COVID-19 Federal Response Update – Monday, July 13, 2020

Posted by

By Capitol Associates, Inc. 

Congress

  • Democrats in Congress and their Republican counterparts in Congress and the Administration are negotiating new COVID-19 relief legislation with the goal of passing legislation before the end of July.
    • One item of contention is how to extend unemployment benefits that are set to expire at the end of this month. Congress previously increased unemployment benefits by $600 per week to help workers who were laid off because of the pandemic. Democrats prefer to extend the increase in unemployment benefits. Republicans support additional assistance for out of work Americans but not in the form of an unemployment benefit increase.
    • In addition, Democrats are requesting $25 billion for vaccine development in the next relief bill.
  • The House Committee on Homeland Security held a hearing on Friday, June 10th to discuss COVID-19’s unequal impact on communities of color.
  • The House Energy and Commerce Committee will hold a hearing on July 21st featuring testimony from five drug manufacturers currently working to develop a COVID-19 vaccine.
  • Democratic members of the Senate Health, Education, Labor and Pensions (HELP) Committee released a white paper that details new safety, efficacy, and accessibility policies for COVID-19 vaccines. The proposal includes $25 billion in emergency funding for vaccine research and development.

HELP Committee Democrats also released a staff report criticizing the federal government’s COVID-19 testing efforts.

White House and Federal Agencies

  • After a rise in demand for telehealth services during the COVID-19 pandemic, the Department of Health and Human Services (HHS) is planning to work with Congress on legislation that expands telehealth coverage in Medicare and Medicaid.
  • HHS will allocate around $4 billion in COVID-19 relief funds for both safety net hospitals and rural providers.
  • HHS released May and June COVID-19 state testing plans to the public to serve as guidance for future testing strategies including responses to surges and reaching vulnerable populations.
  • The Centers for Disease Control and Prevention (CDC) updated information regarding electronic case reporting (eCR), the automated system that sends COVID-19 case reports from electronic health records (EHR) to public health agencies.
  • CDC Director, Robert Redfield, believes that keeping schools closed in the fall could pose a greater public health threat than if they are safely reopened in compliance with CDC guidelines.
    • Education Secretary Betsy DeVos voiced her support for reopening schools safely this coming fall in accordance with CDC guidelines, saying that returning to school would not be dangerous for students.
  • The CDC reports that the COVID-19 death rate for people of color under the age of 65 is twice as high as the death rate among white counterparts.
  • The Food and Drug Administration (FDA) released a statement that they will be resuming on-site inspections of FDA-regulated facilities during the week of July 20.

Vaccines, Testing and Reopening

  • HHS Assistant Secretary for Health, Brett Giroir, states that he expects to see a rise in deaths in the next few weeks as hospitalizations and case numbers rise.
  • Gilead Sciences announced that Remdesivir, an antiviral drug, reduced risk of death in patients with more severe cases of COVID-19 by 62 percent. The U.S. is allocating 11,000 courses of the drug to Texas, Florida, California, and Arizona.
  • Surgeon General Jerome Adams believes that the United States has the potential to reverse its course on COVID-19 outbreaks if individuals continue to follow social distancing, hygiene, and mask wearing guidelines.
  • Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, advised that states experiencing a rise in infection rates should pause their reopening timeline.
  • Robert Kaplan, President of the Dallas Federal Reserve, says that wearing a mask is essential if the U.S. is to experience faster economic recovery.
  • A King’s College study revealed that antibody levels decline in COVID-19 patients only a few months after infections. Declining antibody levels means recovered COVID-19 patients could be susceptible to reinfection.
  • The World Health Organization (WHO) released a scientific brief acknowledging that COVID-19 could possibly be airborne in closed indoor spaces. The WHO came under pressure from scientists for its reluctance to acknowledge airborne spread.
  • The U.S. Food and Drug Administration (FDA) granted an expedited review process for two experimental COVID-19 vaccines under development by Pfizer Inc. and BioNTech, respectively.
  • FDA vaccine official Peter Marks M.D., Ph.D., stated his belief that in order to completely eradicate COVID-19, the U.S. would need a vaccine that is 70 percent effective and received by 70 percent of the population.
  • The FDA identified 59 hand sanitizer varieties as containing methanol, a toxic substance that may cause vomiting, headache, blurred vision, permanent blindness, seizures, etc. with prolonged exposure.

Please  contact the AHRA Regulatory Affairs Committee with any regulatory questions you may have at regulatory@ahra.org.

Post a Comment

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s