Good morning. I’m Phil Galewitz, a senior correspondent at KFF Health News who has written about Canadian drug importation for two decades and just booked a summer trip to the Canadian Rockies. Send any tips and your experience buying drugs from Canada to pgalewitz@kff.org. Not a subscriber? Sign up here.

Today’s edition: The federal government is offering emergency funding to providers affected by the Change Healthcare hack. President Biden’s reelection team is seeking to capitalize on momentum from his State of the Union address with a new advertising blitz. But first …

The FDA has rebuffed Colorado’s appeals for help with its drug importation plan

Colorado hopes to join Florida to become only the second state authorized to import prescription drugs from Canada. But they’re hitting the same hurdles: drugmakers — and the FDA.

Colorado officials recently amended their 2022 importation application with the Food and Drug Administration, in the process revealing new correspondence that shows the state’s so-far fruitless appeals for the agency’s help.

Drug companies typically sell medications for far less in Canada than in the United States, thanks to Canadian government-set price controls. But the companies have no interest or motivation in helping Americans — or states — obtain their drugs from north of the border.

Nearly two dozen drug companies refused Colorado’s entreaties to participate in its importation program, according to a report the state issued last year. And when the state asked the FDA for help, federal officials said the 2003 law allowing drug importation doesn’t authorize it to compel manufacturers to sell drugs intended for the Canadian market to states.

According to minutes released with Colorado’s amended application, state officials said their concerns about obtaining drugs for the program were not “adequately addressed” in a June meeting with the FDA.

Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, said last week that the state still hopes for the FDA’s help.

“While we continue to reach out to manufacturers to ask them to do the right thing for consumers, employers and taxpayers, we are also working with the FDA for additional guidance on how to best navigate sourcing drugs,” she said in a statement. She has worked on Colorado’s importation strategy for more than four years.

One possibility is obtaining drugs from Canadian wholesalers rather than directly from manufacturers — something that would require FDA approval. Canada’s government has also warned that it would intervene if exports to the United States threatened its drug supply.

FDA spokesperson Jeremy Kahn said the agency “will continue to work with states and Indian tribes” that seek to develop importation programs.

The drug industry has fought importation from Canada (or elsewhere) for decades, arguing it would jeopardize the safety of the U.S. drug supply. The industry’s main lobbying group, the Pharmaceutical Research and Manufacturers of America, sued the Trump administration in 2020 after it greenlighted importation, but a judge dismissed the case for lack of standing because it was uncertain whether the FDA would approve a state’s plan.

The FDA in January approved Florida’s plan to import drugs from Canada, marking the first time it gave a state permission to do so.

While Colorado aims to import drugs for consumers in the state, Florida’s plan is intended to lower costs for state agencies such as its Health and Corrections departments.

Florida hasn’t made much headway, either.

“Our vendor is establishing relationships with drug manufacturers and working on negotiating agreements,” said Brock Juarez, a spokesperson for the Florida Agency for Health Care Administration. He said the state set a timeline for negotiations over the first six months of the year, and that “has not changed.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — an independent source of health policy research, polling, and journalism.

From our reporters' notebooks

The Post’s Dan Diamond sends us this dispatch

The Centers for Medicare and Medicaid Services will release emergency funds for physicians ensnared in the Change Healthcare hack. The agency on Saturday said it was making advance payments available to providers and suppliers through Medicare Part B as the payment crisis continued to ripple through health care. 

Senate Majority Leader Chuck Schumer (D-N.Y.) and other members of Congress had pressed CMS to make the move, as physicians clamor for relief. CMS had earlier announced accelerated payments for hospitals through Medicare Part A.

Reminder: Change Healthcare, the nation’s largest processor of medical claims, has been offline since a Feb. 21 hack. Health-care providers warn they’re under pressure as unpaid bills pile up and their cash dwindles.

Schumer’s take: “The opening up of Medicare Part B will directly help our doctors on the front lines of this crisis who for weeks have been seeing unpaid bills pile up, threatening their ability to stay open and continue providing care to patients,” the Senate leader said in a statement.

Unsung hero: Jon Blum. Administration officials and industry leaders said CMS’s chief operating officer has been at the center of agency efforts to address the crisis.

More to do: Chip Kahn, head of the Federation of American Hospitals, said CMS officials had done as much as they could, and it was now up to private health plans to do their part with expedited payments.

“The CMS leadership thinks that these health plans should be stepping up to help us keep patient care rolling and care available,” Kahn said. “Health plans seem to have not gotten the memo.”

Biden officials amp up pressure: HHS Secretary Xavier Becerra and acting labor secretary Julie Su on Sunday laid out voluntary steps for all private plans to help with the crisis, with a special focus on UnitedHealth.

UnitedHealth should “take responsibility to ensure no provider is compromised by their cash flow challenges stemming from this cyberattack on Change Healthcare,” the officials wrote in a letter.

White House prescriptions

Biden campaign shifts to general election with ad blitz

President Biden directly confronts concerns about his age in an ad released by his reelection campaign on Saturday as part of its $30 million post-State of the Union advertising push, The Post’s Tyler Pager reports. 

“Look, I’m not a young guy,” Biden says at the start of the 60-second spot. “But here’s the deal: I understand how to get things done for the American people.” 

The president then outlines his record on issues such as the coronavirus pandemic and reducing health-care costs. He also criticizes his likely opponent in November, former president Donald Trump, for rolling back reproductive rights. 

The ad campaign will air over six weeks on national cable and local broadcasts in seven swing states: Michigan, Pennsylvania, Wisconsin, Arizona, Georgia, Nevada and North Carolina — targeting voters of color and young voters. 

Agency alert

Wegovy wins approval for lowering heart disease risks

The FDA approved Novo Nordisk’s weight-loss drug Wegovy as a treatment to reduce cardiovascular risk in overweight adults, our colleagues Daniel Gilbert and David Ovalle report. 

Why it matters: The agency’s decision to expand Wegovy’s regulatory label could entice more insurers to cover the pricey drug, which carries a list price of more than $1,300 for a monthly supply. 

The first-of-its-kind approval follows a closely watched clinical trial last year that found the drug cut the risk of strokes, heart attacks and other cardiovascular problems by 20 percent among overweight adults with a history of heart disease.

In other news from the FDA …

In a surprise move, federal regulators delayed regulatory action on an experimental Alzheimer’s drug that was widely expected to be approved this month, Daniel and David report. 

The agency will instead convene an advisory committee meeting to further scrutinize Eli Lilly’s donanemab, citing a need for more review to establish its safety and effectiveness. In a statement, the company said it remains “confident” in the drug’s potential as an Alzheimer’s treatment. 

The bigger picture: Experts say the FDA’s action reflects a cautious approach. In 2021, the agency faced backlash for approving a different Alzheimer’s drug despite conflicting efficacy data that sputtered on the commercial market after Medicare declined to broadly reimburse for it. 

Daybook

Welcome back! The House and Senate are both in session. 

On tap today: Biden is slated to send lawmakers his annual budget, which includes plans to cut projected deficits by $3 trillion over the next decade, according to the White House. 

The president will also travel to New Hampshire to deliver remarks, continuing his post-State of the Union victory lap. Biden is expected to call on Congress to pass three health-care policies outlined in his address. (If you need a refresher, we wrote about them here.)

On Tuesday: The House Ways and Means Committee will hold a hearing on enhancing access to care at home in rural and underserved communities; a House Energy and Commerce subcommittee on health will mark up 19 bills covering a range of health-care issues, including Alzheimer’s disease, stillbirth prevention and emergency medical services for children. 

On Thursday: HHS Secretary Xavier Becerra will testify before the Senate Finance Committee on the president’s fiscal 2025 budget request.

Health reads

How Big Pharma is fighting Biden’s program to lower seniors’ drug costs (By Tony Romm | The Washington Post )

ALS drug fails large clinical trial and may be withdrawn from market (By Mira Cheng | CNN)

Democrats hope IVF issue might topple key Republican in Pa. swing seat (By Colby Itkowitz | The Washington Post)

Sugar rush

Thanks for reading! We’ll see you tomorrow.