Emergent faces congressional grilling — Another week without J&J shots — The tale of Verma’s missing cell phone

From: POLITICO Pulse - Wednesday May 19,2021 02:08 pm

May 19, 2021

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With Rachel Roubein, Alice Miranda Ollstein and Dan Goldberg

Quick Fix

— Vaccine manufacturer Emergent is in the hot seat with a congressional hearing today on botched doses.

— Johnson & Johnson's vaccine won't be distributed to states for the second consecutive week.

— Trump-era CMS chief Seema Verma and her missing cell phone are at the center of a watchdog group's pursuit of federal records.

WELCOME TO WEDNESDAY PULSE — where the Brooklyn Nets are doing their part to boost vaccinations and have gifted us with the best political meme material so far this year. Tips to sowermohle@politico.com and acancryn@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

EMERGENT LEADERS FACE CONGRESSIONAL GRILLING — The Maryland vaccine manufacturer’s top executives will appear before a the House Select Subcommittee on the Coronavirus Crisis this morning to explain the cause of an ingredient mix-up that cost 15 million Johnson & Johnson coronavirus vaccines, as well as answer to allegations that benefited from political connections.

Backdrop: Millions of shots from both J&J and AstraZeneca have been held in limbo at Emergent’s Bayview, Md. facility as Emergent works through a series of additional issues raised by FDA, from unsanitary conditions to congested facilities ill suited to manufacturing millions of vaccines. (More on how that’s been playing out for states below). Emergent boasted just months ago that it would produce a billion doses this year, but hasn’t provided a timeline for when it will get back on track.

On the agenda: Emergent CEO Robert Kramer and Chairman Fuad El-Hibri are expected to discuss the company’s history as a relatively small contract manufacturer that nevertheless snagged a series of federal government agreements. Emergent is one of very few contract manufacturers equipped to produce complicated vaccines, which led both J&J and AstraZeneca to enlist the company last year as companies scrambled to lock in vaccine orders.

In a statement to PULSE, Chair Jim Clyburn accused Emergent of hiding a history of manufacturing issues, saying the committee plans “to explore the impact of those past failures on our pandemic response and the extent to which political connections influenced the decision to turn to Emergent yet again.”

Democrats are expected to demand answers on Emergent’s long-running relationship with former Assistant Secretary for Preparedness and Response Robert Kadlec, once a consultant for Emergent. During his tenure at the assistant HHS secretary post, Emergent’s contracts with the U.S. government for products such as smallpox vaccines ballooned, as the Washington Post reported last year.

NO J&J NEXT WEEK, AGAIN — Production problems are continuing to hamper the distribution of the nation’s only authorized single-dose shot, multiple sources with knowledge told POLITICO’s Rachel Roubein and Dan Goldberg.

— On a private weekly call Tuesday, White House officials again informed governors that more J&J shots would not be immediately available to order. Supplies could increase if the FDA gives the OK to use J&J doses made at Emergent.

— However, the new federal pool of doses — from which states can draw if they need more than their weekly allotment of vaccine — does still include some J&J shots, according to one source. The White House and HHS declined to comment on existing J&J supply.

THE CASE OF VERMA’s MISSING CELL PHONE — The Trump administration’s CMS chief lost her agency-issued cell phone two days before President Joe Biden’s inauguration, according to recently filed court documents, resulting in the elimination of all of its stored records. Verma then failed to complete the standard form explaining how she lost her phone, the court records state, POLITICO’s Dan Goldberg reports.

The details come from a Freedom of Information Act lawsuit by American Oversight, a government watchdog group that's seeking communications from top Trump officials. Verma, who led CMS for four years, was issued a new iPhone on Jan. 18, which she returned nine days later. But records from that phone can’t be accessed, either, because the phone was locked and Verma said she had forgotten her passcode, according to the court documents.

Verma is one of several administration officials whose cell phone records are inaccessible because their phones were wiped by staff before they could be backed up. A spokesperson for Verma declined to speak on the record.

Putting aside Verma’s or any other individual’s actions, the government’s process for ensuring records are preserved needs to be reexamined, said Austin Evers, executive director of American Oversight.

“People lose their phones all the time, and cloud-based back-ups of mobile device data have been widely available to the public for years,” he said. “The federal government has a legal obligation to preserve agency records, and there’s no excuse at this point in time for failing to do so.”

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Public Health

PATIENTS’ ACCESS TO DOCTORS’ NOTES CAUSING SOME HEARTBURN — For the first time, millions of patients for the first time can read their doctors’ clinical notes—and it has been a bit unsettling, writes Mohana Ravindranath.

The change is thanks to a new federal mandate for patients to easily access information long hidden from their view. But some tell Mohana that their doctors’ unfiltered assessments can be condescending, stigmatizing and even cavalier. One patient was labelled a drug-seeker after pain complaints; another said notes showed little regard for her emotional well-being after a miscarriage.

While doctors’ groups express support for providing these records to patients, they say the Biden administration must do more to ensure patients aren’t unintentionally harmed by this unprecedented level of disclosure. Some prominent doctors have pushed for limits, arguing that most patients don’t have the expertise to process the medical terminology in these records.

“It can be both technically difficult, and difficult emotionally, to read,” said Erin Gilmer, a health policy lawyer and patient advocate. “But it can be really important.”

In Congress

REPUBLICANS REBEL OVER MASK RULES — A group of House Republicans on Tuesday openly defied requirements that they wear masks on the chamber’s floor, POLITICO’s Melanie Zanona reports.

The roughly dozen GOP lawmakers, including freshman firebrand Rep. Marjorie Taylor Greene (R-Ga.), protested the mask-wearing rules during an evening vote, after arguing Speaker Nancy Pelosi should lift the mandate now that a vast majority of members have been vaccinated.

Greene snapped a selfie with other maskless colleagues, and the group at one point prompted a confrontation on the floor with Rep. Robin Kelly (D-Ill.). Members who don’t wear masks on the House floor are currently subject to fines.

— The House is taking some steps toward normalcy, including shortening voting times and resuming in-person meetings. But that pace has frustrated Republicans, especially now that the CDC has eased its guidelines. Minority Leader Kevin McCarthy is planning to introduce a privileged motion on the issue today.

FIRST IN PULSE: BIPARTISAN BILLS WOULD BOOST MATERNAL HEALTH — Two new bipartisan bills set to be introduced in the House and Senate aim to make birth centers and midwife services more affordable for low-income parents, POLITICO’s Alice Miranda Ollstein reports.

The Birth Access Benefiting Improved Essential Facility Services Act would expand access to freestanding birth centers for Medicaid recipients and services covering prenatal, perinatal and postpartum care. The second bill — the Midwives for Maximizing Optimal Maternity Services Act — establishes new funding streams for midwifery education that prioritize Black, Latino and Asian students.

The legislation comes on the heels of a GAO report that found rural residents and those in underserved areas face a higher risk of maternal death during pregnancy or soon after from pregnancy-related causes.

FIRST IN PULSE: BENNET, TILLIS PITCH NEW FUNDING TO AID STOCKPILE — Sens. Michael Bennet (D-Colo.) and Thom Tillis (R-N.C.) want to allocate $500 million over the next three years to build out the nation’s reserve of medical supplies, under legislation they're introducing today.

The bipartisan bill would incentivize domestic manufacturers to strengthen their supply chains and create reserves of personal protective equipment, testing and vaccines supplies and other medical equipment, as part of an effort to replenish the Strategic National Stockpile and prepare for a future pandemic. Bennet and Tillis are planning to attach the measure as an amendment to a bill now advancing in the Senate.

ALTARUM: NATIONAL HEALTH SPENDING REBOUNDS — Overall health spending in the U.S. has recovered from its pandemic-induced drop, according to the latest analysis of economic data from Altarum. National spending in March was 12.5 percent higher than the same month a year ago, when Covid had just begun to shut down much of the economy.

Yet that bounce back has been uneven, Altarum found. Compared to levels in January 2020, before the pandemic took hold, spending on home health care has seen the most significant rise, up 7 percent. Dental services spending in March, meanwhile, came in 17 percent below where it was in January 2020.

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

New York’s attorney general threatened to sue Eastman Kodak over a series of stock buys that its CEO made ahead of a major U.S. government deal to buy drug ingredients last year, The Wall Street Journal’s Geoffrey Rogow reported.

Women are increasingly abandoning health care jobs, citing burnout and decades of inequities in the system, write Shefali Luthra and Chabeli Carrazana for The 19th.

A growing TikTok trend: Unvaccinated users falsely claiming that they will be sole survivors after broad immunization efforts, complete with audio from the film “Transformers,” Vice’s Anna Merlan writes.

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