This Week’s Dose

The House shifts its focus to government funding and waiving the debt limit. Centers for Disease Control and Prevention (CDC) broadens the recommendation for COVID-19 boosters.

Congress

Government Funding Bill and Debt Ceiling Provisions Remain Unsettled.  House passage of the continuing resolution (CR)—a legislative vehicle that allows for temporary funding of the federal government—came just nine days before the end of the government’s fiscal year on September 30. The bill passed on a party-line vote of 220-211, with one Republican not voting. The House version of the CR included funding for government operations through December 3, 2021, which would necessitate another CR immediately after, unless a more comprehensive deal is struck sooner. The bill included $28.6 billion in emergency funding that the Biden Administration had requested in response to domestic natural disasters, as well as $6.3 billion to assist with Afghan refugee resettlement. Additionally, and perhaps most notably, the CR calls for a waiver of the debt limit (how much debt the government is allowed to carry) through December 2022. The CR is unlikely to pass the Senate, where it would need the support of 10 Republicans to meet the 60 vote threshold required, because it includes the debt limit flexibility. Senator McConnell has introduced a Republican CR containing the same major priorities, without the debt limit waiver.  While both parties have stressed the importance of ensuring the United States does not default on its debt, it is unlikely the CR will pass in its current form. Democrats could pursue a strategy of raising or suspending the debt limit as part of the partisan reconciliation package that is currently moving through the House, but that would be complicated and  Democratic leaders have continued to insist that will not happen.  With just six days left before the end of the government’s fiscal year, resolving the CR is the most critical issue to address by month’s end.  There is also a closing window for the United States to be able to borrow more money with the debt limit expected to be hit by mid-October.  Expect the coming days to be a breakneck race to find solutions.

Administration

CDC broadens booster dose recommendations. On Wednesday, the U.S. Food and Drug Administration (FDA) formally authorized booster shots of Comirnaty, Pfizer and BioNTech’s COVID-19 vaccine, for emergency use in individuals aged 65 years and older, as well as high-risk individuals. This decision came after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) chose not to recommend boosters for the general population last week. The VRBPAC indicated that not enough peer-reviewed data was available for them to determine that the benefits of a booster outweighed the risk, especially in younger populations. This determination is at-odds with the Biden Administration’s earlier stated goal of making boosters available for all vaccinated individuals by the end of September. On Thursday, the CDC’s Advisory Committee on Immunization Practices (ACIP) followed the FDA’s authorization with its own recommendation that individuals who are 65 years-old or 18 and older with an underlying condition get a booster dose of the Pfizer vaccine. However, ACIP voted against allowing the booster for those at risk because of their occupation. Early this morning the CDC Director, Rochelle Walensky, authorized booster shots for those who are 65 or older, high risk individuals and went against the  ACIP by announcing that the CDC would allow individuals working in high-risk occupations, such as health care workers, to receive a Pfizer booster shot. Actions on Moderna and Johnson & Johnson are still pending.

Inspector General of Health and Human Services (HHS) Poised to Investigate Drug Companies in Potential 340B Enforcement Action. In May, the Health Resources and Services Administration (HRSA) issued notices to six drug manufacturers, warning that they were required to sell drugs at the 340B ceiling price to contract pharmacies and that sales could not be conditioned on the collection of additional data. Now, HHS asserts that these companies have not complied with the HRSA’s request and, with court adjudication processes still unresolved, the department is ordering investigations that could result in civil monetary penalties.