal law that oversees the humane use of animals in biomedical research programs.

Perdue is a veterinarian by training, the owner of several small agribusinesses and he was also the governor of Georgia from 2003-2011. Perdue has previously stated that reducing regulatory burden will be one of his goals at the helm of the USDA. Please continue to check your email, follow us on Twitter, or visit NABR.org for the latest news coverage on Secretary Perdue’s confirmation.

White House Calls for $1.2 Billion Elimination from NIH Grants

The White House has announced that President Donald Trump is calling for $1.232 billion in funding cuts from National Institutes of Health (NIH) grant programs. As reported in last week’s NABR Update, the President released his budget proposal for funding the federal government on March 16. To offset a major increase in defense and border security funds, Trump has identified ways to decrease nondefense discretionary spending in FY 17. Included in this supplementary proposal are $1.182 billion in reductions to NIH research grants and $50 million in the elimination of Institutional Development Award (IDeA) grants for FY 17.

Trump’s proposed cuts would undermine the FY 17 spending bill that the Senate Appropriations Committee approved last summer, which included $34.1 billion in funding for the NIH.

Several Members of Congress are not optimistic about these cuts occurring, as the fiscal year has already begun. Representative Tom Cole (R-OK), chairman of the House Appropriations Labor-HHS-Education Subcommittee, told CQ, “It's a little late in the process. We've closed out our bills.”

The government is currently operating on a continuing resolution set to expire on April 28, 2017. To avoid a government shutdown, Congress must approve a budget bill before this date.

18% Cut to NIH, 21% Cut to USDA in President’s Proposed Budget; Regulatory Reform Major Focus

President Donald Trump (R) released his FY 2018 federal budget this morning, and included in the proposal is an almost 20% decrease in federal funding for the National Institutes of Health (NIH). Spending for NIH would decrease from the currently appropriated $31.7 billion to $25.9 billion. The budget states that “major reorganization” and structural changes would occur within the NIH to ensure that resources are refocused on high priority research and training. The President also aims to reduce regulatory burden throughout various federal government agencies, including the NIH, in which administrative costs would be reduced and federal contributions to research funding would be rebalanced. The budget states very clearly that the President plans to remove unnecessary and costly regulations, although it is not yet clear which regulations pertaining to biomedical research would be affected. At this afternoon's White House Press Briefing, Press Secretary Sean Spicer stated that the NIH must "focus on efficiencies and doing what we do better." To accomplish this, he used combining facilities as an example.

“America First - A Budget Blueprint to Make America Great Again,” would reduce funding to the U.S. Department of Health and Human Services (HHS) from $84.1 billion to $69 billion, based on the President’s plan to ‘eliminate programs that are duplicative or have limited impact on public health and well-being.” Plans for HHS funding call for reforming public health programs and reforming the Centers of Disease Control and Prevention (CDC) via block grant programs that would give states more power in addressing statewide public health challenges. Additionally, the proposal would make adjustments to the Food and Drug Administration (FDA) initiatives, and includes “a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products.”

Funding for the U.S. Department of Agriculture would be reduced by 21 percent, from $22.6 billion to $17.9 billion. The budget would also make major funding cuts in other federal agencies including the U.S. Department of State, Department of Housing and Urban Development and the Environmental Protection Agency. Trump’s primary goal for the FY 2018 budget is to increase federal defense spending by $54 billion, with targeted reductions in other agencies to offset this cost.

The federal government is currently operating on a Continuing Resolution (CR) that is set to expire on April 28, 2017.

Next, the budget proposal will be sent to the Hill, where the House and Senate Appropriations Committees will review it thoroughly. Click here to read the President’s budget blueprint.

BREAKING: Some USDA Documents Back Online

The U.S. Department of Agriculture (USDA) has reported that some of the enforcement actions documents from the Animal Care Information Service (ACIS) have been reposted to the agency’s website.

As NABR reported, on February 3 USDA’s Animal and Plant Health Inspection Service (APHIS) removed from its website “inspection reports, regulatory correspondence, research facility annual reports, and enforcement records that have not received final adjudication.” Several animal rights groups, including People for the Ethical Treatment of Animals (PETA), the Beagle Freedom Project (BFP), Physicians Committee for Responsible Medicine (PCRM), Born Free USA, Massachusetts Society for the Prevention of Cruelty to Animals, and an Animal Law & Policy Fellow at Harvard Law School filed a lawsuit against the department demanding that the database be restored. The Humane Society of the United States (HSUS) was preparing to file a lawsuit. Just this week, 101 members of the House of Representatives wrote to President Donald Trump (R) expressing concerns with the removal of the database requesting that it be reinstated.

To read USDA’s statement regarding the restoration of the database, please click here.

New Federal Legislation Would Require Broad Reporting of Animal Use Data

Representative Ken Calvert (R-CA) has introduced H.R. 816, the Federal Accountability in Chemical Testing (FACT) Act. The bill would amend the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Authorization Act of 2000 and would add a requirement that federal agencies must “include a description of the progress on the development, validation, acceptance, and utilization of alternative test methods (including animal use data by species, number, and test type) for toxicological testing conducted, supported, or required.” In short, Calvert’s bill would require the addition of animal census information for all research species (including rodents) to be included in the biannual ICCVAM report. The legislation would appear to represent an additional reporting requirement for federal agencies. Agencies affected include: USDA, DOD, DOE, Department of Interior, DOT, EPA, FDA, NIH, OSHA and the Agency for Toxic Substances and Disease Registry. The impact of this legislation likely extends beyond federal agencies, as a number of them require animal testing to be conducted outside the agency.

The introduction of the bill was stirred by the White Coat Waste Project (WCW), an animal activist organization that aims to end the use of animals in federally funded research. WCW is engaging with Republican members of Congress by claiming taxpayers could save money by eliminating animal research at the federal level. According to WCW’s website, its approach is to “drain the swamp: cut government spending that hurts animals and taxpayers.”

At the time of this writing, the bill has acquired 13 cosponsors: Representatives Ed Royce (R-CA), Vern Buchanan (R-FL), Mike Bishop (R-MI), Dina Titus (D-NV), Betty McCollum (D-MN), Tom Marino (R-PA), Lucille Roybal-Allard (D-CA), Raul Grijalva (D-AZ), Earl Blumenauer (D-OR), Peter DeFazio (D-OR), Mike Quigley (D-IL), Eliot Engel (D-NY) and Julia Brownley (D-CA). The bill has been referred to the House Energy and Commerce Committee and will remain alive until the end of the legislative session in December of 2018. For the full bill text, click here.

HHS Secretary Confirmed by Senate Earlier Today

The U.S. Senate has confirmed Representative Tom Price (R-GA) to be U.S. Secretary of Health and Human Services. Despite efforts by Democrats to delay his confirmation process, he was confirmed early Friday morning by a vote of 52-47.

Sonny Perdue, President Trump’s nomination for U.S. Secretary of Agriculture, will soon be vetted by the Senate Agriculture Committee, although a date for the hearing is yet to be determined. Perdue, a small business owner and veterinarian by training, would oversee a federal department that implements a broad range of programs including USDA’s enforcement of the Animal Welfare Act.

Watch your inbox, visit www.NABR.org, or follow us on Twitter for updates from NABR about Perdue’s confirmation process.

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