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What Happened, What You Missed: November 15-19

  • Posted In FDA

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)

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What Happened, What You Missed: December 13-17

  • Posted In FDA

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.

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Famous Felines in the White House

President Harry Truman famously said, “if you want a friend in Washington, get a dog.”  The 33rd president’s quote especially rings true in the White House, where 33 presidents have owned dogs as pets.  However, plenty of cats have called the White House home, and many have stories as interesting as their canine counterparts.

Dogs versus cats in the US: By sheer numbers, cats are more popular than dogs in America.  According to a 2020 survey by the American Pet Products Association, there are 88.3 million cat’s owners compared to the 74.4 million owners who have dogs.  By volume, however, fish are the most common pets, clocking in at nearly 152 million.

So, it should not be surprising that a few felines have enjoyed their time in the White House and here are some notable examples of the 11 US presidents who have owned cats.

  • Abraham Lincoln.  When Mary Todd Lincoln was asked if her husband had a hobby, she replied, “cats.”  In addition to the two cats he kept in the White House named Tabby and Dixie, Lincoln was known to bring in strays.
  • Theodore Roosevelt.  The 26th president had two six-toed cats named Slippers and Tom Quartz (the latter was named after a character in a Mark Twain book).  Slippers was known for sleeping sprawled out in the middle of hallways, causing guests of a state banquet to walk around her on one occasion.
  • Calvin Coolidge.  “Silent Cal” was an avid cat lover who purportedly saved a litter of kittens from being drowned as a young boy.  While serving as president, Coolidge had at least four cats at the White House – Tiger, Blackie, Timmy, and Smokey.  Coolidge originally brought Tiger (or “Tige” as he was nicknamed) to Washington from his farm in Vermont, and he frequently walked around the White House with Tiger draped around his neck.  After Tiger sneaked out of the White House in March 1924, Coolidge directed the Secret Service to issue a radio broadcast on the missing cat.  A listener eventually spotted Tiger sleeping near the National Mall and brought him back to the White House in a taxicab.
  • Rutherford Hayes, Gerald Ford, and Jimmy Carter.  All three presidents brought Siamese cats into the White House.  Hayes’ cat Siam was one of many animals to occupy the Executive Mansion at the time, while Ford gifted a cat named Shan to his daughter for Easter.  Carter’s cat was named Misty Malarky Ying Yang, which inspired the name of a Gabor Szabo song.
  • Bill Clinton.  A stray, bicolor cat reportedly jumped into the arms of Chelsea Clinton as she was leaving her piano teacher’s house 1991.  Chelsea named the cat Socks, and the rest is history.  During his time in the White House, Socks became somewhat of a pop culture figure, having been the subject of a Murphy Brown episode and a virtual “guide” to children visiting the White House website.  Socks enjoyed sitting on the president’s shoulders, and he even had his own carrying case emblazoned with the presidential seal.  After the Clintons left the White House, Socks went to live with a staffer named Betty Currie  in Maryland, where he died in 2009 at the age of 20.
  • George W. Bush.  George and Laura Bush adopted a black cat in 1991 who they named India after a Texas Rangers baseball player nicknamed “El Indio.”  India, who wasn’t as well known as the Bushes’ Scottish terriers, died in January 2009, just weeks before the Obamas moved into the White House.  The Bushes also had a six-toed cat named Ernie but gave him away to a friend before moving to Washington because of his tendency to claw furniture.

What about the Bidens?  For now, the First Family has two German Shepherds, Major and Champ.  However, the First Lady announced in April 2021 that they plan on adopting a cat from a local shelter but, there have been no updates since then. Therefore, the question remains unanswered on whether the White House will have a feline occupant for the first time since 2009.

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Why Aren’t Rapid COVID-19 Tests More Readily Available in the US?

“Should we just send one to every American?”  That’s what White House Press Secretary said on December 7 when asked during a press briefing why more Americans don’t have access to rapid antigen tests. Psaki’s response – which many deemed sarcastic – sparked a wave of backlash from members of the medical community who think that’s exactly what the Biden administration should do and make tests available to everyone at no cost.  So why isn’t the administration doing it?

Rapid tests are seen as an important public health tool for reducing the spread of COVID-19 because they can be used at home by an individual and provide results in as little as 15 minutes.  While not as accurate as PCR tests, rapid tests are available over- the-counter, which makes it easier and more convenient for people to get access tests.  And more people taking rapid tests would mean identifying more COVID-19 cases than would otherwise be possible with only PCR testing. Having an increase in access to rapid tests could also make forthcoming COVID-19 antiviral pills more useful, since their effectiveness depends on being taken within the first five days of illness.  Due to the convenience of rapid tests and their potential to stop the spread of COVID-19, some public health experts have pointed to over-the-counter tests as a way to potentially control the pandemic and return to “normal life.”

Currently, the availability of rapid tests in the US pales in comparison to other wealthy nations, where people can readily access tests at little or no cost.  In Germany, rapid tests are available in grocery stores for less than $1, while people in the United Kingdom can request mail-order rapid tests free-of-charge.

Here are some of the reasons why Americans can’t get rapid tests as easily as Germans or the British.

  • Regulatory issues.  Some manufacturers say the regulatory framework on rapid tests is too stringent because it requires test performance benchmarks to be at the same level of PCR tests, which test developers say is too high.  Additionally, US standards for approval are higher compared to some other peer nations, including the UK.
  • Supply chain problems.  There has been a consistent shortage of raw materials used to manufacture the diagnostic components of at-home tests.  Additionally, low COVID-19 case numbers during the summer caused some manufacturers like Abbott to pull-back on test production, leaving the company unable to keep up with increased demand for tests once case numbers began to jump in July 2021.
  • Lack of federal investment.  While the US government has invested billions of dollars into the development of vaccines, much less has been put towards the development and purchase of rapid tests.  In contrast, countries like the UK and Germany invested billions in both vaccines and at-home tests.

Fortunately, rapid tests are a part of the Biden administration’s plans to combat COVID-19.  On December 2, President Joe Biden announced that insurance companies will soon reimburse individuals who buy over-the-counter rapid tests.  Other recent actions the administration has taken include investing $650 million to strengthen manufacturing capacity for rapid tests and a $70 million investment to develop an accelerated pathway within the Food and Drug Administration (FDA) to evaluate rapid tests.

But…rapid tests might not make a huge difference, anyway.  While rapid tests were frequently lauded by public health officials as a way to curb the pandemic, real-world evidence in countries where rapid tests are readily available suggests otherwise. In Germany, infections, hospitalizations, and deaths have increased dramatically since October, while the UK has seen COVID-19 case numbers grow since restrictions were fully lifted in July (although hospitalizations and deaths remain low).

And even though Biden recently committed to new investments in testing, which could result in 300 million new rapid tests per month, it would still amount to less than one test per month per person in the US.

While convenience of rapid tests is undeniable, a boost in the availability of tests might accomplish little in the US, where most of the country is already grappling with a surge of new cases.

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What Happened, What You Missed: December 6-10

Pfizer Says Three Vaccine Doses Are Effective Against Omicron

Pfizer announced on Wednesday that three doses of its COVID-19 vaccine – two initial doses plus a booster dose – neutralized the Omicron variant at levels comparable to what two doses against earlier variants like Alpha and Delta.  While the preliminary data cited by Pfizer says two doses offer significantly less protection against infection from Omicron, the company is confident that two doses will still offer strong protection against hospitalization and death from the new variant.  While Pfizer’s announcement is encouraging, their findings on the effectiveness of their vaccine against Omicron has yet to be peer-reviewed or published in a scientific journal. Also, researchers are still studying how well vaccines work against the variant in the real world.

Surgeon General: American Youth Are Facing Mental Health Crisis

In an advisory issued on December 7, US Surgeon General Vivek Murthy stated that American youth are facing a mental health crisis.  In addition to the COVID-19 pandemic, which has exacerbated existing mental health problems, the advisory cites other sources of stress including gun violence, climate change, racism, and social conflict.  In an interview, Murthy said the US cannot wait until the end of the pandemic to address the mental health crisis.  Some of the advisory’s recommendations include addressing economic and social barriers that contribute to poor mental health, ensuring every child has access to high-quality, affordable mental health care, and recognizing that mental health is a crucial component of overall health.

Nunes Resigns from Congress to Lead Trump’s New Media Company

On December 6, Rep. Devin Nunes (R-CA) announced he will resign from Congress at the end of 2021 to become the CEO of the Trump Media & Technology Group, which is a recently formed media company that former President Donald Trump founded.  His announcement comes amid a redistricting process in California, where draft maps were likely to change his congressional district from majority Republican to majority Democratic.  Nunes (pronounced NEW-ness), who has represented California’s San Joaquin Valley in Congress since 2003, is the second highest-ranking Republican on the House Ways and Means Committee, and he would have been poised to chair the powerful committee if the GOP retakes the House majority next year.  California Governor Gavin Newsom, a Democrat, will call a special election to fill the remainder of Nunes’ term once he officially steps down.

Senate Clears Bill to Raise Debt Ceiling by Simple Majority

On Thursday night, the Senate passed a bill in a 59-35 vote that would allow Senate Democrats to raise the debt ceiling by a simple majority vote.  Thursday’s vote is the result of a one-time agreement between Senate Majority Leader Chuck Schumer (D-NY) and Republican Leader Mitch McConnell (R-KY) to tweak Senate rules and allow the Senate to advance the measure without any GOP votes.  Next week, the House and Senate plan to pass another bill that will actually raise the debt ceiling by at least $30 trillion to prevent the federal government from defaulting on its debt obligations.  Of note, last night’s bill would also avert billions of dollars in looming Medicare cuts to providers.

ICYMI: RIP Senator Bob Dole

Earlier this week, former Sen. Bob Dole (R-KS) passed away in his sleep at the age of 98.  The former Senator was a decorated World War II veteran, served in both chambers of Congress for a total of 36 years, served as the Republican Majority leader, and was a presidential candidate in 1996.  During his tenure in Congress, Sen. Dole worked across the aisle to advance Social Security, protect the disabled, and reworked the Supplemental Nutrition Assistance Program, amongst many other issues. He was laid in state at the US Capitol on Thursday where President Biden and congressional leaders paid their respects to honor his memory. President Biden in his remarks stated, “America has lost one of our finest patriots [and Dole] too was a giant of our history, and that’s not hyperbole.” A formal departure from the Capitol will be held early Friday morning ahead of a funeral at Washington National Cathedral and ceremony at the World War II Memorial.

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