The FDA’s ban on menthol in cigarettes clears a major regulatory hurdle

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Right to Try is the latest policy to get “2.0-ed”

2022, it seems, is the year of health policy throwbacks.

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The bipartisan duo behind the 21st Century Cures Act is trying to drum up support for a Cures 2.0. President Biden has announced the launch of the Cancer Moonshot 2.0. And now, there’s a Right to Try 2.0.

The new legislation, from the libertarian think tank the Goldwater Institute, is supposed to speed patients’ access to so-called “N of 1” drugs that are custom made for gravely ill patients. On Monday, Arizona became the first state to enact the law. Now, the Goldwater Institute is planning to pass the bill in several other states before pushing it on Capitol Hill, just as it did with the first right-to-try laws.

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At first glance the bill seems right-minded. After all, mere days of delay could mean death for these gravely ill patients. But, as I explain in a new story for STAT, the Goldwater Institute can’t point to actual problems that necessitate any policy changes. In fact, they couldn’t even name a doctor who say this new pathway is necessary.

For more on the new bill and what’s next in the fight over Right to Try 2.0, check out my new story.

After a month of intense lobbying, FDA’s menthol regulation is on the way

The FDA’s highly anticipated rule banning menthol in cigarettes cleared a major regulatory hurdle on Thursday and is likely to be released in the coming days.

The regulation has been subject to intense lobbying over the last month. The White House has held 25 meetings on the regulation since the start of April, according to STAT’s review of public meeting logs. They’ve brought in everyone from the American Cancer Society Cancer Action Network and the National LGBT Cancer Network to Altria and the National Association of Tobacco Outlets, but we at D.C. Diagnosis are particularly intrigued by the involvement of civil rights groups in the fight.

Earlier this month, Rev. Al Shaprton wrote directly to the White House arguing that the proposed menthol ban “would severely target and harm African American smokers, who overwhelmingly prefer menthol cigarettes.” Sharpton also met with the White House on April 13, according to public logs, and he has penned letters with slews of other influential civil rights organizations — including the ACLU — arguing that a menthol ban would prompt clashes between the Black community and police.

But not everyone in the civil rights community is convinced.

The NAACP penned its own letter to the Biden administration last week endorsing the menthol ban, and it went after Sharpton directly.

“We do not agree with the tobacco industry’s message and strategy presented by a few Black leaders: prohibiting menthol cigarettes would be discriminatory. We reject this view. The failure to prohibit the sale of menthol cigarettes and products would be discriminatory and counter the goal and function of the FDA to protect and promote public health for all, including the African-American community,” the group wrote.

The debate seems at least partially fueled by a sustained lobbying effort from tobacco companies, an LA Times investigation revealed Monday.

Biden’s Paxlovid push

The Biden administration announced a series of initiatives Tuesday aimed at increasing the use of antiviral pills to treat Covid-19. The first step will be simply to make Paxlovid and Merck’s molnupiravir, another oral antiviral treatment, available at more places. Currently, the drugs are available at 20,000 locations and that figure should jump to more than 30,000.

The U.S. government will also substantially increase the number of “test-to-treat” facilities, where eligible patients can receive a Covid test, followed by a prescription and then the prescribed medicine. It also wants to launch an awareness campaign.

My colleague Matthew Herper has the full story here.

Inside the White House’s not-so-open-book approach toward Covid funding

When Jen Psaki told reporters that they could have copies of a White House binder full of Covid-19 funding details, my colleague Rachel Cohrs took the press secretary for her word. Minutes after the press conference wrapped, Rachel was already plotting how to get onto the White House grounds to get her hands on the intel. But when Rachel made it to Psaki’s office, she found the White House was not, in fact, giving out copies of the binder — far from it. Instead, Rachel had just an hour to pour over nearly 400 pages under the watchful eye of a White House staffer.

In a new story, Rachel provides readers with an exclusive glimpse into what the Biden administration was telling lawmakers during the drawn-out fight over the future of Covid-19 funding, which pitted Republicans, angry about the White House’s lack of transparency, against Democrats, apoplectic at Republicans’ unwillingness to keep writing the White House checks.

Take a peek inside the binder — and Rachel’s saga — here.

Keeping hopes of drug pricing reform alive

This morning, advocates will hold a press conference on Capitol Hill to mark the launch of yet another campaign urging lawmakers to quickly pass drug pricing reform. The 70 groups behind the new campaign, dubbed “Push For Lower Rx Prices,” will urge lawmakers to pass comprehensive drug pricing reform before Memorial Day — a lofty goal, given that’s a mere 34 days away.

The campaign is the latest attempt by advocates to drum up support for drug pricing reform after lawmakers’ last legislative push imploded in December. The launch comes just days after Sen. Elizabeth Warren renewed her calls for the Biden administration to use executive action to quickly lower drug prices. That’s part of another advocacy campaign dubbed “Make Meds Affordable,” which launched in February.

One of the groups spearheading today’s campaign, Patients for Affordable Drugs, is also out with a new poll today meant to bolster support for drug pricing reforms. Most of the findings likely won’t surprise loyal readers of D.C. Diagnosis, but we at STAT were intrigued by this one nugget in particular: Only 10% of those polled, including just 12% of Republicans, said that America’s drug pricing system “is fair for the high quality of care, innovation, and access we have to cures.”

STAT stories you may have missed

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What science journalism can’t tell us about Covid-19 deaths.

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What counts as a breakthrough? 8 insights on the FDA’s approach to medical devices.

CDC, FDA, and NIH staffers aren’t reporting political interference, new watchdog report shows.

Pharma R&D payments to European researchers are like ‘dark money’.

Source: STAT