NABR Letter to Congress Opposing PUPPERS Act

Today, NABR sent a letter to the chairmen of the House and Senate Appropriations Committees in opposition to H.R. 3197, the “PUPPERS Act,” and a similar amendment offered by Rep. Dave Brat (R-VA) to the House-passed homeland security minibus. The legislation would effectively end studies with canine models at the U.S. Department of Veterans Affairs.

Earlier this month, 41 scientific and medical organizations and research universities sent a letter to Congress in opposition to these efforts.

NABR’s January Webinar Rescheduled

During NABR’s recent webinar, “Reducing Burden: Options and Opportunities,” we announced our annual review of USDA inspection data was scheduled for January 9, 2018. Since then, a scheduling conflict has occurred, so we are moving the webinar to February 6, 2018. Please mark your calendar for the new date and join us for “The 2017 USDA Inspection Data: Celebrating a New Milestone in Compliance?”

Each year, NABR obtains information from the USDA’s Animal Care Inspection System database to review the inspection results for the previous fiscal year. This year, that effort was complicated by lack of access to the searchable database which could be used to download data into spreadsheets for what would have been a relatively straightforward analysis of the actual inspection data. The new Public Search Tool provides data efficiently, but the data is difficult to analyze. Fortunately, with our analysis, we will provide you with valuable insight into the inspection process.

We invite you to join NABR on February 6, 2018 when we look at the data from FY 2017 as we compare it to analyses from previous years. Our findings will demonstrate how the research community continues to improve its compliance with the letter and spirit of the regulations. This information will help you manage your own animal care and use program in the coming fiscal year. Registration is complimentary for dues-paying NABR members and subscribers.

Over 40 Scientific, Medical Organizations Write to Congress Supporting VA’s Canine Research

The amount of opposition to proposals by Reps. Dave Brat (R-VA), Dina Titus (D-NV), and freshman Brian Mast (R-FL) to cease funding at the U.S. Department of Veterans Affairs (VA) continues to rise. Today, over 40 organizations in science and medicine wrote to Congress in a letter asking them not to end funding for critical research programs for our nation's veterans.

The letter sent to Appropriations Committee Chairmen Rep. Rodney Frelinghuysen (R-NJ) and Sen. Thad Cochran (R-MS) discusses the importance of dogs to scientific progress for humans and animals and encourages Congress not to pass further impediments on research for veterans at the VA. It echoes sentiments already expressed by veteran, military, veterinary, scientific, and medical organizations like the American Association for Laboratory Animal Science (AALAS), American Brain Coalition (ABC), American College of Laboratory Animal Medicine (ACLAM), Federation of American Societies for Experimental Biology (FASEB)The American Legion, American Physiological Society (APS), American Psychological Association (APA), American Veterinary Medical Association (AVMA), Association of the U.S. Navy (AUSN), Friends of VA (FOVA), Iraq & Afghanistan Veterans of America (IAVA), National Defense Committee, Paralyzed Veterans of America (PVA), Square Deal for Veterans, and the Vietnam Veterans of America (VVA). VA Secretary David Shulkin, MD even weighed-in about the issue back in September in a USA Today op-ed.

Currently Congress is considering H.R. 3197 (the PUPPERS Act) and a similar amendment to the House-passed homeland security “minibus,” which seek to end funding for VA studies involving canines.

To read the organizational letter to Congress, please click here.

BREAKING NEWS: President Nominates Next HHS Secretary

Today President Donald Trump (R) nominated Alex Azar to fill the vacancy left by Tom Price as Department of Health and Human Services (HHS) secretary. "He will be a star for better healthcare and lower drug prices," the President announced via Twitter this morning.

Azar, who served as general counsel and then deputy secretary at the HHS under former President George W. Bush, left the pharmaceutical industry in January after almost a decade. Azar, the former president of the U.S. arm of Eli Lilly in Indianapolis, is familiar with the regulatory process and according to former Secretary Mike Leavitt, “understands the process and he knows the levers and how you make it work and where the potential roadblocks are.” He is a pragmatic and highly competent leader, according to POLITICO. Even though he has strong ties to Vice President Mike Pence, Domestic Policy Council Director Andrew Bremberg and HHS acting Secretary Eric Hargan, Azar is described as low-key, a vast difference from President Trump and his replacement at HHS, Price.

The nomination comes at a crucial juncture for the agency as it faces many questions about drug approval, pricing, importation, and the hotly contested debate over Obamacare.

The Hill reports that the nomination process will not be easy for Azar with Democrats in the Senate. He is likely to face tough questions and opposition about his former post as a pharmaceutical executive and drug pricing.

To read more on this breaking story, click here. Please also visit CNBC and POLITICO as news breaks.

AETA Upheld in Appellate Case of Animal Rights Activist Who Released Minks

Wednesday marked the first time a Federal Circuit Court of Appeals has upheld a conviction under the Animal Enterprise Terrorism Act (AETA), which was signed into law in 2006. In a 23-page opinion, the Seventh Circuit found the AETA constitutional, ruling against the claims of animal rights activist Kevin Johnson who trespassed with Tyler Lang onto the property of an Illinois farm in 2013 and set 2,000 minks and foxes loose, causing up to $200,000 of physical damage in addition to the cost of the animals and profits.

The AETA is a critical tool for law enforcement as it is the only federal law specifically designed to protect individuals involved in research from threats, acts of vandalism, property damage, criminal trespass, harassment and intimidation that place them in reasonable fear of death or serious bodily injury. Since its enactment in 2006, the frequency and severity of illegal actions in the U.S. has decreased significantly.

This appellate case arose after Johnson entered a conditional guilty plea and was sentenced to 36 months in prison, but turned to the courts to challenge the AETA arguing that he was being unfairly targeted as an animal rights activist. His challenge was overruled by District Court Judge Amy J. St. Eve in 2015 and the Seventh Circuit came to the same conclusion earlier this week.

The Seventh Circuit Court, in a decision authored by Judge Anne Claire Williams, rejected Johnson’s claim of unfair prosecution stating that “While it may be true that the people most often prosecuted under AETA are animal rights activists, this does not mean the law is vague and is being enforced in a discriminatory manner. Instead, it may simply mean that animal rights activists are the persons who are most often violating the law.”

The Court was also unconvinced by Johnson’s claims that the use of the term “terrorism” in the title of the law was “utterly unreasonable” finding that “Given the serious harms the statute was trying to address, including arson, bombing, and death threats, it was in no way arbitrary or unreasonable for Congress to include the word ‘terrorism’ in the non-codified title of AETA.” In addition, the opinion noted that “It is beyond question that Defendants' conduct of releasing 2,000 minks, destroying their breeding cards, spraying a caustic substance on farm equipment and spray painting ‘Liberation is Love’ on the barn of the mink farm ‘falls squarely in the core of what is prohibited by’ AETA.”

This decision is the latest in a string of legal challenges to the AETA that have been rejected by the Federal Appeals Courts. To read the full story, click here. For more information about NABR’s role in the passage of the AETA and the protections it provides to the biomedical research community, click here.

Yesterday’s Presentation of “Reducing Burden: Options and Opportunities” Now Available for On-Demand Viewing

Did you miss yesterday’s NABR webinar, “Reducing Burden: Options and Opportunities?" Do you want to watch it again? You’re in luck! It has been posted in the Members Only section of our website for on-demand viewing.

Please click here to view "Reducing Burden: Options and Opportunities."  You will need your NABR members-only log-in credentials to watch the presentation.

If you have problems logging-in, please contact us at info@nabr.org.

American Brain Coalition (ABC) Writes to FDA About Importance of Primate Research

The American Brain Coalition (ABC) has sent a letter to U.S. Food & Drug Administration (FDA) Commissioner Scott Gottlieb, MD about the importance of primate research and concerns about the FDA’s decision to halt primate nicotine studies. The studies could potentially increase researchers’ understanding of nicotine addiction in adolescents. FDA announced the studies would be halted until an investigation is conducted, shortly after receiving a letter from Jane Goodall, PhD, about her presumed concerns about the welfare of the animals and doubts about the necessity of the research.

ABC’s letter reiterates the importance of animal research in helping to understand and treat the 50 million Americans affected by neurological and psychiatric conditions. The letter expresses concern that Goodall may have inaccurately described the care the animals received, and also argues that she does not address why she thinks primates are an improper model for the research. The letter reads, “Dr. Goodall paints an overly broad and quite distorted picture of the legal use of animals in research. ABC hopes that the FDA will take the necessary steps to reject false representations of the use of animals in neuroscience research and confirms its support of life-saving research and the advancement of scientific knowledge.”

ABC's full letter is available here.

Congress Holds Hearing on Funding for Indirect Costs

Last Tuesday, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing titled, "The Role of Facilities and Administrative Costs in Supporting NIH-Funded Research." The hearing served as another forum for lawmakers to discuss the Administration’s budget proposal to cut indirect costs at National Institutes of Health (NIH) funded institutions from 30 percent to 10 percent.

Although there were no mentions of animal research, the hearing caused a stir by lawmakers on both sides of the aisle. Subcommittee chairman Rep. Tom Cole (R-OK) said, “I just want to make sure as we go forward that we don’t throw out the baby with the bathwater, looking for savings and disrupting what’s really a pretty complex, now 70-year-old ecosystem that has produced extraordinary benefits for the American people.”

According to an update by Congressional Quarterly (CQ), witness Keith Yamamoto, vice chancellor for science policy and strategy at the University of California, San Francisco (UCSF), expressed concern about cutting funding for indirect costs. He said at the hearing: “I spend all my time kind of chasing down regulatory compliance reports. That really is the biggest problem. Not only is it very wasteful of resources, but it really changes the way, the time and energy one can put into thinking about science.”

The full hearing and witness list is available on the subcommittee’s website.

AAMC, FASEB, COGR, and NABR Announce Groundbreaking New Report on Regulatory Burden

The 21st Century Cures Act instructs the National Institutes of Health (NIH) Director to work with the Food & Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) to identify ways the government can reduce regulatory burden on researchers. A new set of recommendations introduced today proposes changes to federal regulations, policies, and guidelines governing the use of animals in research. Directed to federal agencies involved in the oversight of federally funded animal research – primarily the NIH and the USDA – the recommendations aim to address the numerous conflicting, outdated, or ineffective regulations that do not improve animal welfare. The proposed changes would ensure that standards of care in animal research are maintained and would have the practical effect of promoting efficiency among researchers.

Today's report grew out of an April 2017 workshop convened by the Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), and the National Association of Biomedical Research (NABR). The workshop participants sought to identify federal requirements that demand significant administrative effort but do not enhance animal welfare.

There have been numerous reports dating back nearly two decades that highlight the negative impact overly burdensome regulations have on biomedical research in the United States, and federal research dollars are being stretched more each day.

“The U.S. has long been a world leader in biomedical research and development. If we wish to remain competitive in a global research landscape, we must find ways to decrease burden on investigators,” said NABR President Matthew R. Bailey. “Scientists and the teams who support them shouldn't be spending nearly half their time filling out paperwork or attempting to comply with multiple requirements that each aim to accomplish the same goal in different ways. These recommendations examine ways in which efficiencies can be realized while maintaining the highest standards for animal welfare.”

The use of animals in research continues to be vital to understanding human and animal disease, and researchers take their commitment to the humane care and use of research animals seriously. The sponsoring organizations hope this report will aid federal agencies and Congress in reducing the significant inefficiencies in the animal research oversight process

American Psychological Association (APA) Urges Congress to Oppose Efforts to End VA’s Canine Studies

Earlier today the American Psychological Association (APA) sent a letter to Congress opposing the efforts of Reps. Dave Brat (R-VA), Dina Titus (D-NV), and Brian Mast (R-FL) to cease funding for studies with dogs at the Department of Veterans Affairs (VA).

The letter, signed by Dr. Howard Kurtzman, Acting Director for Science, lauds the importance of animal research. It discusses the importance of animal research to humans and animals and also notes, for over 100 years, how APA has been dedicated towards the caretaking of animals.

H.R. 3197 (the PUPPERS Act) and a similar amendment to the House-passed homeland security “minibus” seek to end funding for VA studies involving canines. Thus far the following are against the propositions by Reps. Brat, Titus, and Mast:

American Association for Laboratory Animal Science (AALAS)
American Brain Coalition (ABC)
American College of Laboratory Animal Medicine (ACLAM)
The American Legion
American Physiological Society (APS)
American Psychological Association (APA)
American Veterinary Medical Association (AVMA)
Association of the U.S. Navy (AUSN)
Friends of VA (FOVA)
Iraq & Afghanistan Veterans of America (IAVA)
National Defense Committee
Paralyzed Veterans of America (PVA)
Square Deal for Veterans
VA Secretary David Shulkin, MD
Vietnam Veterans of America (VVA)

Stay tuned to NABR’s website as more develops on this issue.

Please click on the hyperlinks above to read the opposition statements from veteran, military, veterinary, scientific, and medical organizations.

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