Monday Roundup

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From the Capitol Hill front, Roll Call reports that an extension of the continuing resolution currently funding the federal government appears to be on tap.

Senate Democrats and Republicans are eyeing a two- to three-month continuing resolution that would punt final decisions on fiscal 2022 appropriations into February or March, according to sources familiar with the talks.

That decision, if blessed by House Democrats and the Biden administration, would decouple a complicated omnibus spending bill covering every federal agency from thorny negotiations over budget reconciliation and the debt limit.

But it wasn’t yet clear Democrats across the Capitol were unified behind that strategy, with some pushing a much shorter stopgap measure running for two weeks, to Dec. 17. That would keep the pressure on for a spending deal before the winter holiday season and allow lawmakers to clear the decks for next year’s agenda.

Another possibility is lawmakers try out a stopgap bill to Dec. 17, see how much progress is possible, and then pass another CR, this time through the end of February or March.

From the Delta variant vaccine mandate front —

  • It’s worth noting that the Federal Acquisition Regulation Council is expected to consider a draft proposed rule implementing the mandate for federal government contractors this coming Wednesday November 17.
  • With regard to OSHA’s large business mandate, the Society for Human Resource Management tells us that “

OSHA stated that it “has suspended activities related to the implementation and enforcement of the ETS pending future developments in the litigation,” although it “remains confident in its authority to protect workers in emergencies.” OSHA noted that the court ordered it to take no steps to implement or enforce the ETS until further court order.

“OSHA’s course of action should give some comfort to employers taking a wait-and-see approach,” said Kyle Johnson, an attorney with Frost Brown Todd in Louisville, Ky., Jeff Shoskin, an attorney with Frost Brown Todd in Cincinnati, and Catherine Burgett and Anne Duprey, attorneys with Frost Brown Todd in Columbus, Ohio, in a firm legal update. “Because the future of the order is uncertain, employers should keep apprised of the status of the legal challenges ahead and have a plan to comply with the ETS should the order be modified or dissolved.” 

The Centers for Disease Control reminds us that Antibiotic Awareness Week begins this Thursday November 18. “USAAW is an annual observance that raises awareness of the threat of antibiotic resistance and the importance of appropriate antibiotic use.”

Following up on the large increase in Medicare Part B premiums for 2022, Healthcare Dive informs us that “CMS said the hike is mostly due to potential use of Biogen’s Aduhelm, a drug for Alzheimer’s disease that’s drawn criticism for carrying a high price tag despite unclear effectiveness, along with ongoing uncertainty from the coronavirus pandemic.” That’s puzzling as the Biogen drug has been a colossal sales flop. What’s more, STAT News broke the news tonight that

Al Sandrock, Biogen’s top scientist and the face of its years-long campaign to develop a treatment for Alzheimer’s disease, is leaving the company after more than two decades, STAT has learned.

The surprise departure of Sandrock, who oversees all of Biogen’s research and development, leaves a void in the company’s upper ranks. And it comes as Biogen is facing a worsening business outlook, saddled with a string of setbacks to its research pipeline and forced to defend its scientific integrity after the approval of the polarizing Alzheimer’s treatment Aduhelm.

STAT News also offers an interesting story about the two anti-viral drugs that could become Flonase for COVID. For example,

At the headline level, Pfizer’s pill reduced the risk of hospitalization and death by 89%,while Merck showed a reduction of 50%. But neither firm has disclosed detailed data from its pivotal studies, and the trials were not identically designed.

The studies enrolled similar populations — unvaccinated people with mild to moderate Covid-19 and at least one risk factor for severe disease — but they had slightly different measures of efficacy. Pfizer’s 89% figure comes from patients who started getting its pill, Paxlovid, within three days of their first Covid-19 symptoms. Merck’s 50% applies to patients who began treatment within five days. In the Paxlovid study, patients who started treatment within five days saw an 85% improvement in hospitalization or death versus placebo. Merck has not shared data on patients who got its drug within three days of symptom onset.

We will have to keep our fingers crossed while the Food and Drug Administration considers granting these drugs emergency use authorization.

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