Insights^

FDA Clears Moderna, Pfizer COVID-19 Booster Shots for All Adults

On Friday, the Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for both the Moderna and Pfizer COVID-19 vaccines to authorize booster shots for individuals ages 18 and older at least six months after their second dose.  Previously, boosters had been limited to people ages 65 and older, individuals with underlying medical conditions, and people deemed at-risk due to occupational and institutional exposure.  Later today, the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss whether to recommend boosters for all adults.  Due to rising case numbers, several states including California, Colorado, and Rhode Island preempted the FDA and CDC, and went ahead to recommend that all adults get booster shots.

Administration Finalizes Rule to Require Insurers to Share Data on Drug Costs

On November 17, the Biden administration issued an interim final rule outlining requirements for group and individual health insurance market plans to submit data on prescription drug costs to the federal government.  The data will then be used by the Department of Health and Human Services (HHS) to publish a report on drug pricing trends and their impact on insurance premiums and out-of-pocket costs.  However, the requirements won’t go into effect for some time – insurers will have until December 2022 to comply, and HHS won’t issue its first report until June 2023.  The rule implements provisions of the No Surprises Act and the Consolidated Appropriations Act of 2021.

Build Back Better Act Passes House, Faces Changes in Senate

On Friday, the House approved the Build Back Better Act by a 220-213 vote.  Rep. Jared Golden (D-ME) was the sole Democrat to vote against the $1.75 trillion measure, although he indicated he could support a final bill that includes changes to state and local tax (SALT) deductions.  Today’s vote followed a long Thursday that saw the release of the final score of the bill and ended with a record-breaking eight-and-a-half-hour speech by House Republican Leader Kevin McCarthy (R-CA).  The social and climate spending bill will now proceed to the Senate for consideration, where it could undergo further changes if the parliamentarian strikes provisions that are deemed unrelated to the federal budget.

Leahy, the Most-Senior Sitting Senator, to Retire

On November 15, Sen. Patrick Leahy (D-VT), the president pro tempore of the Senate and the chamber’s current longest-serving member, announced that he will not seek an additional term in 2022.  First elected to the Senate in 1974, Leahy has chaired the Agriculture, Judiciary, and Appropriations committees, and is currently the Chair of the Appropriations Committee after Democrats regained control of the Senate in the 2020 general election.  While Leahy has indicated as recently as May that he would seek a ninth term, he ultimately made the decision to retire and exclaimed that “it’s time to pass the torch.”  Of note, Leahy’s retirement announcement was followed by Rep. Jackie Speier (D-CA), who announced on November 16 that she will not seek an additional term.  Both Leahy and Speier occupy deep-blue seats representing Vermont and the San Francisco Bay Area respectively, that Republican are unlikely to flip.

ICYMI: DC’s Indoor Mask Mandate Ends on Monday

On November 16, Washington, DC Mayor Muriel Bowser announced that the city will drop its mask mandate for public indoor spaces beginning Monday, November 22.  In its place, Bowser said the city will adopt a new set of guidelines on indoor masking based on an individual’s level of risk and vaccination status.  Masks will still be required in certain settings regardless of vaccination status, including schools and childcare facilities, libraries, public transportation, and congregate facilities.  Additionally, private businesses will also maintain the option to impose their own mask requirements. (Xanax)

After Senate Hearing, Califf Poised to Lead FDA

Both Republicans and Democrats serving on the Senate Health, Education, and Labor, and Pensions (HELP) Committee signaled support for Robert Califf, MD in a December 14 nomination hearing for Commissioner of the Food and Drug Administration (FDA).  Ahead of the hearing, several Senators in the Democratic caucus including Bernie Sanders (I-VT) and Joe Manchin (D-WV) had expressed their opposition to Califf due to his response to the opioid crisis while serving as FDA commissioner in 2016-2017 and his ties to the pharmaceutical industry.  However, positive comments from the committee’s Republicans such as Ranking Member Richard Burr (R-NC) and Susan Collins (R-ME) indicates that Califf is likely to attract enough votes to secure his confirmation.  The HELP Committee is expected to vote on Califf’s nomination sometime in early 2022.

Standstill on Negotiations, Parliamentarian’s Review Delay Vote on BBB

A stalemate in negotiations between Sen. Joe Manchin (D-WV) and President Joe Biden means a vote on Democrats’ climate and social spending bill, known as Build Back Better (BBB), probably won’t come until sometime next year.  Given the Senate’s 50-50 split, Machin’s support is critical to securing the bill’s passage, and he has expressed concerns over the scope and size of the bill.  Adding to the delay is Senate Parliamentarian Elizabeth MacDonough’s ongoing review of BBB to ensure its provisions comply with the Byrd rule.  The review is likely to continue into next week and could face further delays due to MacDonough’s ongoing cancer treatment.

CMS: Government Assistance Helped Hospital Spending to Double in 2020

According to a report released by the Centers for Medicare and Medicaid Services (CMS) on Wednesday, health care spending rose 9.7% in 2020, more than double the 4.3% increase in 2019.  In the report, CMS researchers said financial assistance from federal programs like the Provider Relief Fund and Paycheck Protection Program accounted for most of the increase.  Notably, the jump in health care spending came as the economy contracted by 2.2%.  Other key findings from the report include a 3.7% drop in out-of-pocket costs in 2020 due to individuals using fewer health care services and a 3.5% decrease in private insurer spending in 2020 due to a decline in office visits and elective procedures.

Democratic Congressman Cites Potential GOP Takeover in Retirement Decision

On December 16, Rep. Alan Lowenthal (D-CA) announced that he will not seek reelection in 2022, bringing the total number of incumbent Democrat Representatives who are not running for reelection next year to 19.  Originally a psychology professor, Lowenthal began his career in public service with his election to the Long Beach City Council in 1992, followed by a 14-year stint in the California State Legislature and his election to Congress in 2012.  In an interview with the Long Beach Post, Lowenthal said the prospect of Republicans regaining a majority in the House in next year’s midterm election as well as a desire to spend more time with family factored into his decision to retire.  Lowenthal was known for his dedication to protecting the planet while serving on committees focused on transportation, natural resources, and the environment.

ICYMI: DC Faces Champagne Shortage Thanks to Weather, Supply Chain Issues

New Year’s Eve revelers in the nation’s capital might have a tough time finding top-self champagne to ring in 2022 thanks to subpar weather in France’s Champagne region, according to some DC-area liquor suppliers.  And it’s not just champagne – folks in the beverage industry say a shortage of truck drivers and glass have made it difficult to source other liquors like bourbon.  Until things change, DC-area beverage purveyors suggest consumers try different brands of champagne and other alcoholic beverages during the holiday season.

A new era in treating COVID-19 could be upon us. On November 30, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss Merck’s request for an emergency use authorization (EUA) for Molnupiravir, an  oral antiviral drug to treat COVID-19.  But Molnupiravir isn’t the only oral COVID-19 antiviral in the mix – in October 2021, Pfizer requested an EUA for Paxlovid, its antiviral pill.  If FDA advisors recommend an EUA for Molnupiravir, and eventually Paxlovid, could it change the course of the pandemic as we know it?

The FDA has already authorized a few treatments for COVID-19, but they have serious drawbacks.

• Remdesivir the only treatment to have received full FDA approval, has limitations.  For example, it has to be administered intravenously (meaning it’s difficult to provide in an outpatient setting), it’s expensive (about $2,600 for a three-day regimen), and recent research says it’s not very effective.
• Monoclonal antibodies, which have received an EUA from the FDA, offers another treatment option. While studies show monoclonal antibodies are effective at reducing hospitalization and death, they suffer from many of the same drawbacks as remdesivir – they still have to be provided intravenously, and they’re still expensive (about $2,000 per treatment).

Enter Molnupiravir and Paxlovid. Both antiviral drugs stop SARS-CoV-2, the virus that causes COVID-19, from replicating in the body, but do so in different ways.  Molnupiravir, which was first developed as a flu treatment, works by fooling the virus’s RNA into creating mutations that render the virus unable to survive.  Paxlovid takes a different approach by disrupting the virus’s replication by destroying enzymes vital to its reproduction.

Both treatments offer clear advantages compared to their predecessors. A prominent advantage is early intervention, which is key to administering antiviral treatments.

• Severe COVID-19 has two stages – one where the virus initially infects a person, and another when the immune system overreacts and spirals out of control. Remdesivir is typically administered in the second phase, when a patient is already hospitalized – and the damage may already be done.
• Molnupiravir and Paxlovid, on the other hand, attack the virus before it can wreak havoc and put people in the hospital, avoiding further stress on the health care system.

Additionally, both antiviral pills can be administered orally, meaning patients can take them in any setting. And unlike intravenous treatments, Merck and Pfizer’s antiviral drugs are much easier to ship and store.

• Oh, and about that name. Molnupiravir comes from Mjölnir, the mythical hammer of the Norse god Thor.

Plans for distribution of the antiviral pills are shaping up.  The Biden administration purchased 1.7 million courses of Molnupiravir for $1.2 billion back in June and is now considering options to buy 1.4 million more.  Based on this agreement, Molnupiravir will cost roughly  $700 per patient, a more than 50% reduction from currently approved treatments.

Additionally, the administration is planning to buy enough courses of Paxlovid for 10 million people.  To allow their drugs to be manufactured around the globe and sold at lower prices in poorer countries, both Merck and Pfizer have entered into license-sharing agreements.

However, Molnupirabir and Paxlovid aren’t magic bullets, and while they are far better than currently approved treatment options, they still have limitations of their own.

• First, both have a strict dosing regimen.  Each must be taken over a five-day period, with Molnupiravir taken four times a day and Paxlovid taken three times a day.
• Second, both antivirals must be taken within the first five days of illness.  Unfortunately, a lack of access to both rapid at-home antigen tests and testing labs that can quickly process PCR results means the onset of symptoms, a positive test result, and a prescription for an oral antiviral may exceed the five-day window. (https://swatlyoga.com)
• Third, there are questions about the efficacy of the oral antivirals.  Merck originally reported in October 2020 that Molnupiravir reduces risk of hospitalization or death by 50%.  However, in November, updated data from Merck revealed that its antiviral only cut the risk of hospitalization and death by 30%.  Pfizer says that Paxlovid reduces the risk of hospitalization and death by 89%, but these results have yet to be peer-reviewed.

Despite these limitations, both Molnupiravir and Paxlovid could be the most important pharmaceutical development since the introduction of vaccines. However, just like vaccines won’t make a difference until people get their shots, new antiviral pills won’t help unless people take them. If the administration wants to ensure oral antivirals are utilized effectively , it needs to drastically improve the testing infrastructure and ensure adequate distribution to suppliers. Doing so will ensure as many people as necessary have access to antivirals and allow the new drugs to be an effective additional tool to fight the pandemic.

FDA Panel Recommends Pfizer Vaccine for Children Ages 5-11

On October 26, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend amending Pfizer’s Emergency Use Authorization (EUA) to allow its COVID-19 vaccine to be administered in children ages 5-11.  Pfizer has reduced its vaccine dose for children under 12 to one-third of the adult dose and said clinical trials show the lower dose is over 90% effective in preventing symptomatic COVID-19 in children.  Although the vote was unanimous (with one abstention), there was some discussion on weighing the benefits of vaccination against potential risks, namely rare instances of heart inflammation.  Before the vaccine actually becomes available to kids under 12, it will be reviewed by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) on November 2-3, and the CDC director will need to sign-off on the ACIP’s decision.

Dems Release New $1.75T Reconciliation Proposal

On October 28, the House Rules Committee released the text of a new $1.75 trillion social spending and climate bill, a far cry from the $3.5 trillion budget resolution approved by Congress earlier this year.  Notable provisions of the bill include investments in affordable housing, an extension of the child tax credit, and an extension of Affordable Care Act (ACA) premium tax credits through 2025.  Notable provisions that were left out of the legislation, include paid family leave, prescription drug reform, and SALT. Since the proposal’s announcement, Sinema has issued a supportive yet noncommittal statement on the text, while Machin has declined to indicate his position. Based on the noncommittal responses from the Senators and wanting more time to read through the newly released text, the Congressional Progressive Caucus did not quite sign off on the reconciliation bill, which now has led to the delay in passing the bipartisan infrastructure bill.

Biden, Obama Get Involved with Consequential Virginia Gubernatorial Race

Over the past week, both President Joe Biden and former President Barack Obama have separately campaigned alongside Virginia Democratic gubernatorial candidate and former Governor Terry McAuliffe as polls show that McAuliffe is neck-and-next with his Republican opponent Glenn Youngkin.  While Virginia has voted for the Democratic presidential candidate in every general election since 2004, Virginia’s off-year gubernatorial rate is widely seen as a bellwether for the midterm elections. Democrats are worried about an upset similar to Republican candidate Bob McDonnell’s victory in 2009 for the governorship of Virginia, which preceded historic midterm election losses for the party in the House of Representatives the following year.  While former President Donald Trump has endorsed Youngkin, the two have not made any joint campaign appearances.

CDC Okays Fourth Booster Shot for Immunocompromised

On October 25, the CDC quietly updated its COVID-19 vaccine guidelines to allow “moderately or severely immunocompromised” people to receive a fourth “booster” dose six months after their third booster dose.  Back in August, the FDA and CDC recommended third booster shots for immunocompromised who had been initially vaccinated with the two-dose Pfizer and Moderna vaccines.  The CDC’s rationale for the new guidelines is to combat waning immunity and to account for the fact that immunocompromised people do not generate the same immune response to mRNA COVID-19 vaccines as people with healthy immune systems. The guidelines will impact an estimated 2.7 million immunocompromised Americans, according to the CDC.

Lawmakers Celebrate Third-Annual “Bipawtisan” Halloween Parade

On Wednesday, members of Congress gathered in the Hart Senate Office Building for the third-annual “bipawtisan” Halloween parade, which featured lawmakers’ dogs in costumes.   Sen. Thom Tillis (R-NC), who started the parade back in 2018, brought along his two pups who were respectively dressed as Senate Majority Leader Mitch McConnell (R-KY) and Sen. Kyrsten Sinema (D-AZ).  Other notable costumed canine include the dog of Sen. Mitt Romney (R-UT), who appeared as “Pierre Doglecto,” which is a play on his owner’s anonymous Twitter account.   Additionally, Rep. Sara Jacobs (D-CA) brought her pup Nan, who was dressed as Speaker Nancy Pelosi (D-CA).

ICYMI: Sinema’s Denim Vest Draws Reactions

On Tuesday, Sen. Kyrsten Sinema (D-AZ) sparked controversy when she wore a denim vest while presiding over the US Senate.  The attention over Sinema’s sartorial choices comes as the Senator is under increased scrutiny for her role in negotiations over the Democrats’ social and climate spending bill.  While the denim vest might be different from the attire usually spotted on the Senate floor, it’s not out of character for Sinema.  The senior Arizona Senator is known for her eccentric fashion choices, which have ranged from colorful wigs to backpacks.  Notably, journalists in the Senate press gallery are prohibited from wearing denim.

FDA Authorizes Moderna, J&J Boosters, Approves Mixed Booster Regimens

On October 20, the Food and Drug Administration (FDA) authorized “booster” shots for people who initially received vaccines from Moderna and Johnson & Johnson (J&J).  Moderna recipients will be eligible for a third dose six months after their second shot if they’re age 65 or older, between ages 18-64 and are at risk of severe complications from COVID-19, or have frequent “occupational exposure” to the virus.  However, all J&J vaccine recipients will be eligible for a booster at least two months after their initial shot, likely due to the J&J vaccine’s lower efficacy.  Of note, the FDA also authorized a “mix-and-match” approach that allows people to receive a vaccine as a booster dose that’s different from the vaccine used in their initial vaccination regimen.  On October 21, a Centers for Disease Control and Prevention (CDC) advisory panel issued booster shot recommendations that were aligned with the FDA’s authorization.

Two Longtime House Dems Announce Retirement

Earlier this week, Reps. David Price (D-NC) and Mike Doyle (D-PA), both of whom have served in Congress for over 20 years, announced they will not seek an additional term in the 118^th Congress.  Their announcements came just a week after House Budget Committee Chairman John Yarmuth (D-KY) announced that he will not be running for reelection.  While all three Democrats represent safe Democratic districts, their retirements are stoking fears that the party is facing an increasingly uphill battle to maintain its majority in the House in the next Congress.  Already, five Democrats who represent competitive districts have announced their retirement plans.

House Dems Inch Toward $2T Reconciliation Framework, but Questions Remain

Leading House Democrats left a closed-door meeting on Wednesday saying they’re optimistic that they could reach an agreement on a $2 trillion reconciliation package as soon as the end of the week.  Scaling down the package from its originally proposed $3.5 trillion level would require significant changes, and President Biden, suggested on Tuesday in meetings with House Democrats, that two years of free community college and lifting the cap on the state and local tax (SALT) deduction could be dropped from the final measure.  However, Democrats representing high cost-of-living districts in the Northeast have said they won’t support a broader reconciliation package without restoration of the SALT deduction. Also, centrist Sen. Joe Manchin (D-WV), whose vote is essential for ensure passage in the Senate, is staying firm on his demand for no more than $1.5 trillion in new spending.

Senate, House Dems Differ on ARPA-H Funding Levels, Placement

The Biden administration’s proposal to create an Advanced Research Projects Agency for Health (ARPA-H) to drive innovation in biomedical research is advancing in Congress, albeit under two different approaches.  On October 18, the Senate Appropriations Committee released a bill that would provide $2.4 billion to the new agency for Fiscal Year (FY) 2022.  However, there are two bills in the House that offer a different FY 2022 funding level for ARPA-H.  House Energy and Commerce Health Subcommittee Chairwoman Anna Eshoo (D-CA) just recently introduced a bill that would provide the new agency $3 billion for FY 2022, the same amount that the House included in its FY 2022 appropriations minibus it passed in July.  Additionally, both chambers differ on the placement of ARPA-H.  The Senate appropriations bill would house the new agency under the National Institutes of Health (NIH), while Eshoo’s bill would make ARPA-H an independent agency within the Department of Health and Human Services (HHS).

ICYMI: Paris Hilton Meets with Lawmakers on Capitol Hill

On Wednesday, actress and socialite Paris Hilton hosted a press conference on Capitol Hill, where she called on President Biden and Congress to take action against congregate care facilities that abuse children.  Hilton, who endured abuse as a teen in a psychiatric youth treatment center in Utah, appeared with other survivors in Washington to advocate for the Accountability for Congregate Care Act.  During her visit, Hilton met with Sen. Mitt Romney (R-UT), Sen. Jeff Merkley (D-OR), and Rep. Ro Khanna (D-CA).