Alex Azar, Nominee for Secretary of HHS, Confirmed by Senate

Alex Azar, President Donald Trump’s nominee for secretary of Human and Health Services (HHS), was confirmed yesterday by the Senate.

As former president of the U.S. arm of Eli Lilly & Co., Azar’s nomination has been generally well-received by lawmakers, and his confirmation comes as no surprise. Having also served HHS as general counsel under the George W. Bush administration, he brings both executive branch experience and pharmaceutical company experience to the table. Azar is expected to tackle increasing drug prices.

Sen. Orrin Hatch (R-Utah) has expressed full confidence in Azar, stating, “Clearly, Mr. Azar has seen both the good and bad at HHS and knows how to manage them. I don’t think there is anyone here, even on the other side of the aisle, who would contest that.”

HHS Nominee Advanced by the Senate Finance Committee

Alex Azar, President Trump’s nominee for secretary of Human and Health Services (HHS), has been advanced by the Senate Finance Committee.

With a 15-12 vote, decided primarily by party affiliation, Azar was approved by the Committee last Wednesday afternoon. As former president of the U.S. arm of Eli Lilly & Co., Azar’s nomination has generally been well-received by lawmakers, and he is expected to be confirmed by the full Senate. Finance Chairman Orrin Hatch (R-Utah) said, “By any objective account, Mr. Azar is very well qualified for his important position.” If confirmed for the position, Azar has promised to tackle increasing drug prices, citing his ten years with Eli Lilly & Co. as evidence for his leadership on this front.

Though a final vote for the full Senate has not yet been scheduled, his confirmation is expected by the end of the month.

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.

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.

Page 2 of 912345...Last »