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.

Spending Bills Approved and Advanced on Capitol Hill

Late last week the Senate Appropriations Committee approved a $20.5 billion agriculture spending bill. The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act will fund programs at the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) for FY2018. The bill includes a $4.8 billion increase to the amount proposed in President Donald Trump’s budget blueprint, but $7.9 billion less than the previous year’s funding level. Of interest to the animal research community is the allocation of $953.2 million for the USDA Animal and Plant Health Inspection Service (APHIS), the agency that regulates and inspects animal research laboratories. This is $143.2 million above Trump’s budget request for APHIS and $7 million above the funding level for FY2017. The bill was approved by the Senate Agriculture Appropriations Committee on Tuesday.

Also last week the House Appropriations Committee passed a $156 billion Labor-HHS-Education spending bill for FY 2018. The Labor, Health and Human Services, Education, and Related Agencies Bill contains $21.6 billion more than the amount proposed by Trump and $34.7 billion more than the funding level for FY2018. The spending bill contains $35.2 billion for the NIH ($8.6 billion increase to the Trump’s budget proposal and $1.1 billion increase to FY 2017 allocation) and was approved by the subcommittee on July 13. The bill contains language that directs the NIH to develop a plan to speed up the process of transferring retired research chimpanzees to retirement sanctuaries.

Please stay tuned for more important updates from NABR during the Appropriations process.

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.

NABR Submits Comments to FDA on GLP Proposed Rule

Last August, the Food and Drug Administration (FDA) published a proposed rule the in the Federal Register (Vol. 81, No. 164) titled, “Good Laboratory Practice for Nonclinical Laboratory Studies” [Docket No. FDA–2010–N–0548]. FDA has proposed amending the current regulations to require a complete quality system approach which they refer to as a GLP Quality System.

The proposed system would be required for safety and toxicity studies to support applications or submissions to the FDA. Proposed changes that would impact animal research facilities include additional management responsibilities, changes to SOP procedures and changes to address the management of multisite nonclinical laboratory studies.

NABR submitted comments to the FDA this afternoon, expressing concern that creating additional rules would be redundant with existing regulations and confusing for researchers, as research facilities are already governed by numerous other animal welfare requirements. A copy of our comments can be found here and NABR members are encouraged to use them as a basis for filing their own at regulations.gov. Comments must be submitted by January 21, 2017.

BREAKING NEWS: Senate Confirms Robert Califf as New FDA Commissioner

Just moments ago, the U.S. Senate voted to confirm Dr. Robert Califf’s nomination to serve as the new commissioner of the Food & Drug Administration (FDA).  Dr. Califf is replacing Dr. Stephen Ostroff who served as acting commissioner since Dr. Margaret Hamburg stepped down in March of 2015.  Dr. Califf was nominated by President Barack Obama for the post and a nomination hearing was held by the Senate Health, Education, Labor & Pensions (HELP) Committee on November 17.

Dr. Califf is a cardiologist and clinical trial expert from Duke University and his nomination was supported by medical groups like the American Academy of Pediatrics and the American Cancer Society Cancer Action Network.

Dr. Califf was confirmed by an 89-4 vote.  To read more about Dr. Califf's confirmation, please see this report in The Washington Post.

FDA Commissioner Leaving Agency in March

After almost six years leading the Food and Drug Administration, Commissioner Margaret A. Hamburg announced that she will be leaving the post in March, leaving behind a legacy of improving food safety and speeding-up drug approvals.  Dr. Stephen Ostroff, FDA’s chief scientist, is expected to be her temporary replacement.

Hamburg said in an interview that she is leaving the FDA because “this is a difficult and demanding job where you’re buffeted by all sorts of points of view.”  Several controversial issues were tackled by FDA during her tenure such as the approval of Plan B morning-after contraceptives for teens and tackling compounding pharmacies.

Please continue to visit www.NABR.org for more updates.