What Happened, What You Missed: August 9-13

FDA Authorizes Third Vaccine Dose for Immunocompromised Patients

On August 12, the Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for the Pfizer and Moderna COVID-19 vaccines to allow immunocompromised people to get a third dose.  The Centers for Medicare and Medicaid Services (CMS) subsequently announced that Medicare beneficiaries would be able to receive the additional vaccine dose at no extra cost.  FDA’s announcement comes after a number of doctors said the two-dose regiment does not generate a sufficient level of protection in most people with compromised immune systems.  The Centers for Disease Control and Prevention (CDC) estimates that 2.7% of US adults are immunocompromised, including people undergoing cancer treatment and organ transplant recipients.  On August 13, CDC’s Advisory Committee on Immunization Practices will meet to discuss whether a third COVID-19 vaccine dose is needed for certain groups.

Biden Calls on Congress to Allow Medicare to Negotiate Drug Prices

President Biden publicly urged Congress on August 12 to enact legislation to allow Medicare to negotiate on drug prices as a key component of his vision for reducing the high cost of prescription drugs.  Other reforms Biden called for include establishing a cap on out-of-pocket drug costs for Medicare beneficiaries, building on efforts to help states and Tribes to import lower-cost drugs from Canada, and accelerating the development and uptake of generic and biosimilar drugs.  Immediately following Biden’s remarks, PhRMA President and CEO Stephen Ubl issued a statement saying the president’s proposals would undermine access to life-saving drugs and shift drug costs to patients. 

Chamber of Commerce Files Lawsuit over Insurer Price Transparency Rule

On August 10, the US Chamber of Commerce filed a lawsuit in the US District Court Eastern District of Texas to challenge a rule finalized by the previous administration in October 2020 that requires insurers to post pricing information in a machine-readable format online.  In the suit, the Chamber contends that the rule violates the Administrative Procedures Act and that the administration lacks statutory authority to require prices to be listed in a machine-readable format.  According to the Chamber, the price transparency rule has the potential to reduce competition and boost prices consumers pay by requiring insurers to post information that’s otherwise considered confidential.  On August 12, the Pharmaceutical Care Management Association filed a similar lawsuit in the US District Court of the District of Columbia challenging the price transparency rule.

Senate Approves Bipartisan Infrastructure Bill, Kicks Off FY22 Budget Resolution Process

On August 10, the Senate voted 69-30 to approve a bipartisan $1 trillion infrastructure bill, moving forward a major component of President Biden’s agenda.  Passage of the infrastructure bill cleared the way for the Senate to adopt by a 50-49 vote its $3.5 trillion Fiscal Year (FY) 2022 budget resolution that contains key Democratic priorities around childcare, paid leave, climate change, and education.  The House is expected to return early from recess to approve the FY 2022 budget resolution during the week of August 23, which would unlock the budget reconciliation progress and allow the Senate to pass a final bill that only requires 50 votes.  The process to pass the larger measure could take months, however, and Sens. Joe Manchin (D-WV) and Kyrsten Sinema (D-AZ) have started to say  they will not support $3.5 trillion in spending

AAP Calls for FDA to Accelerate EUA of COVID Vaccine for Kids under 12

In an August 5 letter, the American Academy of Pediatrics (AAP) urged the FDA to authorize the emergency use of COVID-19 vaccines for children under age 12 “as soon as possible” due to a rise in pediatric COVID-19 cases sparked by the Delta variant.  According to AAP, FDA should use the clinical trial data it already has collected on the Pfizer and Moderna vaccines to move forward on expanding the emergency use of the vaccine instead of waiting for six months of follow-up data due to “changes in the risk-benefit analysis” posed by the Delta variant.  AAP also noted that cases of myocarditis in adolescents and young adults are “extremely rare” and do not necessitate the collection of additional data to expand the EUA.  

ICYMI: Congressional Staff Express Interest in Telework, Flexible Arrangements

Even though a number of congressional staffers have returned to in-person work in Washington, some staffers are calling for their bosses to consider making telework or hybrid work arrangements permanent.  According to some proponents, more telework opportunities could provide relief to employees with childcare responsibilities, help with employee retention, or provide opportunities to staff who can’t physically be in the Washington, DC area. 

What Happened, What You Missed: August 2-6

Moderna Becomes Second Vaccine Maker to Recommend Third Dose

On August 5, Moderna said a third dose of its COVID-19 vaccine will likely be necessary as a “booster shot” this winter as immunity gradually declines.  The company is currently testing three candidates that could be used as a third dose to boost immunity against rising COVID-19 variants such as Delta.  Moderna also announced that its vaccine is 93% effective six months after the second dose, even against the Delta variant.  Moderna’s calls for a third dose came one week after Pfizer released data that showed a third dose of its vaccine increased antibody levels against the Delta variant.   Amid growing interest in a third vaccine dose, the World Health Organization notably called for wealthy nations to hold off on distribution of third doses to their populations and instead focus on distribution to low-income countries where vaccination rates remain low.

HHS Inspector General to Review FDA’s Accelerated Approval Process

On August 4, the Department of Health and Human Services Office of the Inspector General (OIG) announced it will review the accelerated approval pathway used by the Food and Drug Administration (FDA) to review drugs that treat serious conditions and fill an unmet medical need.  The review was sparked by FDA’s use of the accelerated approval process for Alzheimer’s disease drug Aduhelm, which spurred scientific disputes within FDA as well as allegations of an “inappropriately close relationship” between FDA and the pharmaceutical industry.  Acting FDA Commissioner Janet Woodcock asked OIG to review the process used to approve Aduhelm in mid-July, and she has since pledged full cooperation with OIG’s pending investigation.

Vote on Infrastructure Bill Could Come This Weekend

Senate Majority Leader Chuck Schumer (D-NY) is hoping to hold a procedural vote to end the debate on a $550 billion bipartisan infrastructure bill as soon as Saturday after Senators failed to reach an agreement on Thursday night.  The Senate spent most of Thursday waiting for a Congressional Budget Office score that projected the measure will add $265 billion to the federal deficit over 10 years.  The Senate is out of session on Friday, and several Senators will be using their day-long break to attend the funeral of former Sen. Mike Enzi (R-WY).   If the Senate clears the bipartisan infrastructure bill when it reconvenes on Saturday, Senate Democrats will immediately pivot to working on a budget resolution with instructions for reconciliation that include the “human infrastructure” pieces.

Former Michigan Senator Carl Levin Has Died

Carl Levin, Michigan’s longest-serving US Senator, died on July 29 at age 87.  Elected to the Senate in 1979 after practicing law and serving on the Detroit City Council, Levin helped set military priorities as Chairman of the Armed Services Committee and investigated corporate behavior as Chairman of the Permanent Subcommittee on Investigations.  Throughout his six terms in the Senate, the liberal Michigan Democrat was known for his defense of Senate traditions and tenacity in uncovering corruption.  Levin hailed from a political family – his brother, former Rep. Sander Levin (D-MI), chaired the powerful House Ways and Means Committee, and his nephew, Rep. Andy Levin (D-MI), currently represents a district north of Detroit.

CMS Finalizes 2022 Payment Rates for Acute Care Hospitals

A final rule issued by the Centers for Medicare and Medicaid Services (CMS) on August 2 provides for a 2.5% increase in hospital reimbursement rates under Medicare’s Inpatient Prospective Payment System (IPPS) for Fiscal Year (FY) 2022.  The rule also includes a $1.1 billion decease in disproportionate share hospital payments from FY 2021 and adds a Maternal Mortality measure to the hospital quality reporting program.  Furthermore, the final rule contains several provisions related to the COVID-19 public health emergency, namely a new requirement for hospitals to post vaccination rates among employees as well as authorization of additional payments for COVID-19 diagnostics and therapies.  The final rule goes into effect on October 1, 2021. 

ICYMI: DC Area Athletes Rack Up Medals in Tokyo Olympics

So far in the 2020 Summer Olympics in Tokyo, US athletes who hail from the Washington, DC area have been winning big.  Maryland natives Katie Ledecky, Chase Kalisz, and Andrew Wilson have all won gold medals in swimming events, while Maryland triathlete Katie Zaferes has earned the silver and bronze medals in two separate triathlon events.  Additionally, Noah Lyles of Alexandria, Virginia won a bronze medal in the men’s 200-meter race, while Lucas Kozeniesky of Fairfax County Virginia narrowly missed a gold medal in the mixed 10m air rifle event.  Of note, several athletes hailing in the region are still competing in track, soccer, basketball, and wrestling events.

What Happened, What You Missed: July 19-23

CDC Panel Recommends Continued Use of J&J Vaccine, Despite Risks

On July 22, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) agreed the federal government should continue to recommend Johnson & Johnson’s COVID-19 vaccine amid concerns of side effects.  According to the panel, the benefits of the single-dose vaccine outweigh the risk of Guillain-Barre, a rare neurological disease.  However, two members of the panel felt the risk of Guillain-Barre should be conveyed to potential recipients of the J&J vaccine, noting that two highly effective mRNA vaccines are available as alternatives.  ACIP convened just days after New York University researchers released a study that found the J&J vaccine is only 33% effective against the Delta variant, a significant decrease from the 66% efficacy observed against the original COVID-19 strain in clinical trials.

NEJM: Pfizer, AstraZeneca Vaccines Still Highly Effective against Delta Variant

A study published in the New England Journal of Medicine (NEJM) on July 21 found two doses of Pfizer’s COVID-19 vaccine is 88% effective against the Delta variant, compared to 94% against the Alpha variant.  The same study found two doses of the AstraZeneca vaccine is 67% effective against Delta, a small decrease from a 75% efficacy rate with Alpha.  The release of the NEJM study findings come after a pair of studies released earlier this month found the Pfizer vaccine has varying degrees of efficacy against the Delta variant. Those studies include a research published by the Israeli Health Ministry on July 5, which found a double dose of the Pfizer vaccine to be only 64% effective against Delta, while an analysis posed on June 14 by Public Health England found two Pfizer doses to be at least 90% effective.

Major Hospital Groups Back Vaccination Mandates

On July 21, the American Hospital Association and America’s Essential Hospital separately issued statements urging its member hospitals to require vaccination for all employees.  According to both organizations, vaccines help protect not only health care workers but also patients and their communities.  The announcement comes as hospitals nationwide see a rise in COVID-19 patients who are unvaccinated and growing number of hospitals and health systems mandate their employees be vaccinated.

Details of Bipartisan Infrastructure Bill Could Come as Soon as Monday

A bipartisan group of 22 Senators are hashing out the final details of a $579 billion infrastructure bill that could be released as soon as Monday, July 26.  Senators previously attempted to begin debating the bipartisan infrastructure bill on Wednesday as a way to push negotiations forward, but Senate Republicans mounted a filibuster, saying more time is needed to finalize details and resolve differences.  Since Wednesday’s failed vote, Senators have tentatively agreed to delay a Medicare rule that eliminates Part D drug rebates that drug makers offer to pharmacy benefit managers in exchange for participation on their formularies as a way to partially pay for the infrastructure bill.  Remaining sticking points include how much spending should be directed to public transit and assurances that the Drinking Water and Wastewater Infrastructure Act will be fully funded.

ICYMI: No Smithsonian Tickets? No Problem!

Starting on July 19, visitors to all open Smithsonian museums will no longer need timed-entry passes for general admission.  The two exceptions to the new policy are the National Zoo and the National Museum of African American History and Culture, which already required timed-entry tickets before the pandemic.  Other currently shuttered museums, like the Air and Space Museum and Smithsonian Castle, are also set to reopen later this month.

Who Will Be the Next Drug Czar?

“We need a drug czar, Mr. President,” a young Senator repeatedly uttered in the early 1980s as illicit drug use surged in the nation’s cities.  There were several agencies fighting the war on drugs, and the Senator thought it would be best to have one person coordinating the federal response.  Then, in November 1988, President Ronald Reagan signed into law legislation to create an Office of National Drug Control Policy (ONDCP) to be headed by an official known colloquially as the “drug czar.”   

The young Senator who pushed for this position is none other than Joe Biden of Delaware.  Now as the 45th President, Biden is confronting another drug crisis, and to turn the tide, he needs a permanent drug czar.  Who will that be?

A New Drug War

Just as in the 1980s, a surge in drug use has ushered in a public health crisis that makes it more important than ever for the US to have a permanent drug czar.  This time around, the nation’s drug epidemic is being driven by a surge in opioid use that has only been made worse by the COVID-19 pandemic.  According to the Centers for Disease Control and Prevention (CDC), there were 88,295 predicted overdose deaths September 2019 through August 2020, a record high that is almost 19,000 more deaths, or 27% higher than the total for the previous 12-month period.  Experts say job losses, social isolation, anxiety, financial problems, and other pandemic-induced issues have made it difficult for people with substance use disorders to manage their addiction, leading to a sharp uptake in drug use. 

What Does the Drug Czar Do?

As part of the Executive Office of the President, ONDCP is tasked with coordinating the nation’s drug control policy through development and oversight of the National Drug Control Strategy and Budget, an annual report that is required by law.  In addition to running ONDCP, the Director evaluates, coordinates, and oversees both the international and domestic anti-drug efforts of executive branch agencies.  The Director also advises the President on anti-drug efforts.

The Director of National Drug Control Policy was notably a cabinet-level position from 1993 until 2009, when then-President Obama downgraded the position to a presidential appointment in the Executive Office with seemingly no explanation.  While advocates against substance use disorders have been pushing Biden to restore the position to its former level, the new Administration  has yet to make a decision on changing the drug czar’s status.  Interestingly enough, Biden criticized then-President George H. W. Bush in 1989 for declining to make ONDCP Director a cabinet-level position.

Who’s in the Mix to Lead ONDCP?

A top contender to lead ONDCP is Rahul Gupta, an internal medicine physician who currently serves as Chief Medical & Health Officer at the March of Dimes.  Gupta is no stranger to addiction issues, having previously served as Commissioner for the West Virginia Department of Health and Human Resources, where he was lauded for his efforts to slow overdose deaths in the state.  Gupta also has ties to the current Administration through his leadership of Biden’s transition efforts for ONDCP.  One factor that gives Gupta an edge is his strong relationship with Sen. Joe Manchin (D-WV), who has become a key swing vote in a divided Senate and could likely be counted on to vote to confirm Gupta.  However, Gupta has attracted some criticism for his perceived failure to address a 2017 HIV outbreak in West Virginia that resulted from a safe needle-exchange program.

Another notable contender is Regina LaBelle, who is currently serving as ONDCP’s Acting Director.  LaBelle formerly served as Chief of Staff of ONDCP during the Obama Administration, where she oversaw the Agency’s efforts to address the opioid epidemic and implement the National Drug Control Strategy.  Between serving in the Obama and Biden administrations, LaBelle led the Addiction and Public Policy Initiative at Georgetown University. 

Other contenders for the top job at ONDCP include former Rep. Patrick Kennedy (D-RI), a mental health advocate who has struggled with substance abuse in the past, and H. Westley Clark, a professor at Santa Clara University with extensive experience in addiction psychiatry. 

Slow Progress on Confirmations

The drug czar isn’t the only Administration post to go unfilled for some time.  While the Biden Administration has been nominating appointees at a faster pace than recent administrations, the Senate has been slow to confirm the Administration’s picks.  As of June 10, 2021, the Senate has only confirmed 42 of the current Administration’s nominees.  In contrast, by the end of May of their first year in office, Barack Obama had 145 confirmations, while George W. Bush logged 126 and Bill Clinton secured 151.

A major reason for the slow progress on nominations is a divided Senate.  Control in the upper chamber is currently split 50-50, and with Vice President Kamala Harris tilting the majority in Democrat’s favor with her tie-breaking vote, the Biden Administration needs unanimous support from the Democratic caucus to advance a nominee.  While President George W. Bush also began his first term with a 50-50 Senate, the current Senate is much more polarized, meaning Biden’s chances of attracting votes from Republicans on controversial nominees are slim to none.  The new Administration experienced this polarization firsthand when Neera Tanden, its nominee for Director of Office of Management and Budget, withdrew her name after Sens. Manchin and Susan Collins (R-ME) announced they would oppose her nomination.  Given the 50-50 split and highly polarized environment, it’s no surprise why the current Administration is facing a longer timeline to fill key positions. 

The Week in Review: June 7-11

Administration to Donate Half a Billion Pfizer Vaccine Doses

On June 9, President Joe Biden announced the purchase of 500 million doses of Pfizer’s COVID-19 vaccine to contribute to the global vaccination effort.  The first 200 million doses will be distributed this year, and the subsequent 300 million doses will be sent out in the first half of next year.  COVAX, the World Health Organization initiative to vaccinate the global population, will facilitate distribution efforts and target allocations to low- and middle-income countries.  The President’s announcement comes at the heels of a G-7 summit where world leaders will discuss efforts to end the pandemic. 

White House Takes Action to Bolster Medical Supply Chain

On June 8, the White House announced new initiatives to strengthen the supply chains of four key goods: semiconductor manufacturing and advanced packaging, large capacity batteries, critical minerals and materials, and both pharmaceuticals and active pharmaceutical ingredients.  The new initiatives follow the completion of a 100-day review the President ordered in February to identify disruptions and weaknesses in the supply chain for critical goods that could threaten the nation’s economic and national security.  A principal initiative requires the Department of Health and Human Services to create a public-private partnership to ensure essential medicines are produced domestically.  Additionally, the Administration will establish a Supply Chains Disruption Task Force to address near-term supply changes to the economic recovery.

3 FDA Advisory Committee Members Quit after Approval of Alzheimer’s Drug

This week, Aaron Kesselheim, a professor at Harvard Medical School, David Knopman, a neurologist at the Mayo Clinic, and Joel Perlmutter, a neurologist at Washington University in St. Louis, resigned from the Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee following FDA’s controversial decision to approve a new Alzheimer’s drug on June 7.  The drug, known as aducanumab, is the first new FDA-approved Alzheimer’s treatment since 2003 and the first treatment intended to slow the progression of Alzheimer’s.  When the advisory committee convened in November 2020, 10 of the 11 panelists found that there was not enough evidence that the drug could slow cognitive decline.  The FDA notably cleared aducanumab under accelerated approval, which allows for earlier approval of a drug for a serious illness without meeting the normal conditions for safety and effectiveness.

FDA Extends Shelf Life for J&J Vaccine to 4.5 Months

On June 10, Johnson & Johnson (J&J) announced FDA had authorized an extension of the shelf life for J&J’s COVID-19 vaccine from 3 months to 4.5 months when refrigerated at temperatures of 36-46 degrees Fahrenheit.  The announcement comes as many unused J&J doses were set to expire at the end of the month.  According to data from the Centers of Disease Control and Prevention, 11 million of the 21 million J&J vaccine doses distributed to states remain unused. 

Demings Launches Bid against Rubio for Florida Senate Seat

Rep. Val Demings (D-FL) kicked off her campaign to unseat Sen. Marco Rubio (R-FL) on June 9.  Demings, who served as a manager during then-President Donald Trump’s first impeachment, is considered an early favorite in the Democratic primary race.  Democrats are hopeful that Demings’s background in law enforcement including a four-year stint as Orlando’s police chief will help deflect GOP attacks that attempt to tie Democrats to the “Defund the Police” movement.  Given the Senate’s 50-50 split, flipping Senate seats such as Rubio’s is seen as critical to Democrats’ bid to maintain control of the chamber. 

ICYMI: DC Area Metro to Reduce Fares, Expand Service to Lure Back Riders  

On June 10, the DC Metro Board of Directors approved a new fare and service plan aimed at bringing riders back to the system and help low-income riders.  Most of the changes will take place in the fall when more downtown office workers are expected to at least partially resume their commutes.  Major changes include running Metro until 1 AM on Friday and Saturday nights and charging a flat $2 fare on weekends.  The recently announced changes by Metro reflect efforts other transit system aimed at recouping pandemic-related drops in ridership.  Since last month, Amtrak has restored daily service to 10 routes and New York City’s MTA has reinstated 24-hour service.

The Promise of Non-Profit Drug Companies

With trust in pharmaceutical companies waning and drug prices climbing, it’s clear providers and patients are frustrated with drug manufacturers.  Out of this frustration, providers and philanthropists have banded together to form non-profit drug companies, which aim to deliver low-cost generics by eschewing the profit-driven focus of other drug makers and embracing a mission to make drugs accessible and affordable.  But in an industry dominated by for-profit players, do non-profit drug companies stand a chance at making a difference?

The Major Non-Profit Players

Over the past few years, a handful of non-profit companies have emerged. 

  • Civica Rx, the most prominent non-profit drug maker, formed in September 2018 when several major health systems teamed up to manufacture their own generics.  The company grew out of a need to bring competition to the pharmaceutical industry, with the hopes of reigning in high prices for generics.  Civica first began manufacturing two antibiotics in March 2019 and signed agreement to produce injectable medications later that year.  In January 2021, Civica announced plans to build a 120,000 square foot facility just south of Richmond, VA to produce sterile injectable drugs for hospitals.  Civica has also expanded into drug development – in  January 2020, it signed a deal with Thermo Fisher Scientific to develop and manufacture its own drugs.  The company also notably partnered with 18 Blue Cross and Blue Shield companies in January 2020 to form a new subsidy to reduce the cost of generics.
  • Phlow Pharmaceuticals formed in January 2020 to produce active pharmaceutical ingredients (APIs) used in drug manufacturing.  Beginning in May 2020, the federal government awarded Phlow a total of $812 million to manufacture medicines at risk of shortage, including medicines for the COVID-19 response.  Notably, Phlow partnered with Civica on the new facility near Richmond, VA.
  • Harm Reduction Therapeutics formed in 2017 with the goal of preventing opioid overdose deaths by bringing a low-cost, over-the-counter naloxone spray to market.  In June 2020, the company received $6.5 million in financial support from Purdue Pharma, which produces opioids for prescription use. 
  • Medicines360 formed in 2015 to develop and provide low-cost contraceptives to women.  In October 2019, the Food and Drug Administration (FDA) approved a hormonal intrauterine device (IUD) Medicines360 developed with Allergan that prevents pregnancy for six years, the longest approved duration for IUD use in the US.

Advantages of Non-Profit Drug Makers

When it comes to delivering lower-cost drugs, non-profit pharmaceutical companies have several advantages

  • Non-profit drug companies focus on generic drugs, meaning they are out of the patent protection period and in the public domain. 
  • Additionally, thanks to their non-profit model, these companies don’t need to raise prices to honor fiduciary obligations to shareholders.  Excess funds can also be invested back into the organization to enable it to continue its non-profit mission.
  • Civica specifically operates on a membership model for hospitals that allows the company to make long-term commitments to members at a fair price.  This arrangement also allows Civica to offer the same price per unit to each hospital member.

Challenges for Non-Profit Drug Makers

Success for non-profit drug companies is not guaranteed, and they face major obstacles to fulfilling their mission.

  • Despite financial assistance from philanthropy, grants, and other means, non-profit companies lack access to capital through multiple investment streams that for-profit companies can more readily access.  This leaves non-profits at a serious disadvantage when it comes to research and development, which involves raising large amounts of capital.
  • When it comes to certain rules and regulations, the non-profit status of companies like Civica doesn’t entitle them to many breaks or special treatment.  For instance, the FDA imposes user feels on all drug manufacturers, regardless of their status or mission. 
  • Some reimbursement and payment policies may present obstacles  for non-profits to offer lower prices, particularly Medicaid’s “best price” rule.  To remain sustainable, non-profit drug makers may offer higher prices for some purchasers while keeping prices low for uninsured or low-income patients.  By offering low prices to the aforementioned groups, non-profits would be required to offer the same low price across Medicaid. 

Will Non-Profit Drug Companies Make a Difference?

Non-profits like Civica Rx and Phlow are new entrants to the drug market, and only time will tell if their efforts will pay off in the form of lower drug prices.  However, non-profits could follow a few strategies to increase their odds of success.  While Civica Rx and Medicines360 have become involved in drug development, non-profit drug manufacturers would be better off focusing on generics given their disadvantage in research and development.  Additionally, non-profit drug makers could push for policy and regulatory changes to give them a more favorable position in the market, such as reducing or waiving user fees for non-profits, increasing price transparency, or creating an exemption under the Medicaid “best price” rule.

The Week in Review: May 17-21

Pfizer, Moderna CEOs Say Booster COVID-19 Shots May Be Needed       

During a May 19 virtual event hosted by Axios, the CEOs of Pfizer and Moderna said some Americans may need a COVID-19 booster shot within 8-12 months from the original vaccination.  While it is unknown how long protection from COVID-19 vaccines lasts, NIAID Director Anthony Fauci commented during the same event that immunity against most coronaviruses “is generally not lifelong.”  However, some experts say the rhetoric from Pfizer and Moderna on booster shots may be tied to business goals, and they stress there is no evidence that shows immunity from COVID-19 vaccines has declined.

Emergent BioSolutions CEO Says J&J Vaccine Production Could Restart Soon

The CEO of Emergent BioSolutions told the House Coronavirus Crisis Subcommittee on May 19 that production of the Johnson & Johnson COVID-19 vaccine could resume within days.  The Food and Drug Administration (FDA) ordered Emergent BioSolutions to halt production of the vaccine in April after FDA inspectors found overcrowding and unsanitary conditions at the biopharmaceutical company’s Baltimore facility.  Just a week before FDA ordered the pause, Emergent BioSolutions was forced to toss out 15 million J&J vaccine doses after the company had accidentally mixed J&J ingredients with those used for AstraZeneca’s COVID-19 vaccine. 

Mask Guidance Partially Relaxed in Congress

Recently, the Office of the Attending Physicians issued new guidance saying fully vaccinated individuals in House Office Buildings are no longer required to wear masks and maintain social distancing.  The new guidance also lifted its maximum telework recommendation, meaning individual House offices can begin bringing remote staff back to the Hill.  Despite the new guidance, Speaker Nancy Pelosi (D-CA) has said the mask mandate on the House floor will remain in effect until all members have been vaccinated.  In response, some Republican members have been pushing the Speaker to drop all mask requirements.  On  May 14, 34 House Republicans sent a letter to Pelosi urging her to waive all mask rules, and on May 19, nearly a dozen Republican lawmakers were fined for not wearing masks on the House floor.  Senate Majority Leader Chuck Schumer (D-NY) has yet to officially weigh in on changes to mask guidelines for the Senate floor, where members of both parties have recently been spotted without masks. 

Top CDC Officials Step Down

On May 17, Centers for Disease Control and Prevention (CDC) Principal Deputy Director Anne Schuchat announced she plans to retire in the summer.  Schuchat, the CDC’s second highest-ranking official since 2015, has spent over 30 years at the agency.  Schuchat’s retirement announcement follows the early May resignation announcement of Nancy Messonnier, Director of CDC’s National Center for Immunization and Respiratory Diseases.  Messonnier had spent 20 years at the CDC and most recently led the agency’s COVID-19 task force.  While Schuchat and Messonnier have not specifically commented on their reasons for leaving CDC, reports suggest tension between the two and CDC Director Rochelle Walensky may have been a factor.  The high-level departures follow over a year of scrutiny of the CDC and its approach to issuing COVID-19 guidelines. 

ICYMI: New Mask Policy for Nationals Park, DC Bars in Effect May 21

Starting on May 21, fully vaccinated individuals are no longer required to wear a mask while visiting Nationals Parks or going to a bar or restaurant in Washington, DC.  Additionally, bars and restaurants in the District are once again permitted to offer bar service to customers and allow customers to stand in common areas.  However, bars and restaurants still have the option of requiring guests to wear a mask when not eating or drinking.

The Week in Review: May 3-7

Biden Announces Goal to Partially Vaccinate 70% by July 4

On May 4, President Biden announced a new goal to have 70% or more Americans with at least one shot of a COVID-19 vaccine and 160 million Americans fully vaccinated by July 4.  The President also announced a new vaccination strategy that will try to reallocate vaccine supply from states with weaker demand to areas with a stronger interest in shots.  At the moment, 57% percent of Americans have received at least one dose of a COVID-19 vaccine, while nearly 105 million are fully vaccinated.  While public health experts believe the Administration’s goal is attainable, pockets of vaccine hesitancy in the country present an obstacle. 

Pfizer, Moderna Vaccines Poised for Full FDA Approval

On May 7, Pfizer filed for full Food and Drug Administration (FDA) approval for its COVID-19 vaccine for people ages 16 to 85.  Earlier in the week, Moderna announced in its First Quarter 2021 earnings report plans to seek full FDA approval by the end of May for its COVID-19 vaccine for people ages 18 to 65.  Full approval would provide employers and organizations greater legal authority to require employees and students to get vaccinated. 

Federal Government Likely to Approve COVID Vaccine for Adolescents Next Week

On May 6, the CDC Advisory Committee on Immunization Practices (ACIP) announced it will hold meeting on May 12 vote on whether to extend the Emergency Use Authorization (EUA) for Pfizer’s COVID-19 for adolescents ages 12-15.  While ACIP’s decision is non-binding, the FDA is all but certain to follow through with the committee’s recommendation.  Many states have already begun allowing adolescents to register early for the vaccine, and President Biden has pledged that 20,000 pharmacy sites across the nation will be ready to vaccinate adolescents as soon as the FDA formally extends the EUA.  Pfizer is planning to seek an emergency use authorization for children ages 2 to 11 in September. 

Stefanik Soon to Succeed Cheney as House GOP Chair

Rep. Elise Stefanik (R-NY) is all but certain to succeed Rep. Lynne Cheney (R-WY) as Chair of the House Republican Conference after Cheney’s criticism of former President Trump and his role in the January 6th riot drew strong rebukes from prominent Republicans.  House Republican Leader Kevin McCarthy (R-CA) was recently caught on a hot mic saying he had “lost confidence” in Cheney, while House Republican Whip Steve Scalise (R-LA) and former President Trump have publicly backed Stefanik.  The New York Congresswoman, who served in the Bush White House and has been long considered a moderate in the GOP, rose to national prominence in her defense of the former President during his 2020 impeachment trial.  Many interpret Cheney’s ouster as a sign of Trump’s continued influence on the Republican Party.

ICYMI: Breyer Faces Calls to Retire

Some progressive groups and several members of Congress including Reps. Mondaire Jones (D-NY) and Jared Huffman (D-CA) are calling on 82-year-old US Supreme Court Justice Stephen Breyer to resign.  Their concerns over Breyer are likely rooted in the political fallout from the death of liberal Justice Ruth Bader Ginsburg, who was replaced by conservative Justice Amy Coney Barrett.  Some Democrats feel Breyer should retire while Democrats have control of the White House and Senate, meaning he could be replaced with another liberal-leaning justice.  However, Sen. Dianne Feinstein (D-CA), a member of the Judiciary Committee, has said it would be a “great loss” if Breyer opted to retire.

The Week in Review: April 19-23

Biden Celebrates 200 Million Vaccinations

On April 21, President Biden announced that the US had administered 200 million COVID-19 vaccine doses, meeting his Administration’s goal of putting 200 million shots into American arms within 100 days.  The President also urged unvaccinated Americans to fulfill their “patriot duty” and get their shots.  To encourage more Americans to get vaccinated, President Biden reaffirmed a commitment to a tax credit for small businesses to incentivize them to provide employees the day off to get vaccinated.

Are COVID-19 vaccinations starting to decline?

According to CDC data, the number of Americans who received COVID-19 vaccinations during the week of April 13 declined 11% from the previous week.  This marks the biggest decline in vaccinations since February, when winter storms delayed shipments and forced vaccinations sites to close.  The drop in vaccinations coincides with the federal government’s pause on the JNJ vaccine, forcing many vaccination sites to cancel appointments or switch to offering Pfizer-BioNTech and Moderna doses.  Public health experts attribute the drop to the interruption of the JNJ vaccines and waning interest in vaccinations among residents of rural areas.

ACIP Could Decide Fate of JNJ Vaccine Today

The CDC Advisory Committee on Immunization Practices (ACIP) meets today at 11:00 AM EDT to discuss whether or not the US should resume usage of the Johnson & Johnson (JNJ) COVID-19 vaccine.  ACIP initially voted to maintain the JNJ pause in its last meeting on April 14 after reports of six severe blood clot cases out of the 7.5 million people who had received the JNJ vaccine.  According to reports, ACIP may recommend resuming the use of the JNJ vaccine, but with new warnings about blood clots.  Alternatively, the advisory panel could impose restrictions on continued use of the JNJ vaccine, such as barring those in certain age groups from receiving JNJ shots, or maintain the pause to allow more data to be gathered. 

FDA Finds Overcrowding, Unsanitary Conditions at JNJ Contractor

Following an eight-day inspection, the FDA found multiple flaws at an Emergent BioSolutions facility in Baltimore that had been contracted to produce JNJ COVID-19 vaccines.  The Baltimore facility first hit the news on March 31 after reports that production mishaps required 15 million vaccine doses to be tossed.  Some of the problems FDA inspectors found include unsanitary conditions and insufficient space for materials and equipment.  While FDA and Emergent BioSolutions have committed to addressing the discrepancies, it seems unlikely that JNJ will meet its goal of delivering 100 million vaccine doses to the federal government by June.

Stivers Steps Down from Seat in Solid GOP District

On April 19, Rep. Steve Stivers (R-OH) announced he will leave Congress effective May 16, 2021, to serve as President and CEO of the Ohio Chamber of Commerce.  Stivers, a member of the House Financial Services Committee, has represented communities to the south and west of Columbus in Congress since 2011.   Ohio Governor Mike DeWine, a Republican, has yet to announce a special election to fill Stivers’ seat, which is a solidly red district.  The upcoming vacancy in Stivers’ seat will increase Democrats’ majority in the House from five seats to six.

ICYMI: DC Welcomes New WWI Memorial

The World War I Memorial, DC’s newest national memorial, opened in Pershing Park along Pennsylvania Avenue on April 21.  While the memorial is now open to the public, it’s notably missing its centerpiece – a free-standing bronze relief that won’t be completed for another three years.  However, visitors are still able to view water features, marble walls engraved with quotes and maps, and a statue of General John Pershing leftover from the previous iteration of the park.  The park’s unveiling coincided with a fighter jet flyover that surprised residents across the Washington, DC area.

ICER’s Growing Influence on Drug Value

The Institute for Clinical and Economic Review (ICER) has grown to become a leading voice on drug pricing in the US.  As the emphasis on value in the US health care system and concern over high drug prices continues to grow, more stakeholders are likely to look to ICER for guidance on whether a drug is appropriately priced. 

ICER was founded in 2006 by Dr. Steve Pearson, an ethicist from Harvard Medical School, with the goal of improving value in health care.  One of the main ways ICER seeks to carry out this mission is by publishing reports on whether new drugs are cost-effective.  Using both economic and clinical evidence, ICER determines a “value-based price benchmark” for each drug it studies based on the based on how much a patient’s quality of life improves.   While ICER does take some membership-based funding from companies including CVS-Caremark and Pfizer, the organization does not accept funding to perform research on specific drugs or therapies. 

ICER’s influence began to grow in 2015 thanks to financial support from billionaire John Arnold, who provides the organization over two-thirds of its funding.  Now, the organization plays a critical role in driving the national conversation on drug prices and value.   Only a third of ICER’s reports have found a drug to be cost-effective and appropriately priced, and in response, many drug companies, payers, and providers have adopted some of the organization’s pricing recommendations.  For example:

  • CVS Health allows its commercial plan clients to exclude drugs from their formularies that fail to meet ICER’s cost benchmarks.
  • Novartis set the price of its gene therapy drug Zolgensma in line with ICER’s recommendations.
  • The Department of Veterans Affairs uses ICER drug assessment reports in drug coverage and price negotiations with the pharmaceutical industry.
  • ICER’s cost effectiveness reports on PSCK9 inhibitors, which are used to manage and prevent cardiovascular disease, drove annual list prices down from $14,600-$14,100 to $5,850.
  • A report by ICON plc found over a third of payers surveyed would be likely to request a rebate to match the net ICER cost-effective price.

ICER isn’t without criticism.  As a private organization, ICER has drawn concerns from patient advocates and physicians for its lack of oversight and regulations.  Additionally, the organization has faced pushback over the use of its quality-adjusted life years (QALYs) formula, which estimates a drug’s dollar benefit.  Some patient advocates say QALY determines costs in a discriminatory manner because the formula assigns individuals with a chronic condition or a disability with a lower value.  Notably, the federal government is prohibited from using QALYs to measure cost-effectiveness under the Affordable Care Act. 

In the future, Cost-effectiveness itself is a complicated concept in light of growing trends:  ICER could impact health care based on growing trends:

  • A heightened focus on health disparities could prompt ICER to review how different therapies affect certain demographic groups.
  • In the oft-chance the US adopts a public health insurance option or even a single-payer system, ICER could play a greater role in dictating cost-effectiveness.  For example, the United Kingdom-equivalent of ICER has significantly more clout in the country’s National Health Service. 
  • ICER may be forced to adjust its methodologies to address the growth of personalized medicines such as cell and gene therapies, which benefit a relatively limited number of individuals compared to therapies the organization has traditionally studied.

Furthermore, if the US adopts a public health insurance option or even a single-payer system, ICER could play an even greater role in drug coverage and pricing.  The United Kingdom-equivalent of ICER has direct decision-making authority within the country’s National Health Service.