Congress

• A bipartisan group of House Members called the “Problem Solvers Caucus,” is attempting to break the current impasse between Congressional leadership of both parties. The Caucus is drafting a bipartisan COVID-19 relief bill that seeks to strike a compromise between the versions championed by Republicans and Democrats, respectively. It is still too early to know if this bill will receive serious consideration in either Chamber of Congress. 
• Congress is planning to pass a Continuing Resolution (CR) before federal funding expires after September 30^th. It is not clear exactly how long the CR will extend funding beyond its expiration. However, it appears that Congress will not use the CR as a vehicle to pass policies unrelated to the funding extension such as new COVID-19 relief.
• The House Select Committee on the Coronavirus will investigate a report from Politico that politically appointed communications officials within the Department of Health and Human Services (HHS) are influencing CDC Morbidity and Mortality Weekly Reports (MMWR).

White House and Federal Agencies

• HHS Secretary Alex Azar led a bipartisan call with the chief executives of approximately 50 states, territories, and the city of Washington, DC, and the White House Coronavirus Task Force to discuss local, state, and federal COVID-19 response and recovery, and provide an update on Operation Warp Speed efforts to develop, manufacture, and distribute a safe and effective vaccine. 
• Treasury Secretary Steven Mnuchin reiterated his endorsement for more federal spending to help the economy recover.
• Senior FDA officials released an op-ed in USA Today on following the science to protect public health in pandemic.
• Occupational Safety and Health Administration (OSHA) issued citations to three hospital systems for violating its guidelines on personal protective equipment (PPE) for healthcare providers.

Centers for Disease Control and Prevention (CDC) Updates

• CDC updated interim clinical guidance for clinicians to discover how they can best care for hospitalized patients with a confirmed infection caused by novel COVID-19.​
• CDC updated document provided by CDC and is intended for use in non-US healthcare settings. This document is intended for healthcare facilities that are receiving or are preparing to receive patients with suspected or confirmed COVID-19.
• CDC updated guidance on when to quarantine. You should stay home if you might have been exposed to COVID-19.
• CDC updated information on the duration of isolation and precautions for adults with COVID-19. Accumulating evidence supports ending isolation and precautions for persons with COVID-19 using a symptom-based strategy. This update incorporates recent evidence to inform the duration of isolation and precautions recommended to prevent transmission of SARS-CoV-2 to others, while limiting unnecessary prolonged isolation and unnecessary use of laboratory testing resources.
  • CDC updated information on when you can be around others (end home isolation). It depends on different factors for different situations.
• CDC released an MMWR that found that adults with positive SARS-CoV-2 test results were approximately twice as likely to have reported dining at a restaurant compared to those with negative SARS-CoV-2 test results.
• CDC released an MMWR on the Delay or Avoidance of Medical Care Because of COVID-19 in the U.S. in June 2020. By June 30, 2020, because of concerns about COVID-19, an estimated 41% of U.S. adults had delayed or avoided medical care including urgent or emergency care (12%) and routine care (32%).
  • Avoidance of urgent or emergency care was more prevalent among unpaid caregivers for adults, persons with underlying medical conditions, Black adults, Hispanic adults, young adults, and persons with disabilities.
• Social isolation during the COVID-19 pandemic is a public health concern. Resources are available to help people stay connected even while physically distanced.
• CDC updated guidance on the cleaning and disinfection of rooms or areas of those with suspected or with confirmed COVID-19 in community facilities.
• CDC updated steps and consideration that jurisdictions can use to develop a protocol for the tracing of close contacts.
• CDC updated information on actions to take if your pet tests positive for the virus that causes COVID-19.

Economy, Testing, Treatment and Vaccine.

• AstraZeneca resumed its vaccine clinical trials after abruptly pausing the trials last week due to a suspected adverse reaction observed in one trial participant. Thus far, AstraZeneca has only resumed trials in the UK.
• Pfizer and BioNTech are planning an expansion of the phase three trial for their vaccine candidate.
• Here is helpful background on the vaccine clinical trial process and an overview of the vaccine candidates undergoing clinical trials in the U.S.
• Eli Lilly is reporting that an anti-inflamatory drug it produces could be an effective treatment for COVID-19.
• The National Institutes of Health (NIH) has launched two of three adaptive Phase 3 clinical trials evaluating the safety and effectiveness of varying types of blood thinners to treat adults diagnosed with COVID-19. The new trials are part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative.

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  Updates provided by Capitol Associates, AHRA's Regulatory Affairs Partner in Washington, DC