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.

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.

American Veterinary Medical Association (AVMA): Animal Research is “Key to Improving Animal Health and Welfare”

Just a couple of days ago, the American Veterinary Medical Association (AVMA), which represents over 89,000 veterinarians, reached out to key policymakers sounding-off on the essential need for animals in biomedical research.

To set the record straight on the importance of animals to save lives, improve lives, and decrease suffering for both humans and animals, the AVMA sent letters to the Director of the National Institutes of Health (NIH), the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP), the Secretary of the U.S. Department of Health and Human Services (HHS), and the House Energy & Commerce Committee.

AVMA’s news release notes, “The AVMA will continue to work with lawmakers to educate them on the importance of biomedical research, including biomedical research that requires the use of animal models.”

To read AVMA’s full release, please click here. AVMA’s policy on the use of animals in research can also be found on their website.

More Veterans, Science Groups Tell Congress: Don’t End Funding for VA’s Research with Canines

More veterans organizations as well as medical and scientific groups have stated their opposition against proposals by Reps. Dave Brat (R-VA), Brian Mast (R-FL) and Dina Titus (D-NV) to cease funding for important medical research studies involving canines at the U.S. Department of Veterans Affairs (VA).

The Iraq & Afghanistan Veterans of America (IAVA), Vietnam Veterans of America (VVA), Association of the U.S. Navy (AUSN), National Defense Committee, Square Deal for VeteransAmerican Brain Coalition (ABC) and the American Association for Laboratory Animal Science (AALAS) have shared letters of opposition to H.R. 3197 (the PUPPERS Act) and a similar amendment to the House-passed homeland security minibus.

So far, those now against these proposals include:

American Association for Laboratory Animal Science (AALAS)
American Brain Coalition (ABC)
The American Legion
American Physiological Society (APS)
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)

Dogs are rarely used in research but sometimes they are the best model for specific studies because of factors like physiological similarities. All research, including research with dogs, is covered by strict oversight at institutions and by the federal government, and animal welfare is a top priority.

Research with dogs has been and continues to be influential in developing new drugs, therapies, and treatments for humans and animals. Of the top 25 most prescribed medications, 22 were developed with research involving dogs; and canines are on the front lines of everything from cardiology, cancer, diabetes, late-stage eye disease and spina bifida research.

To read the letters of oppositions from the organizations above, please click on the hyperlinks.

Registration Now Open for NABR’s Next Webinar!

Are administrative and regulatory burden affecting your institution? Join NABR and special guest Dr. Sally Thompson-Iritani, Director of the Office of Animal Welfare at the University of Washington, on November 7, 2017 for an exclusive webinar, "Reducing Burden: Options and Opportunities." Members of your Animal Care and Use Program (ACUP) are encouraged to attend.

Dr. Thompson-Iritani has played a key role in the development of a program called Compliance Unit Standard Procedure (CUSP). The goal of this project is to create a repository where participating institutions can share standard substances and procedures to be used in animal care and use protocols with the broader animal welfare compliance community. To date, the participating institutions have developed almost 1,000 standard substances and 700 standard procedures that will populate the site as a starting database. Having access to the database offers all those involved with the preparation and review of proposed activities involving animal research a valuable resource which can be used to reduce the administrative burden on investigators and members of the Institutional Animal Care and Use Committee (IACUC) and IACUC support staff.

During the webinar we will also review the opportunities provided by the language in the 21st Century Cures Act and the U.S. Department of Agriculture's (USDA) request to Identify Regulatory Reform Initiatives to address the issue of regulatory and administrative burden at your institution.

Registration is now open for this exclusive, NABR members-only opportunity.

Friends of VA Publicly Opposes Defunding VA Dog Studies

On Friday, Friends of VA Medical Care and Health Research (FOVA) sent a letter to Representatives Rodney Frelinghuysen (R-NJ) and Nita Lowey (D-NY), the Chair and Ranking Member of the House Committee on Appropriations, opposing an amendment passed in the homeland security minibus that would prohibit funding at the Department of Veterans Affairs (VA) for certain studies involving dogs.

FOVA is a coalition of more than 80 national academic, medical, and scientific societies, voluntary health and patient advocacy groups, and veteran service organizations dedicated to providing veterans with high-quality care. FOVA believes “The policy included in the appropriations bill will impede scientific research and unnecessarily delay research advances for our nation’s veterans.”

The amendment to the minibus was introduced by Rep. Dave Brat (R-VA) and passed by the House of Representatives in July. It contains similar language as House standalone bill H.R. 3197, the PUPPERS Act, which would prevent Class D and E studies from being performed at the VA, a move that could set the precedent for a prohibition against the use of dogs in all biomedical research. The legislation is troubling, as it could represent the first time Congress has prohibited the use of an animal species in scientific/medical studies, and it could lead to future laws that target additional species of research animals. The studies performed by the VA involving dogs are critically important in the search for treatments for diseases that impact the veterans’ community and civilians, and are strictly regulated.

As mentioned above, there are two pieces of House legislation that, if signed into law, would limit the use of dogs at the VA. The first piece of legislation is Brat's amendment to the homeland security minibus, a spending bill that would need to be reauthorized each year. The second piece of legislation is a standalone bill that would serve as a more permanent prohibition of certain dog studies at the VA. Although the House amendment to the homeland security minibus was passed in July, the House standalone bill has not yet been considered by the Veterans' Affairs Committee. A Senate standalone companion bill has not been introduced either. Congress is currently in recess until after Labor Day.

Stars and Stripes, a publication widely read by the military community, published a story yesterday about FOVA’s letter. The publication touts a readership of more than one million per day, including “active-duty service members, DoD civilians, contractors, and their families.”

To read FOVA’s letter, please click here. We encourage you to share the letter as well as the Stars and Stripes’ article on your social media pages to help educate the public and policy makers about this harmful legislation.

USDA Asks for Input on AWA Licensing Requirements

This morning the U.S. Department of Agriculture (USDA) published in the Federal Register an advanced notice of proposed rulemaking and request for public comments regarding procedures for applying for licenses and renewals at the department’s Animal and Plant Health Inspection Service (APHIS). The notice in the Federal Register states, “We are soliciting public comment on potential revisions to the licensing requirements under our Animal Welfare Act (AWA) regulations to promote compliance with the Act, reduce licensing fees, and strengthen existing safeguards that prevent any individual whose license has been suspended or revoked, or who has a history of noncompliance, from obtaining a license or working with regulated animals. We are soliciting public comment on these topics to help us consider ways to reduce regulatory burden and more efficiently ensure the sustained compliance of licensees with the Act.”

The notice outlines several changes regarding licensing requirements that are under consideration by the USDA, such as eliminating license application fees and annual license fees, requiring applicants to disclose animal cruelty violations, and specifying procedures so licensees have time to apply for licenses.

The USDA invites the public to provide data and information regarding potential economic effects, alternatives to reduce regulatory burden, and suggestions to ensure the compliance of licensees with the AWA.

Additionally, the USDA’s notice calls for comments on four questions, which are excerpted below in full:

  1. Should we propose to establish a firm expiration date for licenses (such as 3-5 years) and if so, what should that date be and why? Please provide supporting data.
  2. What fees would be reasonable to assess for licenses issued? Are the existing license fees (9 CFR 2.6) reasonable, or should they be adjusted to take additional factors into consideration, such as the type of animals used in regulated activities? Please provide data in support of any proposed adjustments to the license fees.
  3. In addition to the existing prohibitions on any person whose license has been suspended or revoked from buying, selling, transporting, exhibiting, or delivering for transportation animals during the period of suspension or revocation (9 CFR 2.10(c)), should such persons be prohibited from engaging in other activities involving animals regulated under the AWA, such as working for other AWA-regulated entities or using other individual names or business entities to apply for a license? Please suggest specific activities that should be covered and provide supporting data and information.
  4. Do you have any other specific concerns or recommendations for reducing regulatory burdens involving the licensing process or otherwise improving the licensing requirements under the AWA?

The announcement of this notice coincides with the 51st anniversary of the AWA. Public comments may be submitted online or in writing through October 23, 2017. Comments will be available for public viewing after submission. NABR plans to submit comments and we encourage your institution to do so as well.