WASHINGTON — HHS Secretary Alex Azar defended the Trump administration’s FY 2020 budget proposal and responded to criticism over his role in the government’s family separation policy.
White House Proposes Budget Cut for NIH, Increase for FDA
The White House released a 2020 budget proposal Monday that included what one official called a historic number of budget cuts as well as an initiative aimed at ending the HIV epidemic.
The budget “will have more reductions in spending than any president in history ever proposed,” including a 5% overall cut in non-defense spending. He also outlined measures to lower drug prices, “everything from speeding generics to market to eliminating cost-sharing for generics. We also want to change the incentive structures in Medicare that lead to higher list prices … We also offer for the first time a real out-of-pocket cap for seniors so they can receive certainty that their out-of-pocket costs are over.”
The $4.7 trillion budget includes $1.29 trillion for the Department of Health and Human Services (HHS). Specific budget allocations — listed as “program level” allocations — include a 13% cut for the NIH to $34.4 billion; an 8% cut for the Health Resources and Services Administration (HRSA) to $10.7 billion and a 4% cut to the Centers for Medicare and Medicaid Services at $6.3 billion.
The budget proposal does however include $7.3 billion for the Indian Health Service (a 6% increase over last year) and $6.1 billion for the FDA (12% increase).
Dems Slam Medicaid Overhaul in FY 2020 HHS Budget Proposal
Health and Human Services (HHS) Secretary Alex Azar fielded sharp criticism from Democrats over the Trump administration’s fiscal year 2020 budget proposal during a House Energy & Commerce Health Subcommittee hearing on Tuesday.
“The Trump administration has taken a hatchet to every part of the healthcare system, undermining the Affordable Care Act, proposing a fundamental restructure of Medicaid, and slashing Medicare,” Chairwoman Anna Eshoo (D-Calif.) said in her opening remarks. “This budget proposes to continue that sabotage.”
Rep. Frank Pallone (D-N.J.), chairman of the full committee, said the “sham” of a budget proposal, along with efforts to restrict contraception access and squeeze Medicaid funding, amounted to a “devastating record for an agency whose mission is to advance the health and well-being of all Americans.”
NCI’s Sharpless Tapped as Acting FDA Chief
Norman E. “Ned” Sharpless, MD — currently the National Cancer Institute’s director — will serve as acting FDA commissioner after Scott Gottlieb, MD, leaves the post in early April, the Department of Health and Human Services announced.
Sharpless, a medical oncologist, became NCI director in October 2017. In his absence, Deputy NCI Director Doug Lowy, MD, will serve as acting director, the HHS announcement said.
One sidelight to the announcement was that tobacco stocks took a hit after Sharpless was named to the FDA job, according to Reuters. Gottlieb had promised increased restrictions on tobacco products and had already begun to deliver when he suddenly announced his resignation last week. Tobacco interests interpreted his departure as a positive for them and those with publicly traded stocks saw increases in the following days.
However, the appointment of an oncologist as Gottlieb’s replacement appears to have thrown cold water on investors’ hopes that the FDA would defer action on tobacco.
House Dems Press Azar on Family Separation Policy
Democrats grilled HHS Secretary Alex Azar regarding what he knew, and when, about the Trump Administration’s “zero tolerance” policy on family separations, during a House Appropriations Subcommittee on Labor, Health and Human Services, and Education hearing on Wednesday afternoon.
In her opening statement, Chairwoman Rep. Rosa DeLauro (D-Conn.) suggested that the separations at the U.S./Mexico border may have started roughly a year before the policy was publicly announced — as reported by the Office of the Inspector General in January — and that thousands more children may have been separated than previously realized.
“We have to understand how this happened, why it happened, who is responsible? Is it happening now? … How do we stop this?” DeLauro said.
During the hearing, DeLauro asked Azar when he “personally learned” that the Department of Homeland Security was implementing a policy of family separation.
PTAC Snubs Two Wound Care Payment Models
The Physician-focused Payment Model Technical Advisory Committee (PTAC), the group tasked by Congress with reviewing payment models, voted not to recommend two separate wound care models on Monday.
While these specific models may not be ready for “prime time,” Jeffrey Bailet, MD, PTAC chair, an otolaryngologist and executive vice president of Blue Shield of California, stressed that wound care models are indeed a priority.
“There’s a disconnect today between the way the payment is delivered and the care that’s needed and that’s a barrier to providing the care … So, what we know is there’s more work to do,” he said.
Bailet, and the full committee, urged stakeholders to collaborate on a more robust, comprehensive model for the committee to review.
FDA Allows For a New Generic Valsartan
The FDA approved a new generic for valsartan (Diovan) after a priority review, according to an agency announcement. This valsartan product is made by Alkem Laboratories Ltd.
Approval comes in the middle of a valsartan shortage stemming from multiple rounds of recalls of the angiotensin receptor blocker (ARB). Products were taken off the shelves starting last year in response to findings of potentially carcinogenic impurities, including N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), in numerous lots of generics.
“So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
“For this approval, the FDA evaluated the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the valsartan product approved today does not contain NDMA or NDEA,” the statement continued. “The FDA’s assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.”
Congress is on recess.
On Tuesday, The Brookings Institution will host a discussion with departing FDA Commissioner Scott Gottlieb, MD.
On Wednesday and Thursday, the FDA’s Blood Products Advisory Committee will make recommendations regarding “strategies to reduce the risk of Zika virus (ZIKV) transmission by blood and blood components.”
On Thursday, the FDA’s Neurological Devices Panel of the Medical Devices Advisory Committee will make recommendations related to clinical information related to the NeuroAD Therapy System intended for providing neurostimulation and cognitive training to treat mild to moderate Alzheimer’s dementia.
On Friday, the FDA’s Vaccines and Related Biological Products Advisory Committee will make recommendations regarding the H3N2 strain for use in the 2019-2020 seasonal influenza vaccines.