Overnight Health Care — Democrats face setback on drug pricing

by Peter Sullivan,Nathaniel Weixel and Justine Coleman - 09/15/21 6:50 PM ET

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

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@digital-stage.thehill.com), Nathaniel Weixel (nweixel@digital-stage.thehill.com) and Justine Coleman (jcoleman@digital-stage.thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.

Let’s get started.

Drug pricing vote fails in key panel

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.

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

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.

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.

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.

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.

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

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