Health Care – Biden set to mark drug pricing milestone

by Joseph Choi, Peter Sullivan and Nathaniel Weixel - 08/15/22 6:58 PM ET

Congratulations are in order to one Pennsylvania woman who just recently welcomed her 100th great-grandchild. Just imagine that family reunion.

In health news, President Biden is set to sign the recently passed health, climate and tax legislative package into law on Tuesday, marking the most significant action taken to lower drug costs in decades. Plus: WHO renames two monkeypox variants.

Welcome to Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. For The Hill, we’re Peter Sullivan, Nathaniel Weixel and Joseph Choi. Subscribe here.

President to sign health, climate bill Tuesday

President Biden will sign into law the sweeping climate, health care and tax legislation that has been Democrats’ priority for more than a year during a ceremony at the White House on Tuesday.

The signing will represent a major milestone for Biden and his domestic economic agenda.

Drug pricing milestone: With the signing, Medicare will for the first time be able to negotiate lower prices for some drugs — though the lower prices do not go into effect until 2026.

“This historic bill will lower the cost of energy, prescription drugs, and other health care for American families, combat the climate crisis, reduce the deficit, and make the largest corporations pay their fair share of taxes,” a White House advisory said.
“In the coming weeks, the President will host a Cabinet meeting focused on implementing the Inflation Reduction Act, will travel across the country to highlight how the bill will help the American people, and will host an event to celebrate the enactment of the bill at the White House on September 6th,” it added.

The legislation, called the Inflation Reduction Act, passed the House in a party-line vote Friday, about a week after passing the Senate with only Democratic votes through a process known as budget reconciliation. Vice President Harris cast the tie-breaking vote.

Sales pitch: Biden administration officials are preparing to traverse the country to promote the bill in the coming weeks, making the case to voters that Democrats can deliver on their promises in the critical three months before the November midterm elections.

Read more here.

UK is first to approve updated Moderna omicron vax

The United Kingdom on Monday became the first country to approve an updated COVID-19 vaccine from Moderna targeting the omicron variant as well as the original strain of the virus.

The move is a step toward a booster campaign that could provide people with better protection against the variants that are currently circulating.

“The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives,” said June Raine, chief executive of the U.K.’s Medicines and Healthcare products Regulatory Agency. “What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.”

A different twist than the US: The United States is also working on updated vaccines for a possible fall booster campaign, though the shots might be slightly different.

The vaccine approved by the U.K. targets the first version of the omicron variant, known as BA.1
The U.S. Food and Drug Administration has instructed vaccine makers to target the more recent subvariants of omicron, known as BA.4 and BA.5.

The U.K. regulator on Monday said the updated Moderna vaccine was shown to provide a “strong immune response” against BA.1 as well as BA.4 and BA.5.

Read more here.

PFIZER CEO TESTS POSITIVE FOR COVID

Pfizer CEO Albert Bourla on Monday disclosed that he has tested positive for COVID-19 and will be going into isolation while he experiences “very mild symptoms.”

Bourla tweeted Monday morning that he had tested positive for COVID-19 despite having received four doses of his company’s COVID-19 vaccine.

The Food and Drug Administration (FDA) in March cleared the way for second coronavirus booster doses from Pfizer and Moderna to be administered to those over the age of 50 as well as immunocompromised individuals over the age of 12.

“I am thankful to have received four doses of the Pfizer-BioNTech vaccine, and I am feeling well while experiencing very mild symptoms. I am isolating and have started a course of Paxlovid,” he wrote.

Paxlovid is one of two COVID-19 antivirals that have been authorized for use by the FDA for the treatment of coronavirus, along with molnupiravir from Merck and Ridgeback.

Bourla, 60, added that he was confident that he would have a “speedy recovery” thanks to efforts that have been made over the past few years to combat the SARS-CoV-2 virus.

“I am incredibly grateful for the tireless efforts of my Pfizer colleagues who worked to make vaccines and treatments available for me and people around the world,” wrote Bourla.

Read more here.

NORTH DAKOTANS TO VOTE ON MARIJUANA LEGALIZATION IN NOVEMBER

North Dakota voters will decide this fall whether to legalize recreational marijuana, following the official certification of a ballot measure.

Secretary of State Al Jaeger (R) said his office determined that 23,368 signatures out of the submitted 25,000 were valid, clearing the ballot qualification threshold of 15,582 signatures needed.

Rules: If enacted, the measure will permit adults 21 and older to possess up to one ounce of cannabis and small quantities of cannabis products, such as concentrates and infused products.

It will also establish a regulatory system for registered cannabis businesses, run by the state Department of Health and Human Services or another agency designated by the Legislature.
The ballot measure would prohibit public consumption of marijuana. It would allow only 18 state-approved dispensaries and seven manufacturing facilities.

Trending: Adult-use legalization measures have already qualified for the 2022 ballot in Maryland, Missouri, and South Dakota. In addition, signatures have been turned in and are awaiting verification in Nebraska (medical only) and Oklahoma.

Read more here.

WHO renames two monkeypox variants

The World Health Organization (WHO) announced Saturday that it renamed variants of the virus monkeypox as it looks to counter concerns about the original naming conventions.

“Newly identified viruses, related diseases & virus variants are given names to avoid causing offence to any cultural, social, national, regional, professional, or ethnic groups, & minimize the negative impact on trade, travel, tourism, or animal welfare,” the WHO said in its announcement.

New names: The Congo Basin and West African variants were reclassified as Clade I and Clade II, the latter of which has two subclades. The new names go into effect immediately.

A global expert group decided on the new naming convention “as part of ongoing efforts to align the names of the monkeypox disease, virus, and variants—or clades—with current best practices.”

Going further: The WHO is also workshopping new names for the monkeypox virus as a whole, including the disease it causes, after outcry over potential stigmatization. The WHO cautioned early in the COVID-19 pandemic against referring to the virus as the “China virus” or the “Wuhan virus” due to potential discrimination.

WHAT WE’RE READING

Post-Roe, more Americans want their tubes tied. It isn’t easy. (The Washington Post)
Newly-launched U.S. drugs head toward record-high prices in 2022 (Reuters)
‘What aren’t we facing?’: Immunization leader lays bare challenges to the monkeypox response (Stat)
As fungal infections grow resistant to medication, desperate patients try drug after drug (NBC News)

STATE BY STATE

New York City officials host monkeypox town hall as disease continues to sweep city (ABC News)
All three Louisiana abortion clinics are leaving the state, staff say (WWNO)
Idaho colleges don’t have much freedom to move in a post-Roe climate (Idaho Education News)
‘Frustration and stress’: state officials fault rollout of monkeypox vaccine (New York Times)