HEALTH CARE BRIEFING: U.S. Asks to Lift Block of Vaccine Rule

The Biden administration asked a federal appeals court to lift the temporary order blocking its regulation requiring large employers to mandate that their workers get Covid-19 vaccinations or submit to regular testing, arguing that there’s no emergency that requires the rule to be immediately suspended.

The companies that won an emergency stay from the U.S. Court of Appeals for the Fifth Circuit claim no major prospect of harm from the rule until early December, or about a month before the standard’s Jan 4. compliance date, the administration said in a brief yesterday.

“Accordingly, there is no need to address petitioners’ stay motions now, and the Court should lift its administrative stay and allow this matter to proceed under the process that Congress set forth for judicial review of OSHA standards,” administration lawyers argued.

The Occupational Safety and Health Administration’s regulation issued last week applies to companies with at least 100 workers. The agency developed the rule under its authority to create emergency temporary standards that are necessary to address a “grave danger.”

The rule was met with a wave of lawsuits from Republican state attorneys general, companies, business groups, and others. Thus far challengers have filed at least 12 petitions seeking review of the OSHA rule in six different circuit courts, and more are expected. Read more from Robert Iafolla.

• The Occupational Safety and Health Administration notified the Judicial Panel on Multidistrict Litigation of the 12 legal challenges filed in the Fifth, Sixth, Seventh, Eighth, Eleventh and D.C. Circuits. The panel is expected to hold a “multi-circuit lottery” on Nov. 16 to assign the consolidated bids to any one of those federal appeals courts. Read more from Kathleen Dailey.
• The Biden administration signaled yesterday it won’t seek immediate U.S. Supreme Court intervention after the federal appeals court halted its emergency rule. While the White House could seize upon the interim stay issued by the Fifth Circuit on Nov. 6—or a permanent injunction the circuit court panel could hand down later this week—to quickly take the case up to justices, it also has the luxury of waiting as the OSHA rule doesn’t kick in until Jan. 4. Robert Iafolla has more.

Experts Say Health Worker Mandate Likely to Succeed: In a separate vaccine mandate fight on the administration’s requirement that health-care workers at facilities paid by Medicare and Medicare get a Covid-19 vaccination—without a testing option—legal observers say it’s likely to hold up against future court challenges, putting it on firmer ground than the vaccine-or-test rule for large companies that has already been halted.

The CMS rule requires medical employers to consider religious and medical exemptions and doesn’t apply to employees who work fully remotely. “These provisions eliminate two of the most serious potential bases for contesting the mandate,” said Brian Dean Abramson, who teaches vaccine law at Florida International University College of Law. In addition, federally administered programs are allowed to govern the terms of participation for facilities they fund—and can withhold funding for facilities that don’t meet those standards. Read more from Allie Reed.

Related:

• California Set to Consider Worker Covid Shot-or-Test Mandate

Happening on the Hill

TikTok, YouTube, Snapchat Pressed on Research on Kids: Snapchat, TikTok, and YouTube were asked by Sen. Richard Blumenthal (D-Conn.) to disclose their internal data on the effects of the platforms on children and teens, Maria Luiza Rabello reports. The request follows pledges made by the companies during last month’s hearing, said Blumenthal, chairman of the Senate Commerce Committee’s consumer protection subcommittee. Researchers should be able to effectively assess the data on children and teens’ mental health “without being undermined or blocked by opaque data practices,” Blumenthal said in the letters.

Synthetic Nicotine Firms Probed by Democrat: Next Generation Labs and Puff Bar received questions from House Oversight Economic and Consumer Policy Subcommittee Chair Raja Krishnamoorthi (D-Ill.) over their manufacturing and sale of synthetic nicotine. Certain e-cigarette and e-liquid manufacturers, banned from selling their products, allegedly intend to switch to “synthetic nicotine in an effort to avoid FDA regulation,” Krishnamoorthi said in a statement yesterday. The lawmaker asked the e-cigarette companies to supply documents and answer questions by Nov. 22, Daniela Sirtori-Cortina reports.

The Coronavirus Pandemic

After 600 Days, U.S. Reopens to Europe: After more than 600 days, passengers across Europe crowded into airports to catch their first flights to the U.S. since early in the coronavirus pandemic. What united travelers was a sense of exhilaration, coupled with the arduous process of getting through long lines and having all their paperwork at hand as passengers flew out of Paris, London, Milan, and Frankfurt under the rules. Read more from Tara Patel, Siddharth Philip, and William Wilkes.

• Reopened travel comes even as Europe has become an epicenter for the coronavirus, calling into question the region’s efforts to recover from the pandemic. Despite an abundance of vaccines, countries from Germany to Greece have seen record infections in recent days, while Romania and Bulgaria are suffering overwhelmed hospitals and widespread deaths. That’s put renewed urgency on efforts to vaccinate the masses, from first doses for millions of holdouts to booster shots to millions of others. Read more from Tim Loh.

More Headlines:

• White House Pushes Schools to Boost Vaccinations in Kids
• QuickTake: What Covid-19 Therapies Exist and How Effective Are They?
• Arizona Asks Court to Overturn U.S. Limits on Covid-19 Aid
• Covid Test Startup Valued at $5 Billion Preps for Post-Pandemic

What Else to Know

Emails Reveal J&J’s Role in Shaping Cancer Report: Unsealed emails reveal the role baby-powder maker Johnson & Johnson played in a report that an industry group submitted to federal regulators deciding whether to keep warnings off talc-based products linked to cancer. The emails—opened in the state of Mississippi’s lawsuit against J&J over its refusal to add a safety warning—show the company and its talc supplier chose the scientists hired by their trade group to write the 2009 report assessing talc-based powders’ health risks. They also show the researchers changed the final version of their report at the companies’ behest. Read more from Jef Feeley and Anna Edney.

Sanofi, Novartis Split Courts on HHS Drug Discount Enforcement: Two federal courts handed down diverging rulings over the government’s ability to force pharmaceutical giants to resume previously-limited drug discounts, with one backing the HHS and the other saying it was out of line. The rulings, in cases brought by Novartis Pharmaceuticals, Sanofi-Aventis U.S. and others, throw additional wedges into a swirl of litigation surrounding the 340B program, which assists low-income Americans by requiring drugmakers to offer products to certain health-care entities at discounted prices. Read more from Ian Lopez.

More Headlines:

• BioNTech’s Success Offers Antidote to EU Biopharma Skittishness
• ‘Pharma Bro’ Shkreli Loses Bid to Nix Proof of Prior Markup
• Mentor Breast Implant Preemption Challenge SCOTUS Skip
• Kidney Transplant Allocation Policy Change Clears Legal Hurdle
• Device Maker Arthrex to Pay $16 Million to Settle Kickback Case
• Beam Rises After FDA Clears ‘Milestone’ Sickle-Cell Analysis

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com