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US health chief defends Trump's budget; vows to lower drug prices, uphold ACA

Health and Human Services Secretary Alex Azar was peppered with questions over funding cuts in President Donald Trump's fiscal-year 2019 budget proposal at a House hearing. But the double-digit percentage reduction proposed for the Centers for Disease Control and Prevention, or CDC, that has alarmed the public health community was not raised by members of the House Ways and Means Committee.

If Trump gets his way, the CDC — which is in the midst of responding to one of the worst flu epidemics the U.S. has experienced, with record-high hospitalization rates — would lose about $1 billion.

The CDC's Public Health Preparedness and Response Program would see a 43% reduction in its funds under Trump's plan.

Former CDC Director Tom Frieden, who helped lead the Obama administration's response to the Ebola crisis in 2014 and 2015 and the Zika virus in 2016, has been sounding the alarm over the proposed cuts, declaring on Twitter that the last time the CDC's budget was as low as the Trump administration has proposed was 2003.

"This is not the way to protect Americans. It risks more cancer, more outbreaks, less safe Americans," Frieden said on Feb. 14 on CBS This Morning.

Praise for CDC acting chief

While Azar was not grilled at the Feb. 14 Ways and Means hearing over Trump's request to slash the CDC's budget, he did praise the current leader of the agency, Anne Schuchat. She is serving in an acting capacity as director for the second time in the past year after the sudden resignation on Jan. 31 of Brenda Fitzgerald over questions involving her financial conflicts of interest.

"I am just delighted that we have such an amazing career professional in Anne Schuchat, who is so respected globally in the world of infectious diseases and epidemiology," Azar said.

Azar said Trump has not yet identified a candidate to permanently run the CDC, but Schuchat has been viewed by the public health community as a popular choice.

Addressing high drug prices

Rep. Kevin Brady, R-Texas, the chairman of the Ways and Means Committee, said he was pleased to see Trump made reducing drug prices a top priority in his budget request.

"I believe the best path forward is to continue to emphasize competition, new innovations and individual choice rather than top-down mandates from Washington that interfere with the efficiency," Brady said.

Azar, a former president of Eli Lilly and Co.'s U.S. division, noted that among the Trump administration's initiatives to fulfill the president's promises on reducing drug prices was a proposal to move certain therapies currently covered under Medicare Part B — the government's program for seniors that pays for injectable medicines administered in an outpatient setting — into the Part D program, where the administration thinks pharmacy benefit managers could get a better bargain for beneficiaries.

He did not address Trump's promise to allow Medicare Part D to have the authority to negotiate drug prices directly with biopharmaceutical companies.

Rep. Lloyd Doggett, D-Texas, however, pressed Azar on the matter, reminding him Trump vowed in January 2017 that "new bidding procedures" would be used for Medicare and that he said drugmakers were "getting away with murder" — an accusation the president repeated in October 2017.

"Instead of addressing the murder, Trump in his budget proposes to reward the murderers," Doggett insisted, accusing Trump of trying to "put more money into the pockets of big pharma and cost taxpayers and Part D recipients more."

Spurring generic, biosimilars competition

Azar said the administration also plans to take a number of steps to increase competition in the biopharmaceutical marketplace by quickening the pace of generic drug approvals and ensuring there is a "robust" and "viable" market for biosimilars, which are intended to be lower-cost versions of biologics — large molecules derived from natural sources, such as microorganisms or plant or animal cells.

He noted the Food and Drug Administration approved 1,027 generic drugs in 2017, the highest number in the agency's history.

In a Feb. 13 statement, FDA Commissioner Scott Gottlieb said his agency wants to use some of the added funds it would get under Trump's budget request to create a new review platform that would significantly modernize the generic drug review process from a text-based to a data-based assessment with structured submissions and agency assessments.

"This more automated system would help to support timely development and review of generic drugs by improving clarity for generic sponsors, making initial reviews more efficient and decreasing the risk of refuse-to-file letters, increasing the rate of first-cycle approvals and greatly increasing overall efficiency," Gottlieb stated.

The investment would also support efforts to update generic drug labeling, with an initial focus on oncology products, as part of the agency's efforts to ensure patients and their providers have access to up-to-date information to inform clinical decisions, he said.

"If more generic drugs had up-to-date product labels reflecting the latest treatment information, it would encourage wider adoption of generic medicines," the FDA chief said.

Gottlieb had a wish list of other things he would like to do with the additional funding, including having the FDA's Oncology Center of Excellence stand up a new model for team-based product review that fosters collaboration across the agency's medical product centers.

He also wants to create centers of excellence for digital health and compounding facilities.

Cutting Medicaid but upholding ACA rules

During the Feb. 14 hearing, several Democratic members of Congress criticized Trump's proposed cuts to Medicaid; he administration's desire to end the expansion of the program under the Affordable Care Act, or ACA; and the Centers for Medicare and Medicaid Services' change in policy to permit states to test imposing work requirements on beneficiaries.

"This budget strikes fear in the hearts of those who rely on Medicaid," Rep. John Lewis, D-Ga., said.

"This budget seeks to dismantle the social safety net," he said. "That is not right, it is not fair and it's not just. Every person watching should understand that this budget is dangerous and unrealistic."

But Azar vowed to uphold the ACA's rules and would act against Idaho if it permits insurers to sell plans to consumers that fail to meet the 2010 law's requirements, so-called skimpy plans.

Blue Cross of Idaho on Feb. 14 said it planned to be the first to offer such plans, after the state's governor signed an order saying he would permit it.

But, Azar said, "There are rules and there's a rule of law that we need to enforce."