What Happened, What You Missed: September 5-9

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Becerra Authorizes FDA to Issue EUAs for Monkeypox Tests 

Health and Human Services (HHS) Secretary Xavier Becerra issued an emergency declaration on Wednesday to allow the Food and Drug Administration (FDA) to issue emergency use authorizations (EUAs) for monkeypox tests.  The announcement comes one month after HHS declared monkeypox to be a public health emergency.  According to Becerra, the declaration will help propel the government’s response to monkeypox by expanding access to testing.  In a separate announcement, the FDA issued its first EUA for a monkeypox test to Quest Diagnostics.  While the US is currently conducting more than 80,000 tests per week, some experts warn confusion over where patients get tests could be limiting access to monkeypox tests.    

White House Pushes for COVID-19 Funding in CR 

The Biden administration is pushing Congress to include $22.4 billion in a continuing resolution (CR) to help the domestic fight against COVID-19.  Due to dwindling funds, the administration has already announced it will no longer send free COVID-19 tests to people’s homes, and federal funding for COVID-19 vaccines is likely to end soon.  Additionally, the White House has communicated that it has no objection to attaching the reauthorization of FDA user fees to a CR, although the administration declined to offer its outright support for the proposal.   However, the likelihood that either proposal makes it into a CR is uncertain, as congressional appropriations leaders are currently hashing out whether to include Democratic energy policies in a stopgap spending measure.  Even if Congress is able to quickly pass a CR later this month, lawmakers could become embroiled in another appropriations fight later this year when the CR is expected to end.   

Study: Private Equity-Owned Practices Leave Patients with Higher Bills 

Physician practices acquired by private equity firms were associated with higher spending and more patient visits, according to a study published by the Journal of the American Medical Association.  The study found an average increase of 20%, or $71, in charges per claim, and 11%, or $24, in amount allowed per claim.  Private equity-owned practices were also reported to have about 26% more unique patients.  According to a press release by the study’s authors, the higher billing could be due to either more efficient documentation of services or up-coding/up-charging to insurance companies.   The study only examined dermatology, gastroenterology and ophthalmology medical practices purchased by private equity. 

Federal Judge Rules HIV Drug Coverage Requirement Violates Religious Freedom 

On Wednesday, US District Judge Reed O’Connor ruled that requiring employers to provide the HIV prevention drug PrEP violates their religious freedom, potentially jeopardizing the mandatory coverage of preventative health care services under the Affordable Care Act (ACA).   According to the Texas employers behind the suit, the provision violates the Religious Freedom Restoration Act by forcing people to pay for coverage that conflicts with their faith and values.  The ruling is not the first time O’Connor has challenged the ACA – in 2018 he ruled the entire health care law to be unconstitutional, which the Supreme Court overturned in 2021.  It was not immediately clear what kind of impact the ruling will have beyond the employers challenging the ACA provision.   

ICYMI: Portraits of Barack and Michelle Obama Unveiled at White House  

Former President Barack Obama and former First Lady Michelle Obama returned to the White House this week for the unveiling of their official portraits.  President Obama’s photo-realistic portrait was painted by Robert McCurdy and Michelle Obama’s portrait was painted by Sharon Sprung.  The portrait unveiling is a long tradition that goes back to 1978 when President Jimmy Carter invited his immediate predecessor, Gerald Ford, back to the White House. Wednesday’s unveiling event would have traditionally been held during the Trump presidency, although both parties mutually declined to participate according to sources

What Happened, What You Missed: August 29-September 2

FDA Authorizes Boosters Tailored to BA.5 

On Wednesday, the Food and Drug Administration (FDA) authorized bivalent COVID-19 booster shots from Pfizer and Moderna that target both the original COVID-19 strain and the Omicron BA.4/5 subvariants.   The Centers for Disease Control and Prevention (CDC) is widely expect to sign-off on the boosters today, which means pharmacies could start administering doses after Labor Day weekend.  According to the FDA, it may take up to two months before data is available on how effective the updated boosters are at preventing infection.  So far, the federal government has secured 171 million doses from Pfizer and Moderna.   

House Democrats Consider CR through December 16 

According to news reports, House Democratic leaders are working on a continuing resolution (CR) that would extend current government funding levels through December 16.  The current fiscal year ends on September 30, and House Democrats are hoping to bring their CR to the House floor for consideration during the week of September 12.  While negotiations over stopgap spending bills have typically been contentious, lawmakers may be more willing to cut a deal sooner rather than later this month due to an eagerness to return to the campaign trail ahead of November’s midterm elections.   Of note, a CR could include a reauthorization of FDA user fee programs, which are also set to expire at the end of September.     

CDC: Life Expectancy in US Dropped to 76 Years in 2021 

Life expectancy in the US fell from 79 years in 2019 to 76.1 years in 2021, according to data from the CDC.  The decline marks the first time life expectancy dropped two consecutive years in nearly a century.  According to the CDC, the decline in life expectancy can be attributed to the COVID-19 pandemic and increases in unintentional injuries, namely drug overdoses.  While a drop in life expectancy was observed in all 50 states, the CDC found that Southern states saw the biggest declines, as well as Indiana, Missouri, New Mexico, Ohio, and Oklahoma.   

HHS Issues $20M in Grants on Maternal and Infant Health 

On Monday, the Biden administration took a major step in carrying out its Blueprint for Addressing the Maternal Health Crisis by announcing investments of over $20 million to improve maternal and infant health.  According to a press release from the Department of Health and Human Services (HHS), the awards include $9 million to the State Maternal Health Innovation Program, $4 million to the Rural Maternity and Obstetrics Management Strategies Program, $3 million to 19 Healthy Start programs to reduce maternal health disparities, and $4.5 million to the Catalyst for Infant Health Equity Program.   

ICYMI: Fencing Around Supreme Court Removed 

Metal fencing that had surrounded the Supreme Court building for the past few months finally came down earlier this week.  The fences were initially erected in May after a draft decision to overturn Roe v. Wade leaked, which prompted protests in front of the court building.  However, the building itself remains closed, and the court has yet to comment on when the building will reopen to the public. 

Why the Hearing Aid Rule is a Big Deal

On August 16, the Food and Drug Administration (FDA) finalized rulemaking to allow hearing aids to be purchased over-the-counter (OTC), which is widely expected to increase access for millions of Americans with mild to moderate hearing loss.  This rule was 5 years in the making – why now? 

Background 

While FDA has regulated hearing aids for decades, the agency had previously only focused on assuring safety and effectiveness of prescription hearing aids.  In 2017, Congress stepped in and passed a law to require the agency to issue rules for over-the-counter devices. Lawmakers were hoping establishing a new category of hearing aids would address: 

  • Cost:  Lack of competition in the market means hearing aids can cost between $2,000 and $7,000 per pair.   
  • Coverage:  Most commercial insurance plans and Medicare don’t cover the cost of hearing aids for people with mild to moderate hearing loss because they’re not considered an essential medical device – or in other words, they’re considered “elective.”  
  • Access:  Additionally, getting hearing aids requires a prescription from an audiologist or other specialist.  Buying devices in a retail setting or online would provide more options for consumers. 

A Rule that Was Years in the Making 

It’s taken a long time for the idea of over-the-counter hearing aid sales to go from initial concept to final rule.  Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) got so fed up with the agency dragging its feet that they introduced legislation to require FDA to issue rulemaking on OTC hearing aids.  Even though the bill was signed into law as part of the FDA Reauthorization Act of 2017, it still took the agency 5 years to finalize the rule.  Why?   

COVID.  Yes, the needed change in focus of the agency to address COVID was a no-brainer, but President Trump signed the bill 2+ years before the virus struck….   

Change in administration.  Yes there was a change in administration but it took President Biden until July 2021 to issue an executive order directing his own agency to issue rule making. 

So why the delay?  It turns out that balancing stakeholder concerns was complicated.  When FDA issued the proposed rule in October 2021, the agency received more than 1,000 comments from the public.  Here is where the rule ended up: 

  • Output levels:  Lowers the maximum sound output to reduce the risk from over-amplification of sound 
  • Volume control:  Requires all OTC aids have a user-adjustable volume control 
  • Label and packaging language:  Simplifies phrasing so safety concerns can be easily understood 
  • State authority:  Retains authority by States to require an audiological evaluation for minors and other previously granted State exemptions applicable to non-OTC hearing aids 

What’s Next?  

The final rule goes into effect in 60 days, which is the date that over-the-counter hearing aids can officially be marketed.  Already, Best Buy has announced that it plans to have hearing aids available in 300 of its 1,000 stores by the fall.   

Even though Congressional Democrats weren’t able to get Medicare coverage for hearing aids signed into law, the rule signals real financial relief and a step toward health equity for millions.  Good news for consumers makes for good politics…right ahead of the November 8th elections. 

It Is Time to Separate Food Safety from the FDA?

Between the baby formula debacle and longer-than-expected review periods for COVID-19 vaccines, it’s been a rough year for the Food and Drug Administration (FDA).  The extent of the FDA’s problems is reflective of all the different responsibilities the vast agency has, ranging from control and supervision of food safety and tobacco products to pharmaceutical drugs and medical devices.  With the FDA’s plate so full, some policymakers feel splitting off food safety into its own agency is the best way forward.

The latest proposal to split up the FDA is the Food Safety Administration Act.  Introduced by Sen. Dick Durbin (D-IL) and Rep. Rose DeLauro (D-CT), the bill would spin-off the FDA’s food-related responsibilities into a separate Food Safety Administration.  DeLauro has referred to food safety as a “second-class citizen” at the FDA, and both she and Durbin have said creating a separate agency led by a Senate-confirmed food expert would lead to better outcomes for consumers.

They argue that establishing a separate Food Safety Administration would improve food safety and benefit consumers by applying “focused leadership” from a food safety expert capable of providing more accountability.  Additionally, the newly formed agency’s unified structure and direct oversight capabilities would ensure constant attention to food safety issues and more bandwidth to stay on top of foodborne illnesses.  

Indeed, policymakers have been discussing the separation of food safety from other FDA-regulated industries for years, or at least instituting reforms that would bolster the agency’s food safety responsibilities.  Here are some key examples from the past 15 years.

  • Some critics called for the FDA to be split into two agencies – one that handles drugs/medical devices and another than handles food safety and cosmetics – in the wake of a salmonella outbreak in 2008.
  • Other approaches have attempted to provide more resources and authorities for the FDA’s food safety arm as a way to bring about change from within.  In 2011, Congress enacted new measures that provided new regulatory programs for food importers, foreign producers, and fresh produce growers. 
  • In 2010, the Obama administration established the new position of a deputy commissioner for foods and veterinary medicine to provide direct oversight on food issues.  However, the Trump administration later took away the deputy commissioner’s authority over the agency’s respective policymaking units on food and veterinary medicine.  Notably, neither administration gave the deputy commissioner oversight authority on the agency’s food inspection and import activities.
  • In June 2018, the Trump administration proposed a plan to consolidate the FDA’s food safety functions into a new agency within the US Department of Agriculture (USDA) known as the Federal Food Safety Agency.  The FDA would have been renamed the Federal Drug Administration, but Congress would not extend him the power to reorganize the government. This similarly happened during the Obama administration where the administration put together a similar proposal to fold the FDA’s food inspection and enforcement services into the USDA Food Safety and Inspection Service in 2015.

The FDA is also focusing on ways to improve.  Scrutiny over the agency’s regulation of electronic cigarettes and baby formula prompted the agency to order an external review of its activities on tobacco regulation and food safety.  The review will focus on the agency’s Human Foods Program, which Commissioner Robert Califf said has been stressed from the COVID-19 pandemic. 

The Reagan-Udall Foundation, which has been tasked with reviewing the agency, is set to complete its report by the end of September.  While it remains to be seen what the foundation will recommend, breaking up the agency into a separate entity focused on food might be the best move for consumers.  Former Deputy Commissioner for Food Michael Taylor recently wrote that food has been a “low priority” at the agency for decades.  One reason for this is the fact that most FDA commissioners are physicians whose expertise pertains to drugs, meaning they have little time or bandwidth set aside for food. 

Another reason for FDA’s second-class status is a lack of sufficient funding.  Over the past 10 years, FDA’s food funding has grown by 42%, while funding for the agency’s drug and device-related programs has increased 122%.  

But does the FDA even have to wait for Congress to split it up?   As Taylor argued, the FDA commissioner and the secretary of health and human services (HHS) could use their own authority to unite all the FDA’s food offices under a single deputy commissioner with strong oversight powers.  But until any serious reforms are made, the agency will likely struggle to find a way to give the proper time and attention to its long list of priorities.

What Happened, What You Missed: July 4-8

FDA Allows Pharmacists to Prescribe Paxlovid

Authorized state-licensed pharmacists can now prescribe the COVID-19 antiviral Paxlovid to eligible patients, according to a revised emergency use authorization (EUA) from the Food and Drug Administration (FDA).  The revision will increase access to the medication, which has been a priority of the Biden administration for the past few weeks.  While Paxlovid has shown to be 89% effective in reducing the risk of hospitalization, use of the drug has been lower than expected due to complex eligibility requirements and reduced testing.  The FDA has recommended that pharmacists refer patients for clinical evaluation if not enough information is available to assess possible drug interactions or renal and hepatic function.   

BA.5 Becomes Dominant Omicron Subvariant in US

Omicron subvariant BA.5 comprises 53.6% of COVID-19 cases in the US, making it the nation’s dominant strain according to data from the Centers for Disease Control and Prevention (CDC).  A similar subvariant, BA.4, makes up 17% of cases.  Scientists estimate that BA.4 and BA.5 are about three times less sensitive to neutralizing antibodies from existing COVID-19 vaccines than the original Omicron subvariant BA.1, although current vaccines still offer strong protection against hospitalization and death from BA.4/5 infection.  Due to waning vaccine protection, the FDA has recommended that vaccine manufacturers update their shots to specifically target BA.4/5 ahead of a fall booster campaign. 

Senate Dems Release Updated Drug Pricing Proposal

On Wednesday, Senate Democrats released legislative text for an updated drug pricing proposal as part of an attempt to revive the reconciliation bill, Build Back Better that failed to move forward last year.  While the text overall matches last year’s initial agreement, key changes include moving the implementation date for drug price negotiations from 2025 to 2026 and requiring Medicare to negotiate prices on as many drugs as possible in order to prevent future Republican administrations from interfering with negotiations.  While there are no agreements on a broader reconciliation package, Senate Majority Leader Chuck Schumer (D-NY) has said that if a deal can be made, a bill could be considered on the Senate floor before August recess.

FDA Weighing Vin Gupta as New Advisor

According to reports, the FDA is considering tapping Dr. Vin Gupta, a pulmonologist and medical analyst for NBC, as a senior advisor to lead the agency’s communications strategy.  The FDA’s decision to consider onboarding a communications expert is likely a response to the criticism over the agency’s messaging on baby formula and COVID-19 vaccines.  Currently a chief medical officer at Amazon, Gupta his risen in prominence as a health commentator over the last two years of the COVID-19 pandemic and helped advise the Biden campaign and transition team on the pandemic response.  If hired, Gupta would be responsible for reforming the FDA’s image as well as guiding the agency’s messaging on vaping and nicotine.

ICYMI: The Reflecting Pool Isn’t a Swimming Pool

Earlier this week, people were spotted taking a dip in the Reflecting Pool on the National Mall in Washington, DC, probably as a respite to the brutal humidity that’s been lingering around the region.  Yesterday, the National Park Service erected a fence around most of the Reflecting Pool – seemingly as a way to keep swimmers out.  This week’s escapades weren’t the first time people have used the Reflecting Pool for something other than its intended purpose – in 2018, some people took to ice skating on the pool during a particularly cold winter.

What Happened, What You Missed: June 20-24

Moderna Says Updated Vaccine Effective against Omicron Subvariants

Moderna announced on Wednesday that an updated version of its COVID-19 vaccine provides strong protection against a symptomatic infection of the Omicron subvariants BA.4 and BA.5, which are rapidly spreading worldwide.  The updated vaccine candidate is bivalent, meaning it targets both the original version of COVID-19 and the Omicron variant.  The World Health Organization (WHO) labeled BA.4 and BA.5 as “variants of concern” as they are better able to evade immune defenses from previous infections and the current available vaccines.  Moderna is currently manufacturing the bivalent vaccine doses with the hope that they could be employed as a booster in the fall and winter, when experts say COVID-19 cases could spike.   

Administration Approves Waiver to Expand Insurance Options in Colorado

Up to 10,000 people in Colorado will soon have access to lower health insurance premiums, according to the Section 1332 Innovation Waiver that the Biden administration approved on Thursday.  The Department of Health and Human Services (HHS) estimates that a combination of additional federal funding and more competition between insurers will allow the Colorado Option to lower premiums by 15% for individuals, families, and small businesses by 2025.  Colorado is also working to establish premium reduction targets for insurers as a way of attracting new consumers to the state’s individual marketplace.  Of note, Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure urged Congress to pass legislation that  extends the Affordable Care Act (ACA) premium tax subsidies during a press call on the waiver’s approval.

House Passes Bill to Authorize New Biomedical Research Agency

The House passed (336-85) an amended bill to establish the Advanced Research Projects Agency for Health (ARPA-H) as a new biomedical research agency on Wednesday evening.  While the Fiscal Year (FY) 2022 omnibus provided $1 billion in funding for the new agency, separate authorizing legislation is required to fill in key details on the structure and organization of ARPA-H.  Notably, the legislation establishes ARPA-H as an independent agency within HHS, which differs from the administration’s preference of housing the new agency within the National Institutes of Health (NIH).  To ensure bipartisan support, key amendments to the original legislation include capping administrative costs at 15%, limiting the number of program offices to six in order to address concerns over “mission creep,” and the removal of the requirement that the ARPA-H director be confirmed by the Senate.  While members of both parties are eager to make ARPA-H a reality, it remains unclear when the Senate will vote on authorizing legislation. 

Senate Passes Gun Safety Legislation

On Thursday night, the Senate approved bipartisan gun safety legislation by a 65-33 vote, clearing the way for a vote in the House later today.  Known as the Bipartisan Safer Communities Act, the bill expands background checks on gun buyers 21 and younger to include their mental health and juvenile justice records.  It would also expand current law to prevent people from buying guys if they have previously abused a current or former romantic partner and incentivize states to create laws to seize guns from people who are deemed a danger to the community.   Additionally, the measure includes millions of dollars for mental health, school safety, and crisis intervention programs. 

ICYMI: Smithsonian Selects 4 Possible Sites for New Museums

The Smithsonian has narrowed down its choices to four possible locations for the future National Museum of the American Latino and the Smithsonian American Women’s History Museum. These four site locations include the Arts and Industries Building, a section of undeveloped land north of the Reflecting Pool, an undeveloped lot next to the National Museum of African American History and Culture, and an undeveloped section of land along Maine Avenue SW and the Tidal Basin.  To decide on a final location for each museum, all four sites will go through an evaluation process to determine environmental impact, accessibility, and other factors.   

What Happened, What You Missed: May 23-27

Pfizer’s COVID-19 Vaccine Is 80% Effective in Kids under 5

This week, Pfizer finished submitting clinical trial data to the Food and Drug Administration (FDA) to seek emergency approval of its three-dose COVID-19 vaccine for children ages six months to five years.  On Monday, the company announced that its vaccine is 80.3% effective in preventing against symptomatic COVID-19 in young children.  The FDA is expected to complete its review of both Pfizer and Moderna’s emergency use authorization (EUA) applications within days of each other, and an advisory committee is scheduled to meet on June 15 to review data on both companies’ vaccines.  If the independent committee recommends one or both vaccines, young kids could get their first shots as soon as late June.

Senators Release Bipartisan Telehealth Proposal Aimed at Improving Mental Health

On Thursday, a bipartisan group of Senate Finance Committee members released a discussion draft on telehealth politics intended to improve mental health care.  The discussion draft includes policies that would direct Medicare and Medicaid to promote and support provider use of telehealth, remove Medicare’s in-person visit requirement for mental health services, and preserve access to audio-only mental health coverage in Medicare under certain circumstances.  The Senate Finance Committee is among four congressional committees that have so far committed to advancing legislation to improve mental health care.  Lawmakers behind the mental health legislation were initially hoping to combine their respective measures into a package that can be enacted this summer, but staffers and lobbyists say unfinished work on Fiscal Year (FY) 2023 appropriations and a busy campaign season means a comprehensive mental health package probably won’t be signed into law until the end of the year.

Becerra Taps Adam Russell as Acting Deputy Director of ARPA-H

Health and Human Services (HHS) Secretary Xavier Becerra on Wednesday appointed Adam H. Russell, DPhil, to be acting deputy director of the Advanced Research Project Agency for Health (ARPA-H).  Set to start his new role in June, Russell will be tasked with building out the administrative structure of the new agency and hiring initial staff until President Joe Biden appoints an ARPA-H Director.  Currently the chief scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security, Russell gained experience managing research projects at both the Intelligence Advanced Research Projects Activity (IARPA) and the Defense Advanced Research Projects Agency (DARPA) – two agencies focused on breakthrough technologies that served as an inspiration for creating ARPA-H. 

Of note, Becerra also formally established ARPA-H on Wednesday as a separate agency within the National Institutes of Health (NIH)Many lawmakers have disputed the administration’s decision to place ARPA-H within NIH because they say it will prevent the new agency from fostering an independent culture that’s necessary for innovation.  Last week, a House committee advanced an authorization bill that would establish ARPA-H as an independent agency within HHS.

Lawmakers Take Another Swing at Gun Control Reform

In the wake of the mass shooting at a Texas elementary school, members of Congress are making another attempt at reaching a deal on gun control legislation.  Instead of starting out with a House-passed background check bill that faces no chance of being considered in the Senate, bicameral, bipartisan leaders are starting fresh.  Senate Majority Leader Chuck Schumer (D-NY) and Majority Leader Dick Durbin (D-IL) are tapping Sens. Chris Murphy (D-CT) and Kyrsten Sinema (D-AZ) to reach out to Republicans, while Senate Republican Leader Mitch McConnell (R-KY) has asked Sen. John Cornyn (R-TX) to have conversations with Democrats.  However, it remains unlikely that both parties will make a breakthrough on gun legislation in the 50-50 Senate, especially in the months leading up to a contentious midterm election. 

ICYMI: New Graphic Novel Tells Story of Former Congressman

This month marks the release of Smahtguy, a graphic novel that details the life of former Rep. Barney Frank (D-MA).  The graphic novel’s author is a Disney cartoonist-turned-staffer who chronicled his time working for Frank in a sketchbook for nearly two decades.  Among the first members of Congress to publicly identify as gay, Frank was a leading progressive who was best known for leading the Dodd-Frank financial reform package in the wake of the 2008 financial crisis. 

What Happened, What You Missed: May 16-20

FDA Authorizes Pfizer COVID-19 Booster Shots for Kids Ages 5-11

On Tuesday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a third “booster” dose of Pfizer’s COVID-19 vaccine for children ages 5 to 11 at least five months after their most recent shot.  The FDA decided to authorize a third dose because data increasingly shows that a booster can improve protection for children in this age group and that the benefits of a booster outweigh the risks.  While COVID-19 tends to be less severe in children than adults, a top FDA official noted in a press release that the Omicron variant has caused more kids to be infected and subsequently hospitalized, justifying the need for additional protection.  Two days later, a Centers for Disease Control and Prevention (CDC) advisory panel voted to recommend a third dose of Pfizer’s vaccine to children ages 5 to 11.

House Committee Advances Legislation on FDA User Fees, ARPH-A

The House Energy and Commerce Committee advanced legislation to reauthorize the FDA medical product user fee programs Wednesday alongside five other health care bills.  The current statutory authority for the FDA to collect user fees expires on September 30, 2022, and it remains unknown as to when the full House will vote on the user fee bill.  Of note, a Senate panel on Wednesday unveiled its own legislation to reauthorize FDA user fee collection.  Among the other bills the House committee advanced on Wednesday was legislation to authorize the Advanced Research Projects Agency for Health (ARPA-H).  Notably, this legislation goes against the Biden administration’s wishes of making ARPA-H a part of the National Institutes of Health (NIH), instead making it an independent agency within the Department of Health and Human Services (HHS).

Administration Offers Third Round of Free COVID-19 Tests

The White House announced on Tuesday that households can now order a third round of free at-home rapid COVID-19 tests at COVIDTests.gov.  Unlike the first two rounds that limited households to four test per order, the third round will provide eight tests per household.  To date, the administration has delivered 350 million tests to more than 70 million households across the nation.  The administration’s announcement comes as the nation sees a rise in case numbers driven by the BA.2.12.1 subvariant.

Administration Poised to Renew Public Health Emergency in July

The current COVID-19 public health emergency (PHE) is set to expire on July 16, 2022.  In recent weeks, HHS Secretary Xavier Becerra reiterated the administration’s commitment on multiple occasions to provide 60 days’ notice before letting the PHE expire.  However, the 60-day mark came and went earlier this week, meaning the administration is all but certain to renew the PHE come mid-July.  Numerous waivers are tied to the end of the PHE, including telehealth flexibilities under Medicare as well as a prohibition against states disenrolling people from Medicaid.

ICYMI: Lawmakers Hold First Hearing on UFOs in 50 Years

On Tuesday, top Pentagon officials testified before a House Intelligence Subcommittee on unidentified aerial phenomena (UAPs) – the military’s parlance for unidentified flying objects (UFOs) – marking the first public hearing on the subject in over a half-century.  During the hearing, top Defense Department officials promised to bring transparency to an ongoing investigation of reports of UAPs by military pilots and other personnel at the urging of lawmakers who were disappointed by the secrecy and confusion that have consistently plagued the investigation into UAPs thus far.  The Pentagon officials also testified under oath that the government had not collected materials from any extraterrestrial landings on Earth. 

What Happened, What You Missed: May 2-6

E&C Leaders Release FDA User Fee Package

On Wednesday, bipartisan leaders of the House Energy and Commerce Committee released a legislative proposal to reauthorize the Food and Drug Administration’s (FDA) ability to collect fees from drug, biosimilar, and device manufacturers for five years.  Additionally, the bill contains several policy riders that would give the FDA more control over the accelerated approval program, promote diversity in clinical trials, and reinstate a ban on electric shock devices for aggressive behavior, among other items.  The Health Subcommittee is expected to markup the user fee bill next Wednesday, with the goal passing the legislation in Congress by August.

FDA Approves Marketing of New Alzheimer’s Test

The FDA on Wednesday approved the marketing of an in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.  Produced by Fujirebio Diagnostics, the test works by measuring the ratio of certain proteins in the fluid that surrounds the brain.  In a press release, the FDA said the availability of an in vitro diagnostic test could eliminate the needs for PET scans, which are time-consuming and expensive.  In a clinical study, the test detected Alzheimer’s disease in 97% of people who had amyloid plaques present in a PET scan.  The National Institute of Health (NIH) estimates that over six million Americans may have Alzheimer’s disease. 

Survey: Most Parents Will Wait to Get Young Kids Vaccinated

18% of parents of children under 5 say they’ll get their kids vaccinated for COVID-19 as soon as a shot is authorized, according to a survey from the Kaiser Family Foundation.  Another 38% say they’ll take a “wait and see” approach before getting their kids vaccinated, while 56% want more information about vaccine safety and efficacy before making a decision.  Delays in FDA authorization of vaccines for young kids also left parents with mix feelings, with 22% saying the delays have made them more confident in the vaccine and 13% sayings the delays have made them less confident.  The survey was conducted in mid-April 2022, right before Moderna filed to authorize its vaccine for kids under 5 with the FDA.

Rent-A-Cops Arrive on Capitol Hill to Provide Security

To help address staffing shortages, the US Capitol Police (USCP) recently started deploying private security guards around the US Capitol Complex.  The private officers will wear grey dress pants and a navy-blue blazer rather than the police uniform and will be unarmed.  According to the USCP, the private officers will be stationed inside secure building like the House and Senate office buildings and will help augment existing patrols.

ICYMI: Jazz in the Garden Returns to National Mall on May 20

In two weeks, Jazz in the Garden will return to the National Gallery of Art Sculpture Garden along the National Mall.  The free concert series is a favorite summer tradition in Washington, DC, and this year’s series is set to features several genres including jazz, Afro-Brazilian, and bluegrass.  The series was closed during summer 2020 and was only open on a limited basis for summer 2021.  Guests will be required to register for the concert in advance.

Is Public Pressure Impacting the FDA’s Vaccine Review Strategy?

Parents of young children are frustrated and mad.  While adults have been able to get third and even fourth COVID-19 vaccines doses for some time now, children under six years are still unable to get their shots while the rest of society reverts to a pre-pandemic normal.

Anger among parents hit a boiling point last week when White House Chief Medical Advisor Dr. Anthony Fauci confirmed reports that the Food and Drug Administration (FDA) will not approve vaccines for kids under 6 until it can simultaneously review and approve vaccines from both Pfizer and Moderna.

However, less than a week later, FDA officials seemingly changed course when they announced that they may move forward on reviewing Moderna’s vaccine without waiting for Pfizer’s application – meaning that young children could get vaccinated as soon as June.  What caused the FDA to take an about face on its vaccine review strategy?

At the time of Fauci’s comment on April 21, Moderna was poised to begin applying for an emergency use authorization (EUA) within the next week or two, as initial data showed its vaccine generated strong protection in kids.  News that the FDA could soon begin reviewing Moderna’s EUA application set off a sign of relief among parents, who have had to contend with constant delays in the race to get young kids vaccinated.

However, Pfizer’s vaccine for children under 5 is still undergoing clinical trials for a three-dose regimen after results from a two-dose regimen did not yet provide strong protection against the virus, and it’s not clear when Pfizer will be ready to submit its data.  By waiting to review vaccines from both companies, the timeline for getting shots into kids’ arms faced a decent chance of getting extended once again.

What was the FDA thinking?  According to reports,  FDA officials wanted to review vaccines from Moderna and Pfizer simultaneously because approving both at the same time would be less confusing for parents than approving each at different times.  Additionally, FDA officials were worried about a possible backlash from parents if the agency approved Moderna’s vaccine first and Pfizer’s several week later when Pfizer’s vaccine demonstrated stronger efficacy. 

Despite the FDA’s rationale, reports that federal officials were delaying the review process once again elicited a strong backlash from concerned parents and lawmakers.  In the days following Fauci’s comments, lawmakers wrote to the FDA requesting an explanation as to why vaccines for young children were being delayed again, and parents and pediatricians launched an advocacy campaign to urge the FDA to review each vaccine application “at the earliest opportunity.”

Did Public Pressure Make a Difference?

The FDA finally changed its tune on April 29, when a top official announced the agency will consider vaccine applications as soon as they are ready.  While it is not clear if the FDA shifted its strategy purely in response to political and public pressures, it wouldn’t be first time public pressure might have made a difference. 

In mid-2021, the FDA appeared to be on track to approve the vaccine for children aged 5-11 by early fall, just in time for the start of school.  However, in July, the FDA asked Pfizer and Moderna to expand the size of their clinical trials for children to make sure they could detect potentially rare side effects, namely myocarditis, or heart inflammation – effectively pushing the timeline for vaccine approval out to winter 2021 or early 2022.  This drew sharp criticism from parents and pediatricians, who argued that complications from COVID-19 posed a greater threat to kids than myocarditis.

The strongest sign of pressure on the FDA came in the form of an August 2021 letter from the American Academy of Pediatrics (AAP) that called on agency to stick to its original timeline for collecting data and authorize vaccines for children under 12 as soon as possible.  A month after the pediatricians weighed in, the FDA issued an unprecedented statement saying that it would no longer wait for additional follow-up data from expanded clinical trials to made a decision on an EUA and stick to its original timeline. 

Like many things with the pandemic, nothing is certain as the FDA determines how it will review vaccines for younger children.  Moderna only began to submit data for its EUA on April 28, and the FDA has laid out a tentative schedule that leaves open the possibility that kids under 6 could get their shots sometimes this June.  However, things could still change. An FDA official say the agency could still review EUA applications from Moderna and Pfizer simultaneously if both are filed less than a week apart, and many parents and pediatricians say June is still too long of a wait for young kids to get vaccinated, especially considering that the review process for other age groups took less time. 

However, actions undertaken by the FDA last fall and last week suggest that the agency isn’t immune to public pressure.  This sets up a precedent where advocacy could sway the FDA review process in the future – for better or for worse.

Will We Need More Booster Shots?

People will only need annual COVID-19 booster shots after getting their third vaccine dose, according to a top Food and Drug Administration (FDA) official at the 2022 Innovation in Regulatory Science Summit in January 2022.  Since then, however, mounting evidence over waning immunity plus the potential of a new wave of COVID-19 are feeding calls for people to get their fourth vaccine doses sooner rather than later.  Does that mean Americans can expect to get a second booster shot in the coming months?

First, some Americans are already able to get a second booster shot.  According to guidance from the Centers for Disease Control and Prevention (CDC), people ages 12 years and older who are moderately or severely immunocompromised should receive a total of four mRNA vaccine doses.  This includes transplant patients and those undergoing chemotherapy for cancer.

Drug manufacturers are already asking for approval on second boosters for additional populations.  In mid-March, Pfizer and Moderna submitted applications to the FDA for an emergency use authorization (EUA) for a second booster dose of their respective COVID-19 vaccines.  While Pfizer is specifically seeking an EUA for adults over age 65, Moderna is requesting an EUA for anyone over 18 years of age. 

The submission of both applications came just days after Pfizer CEO Albert Bourla said a fourth vaccine dose will probably be needed for everyone.

  • One reason for this is mounting data that shows protection acquired from a third COVID-19 vaccine dose wanes over time.  According to CDC data, a booster shot’s effectiveness in protecting against hospitalization dropped from 91% to 78% between August 2021 and January 2022 – a timeframe that includes both the Delta and Omicron variants. 
  • Another reason for a fourth shot is a need to protect Americans ahead of a new wave of COVID-19 cases.  In recent weeks, a new Omicron subvariant known as BA.2 has driven an increase in cases across Europe, which many experts say could foreshadow an increase in cases in the US within the coming weeks.  Although BA.2 is roughly 30% more transmissible than the original Omicron strain, it does not appear to be more severe or lead to more hospitalizations.  While overall COVID-19 case numbers are still trending downward in the US, 10 states have reported an increase in case numbers over the last 14 days. 

Due to these concerns over waning immunity and growing case numbers, nearly a dozen countries including Australia, Belgium, Denmark, Israel, Poland, Sweden, and the United Kingdom have already begun offering fourth doses, albeit eligibility is limited to seniors and medically vulnerable people in most cases.  Additionally, reports suggest the FDA could authorize second boosters for all adults over age 50 as soon as March 29.  However, that doesn’t necessarily mean the government will follow suit in recommending a fourth mRNA vaccine dose to every individual age 12 and up who’s already cleared to get a third dose anytime soon, as a couple issues stand in the way.  These include:   

  • Regulatory approval.  The FDA’s vaccine advisory committee will meet on April 6 to discuss the need for additional COVID-19 booster shots.  However, the advisory panel will NOT be reviewing any EUA applications from Pfizer or Moderna or taking a vote on recommendations – instead, the committee will discuss the timing and populations for additional doses in the coming months.  The April 6 agenda is a sign of the federal government’s cautious approach to boosters, which means it might take some time for federal regulators to sign off on additional doses, especially for the broader population.  In September 2021, for instance, a CDC advisory panel declined to recommend third doses for people who work in “high-risk” settings like health care practitioners and teachers – a decision which was ultimately overruled by CDC Director Rochelle Walensky.
  • Data.  Even though a number of countries have already cleared fourth shots for certain populations, the jury’s still out on whether a second booster will make a difference for non-elderly adults who are not considered medically vulnerable.  Preliminary results from a study involving 154 health care workers in Israel found that a fourth mRNA dose is only “partially effective” in protecting against the Omicron variant.  Without any strong evidence of the effectiveness of a fourth shot, US regulators are likely to continue to take a cautious approach on recommending additional boosters for the broader population.
  • Funding.  Lawmakers dropped $15 billion in additional COVID-19 funding from the Fiscal Year (FY) 2022 omnibus appropriations bill, and so far, congressional leaders are locked in a stalemate on passing separate legislation on additional COVID-19 support.  Without additional funding, Biden administration officials have warned that they won’t have enough money to purchase a potential fourth vaccine dose for even 70% of all Americans.  And barring additional funding, the federal government will no longer be able to cover the cost of vaccinations for uninsured people starting on April 5, which means uninsured immunocompromised Americans may not be able to afford a booster if they need one.

Ultimately, the trajectory of the COVID-19 pandemic may ultimately inform whether additional boosters are necessary for Americans, and in turn, whether Congress decides to allocate enough money to pay for additional vaccine doses.  While White House Chief Medical Advisor Anthony Fauci has acknowledged that the BA.2 subvariant is likely to cause cases to rise in the US, he doesn’t anticipate new cases will culminate in a major surge that results in high levels of hospitalizations

Indeed, a good portion of the US population has acquired some degree of immunity through infection, vaccination, or both over the last two years of the pandemic, which could protect Americas from the worst consequences if case numbers continue to rise over the next few weeks.  However, if hospitalizations suddenly spike across multiple populations, it may be too late for the federal government to act swiftly on additional boosters.

What Would the End of the Public Health Emergency Mean for EUAs?

The current public health emergency (PHE) is set to expire on April 16.  While the Biden administration is likely to extend the PHE, administration officials have yet to comment on their specific plans.  Uncertainty over the end of the PHE has fueled conversations over what the implications would look like for temporary health care policies that expire once the PHE officially concludes. 

Blog posts from the last two weeks have looked at how the end of the PHE would affect Medicare’s temporary telehealth waivers and Medicaid coverage.  This week’s blog post focuses on how ending the PHE would impact the Food and Drug Administration’s (FDA) emergency use authorizations (EUAs).

Background:  An EUA allows the FDA to authorize unapproved medical products or unapproved uses of approved medical products – like vaccines and treatments – to be used to diagnose, treat, or prevent serious or life-threatening diseases in cases where there are no adequate, approved, and available alternatives.  Since the start of the COVID-19 PHE on January 31, 2020, the FDA issued hundreds of EUAs for pharmaceutical and medical devices related to COVID-19.

How? Section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act allows the FDA to issue four different types of EUAs during a PHE for diagnostics, respiratory equipment, medical devices, and drugs/biologics.  However, the FDA still has the authority to issue an EUA outside of a PHE thanks to the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, which grants Department of Health and Human Services flexibility to declare that “circumstances exist” outside of a PHE to allow EUAs to be issued.

What does the end of the PHE mean for the EUAs?  Unlike the other temporary authorities related to telehealth and Medicaid, all EUAs that are issued by the FDA remain in effect until the FDA withdraws the EUA declaration.  For instance, the EUA declarations issued for the Zika and Ebola pandemics were never withdrawn and are currently in effect, even though their respective PHEs have long since expired. 

However, one FDA policy, separate from EUAs, will expire at the conclusion of the PHE – enforcement discretion.  This policy allows the FDA to waive enforcement of its usual requirements for pre-market approval to allow drug products to be modified for additional uses without full approval from the agency.  In contrast, drug products approved via an EUA must still meet specific criteria on safety and effectiveness.  Once the PHE ends, the FDA will revert to its regular enforcement policies, and all products where enforcement discretion once applied must then meet all standard FDA legal requirements in order to continue to be sold in the US.  

Planning for a Post-EUA Future

Unlike the EUAs for Zika and Ebola treatments, the FDA has communicated that it doesn’t want the COVID-19 EUAs to stick around forever and manufacturers should expect an “eventual resumption of normal operations.”  To this end, the FDA issued two draft guidance documents in late December to help facilitate a return to normal:

Uncertain Future for Stakeholders

On February 22, the FDA held a webinar for industry stakeholders about its draft guidance documents on its post-pandemic transition plans, and like their counterparts in telehealth and Medicaid, the stakeholders from the pharmaceutical and medical device industries had a lot of questions. 

  • Of the four EUA declarations, three are specific to devices, and it’s not clear if the agency will withdraw those EUAs all at once or at different times.
  • The webinar did not offer stakeholders a clear answer on whether HHS issues the advance notice on withdrawing the EUA declarations first, or FDA will finalize its two guidance documents on its transition plans.   Instead, FDA staff told attendees that whatever happens first depends on the course of the pandemic.  If hospitalizations continue to decline and stay low, HHS may pull the EUA declarations first; otherwise, finalization of the guidance documents could come sooner.
  • The FDA says more guidance is on the way, but it’s unknown when it will be released.  According to FDA staff, this would pertain to the types of data FDA will consider when transitioning a drug product from an EUA to formal market access, such as how real-world evidence will be considered. 

While pharmaceutical industry stakeholders can feel relieved that EUAs won’t expire with the end of the PHE and that the FDA is making plans for a post-pandemic world, question about what that world will look like simply add to the narrative that the federal government’s take on health care policies once the PHE ends need significant refinement.