Insights^

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.

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. (Provigil)
• 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.

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. (jensen-jensen.com)   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.

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 6^th 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.

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.