Insights^

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.

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.

“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 45^th 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.