What Happened, What You Missed: January 2-6, 2023 

House Report Criticizes FDA’s Approval of Alzheimer’s Drug 

The Food and Drug Administration (FDA) inappropriately worked with the drug manufacturer Biogen for approval of the Alzheimer’s disease drug Aduhelm, according to a report from Democrats on two House committees.  Originally approved in July 2021, Adulhelm came under intense criticism for its uncertain clinical benefits, high list price, and potential for side effects like brain bleeding and swelling.  The report found the FDA’s interactions with Biogen were “atypical” – particularly through use of joint briefing documents – and failed to follow the agency’s own documentation protocol.  The report’s release precedes a highly anticipated January 6 announcement from the FDA on the approval of Lecanemab, another Alzheimer’s drug that uses a technology similar to Aduhelm that targets amyloid proteins in the brain. 

OIG Report Calls for Better Part B Oversight 

The Centers for Medicare and Medicaid Services (CMS) needs to conduct “robust oversight” to ensure that the agency makes appropriate payments for Part B-covered drugs, according to a new report from the HHS Office of the Inspector General (OIG).  Medicare spends about $40 billion every year on Part B drugs, and CMS uses manufacturer-reported average sales price (ASP) for the drug from quarterly sales to calculate provider payments.  However, due to incorrect or missing ASP data from manufacturers, CMS was unable to calculate an ASP-based payment amount for 8% of drug codes at least once between 2016 and 2020.  According to the report, CMS does not check the accuracy of the manual processes used to analyze ASP data.  The report also found that CMS does not incorporate its ASP data collection into watchdog reports. 

SAMHSA: 25% of Adults Had A Behavioral Health Disorder in 2021 

Roughly a quarter of US adults had a mental illness or substance use disorder in 2021, according to an annual survey released earlier this week by the Substance Abuse and Mental Health Services Administration (SAMHSA). The survey also found that 16% of the population, or 46 million people, met the criteria for a substance disorder in 2021, and only 6% of the 46 million actually sought treatment.  Additionally, the survey found that 22% of the population, or 61 million people, used illicit drugs in 2021, with the most commonly used drug being marijuana. The report echoes growing concerns on the prevalence of substance abuse and mental health issues across the nation.   

NIH Launches Pilot Telehealth Program for COVID-19 

On Thursday, the National Institutes of Health (NIH) launched the Home Test to Treat program, a new pilot program that will provide free COVID-19 health services like tests, telehealth sessions and at-home treatments in selected communities.  Later this month, local and state officials in Berks County, Pennsylvania, will be the first to pilot the program. Other communities around the nation will be selected to participate in this program based on need, socioeconomic factors, and access to health care.  The NIH is aiming to offer this service to up to 100,000 Americans over the next year. 

Sen. Debbie Stabenow Announces Retirement  

Sen. Debbie Stabenow (D-MI) announced Thursday that she will not seek re-election and will leave the Senate at the end of her term on January 3, 2025, making her the first Senate Democrat to announce that she won’t be on the ballot in 2024.  Formerly a member of the Michigan state Senate and later a member of the US House of Representatives, Stabenow was first elected to the Senate in 2000.  Stabenow is the Senate Agriculture Committee’s top Democrat since 2011 and has been a longtime advocate for mental health care and tireless proponent for increasing domestic manufacturing.  Stabenow’s retirement announcement created an opening in a key swing state that is likely to attract strong interest from both parties.  According to reports, Reps. Debbie Dingell (D-MI) and Elissa Slotnik (D-MI) are already considering a run.   

ICYMI: House Offices Reopened to Visitors 

After nearly three years of pandemic and security-related restrictions, visitors on official business will no longer require a staff escort in the House office buildings and tourists will be able to access the gallery overlooking the House floor.  The removal of these restrictions was ordered by House Republicans, who now control the House with a slim majority in the 118th Congress.  The new Republican House majority also ordered the removal of metal detectors at the House chamber, which were first installed in the wake of the January 6, 2021, insurrection on the US Capitol.  For the time being, however, staff escorts are still required for visitors to Senate office buildings. 

What Happened, What You Missed: December 5-9

Report Calls for FDA to Break Up 

The Food and Drug Administration (FDA) should be split up to address problems plaguing the agency’s food oversight arm, according to a new report by the Reagan-Udall Foundation.  The agency asked the Reagan-Udall Foundation to analyze its operations in the wake of the infant formula crisis earlier this year.  According to the report, flaws in the FDA’s leadership structure and poor communication among agency officials has resulted in the agency’s food safety operations being consistently underfunded, understaffed, and underprioritized.  The report also suggested a less drastic measure that would create a deputy commissioner position with authority for overseeing food.  Any move to split up the agency would require approval from Congress. 

FDA Authorizes COVID-19 Boosters for Kids under 6 

On December 8, the FDA approved bivalent COVID-19 booster shots from Pfizer and Moderna for children six months to six years of age.  The announcement comes as children’s hospitals across the country are at capacity for kids suffering from a range of respiratory illnesses, including COVID-19, respiratory syncytial virus (RSV), and the flu.  However, the rules on who can get a shot when differ depending on whether the initial vaccine regimen came from Pfizer or Moderna.  Children under age six who have completed Moderna’s two-dose regimen can get their bivalent booster if it’s been at least two months since their last shot, while children under six who received the first two doses of Pfizer’s three-dose regimen can use the new bivalent booster for their third shot.  However, children who received all three initial vaccine doses from Pfizer aren’t yet eligible for a booster shot. 

ICER: Biggest Drug Price Increases Not Substantiated 

According to a report by the Institute for Clinical and Economic Review (ICER), price increases among seven of the ten drugs in 2021, which saw the largest increases from the year prior, were not supported by clinical evidence.  Out of the $805 million increase in drug spending from 2020-2021, Bausch Health’s Xifaxan, an antibiotic drug for traveler’s diarrhea, saw the biggest increase of nearly $175 million in spending, while Johnson & Johnson’s schizophrenia drug Invega Sustenna and Amgen’s osteoporosis drug Prolia were second and third with respective spending increases of $170 million and $124 million.  According to ICER, the report is intended to inform policymakers and lawmakers on policies they can pursue to address high drug prices.  However, the report acknowledged that the impact of the Inflation Reduction Act’s Medicare drug price negotiation on commercial payers remains uncertain. 

ACA Marketplace Enrollment Reaches 5 Million 

Nearly 5.5 million individuals from November 1 to December 3 selected a 2023 health plan through the federally facilitated and state-based marketplaces, according to the Centers for Medicare and Medicaid Services (CMS).  Roughly 80% of enrollees renewed their health care coverage, while the rest were new enrollees.  33 states currently use the federal marketplace for the 2023 open enrollment period, which runs through January 15, 2023.  CMS also reported that state-based exchanges will automatically renew coverage for about 2.9 million residents nationwide.  

Top Ways and Means Republicans Make Their Case for Chairmanship 

With current Ways and Means Committee Ranking Member Kevin Brady (R-TX) set to retire soon with the end of the 117th Congress, three senior Republicans on the committee are making the case to succeed Brady and chair the committee in the next Congress.  As the Republican Steering Committee prepares to vote on who will get the chairman’s gavel in January, Rep. Vern Buchanan (R-FL) is touting his business background, Rep. Jason Smith (R-MO) is taking a populist approach while emphasizing his ties to working class voters, and Rep. Adrian Smith (R-NE) is presenting himself as a top policy expert.  Whoever is elected chairman will have the opportunity to shape health care policy, due to the committee’s jurisdiction on Medicare.   

ICYMI: Representatives Vie for New House Offices 

73 incoming House members were assigned their designated workspaces on Capitol Hill as a part of a biennial office lottery that took place late last week in the Cannon House Office Building.   While past lotteries followed the alphabetical order of members’ names, this year’s lottery was completely randomized.  The Rayburn House Office Building is usually seen as the most desirable office location, since the building is connected to the Capitol by the subway.  

What Happened, What You Missed: November 28-December 2 

New Drug Shows Potential to Slow Alzheimer’s Disease  

The experimental drug lecanemab has the potential to slow the progression of Alzheimer’s disease, according to late-stage clinical trial data from drugmakers Biogen and Eisai.  While Phase 2 trial data released in the summer did not show a large difference between lecanemab and a placebo in Alzheimer’s disease patients over 12 months, newly released Phase 3 trial data found that the drug was associated with less cognitive decline after 18 months of use.  However, instances of patients experiencing brain swelling and brain bleeding have raised concerns over the drug’s safety.  The news follows controversy over the decision by the Food and Drug Administration (FDA) last year to approve another Alzheimer’s drug from Biogen, in spite of clinical trial data that showed the drug’s efficacy to be limited.   

Senate Panel Discusses Prior Authorization, Kids’ Mental Health 

Senators from both parties touted legislation to expand mental health integration into pediatric care in a Wednesday hearing from the Senate HELP Subcommittee on Children and Families that focused on how the pandemic has exacerbated mental health challenges facing adolescents.  Other bipartisan legislation discussed in the hearing would streamline transitions from high school to college for students with disabilities and increase Medicaid reimbursement for children’s mental health services.  Prior authorization reform was also a topic of discussion during the hearing, as several witnesses pointed out that long wait times and high administrative costs are preventing many teens from accessing mental health care services in a timely manner.   

HHS Proposes Changes to Privacy Records for Substance Use Disorder Patients 

Currently, a substance use disorder patient must provide consent every single time a health care provider needs to share the patient’s records.  However, a newly proposed rule from the Department of Health and Human Services (HHS) would allow providers to share a patient’s records multiple times after receiving a patient’s consent only once.  According to a press release, the new privacy rules would ensure individuals are not denied “life-saving care” due to concerns about records disclosure.  The rule would also increase coordination among providers of treatment for substance use, expand HHS enforcement authority under 42 CFR part 2, and update breach notification requirements to HHS.  Stakeholders have until January 31, 2023, to comment on the proposed rule. 

CDC: Deaths Linked to Substance Abuse Climb among Seniors 

Deaths associated with drug and alcohol abuse are steadily rising, according to new data from the Centers for Disease Control and Prevention (CDC).  According to the data, death rates from drug overdoses among people 65 and over have more than tripled since 2000, while alcohol-related deaths among seniors have jumped more than 20% from 2019 to 2020.  The CDC also noted that alcohol-related death rates are higher overall among men over the age of 65, with older men seeing death four times higher than women when considering seniors 75 and older.   The report additional found growing use of fentanyl and synthetic opioids among seniors. 

CDC to Start Wastewater Testing for Polio 

The CDC announced on Wednesday plans to begin wastewater surveillance for polio in select communities with low vaccination rates.  The CDC will use data from the surveillance program to assist with vaccination programs if necessary.  Communities in Michigan, New York, and Pennsylvania will be the first to adopt the wastewater testing programs, which will last for at least four months.  The CDC first hinted that it may begin wastewater testing program for polio in the summer when a single case of paralytic polio was found in Rockland County, New York.  The risk of polio to the public remains low because more than 92% of Americans were vaccinated during childhood. 

ICYMI: White House Celebrates 100th Lighting of National Christmas Tree  

President Joe Biden celebrated the 100th lighting of the National Christmas Tree on Wednesday in a ceremony that included performances from Shania Twain and Gloria Estefan.  During the ceremony to light the 27-foot white fir, President Biden emphasized the importance of national unity and called on Americans to reflect on their blessings. The lighting of the National Christmas Tree began as a tradition a century ago under President Calvin Coolidge.   

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.