Health Care — Democrats rev up their drug pricing push

The Stanley Cup, already dented from the Colorado Avalanche’s on-ice celebration, was delivered to the wrong house. (There are worse mistakes to find on your doorstep.)

Today in health care, we’ll look at some of the small revisions Senate Democrats have made to their drug pricing plan. And Democrats are hoping to have another go at including it in a larger economic legislative package.

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.

Revised pricing plan and a push for a larger package

A measure to lower drug prices, and President Biden’s larger economic package, are alive…for the moment.

• Senate Democrats plan to submit a revised proposal to lower prescription drug prices for a key procedural review in the coming days as they press forward with preparations for a vote on Biden’s economic package.
• Lawmakers have made some revisions to a deal to lower drug prices and plan to submit it to the Senate parliamentarian in the coming days for a review of whether it can pass muster with the chamber’s complicated rules for avoiding a Republican filibuster, a source familiar said. 

The big caveat: There is still no deal between Senate Majority Leader Charles Schumer (D-N.Y.) and Sen. Joe Manchin (D-W.Va.) on the other major pieces of the package: tax and energy policy.

Schumer has told senators that if a broader deal can be reached, the package could get a vote “as early as late July,” the source familiar said.

What’s in the proposal? There do not appear to be drastic changes to the drug pricing provisions that passed the House as part of its package in November, after a deal was reached with a group of moderate Democrats including Sen. Kyrsten Sinema (D-Ariz.).

The basics: 

• Allow Medicare to negotiate lower prices for a limited subset of older drugs 
• Prevent drug companies from raising prices faster than inflation
• Cap out of pocket drug costs for seniors on Medicare at $2,000 per year 

Read more here.  

Biden calls for filibuster carveout for abortion rights

President Biden on Thursday said the Senate should carve out an exception to the 60-vote filibuster to codify abortion rights after the Supreme Court overturned the precedent set by Roe v. Wade.

“The most important thing to be clear about is I believe we have to codify Roe v. Wade in the law, and the way to do that is to make sure the Congress votes to do that,” Biden said at a press conference at the NATO summit in Spain.

“And if the filibuster gets in the way, it’s like voting rights, it should be we provide an exception for this, requiring an exception to the filibuster for this action to deal with the Supreme Court decision,” Biden added.

• A change to the filibuster, which requires 60 votes in the Senate for most legislation to pass, would make it so that abortion rights or broader privacy rights like access to contraception and the right to same-sex marriage could be codified into law with a simple majority.
• The White House has so far expressed frustration with the decision, but it has offered few tangible measures to try to protect abortion access in the immediate aftermath of the ruling.

Read more here.

PFIZER ASKS FOR FULL FDA APPROVAL OF COVID PILL

Pfizer on Thursday announced it had submitted an application to receive full approval from the Food and Drug Administration (FDA) for its COVID-19 antiviral Paxlovid for use in high-risk individuals.

The FDA in December issued an emergency use authorization for Paxlovid to be used as treatment of mild-to-moderate COVID-19 in adults and children over the age of 12 who are at a high risk of developing cases that progress in severity.  

“As the COVID-19 pandemic continues to evolve and be highly unpredictable, we must remain vigilant in protecting those who are at greatest risk of getting very sick from COVID-19, as they remain vulnerable to potential hospitalization or even death,” Pfizer CEO Albert Bourla said in a statement.

According to Bourla, recently gathered data had “reinforced” Paxlovid’s importance as an oral treatment for the coronavirus. Data from Pfizer’s Phase 2/3 studies indicated that Paxlovid reduced the risk of hospitalization and death by 88 percent when compared to placebos among non-hospitalized, high-risk patients.

Read more here.

JUDGE TO TEMPORARILY BLOCK FLORIDA’S 15-WEEK ABORTION BAN

A judge on Thursday was set to temporarily block Florida’s 15-week abortion ban one day before it was set to go into effect. 

• The law, which is not a “trigger law” like other states have set up to take immediate effect upon Roe v. Wade’s reversal, is modeled after Mississippi’s own 15-week abortion ban that was heard in front of the Supreme Court and ultimately led to the decision in Roe being overturned.
• The American Civil Liberties Union (ACLU), one of the plaintiffs in the complaint against Florida, confirmed to The Hill that Leon County Circuit Judge John C. Cooper will be issuing a block on the abortion ban following a hearing on Thursday. 

What’s being blocked: The Florida law, signed by Gov. Ron DeSantis (R) in April, bans all abortions past 15 weeks with no exceptions for rape or incest. 

Under the law, exceptions can only be made when two physicians put in writing that an abortion is necessary to prevent death or severe physical harm to the mother, explicitly excluding potential harm to a woman’s psychological condition from that exception.

The ACLU noted in a statement that the ban will likely go into effect for a short period while the circuit court prepares its written order. 

Read more here. 

FDA: Omicron-specific boosters must target new strains

New COVID-19 booster shots should be tailored to target omicron’s BA.4 and BA.5 subvariants as well as the original strain in order to give people the broadest possible protection, U.S. regulators advised drugmakers on Thursday. 

• The announcement from the Food and Drug Administration (FDA) comes two days after an agency advisory panel recommended tailoring booster shots to target the omicron variant for a fall vaccination campaign.
• The BA.4 and BA.5 subvariants now account for the majority of new infections in the U.S., according to the Centers for Disease Control and Prevention.  

According to the FDA, currently available vaccines have helped reduce the most serious outcomes caused by COVID-19, but the effectiveness of primary vaccination wanes over time against certain variants, including omicron. The first booster doses helped restore that protection, but the effectiveness is also waning.

The Biden administration needs to give drug makers enough time to develop and adapt the new booster in time for the fall and winter, which is why they made the decision in June. 

Timing: Moderna told FDA’s advisory committee that it will take until late October or early November to create a vaccine targeting the BA.4 and BA.5 subvariants.  

Pfizer has already reported some success with a bivalent vaccine targeting the spike protein of the omicron BA.1 variant, and in a statement the company said it will have a BA.4/BA.5 vaccine ready to distribute to the world by early October 2022. 

Read more here