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Politics Overnight Health Care — Democrats face setback on drug pricing

02:51  16 september  2021
02:51  16 september  2021 Source:   thehill.com

Medicare drug prices: White House plan to lower drug costs supports letting Medicare negotiate prices

  Medicare drug prices: White House plan to lower drug costs supports letting Medicare negotiate prices The Biden administration is lending its weight to congressional Democrats' controversial push to allow Medicare to negotiate drug prices. © Photo Illustration: Shutterstock/CNN The measure is a key pillar of the White House's plan to lower prescription drug prices that was released Thursday and comes as the House starts tackling the issue as it crafts a $3.5 trillion budget reconciliation plan. The Senate Budget Committee last month recommended that the plan, which would not need Republican support if it is passed through reconciliation, reduce drug costs for patients.

Welcome to Wednesday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.

Overnight Health Care — Biden defends push for vaccine mandates

  Overnight Health Care — Biden defends push for vaccine mandates Welcome to Friday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.Remember the zebras? They're still on the loose following an escape from a D.C. suburb in Maryland, but Del. Eleanor Holmes Norton (D-D.C.) says despite her support for freedom and opposition to fences, she has a "solid" alibi and was not involved.President Biden is forcefully defending his move on vaccine mandates in the face of Republican outcry. He's also received support from the business community.For The Hill, we're Peter Sullivan (psullivan@thehill.

a stack of flyers on a counter: Overnight Health Care — Democrats face setback on drug pricing © iStock Overnight Health Care — Democrats face setback on drug pricing

It's been over a week, and the zebras running loose in Maryland-which were definitely not freed by Eleanor Holmes Norton- are still out there. Be safe!

Three Democrats in the House voted against a drug pricing amendment, throwing the party's signature plan to lower the cost of prescription drugs into question.

For The Hill, we're Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.

3 Key Divides in Democrats’ Civil War Over the Biden Agenda

  3 Key Divides in Democrats’ Civil War Over the Biden Agenda It’s not just progressives versus moderates.Joe Biden may have less room for error.

Let's get started.

Drug pricing vote fails in key panel

Kurt Schrader holding a microphone © Provided by The Hill

Democrats' signature legislation to lower drug prices was defeated in a House committee on Wednesday as three moderate Democrats voted against their party.

Reps. Kurt Schrader (D-Ore.), Scott Peters (D-Calif.) and Kathleen Rice (D-N.Y.) voted against the measure to allow the secretary of Health and Human Services to negotiate lower drug prices, a long-held goal of Democrats.

The vote is a striking setback for Democrats' $3.5 trillion package. Drug pricing is intended to be a key way to pay for the package.

It's far from over: Leadership can still add a version of the provision back later in the process, but the move shows the depth of some moderate concerns. A separate committee, the House Ways and Means Committee, did advance the drug pricing measures on Wednesday, keeping the provisions in play for later in the process.

Moderate House Democrats threaten drug pricing bill in House panel

  Moderate House Democrats threaten drug pricing bill in House panel Three moderate House Democrats announced that they would vote against their party's legislation to lower drug prices in committee on Tuesday, threatening a defeat for one of Democrats' signature measures. Reps. Kurt Schrader (D-Ore.), Scott Peters (D-Calif.) and Kathleen Rice (D-N.Y.) announced in separate statements on Tuesday that they would vote against the section of Democrats' $3.5 trillion package dealing with lowering drug prices during a markup in the House Energy and Commerce Committee, which is currently ongoing.

Big picture: Changes were coming anyway. The House legislation was already expected to change before the final version, given moderate Democratic concerns in the Senate as well. Senate Democrats are working on their own bill, which is not yet finalized but is expected to be less far-reaching.

Read more here.

FDA spurs more debate over boosters

  Overnight Health Care — Democrats face setback on drug pricing © Provided by The Hill

Food and Drug Administration (FDA) scientists on Wednesday did not immediately endorse the evidence that a booster dose of the Pfizer-BioNTech COVID-19 vaccine was necessary for all Americans who received the shot.

The highly anticipated review, posted online ahead of an agency advisory meeting Friday, took a largely neutral tone. Agency staff sounded a skeptical note on the evidence presented by the drug company and noted that all available data has not been submitted or reviewed yet.

"Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States," scientists said in a briefing document.

Overnight Health Care — Nicki Minaj stokes uproar over vaccines

  Overnight Health Care — Nicki Minaj stokes uproar over vaccines Welcome to Tuesday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.Rap star Nicki Minaj is under scrutiny from many critics for tweeting about her decision not to get the COVID-19 vaccine, and for promoting an unsubstantiated story to her millions of followers."She should be thinking twice about propagating information that really has no basis as except a one-off anecdote," White House chief medical adviser Anthony Fauci told CNN's Jake Tapper. "That's not what science is all about.

The FDA's independent panel of experts on Friday will review the evidence from Pfizer and will likely vote on whether there's enough evidence to show boosters are necessary. FDA staff didn't tip their hand, so Friday's debate could be contentious.

The FDA does not have to follow the agency's advice, but if the agency breaks with the panel's recommendation it would likely stoke public confusion and raise major questions about political interference.

Pfizer's argument: In making its case for a third dose, Pfizer argued that protection against COVID-19 infection wanes primarily because of time, rather than because of the delta variant.

Pfizer cited evidence from lab studies as well as real-world data from Israel, which has been administering boosters to people over 60 since the end of July. The country recently expanded boosters to people over age 30.

"The totality of the available data supports the public heath need for a booster [third] dose ... at approximately 6 months after the second dose" for individuals 16 years of age and older, Pfizer wrote.

Senate approval for drug pricing reforms will be uphill battle, advocates warn

  Senate approval for drug pricing reforms will be uphill battle, advocates warn Efforts to push a proposal for direct drug pricing negotiations between the government and pharmaceutical companies over the finish line will face a steep uphill battle, liberal health reform groups warn. © Provided by Washington Examiner Big Pharma is a monopoly industry, according to David Mitchell, founder of Patients For Affordable Drugs NOW. “By definition, monopolies have unlimited power because if they need more money for campaign contributions or ads or lobbying, they can just raise prices," he said. "This is a very, very difficult uphill fight, and no one ever expected anything else.

The view from Israel: Citing the Israeli data, Pfizer said that a third dose restores protection from infection to 95 percent in a real-world setting, the same level of protection at the end of the initial dosing regimen. The data was collected from July 1 through Aug. 30, a period when the delta variant was spreading.

Biden administration officials have been making the case for booster shots based on data from Israel, which they say indicates a substantial drop in protection against both infection and severe disease. The U.S. evidence only shows a decrease in protection against mild disease, but not against severe disease. Israeli health officials are scheduled to present data Friday.

Read more here.

Drug companies on verge of sinking longtime Democratic priority

  Drug companies on verge of sinking longtime Democratic priority The pharmaceutical industry is on the verge of defeating a major Democratic proposal that would allow the federal government to negotiate drug prices.Speaker Nancy Pelosi (D-Calif.) can afford only three defections when the House votes on a sweeping $3.5 trillion spending package, but Reps. Scott Peters (D-Calif.), Kurt Schrader (D-Ore.) and Kathleen Rice (D-N.Y.) last week voted to block the drug-pricing bill from advancing out of the Energy and Commerce Committee. Rep. Stephanie Murphy (D-Fla.) voted against advancing the tax portion of the legislation in the Ways and Means Committee.

US MANDATING COVID-19 VACCINES FOR NEW IMMIGRANTS

The Biden administration will begin requiring immigrants to be fully vaccinated against the coronavirus before they can become permanent residents.

Starting Oct. 1, proof of vaccination will be required as part of the general medical examination form that requires would-be residents "to show they are free from any conditions that would render them inadmissible under the health-related grounds."

The U.S. already requires those seeking residency to have a number of other vaccinations, including those for measles, mumps, rubella and chicken pox.

Overnight Health Care — Presented by Indivior — Biden makes global COVID-19 push

  Overnight Health Care — Presented by Indivior — Biden makes global COVID-19 push Welcome to Wednesday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.Still have questions about how the COVID vaccines work? A new PSA from Seth MacFarlane's "Family Guy" will help answer them. It even impressed the former Surgeon General.President Biden convened a global COVID-19 summit to push for greater action to vaccinate the world, while some advocates said the effort is still coming up short.For The Hill, we're Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com).

The requirement allows for exemption for medical and religious reasons. Children are also exempted from the order.

Follows: The Wednesday announcement from U.S. Citizenship and Immigration Services follows an announcement from President Biden that private businesses with more than 100 employees must mandate the coronavirus vaccine or weekly testing for their workforce.

Read more here.

NIH awards $470M to study long COVID-19

text © Provided by The Hill

The National Institutes of Health (NIH) awarded almost $470 million to New York University (NYU) Langone Health to build a national study population of tens of thousands of people to research the long-term effects of COVID-19.

Officials aim to enroll between 30,000 to 40,000 participants as part of a combined population of new and existing study groups, in a meta-cohort called Recover, to investigate the mystery surrounding long COVID-19.

The NIH's goal represents a "substantial" boost in participants from typical cohort studies with an "ambitious" enrollment timeline of 12 to 18 months, officials said.

"Normally it would take two or three or four years to set up something like this, given the scale," NIH Director Francis Collins said during a briefing. "But given the urgency, we have moved to put this together considerably faster but without sacrificing rigor."

Why it matters: Cases and stories of long COVID-19 have emerged throughout the pandemic with the Centers for Disease Control and Prevention (CDC) estimating that 10 to 30 percent of people infected with the virus experience symptoms lasting at least one month. With more than 41 million confirmed cases in the U.S., the estimate suggests millions could be affected by long COVID-19.

"This is really the only way that we're going to have truly meaningful results for patients with regard to this broad and complex set of symptoms," said Amy Patterson, the deputy director of clinical research and strategic initiatives at the National Heart, Lung, and Blood Institute.

Read more here.

PHRMA LAUNCHES A BIG NEW AD CAMPAIGN

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced Wednesday that it is launching a seven-figure ad campaign against the proposals moving through Congress to lower prescription drug prices.

The group also released an open letter signed by the heads of all of its member companies pointing to the COVID-19 vaccines and treatments developed by the industry and arguing the proposals would "sacrifice future medical advances."

The moves are part of an aggressive campaign against the measures to lower drug prices backed by congressional Democrats, which threaten to take a large chunk of money out of the pharmaceutical industry.

In its ad, PhRMA states that the new drug pricing measure would mean politicians would be deciding what "medicines you can and can't get."

"Politicians say they want to negotiate medicine prices in Medicare," the new ad states. "But make no mistake: What politicians mean is they'll decide which medicines you can and can't get."

Tricia Neuman, a Medicare expert at the Kaiser Family Foundation, pushed back on that claim, noting that the legislation in Congress would not allow the government to decide not to cover certain drugs.

"The bill working its way through Congress focuses on drug prices," Neuman wrote in an email. "There's really nothing in the proposal that would allow the government to decide which medications people on Medicare can get."

Read more here.

WHAT WE'RE READING

  • At the besieged FDA, 'it never stops!' as decisions loom on boosters, pediatric shots and more (The Washington Post)
  • As COVID-19 vaccine mandates rise, religious exemptions grow (The Associated Press)
  • Over half of states have rolled back public health powers in pandemic (Kaiser Health News)

STATE BY STATE

  • 6th child dies of COVID in Missouri as official vows change (The Associated Press)
  • Indiana ICUs stressed by COVID-19 surge gripping the state (Chicago Tribune)
  • Alabama saw more deaths in 2020 than any year in history (AL.com)

OP-EDS IN THE HILL

  • Anthrax was the COVID-19 of 2001

That's it for today, thanks for reading. Check out The Hill's healthcare page for the latest news and coverage. See you Thursday.

Overnight Health Care — Presented by Indivior — Biden makes global COVID-19 push .
Welcome to Wednesday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.Still have questions about how the COVID vaccines work? A new PSA from Seth MacFarlane's "Family Guy" will help answer them. It even impressed the former Surgeon General.President Biden convened a global COVID-19 summit to push for greater action to vaccinate the world, while some advocates said the effort is still coming up short.For The Hill, we're Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com).

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