Overnight Health Care: FDA narrows use for controversial new Alzheimer’s drug after criticism | Pfizer to seek FDA authorization for booster of COVID-19 vaccine | House report: Drug companies spent more on buybacks, dividends than research

Welcome to Thursday’s Overnight Health Care. You may be having a bad day, but it’s much, much worse if you need to navigate a flooded NYC subway today.

If you have any tips, email us at nweixel@digital-staging.thehill.com, psullivan@digital-staging.thehill.com and jcoleman@digital-staging.thehill.com 

Follow us on Twitter at @NateWeixel, @PeterSullivan4, and @JustineColeman8.

Today: The FDA narrowed the use of Biogen’s Alzheimer’s drug after criticism, a majority of states accepted Purdue Pharma’s bankruptcy settlement, and House members released a report on drug company pricing practices.

We’ll start with Biogen:

FDA narrows use for controversial new Alzheimer’s drug after criticism

The Food and Drug Administration (FDA) on Thursday approved an update to the prescribing label for a controversial new Alzheimer’s drug in an attempt to narrow its intended use.

The agency recommended that Biogen’s Aduhelm drug should only be used in patients with mild Alzheimer’s dementia or mild cognitive impairment, a departure from the initial approval that was much broader.

The change, which was announced by Biogen, emphasizes that the drug was only studied in people with mild forms of the disease. It makes clear “there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

What it means: The narrow label could make it cheaper for Medicare to cover the drug, which was priced at a staggering $56,000 a year per patient.

Physicians and drug pricing advocates criticized the high cost and broad approval, saying it could wreak havoc on Medicare spending, especially for a drug that had an unproven benefit. 

Still really expensive: Under the narrower label, the company has estimated about 1.5 million people with mild Alzheimer’s would be eligible for the drug. 

But total Medicare spending for all prescription drugs was $37 billion in 2019. That amount could be blown out of the water if Medicare paid for all eligible patients. 

The controversy: It’s extremely rare for a company to change a drug’s indication so soon after getting approval. But the decision to narrow the label was started at FDA. Agency officials approached Biogen and initiated meetings with the company to clarify labeling. Critics said the move by FDA is an attempt to clean up a mess of its own making.

Read more here.

Pfizer to seek FDA authorization for booster of COVID-19 vaccine

Pfizer and BioNTech announced Thursday that they plan to seek authorization from the Food and Drug Administration (FDA) for a third dose of their COVID-19 vaccine, saying it would provide even stronger protection.

In a statement released Thursday afternoon, the companies said they have seen “encouraging data” from an ongoing trial of the booster shot, adding that it provides levels of neutralizing antibodies five to ten times higher when administered six months after the second dose. The companies plan to submit data “in the coming weeks.”

But: It will be up to U.S. regulators — the FDA and the Centers for Disease Control and Prevention — whether to recommend a third dose.

Some experts have cautioned that vaccine makers have a financial incentive to develop booster shots and for the government to invest in more doses.

U.S. health officials have thus far said it is not clear whether a booster shot is needed.

Anthony Fauci, the government’s top infectious disease expert, reiterated earlier Thursday that two shots of the Pfizer and Moderna vaccines are protective even against the delta variant.

Read more here. 

House report: Drug companies spent more on buybacks, dividends than research

House Democrats on Thursday released a report that found that the 14 leading drug companies paid out more in stock buybacks and dividends from 2016 to 2020 than they spent on research and development. 

The report from the House Oversight and Reform Committee finds that the 14 companies spent $577 billion from 2016 to 2020 on stock buybacks and dividends, $56 billion more than the $521 billion they spent on research and development over the same time period. 

Broader purpose: The release of the report comes as House Democrats try to make the case for their sweeping bill aimed at lowering drug prices, known as H.R. 3, which would allow the secretary of Health and Human Services to negotiate lower prices. 

Democrats sought to push back on the pharmaceutical industry’s argument that the bill would harm innovation, saying that drug companies could simply cut back on payouts to shareholders, rather than cutting research and development. 

“Even if the pharmaceutical industry collected less revenue due to reforms such as H.R. 3, drug companies could maintain or even exceed their current levels of R&D if they spent less on rewarding shareholders and executives,” said House Oversight Committee Chairwoman Carolyn Maloney (D-N.Y.). 

Read more here.

15 states drop opposition to OxyContin maker Purdue’s bankruptcy plan

More than a dozen states have dropped their objections to a controversial bankruptcy plan for opioid-maker Purdue Pharma, clearing the way for its adoption.

According to court documents filed by a mediator late Wednesday, fifteen state attorneys general accepted the $4.5 billion settlement deal after Purdue agreed to additional concessions. 

The plan now calls for tens of millions of internal documents related to the Sackler family and Purdue’s marketing of OxyContin to be publicly released, including all the transcripts and audio of the bankruptcy trial depositions. 

The Sackler family, which owns Purdue Pharma, would also boost the monetary settlement by a modest $50 million paid in two $25 million installments. Purdue Pharma, which has not actively marketed OxyContin for two years, will be wound down or sold by 2024.

As recently as last month, 24 states and the District of Columbia objected to the proposed settlement, saying it failed to hold individual shareholders appropriately accountable. They said the settlement amounted to a “stretched-out payment of only a tiny fraction” of the Sacklers’ liability.

Sticking point: The Sacklers did not declare bankruptcy, but the settlement plan would shield members of the family from future opioid lawsuits. They would admit no wrongdoing, and would retain much of the fortune they made from Purdue. In return, they would give up ownership of the company and pay more than $4 billion in cash and charitable assets. 

Read more here.

Racial disparities in COVID-19 vaccination rates persist as delta variant gains steam

Even as the U.S. approaches a coronavirus vaccination rate of 70 percent, racial disparities in who has gotten vaccinated persist, raising questions about how the communities of color that were hit hardest by the first wave of the pandemic will fare against the rapidly spreading delta variant.

That gap is beginning to close, but the road to an equitable distribution of vaccinations has been rocky.

It quickly became clear after the federal vaccination program began in December that vaccines weren’t reaching people who had fared worst in the pandemic, specifically Black and brown communities. Upon taking office in January, President Biden made the commitment to advance racial equity in every part of the federal government, including his administration’s ambitious national COVID-19 response and vaccination strategy.

But inadequate health care resources in minority communities, rampant misinformation about the vaccines and the country’s sordid history of medical racism have all hampered inoculation efforts among Black people and other people of color.

Delta factor: There is mounting concern that communities of color in states with low vaccination rates could be susceptible to the quickly proliferating delta variant of COVID-19 that now makes up the majority of the U.S.’s coronavirus cases. While the variant, which appears to respond to vaccines currently on the market, does not appear more dangerous than previous strains, it is more transmissible.

Read more here.

What we’re reading

Can we stretch existing Covid vaccines to inoculate more people? Experts are divided (Stat News)

Most inmates have had their Covid shots — but their guards likely haven’t (Kaiser Health News)

New study on delta variant reveals importance of receiving both vaccine shots, highlights challenges posed by mutations (Washington Post)

State by state

As a blood shortage unfolds in NC, many gay and bisexual men are still barred from donating (North Carolina Health News)

Elizabeth Warren and Ayanna Pressley urge Baker administration to reconsider change to COVID-19 hospitalization data reporting (Boston.com)

Delta variant surges in Colorado as the bands play on (Kaiser Health News)

Op-eds at The Hill

An economist’s perspective on ‘gain-of-function’ virus research

Beyond ample supply, hurdles abound in the race to vaccinate the globe