Labs burdened with record testing volumes amid workforce infections

From: POLITICO's Prescription Pulse - Friday Jan 07,2022 05:01 pm
Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
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By David Lim and Lauren Gardner

With Katherine Ellen Foley, Megan R. Wilson and Rachael Levy.

On Tap

Labs are being tasked with processing a record number of Covid-19 tests. But their workforces are being depleted by the Omicron variant’s rapid spread.

West Virginia wants Washington’s blessing to administer a fourth Covid-19 vaccine dose to certain residents.

Robert Califf’s nomination to become FDA commissioner will get a Senate committee vote next week. The business meeting was rescheduled from Wednesday.

It’s Friday. Welcome back to Prescription Pulse. Star Trek: Picard is the latest show impacted by a Covid-19 outbreak on the enterprise.

Send tips and feedback to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

Coronavirus

LABS MIRED BY STAFF INFECTIONS AMID RECORD TESTING DEMAND Testing laboratories at the center of efforts to track the spread of Covid-19 expect to face record demand in the coming weeks while their workforces are depleted by the very virus they’re surveying.

The Biden administration is relying on testing to keep the country going and help avoid a return to stricter public health restrictions. But there may not be enough workers to process an avalanche of tests, even as the supply chain for once-scarce equipment like test kits and pipette tips remains intact.

“I think what’s going to happen is as this thing moves across the big population states like Texas and California the s--- is going to really hit the fan because there’s just not enough capacity of people, lab techs to keep these labs going,” Vault Health CEO Jason Feldman said.

The White House is “actively tracking the issue of staffing shortages and currently exploring ways we can assist,” a senior administration official told POLITICO.

“I think the staffing is a rate-limiting factor for laboratories of all kinds,” Association of Public Health Laboratories CEO Scott Becker said. “It’s not like the Biden administration can just use the [Defense Production Act] for people.”

CDC RECOMMENDS ALL TEENS GET PFIZER COVID BOOSTER — Centers for Disease Control and Prevention Director Rochelle Walensky endorsed her advisers’ recommendation Wednesday night to offer booster doses of the Pfizer-BioNTech Covid-19 vaccine to teens ages 12 to 17, Lauren reports. The new guidance, which followed FDA’s decision to authorize the boosters for younger adolescents Monday, strengthened CDC’s suggestion that 16- and 17- year-olds “may” get a booster shot five months after their second dose and now includes 12- to 15-year-olds.

The agency’s external advisory committee voted 13-1 for the new teen booster recommendation. The only points of contention were around whether this recommendation would be the best strategy to mitigate the pandemic’s effects, given the sheer number of unvaccinated people.

A stressor for pharmacies: Michael Hogue, a non-voting member representing the American Pharmacists Association, argued that recommending more teens and adolescents to get a booster would strain an already heavily burdened pharmacy system. “There is an increasing severe shortage of staff personnel at pharmacies … We have to think about what is reasonable to ask of our limited resources.”

What about vaccines for younger children? After the committee’s vote, Alejandra Gurtman, the vice president of vaccine research and development for Pfizer, reiterated that trials for vaccines for children younger than 5 were still ongoing. Lab data suggests that the vaccine would need to be three doses instead of two. Pfizer and BioNTech had updated their trials accordingly, she said, to deliver data by March or April. In mid-December of last year, the company announced its vaccine generated immunity comparable to young adults in children 6 to 24 months old but not for those between ages 2 and 5.

WEST VIRGINIA: LET US GIVE OUT 4TH DOSESGOP Gov. Jim Justice said Thursday he wrote to the Biden administration to seek permission to dole out fourth doses of the Pfizer and Moderna Covid vaccines to certain West Virginians. Citing studies from Israel showing higher antibody levels after boosters — and the country’s recent decision to administer a second booster to certain populations — Justice said his state wants to “walk hand-in-hand with Israel.”

Background: West Virginia was one of the states that got ahead of Washington on booster shots. Justice encouraged adult residents to get them for weeks before they were technically recommended for everyone, arguing that most, if not every, West Virginian were considered “high risk” given the state’s poor health profile. State leadership has also long admired Israel’s Covid data and thinks there are parallels between their populations.

The White House, CDC and FDA didn’t respond to requests for comment.

SAY YES COVID TEST VERMONT — More than 500,000 rapid Covid-19 at-home tests will be distributed to Vermont citizens under an initiative by NIH and CDC to study their effectiveness, Republican Governor Phil Scott announced Thursday.

“While our primary objective is to get tests into the field as efficiently as possible, we are also assessing how well the system works so we can continue to improve testing options and work with President Biden’s team to make future testing programs successful,” Scott said in a statement.

J&J: COVID VACCINE OFFERS ‘DURABLE PROTECTION’ — Johnson & Johnson touted results of a company-sponsored study Thursday it says shows its single-shot Covid vaccine provides “durable protection” for at least six months against breakthrough infections and hospitalizations. The study, which hasn’t been peer-reviewed, compared the J&J vaccine against primary vaccination with the Pfizer and Moderna mRNA options.

While the J&J shot has a lower efficacy level overall compared to the mRNA vaccines, the authors — all but one of whom work for J&J subsidiary Janssen — wrote that the study shows the single-dose product posted the smallest reduction in efficacy over time against those two benchmarks, followed by Moderna then Pfizer. All three maintained steady protection against ICU admissions, they said.

 

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In Congress

CALIFF TO GET COMMITTEE VOTE NEXT WEEK (YES, REALLY)Thanks to “a number of scheduling and logistical changes,” per a Senate HELP aide, the committee vote on Robert Califf’s nomination to be FDA commissioner got bumped from this week to next, Lauren reports. The Wednesday markup comes after the Senate’s first week back in session was marked by wintry weather and scores of nominees the White House had to resubmit to the chamber for Congress’ second session, including Califf’s.

Also on deck: The committee will hold another pandemic response hearing with a focus on “addressing new variants” on Tuesday. Acting FDA Commissioner Janet Woodcock, CDC Director Rochelle Walensky, White House medical adviser Anthony Fauci and Assistant Secretary for Preparedness and Response Dawn O’Connell will testify.

HHS GIVES CONGRESS FEEDBACK ON VALID ACT — The Biden administration this week provided technical assistance on the VALID Act of 2021 — legislation that aims to overhaul how laboratory developed tests and in vitro diagnostics are regulated — to Capitol Hill.

Alongside a laundry list of suggestions, the HHS document takes note of the experience FDA had evaluating early emergency use applications for Covid-19 tests when it discovered that among 125 requests from labs, about two-thirds had design or validation issues.

“Most of the validation issues were related to improperly designed validation studies such that FDA couldn’t tell if the tests worked or not,” the document states. “In many cases, follow-up studies revealed performance issues that had been masked by improperly performed validation studies.”

Drug Pricing

CMS FLOATS PART D CONCESSIONS AT THE COUNTER The Biden administration on Thursday proposed a new rule that aims to lower prescription drug prices for Medicare Part D beneficiaries by taking aim at fees paid by pharmacies to drug middlemen, POLITICO’s Megan R. Wilson reports.

The proposal, one of several the Centers for Medicare and Medicaid Services released, includes moving any fees and discounts that Medicare Part D plan sponsors and their pharmacy benefit managers extract from drug manufacturers — collectively known as pharmacy price concessions — to the point of sale, passing on any savings to patients at the pharmacy counter.

 

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In the courts

SCOTUS HEARS VAX CASES — The Supreme Court is hearing big vaccine mandate arguments this morning as Covid-19 infections surge to record highs nationwide.

The special session is the culmination of months of litigation over whether the White House has the legal standing to issue the pair of emergency rules in an effort to protect Americans from contracting coronavirus while at work, POLITICO’s Eleanor Mueller reports.

Justices will decide whether the Labor Department can require employers with 100 employees or more to mandate their workers get vaccinated — or agree to wear a mask and submit to weekly testing. They will also consider a separate rule requiring employees of health care facilities that receive federal funding to get vaxxed, with no testing opt-out.

Pharma Moves

Michael Felberbaum — a former Associated Press tobacco reporter — has been named FDA’s permanent assistant commissioner for media affairs effective Jan. 16. Felberbaum began working for FDA in 2015 and has served as acting assistant commissioner for media affairs for more than a year.

Pharma Worldwide

BELGIUM HOLDS OFF ON NEW CORONAVIRUS MEASURES — Belgium refrained from introducing new Covid-19 measures Thursday despite a looming peak in Omicron cases and hospitalizations, POLITICO Europe’s Thibault Spirlet reports. The decision comes two days after the Consultative Committee in charge of pandemic policies decided to drop quarantine requirements as of Jan. 10 for fully vaccinated close contacts.

Inside AgencyIQ

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.

FDA novel drug approvals fourth highest in history — The FDA’s drugs review division, the Center for Drug Evaluation and Research, approved the fourth-most novel drugs in its history in 2021, according to a review by AgencyIQ. The 50 novel drugs, defined as products never before approved by the FDA, were second in number only to those approved by CDER in 2018 (59), 1996 (59) and 2020 (53). Approvals in 2021 benefited from priority review (34/50), accelerated approval (14/50), and orphan drug designation (26/50). According to an FDA report released after AgencyIQ’s analysis was published, 54% of approved drugs were also “first-in-class” (meaning they used novel mechanisms of action), benefited from breakthrough status (14/50) or Fast Track status (18/50), were approved first in the U.S. (38/50) and were approved during the first review cycle (43/50).

Quick Hits

An NIH-funded study suggests Covid-19 vaccination is linked to a small and temporary increase in menstrual cycle length for women.

Former members of the Biden administration’s Transition Covid-19 Advisory Board call for feds to develop a public health strategy for the “new normal” in which Covid-19, like other respiratory infections, is endemic.

Biogen is holding out hope for next week’s draft decision from CMS on whether it will cover Aduhelm for patients, but as of now, demand for the drug is practically nonexistent, STAT’s Nicholas Florko reports.

 

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