With Megan Wilson
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— Lawmakers are set up for an intense month to ward off a government shutdown and curry enough votes for sweeping legislation.
— FDA makes pivotal moves on e-cigarette regulation this week that’s expected to reshape the industry for good.
— Half of hospitals couldn’t share data with public health agencies pre-pandemic in a sign of challenges to come that hampered our understanding of the virus.
WELCOME TO WEDNESDAY PULSE — This is one of the few times your authors can talk football. Send NFL pointers and health news to [email protected] and [email protected].
BIDEN UPS THE ANTE ON BUDGET WISHES — The White House asked Congress on Tuesday to include hurricane relief and money for Afghan resettlement in the impending funding package, raising the stakes for an already tight timeline on two major legislative beasts lawmakers must conquer this month.
Biden’s budget request will increase the political pain for any lawmaker planning to oppose the funding patch Congress needs to pass this month to keep government agencies open beyond Sept. 30, Caitlin Emma reports. The White House is calling for more than $14 billion to address disaster aid needs that existed before Hurricane Ida swept the Louisiana coast, plus $10 billion more for Ida aid alone and $6.4 billion for various agencies to help Afghan allies resettle.
Meanwhile: Debate over the Build Back Better Act, the $3.5 trillion reconciliation bill packed with health and social provisions, starts in earnest with a House Ways and Means markup Thursday. According to draft text released Tuesday, Medicare vision benefits would start next year, followed by hearing benefits in 2023. But dental wouldn’t kick in until 2028, leaving a big gap for lobbyists to push for a pared-down version or longer delay.
As expected, paid medical and family leave and benefits aimed at reversing staff shortages in long-term care facilities are also in the package along with a provision to improve data collection at those facilities. With moderate Democrats like Sens. Kyrsten Sinema (D-Ariz.) and Joe Manchin (D-W.Va.) already voicing concerns about the multitrillion-dollar price tag, those provisions aren’t the most at-risk — but costly measures like the Medicare boosts could give rise to big fights.
A NEW VAPING LANDSCAPE AROUND THE CORNER — The Food and Drug Administration is barely a day away from a deadline that could signal how it will approach tobacco regulation for years to come, Katherine Ellen Foley writes.
The agency is reviewing millions of applications from e-cigarette makers, and must decide by Sept. 9 whether their products are “appropriate for the protection of public health,” including safety for both current smokers and nonsmokers. While the FDA has said it will likely miss that deadline for some applications, it’s prioritizing submissions based on market share — so expect some moves for Juul, which commands more than 40 percent of the e-cigarette field.
The FDA already said it’s considering major changes. Officials announced in April that it planned to release a proposal within a year to ban menthol cigarettes and flavored cigars — products disproportionately used by African Americans and teens. The FDA is also reportedly considering whether to seek limits on nicotine levels in cigarettes to reduce their addictive potential.
Divides are already apparent. While the agency hasn’t weighed in on major manufacturers like Juul yet, it’s already told a number of smaller companies to quit selling their products. In practice, the industry is bracing for the possibility of a regulatory decision that would forever tilt the balance in favor of big tobacco companies — like Altria, a stakeholder in Juul — who have expanded into the e-cigarette market.
“FDA really is at a critical juncture,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids. “In some critical ways, how FDA will be perceived will probably be defined with what it does now with regard to pending applications.”
SURVEY: HALF OF HOSPITALS HAD DATA TROUBLES PRE-PANDEMIC — Half of privately owned U.S. hospitals lacked the ability to electronically share data with public health agencies in the run-up to the Covid-19 pandemic, potentially hampering agencies’ responses to the virus, according to newly released survey findings.
Either the hospitals couldn’t send the data or the agencies couldn’t receive it in 2018 and 2019, Ben Leonard reports. Forty percent of hospitals surveyed in 2019 said issues such as technology costs or complexity complicated sending the data.
The American Hospital Association data, published in an Office of the National Coordinator for Health Information Technology report, also showed interoperability worsened during the period studied because of differing vocabulary standards. Nearly three-quarters of hospitals reported at least one challenge in sharing data with agencies.
Rural and critical access hospitals were disproportionately more likely to face issues with pulling pertinent EHR information from records and confusion over where to send data, according to the report.
“A majority of hospitals experienced public health reporting challenges that could impact public health agencies’ ability to monitor and respond to disease outbreaks,” the report said.
FTC CHIEF DENIES PARTISANSHIP AMID GOP BACKLASH — Disputes among commissioners at the Federal Trade Commission are “not rooted in partisanship,” the agency’s chair told Republican lawmakers who expressed concern that she is politicizing the bipartisan commission.
Chair Lina Khan acknowledged in identical Sept. 2 letters to three House Republicans that “the FTC is at a crossroads,” writing that the commission is heeding calls from people in both parties to address its decades-long record of erring on the side of inaction. That “unduly permissive” approach enabled increasingly massive and concentrated companies across the economy, she said.
Background: Khan — a Democrat who took over agency leadership in June — was responding to a July letter from the top GOP members of three House panels, who accused the agency of “partisan changes [to] position the Biden FTC to reshape radically the American economy.”
The five-member FTC has historically operated in a bipartisan manner, but several recent decisions have led the agency’s Republicans to split with the Democratic majority, Leah Nylen writes. Republican FTC Commissioner Christine Wilson publicly criticized the commission’s Khan-era leadership Friday, writing that she has been unable to get anyone at the agency to provide her with document requests it had sent to three companies. Instead, she had to request copies from the companies themselves — in letters she publicly released on Twitter.
The document requests involve Thermo Fisher Scientific’s $17.4 billion merger with PPD, which offers clinical research services to pharma and biotech companies, and a $5.3 billion merger between information providers Clarivate and ProQuest.
ABORTION DECRIMINALIZED IN MEXICO — Mexico’s supreme court has voted to decriminalize abortion, in a significant step for a nation with one of the world’s largest Catholic populations.
The court Tuesday ruled that a law allowing women to be jailed for having illegal abortions was unconstitutional — a decision that will apply throughout the entire country. That ruling will give states across Mexico criteria for changing their laws to make abortion more available.
It could also influence the broader region of Latin America, The Washington Post reported, where most abortion is still illegal in most nations. Currently, just four countries allow abortion under nearly all circumstances in a pregnancy’s early stages. But Mexico and other parts of the region have seen a surge in campaigns for women’s rights.
The split screen: The decision in Mexico came just days after the U.S. Supreme Court allowed a Texas law to stand that effectively bans abortions after six weeks. That law has outraged abortion rights groups yet also offered red states a roadmap to enacting similar restrictions.
On Tuesday, South Dakota Gov. Kristi Noem separately sought to curtail access to abortion drugs by requiring they be prescribed or dispensed only after an in-person examination.
Camille Lepire, most recently deputy chief of staff to Rep. Kevin Brady (R-Texas), has joined the Petrizzo Group. On Capitol Hill, she advised Brady, the top Republican of the House Ways and Means Committee, on health care issues. Before that, she worked for Rep. David Schweikert (R-Ariz.).
Reina Munsch is the new vice president of marketing at the American College of Radiology. Munsch was previously director of marketing at Industry Data Exchange Association and senior director of marketing at the American Pharmacists Association.
Katie McBreen will become vice president of communications for Blue Cross Blue Shield Association later this month. She previously held the same role with Consumer Brands Association.
Newly released court documents show former Mylan CEO Heather Bresch discussing a deal with Pfizer to eliminate a chief competitor to EpiPen, clearing the way for major price hikes, The Intercept’s Ryan Grim reports.
In defending his restrictive abortion law, Texas Gov. Greg Abbott misstated the basics of how pregnancy works, The 19th’s Shefali Luthra writes.
The Wall Street Journal breaks down the main players in Elizabeth Holmes’ criminal trial for Theranos claims, beginning with opening statements today.
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