J&J vaccine production could restart soon — Most nursing homes had multiple Covid outbreaks, GAO finds — Democrats face more pressure on drug pricing

From: POLITICO Pulse - Thursday May 20,2021 02:06 pm
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With Rachel Roubein and Alice Miranda Ollstein

Quick Fix

Troubled vaccine manufacturer Emergent BioSolutions could resume making Johnson & Johnson coronavirus vaccines in a matter of days, its CEO testified Wednesday.

Nearly every U.S. nursing home reported multiple Covid-19 outbreaks over the past year, a government watchdog found.

Supporters of a sweeping crackdown on high drug prices are mounting a pressure campaign against House Democrats.

WELCOME TO THURSDAY PULSE — where Nationals fans will finally be able to fill the ballpark again starting in June, just in time to watch their team get swept by the Mets. Winning tips only to acancryn@politico.com and sowermohle@politico.com.

 

A message from PhRMA:

Americans don’t need another barrier to their medicines. We have to lower what patients pay for their medicines. We also have to make sure they are getting the medicines they need. H.R.3 forces a choice between one or the other, but there’s a way to do both. Get the facts at phrma.org/betterway.

 
Driving the Day

J&J VACCINE PRODUCTION COULD RESUME SOON — That’s the prediction from the head of Emergent BioSolutions, the contract manufacturer forced to stop making Johnson & Johnson’s vaccine over problems at its Baltimore plant, Sarah reports.

CEO Robert Kramer told a House panel Wednesday that the company is “very close” to fixing the issues raised by the FDA last month, which included unsanitary conditions and congested facilities. Emergent may get the go-ahead to resume production within a matter of days, he testified.

That would be a boon to the U.S. vaccination campaign. The single-shot J&J vaccine was once viewed as critical to inoculating hard-to-reach communities, and a new surge of production could revitalize those efforts just as Biden officials are targeting Americans who want a shot but have struggled to get one.

The U.S. is currently relying on just the Pfizer and Moderna vaccines; the White House told states Tuesday that they won’t get any additional J&J supply for a second straight week.

Kramer also detailed how Emergent wasted 15 million J&J vaccines earlier this year, telling lawmakers that waste from the manufacturing process for AstraZeneca’s vaccine ended up too close to J&J production materials.

He and Emergent chair Fuad El-Hibri also sought to blame the U.S. government for some of the mishaps that have delayed the distribution of both the J&J and AstraZeneca shots, contending it was ill-prepared for a public health crisis and imprudently relied on a single plant to produce much of its vaccine supply.

That line of argument fell flat with many lawmakers, including Rep. Bill Foster (D-Ill.), who noted Emergent’s contamination issues were only detected when J&J ran tests in the Netherlands, and were missed entirely by Emergent’s own quality control workers.

MOST NURSING HOMES HAD MULTIPLE COVID OUTBREAKS, GAO FINDS — A report from the Government Accountability Office found that 94 percent of the nation’s nursing homes suffered more than one coronavirus outbreak, POLITICO’s Rachel Roubein reports.

The report, released Wednesday, sheds new light on how the coronavirus, which has killed more than 132,000 nursing home residents and causes more severe disease in older adults, swept through facilities across the country. The GAO based its conclusions on data collected from 13,380 of the roughly 15,000 nursing homes in the U.S. Among its other findings:

— Just 64 nursing homes surveyed reported no coronavirus outbreaks at all;

— About 85 percent of facilities faced outbreaks that stretched on for five weeks or more;

— And facilities with outbreaks lasting at least five weeks averaged 56 Covid-19 cases. Those with shorter outbreaks averaged 13 cases.

 

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DEMOCRATS FACE MORE OUTSIDE PRESSURE ON DRUG PRICINGThe progressive group Patients for Affordable Drugs Now will spend more than $1 million to urge House Democrats to support legislation allowing Medicare to negotiate drug prices, POLITICO’s Alice Miranda Ollstein reports.

The new ad campaign targets 42 members across 22 states, and aims to counter a competing ad blitz from the conservative American Action Network, which has derided the pricing proposal as a “socialist prescription drug takeover plan.”

“The best indication that we have a shot at passing H.R. 3 is the fury with which pharma and its allies have unleashed negative attack ads,” Patients for Affordable Drugs Now founder David Mitchell said, referring to the bill that would allow Medicare negotiation.

— The state of play: Democrats are still hoping to pass a drug pricing overhaul as part of President Joe Biden’s infrastructure spending bills, even though Biden himself has decided against that.

But House Democratic leaders are also grappling with resistance within their own ranks, after several moderate Democrats came out against the legislation and called for a more bipartisan, industry-friendly alternative.

The Senate has not yet introduced its own version of the legislation, amid similar disagreement over how aggressive Democrats should be in slashing drug prices.

Coronavirus

HOUSE MASK WARS RAGE ON — Democrats tabled a GOP resolution Wednesday to lift mask-wearing requirements for vaccinated lawmakers, in a party-line vote that marked the latest escalation in the showdown over the chamber's mask mandate.

Republican Reps. Thomas Massie of Kentucky and Marjorie Taylor Greene of Georgia, meanwhile, trashed and shredded warning letters from Speaker Nancy Pelosi , after they defied the House's mask requirements on Tuesday.

U.K. LAUNCHES COVID VACCINE BOOSTER TRIAL — A new U.K.-based clinical trial will evaluate whether a range of Covid-19 vaccines can be used as booster shots to reinforce people’s protection against the virus, POLITICO Europe’s Ashleigh Furlong reports.

Notably, the booster shot, which would be given 10 to 12 weeks after the patient’s second dose, could be a different brand from the one originally used. The trial includes vaccines from AstraZeneca, Pfizer, Moderna, J&J, Novovax, Valneva and CureVac, and is the first to examine the immune response of those different brands side-by-side.

 

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On the Hill

FIRST IN PULSE: PROPOSAL WOULD TIGHTEN CONTACT LENS RULES — Bipartisan legislation introduced today would force online contact lens sellers to follow stricter rules, in an effort to root out questionable business practices.

The bill, backed by Reps. Bobby Rush (D-Ill.), Michael Burgess (R-Texas), Lisa Blunt Rochester (D-Del.) and David McKinley (R-W.Va.) would ban retailers’ use of robocalls to verify patient information and require them to encrypt all medical information sent over email. It would also mandate that contact lens sellers offer an online portal for customers to upload their prescriptions.

Names in the News

Kathleen Jaeger is joining All Sober as its executive vice president of health and wellness, strategy and external relations, POLITICO Influence reported. She will also be president of the All Sober Foundation. Jaeger most recently worked at the National Association of Chain Drug Stores as its senior vice president of health and wellness strategy, policy and patient advocacy.

 

A message from PhRMA:

Americans don’t need yet another barrier to their medicines. Especially now. Now is the time for us to rethink how we get the medicines we need. But there are right ways and wrong ways. While it may sound good on paper, H.R.3 would threaten patients’ access to treatments, put nearly a million American jobs at risk and jeopardize current and future medical innovation – all while failing to address the broader challenges facing America’s health care system.

We have to lower what patients pay for their medicines. We also have to make sure patients are getting the medicines they need. There’s a way to do both, but H.R.3 isn’t it. Get the facts at phrma.org/betterway.

 
What We're Reading

Salma Hayek nearly died from Covid-19 early in the pandemic, at one point needing to be put on oxygen, she told Variety’s Marc Malkin.

Nevada could soon become the second state to implement a public insurance option, Vox’s Dylan Scott reports.

A group of scientists’ demand that Covid-19’s origin be more closely investigated has reignited a polarizing debate over whether the virus could have escaped from a lab, Kaiser Health News’ Arthur Allen reports.

 

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