FDA, Pharmacies Take Action in Preparing for COVID-19 Outbreak

In its first action, the FDA has decided to not object to the New York State Department of Health’s (NYSDOH) action authorizing certain laboratories in New York to start patient testing for COVID-19.

The FDA announced today 2 significant actions towards addressing the novel coronavirus (COVID-19) outbreak in the United States.1 Major pharmacy organizations also are taking action to confront the outbreak.

As of March 13, 2020, there have been at least 132,567 cases confirmed globally by the World Health Organization, and the outbreak has officially been classified as a pandemic. In the United States, there have been 1629 cases total and 41 deaths, according to the CDC.2,3

In its first action, the FDA has decided to not object to the New York State Department of Health’s (NYSDOH) action authorizing certain laboratories in New York to start patient testing for COVID-19 after validating their tests and notifying the NYSDOH. Laboratories will provide validation data to NYSDOH within 15 days in lieu of pursing an Emergency Use Authorization (EUA) with the FDA, according to the NYSDOH.1

The FDA is granting this flexibility to NYSDOH based on the urgent public health need for additional testing capacity. The agency weighed several factors in this decision, including that the NYSDOH has a long-established framework in place for oversight of laboratory developed tests in New York State.

In its second act, the FDA has authorized Roche Molecular Systems’ cobas SARS-CoV-2 test as the third granted EUA for a diagnostic test during the ongoing COVID-19 outbreak. This test is to be used within 24 hours of the application being received, and is the first commercially distributed diagnostic test to receive an EUA during the COVID-19 outbreak.1

In addition to the FDA, pharmacy organizations are taking action against COVID-19 in other ways. Their actions aim to protect medications on federal and state levels, and spread awareness to the public to keep them as healthy as possible.

For example, the American Society of Health-System Pharmacists (ASHP) has recommended to federal policymakers multiple solutions that could help protect the drug supply chain from shortages, ensure Medicare and Medicaid beneficiaries have adequate access to pharmacist care, provide resources to support clinician readiness and resilience, and address emerging risk areas.4

For state policymakers, ASHP has said that pharmacists should be taking steps towards supporting prevention and response efforts of the outbreak, including:

  • Ensure that pharmacists are authorized under your state pharmacy practice act to order and administer immunizations for prevention of infectious diseases
  • Ensure that pharmacists are authorized under your pharmacy practice act to initiate time-sensitive therapies, such as antivirals, and
  • Involve pharmacists in emergency response planning and coordination.5

Additionally, the Centers for Medicare & Medicaid Services (CMS) is launching coverage on Frequently Asked Questions on Essential Health Benefits in response to COVID-19. These answers include information on testing, isolation/quarantine, and vaccination.6

“Amid a serious outbreak like this one, Americans understandably crave the security and peace of mind that comes from understanding exactly how they will be covered,” CMS Administrator Seema Verma said in a prepared statement. “Today’s guidance aims to give it to them.”6

REFERENCE

  • Coronavirus (COVID-19) update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic [news release]. Silver Spring, MD; March 13, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-gives-flexibility-new-york-state-department-health-fda-issues?utm_campaign=031020_PR_Coronavirus%20Update%3A%20FDA%20actions%20on%20NYSDOH%2C%20Roche%20diagnostic&utm_medium=email&utm_source=Eloqua. Accessed March 13, 2020.
  • FDA issues emergency authorization for cobas SARS-CoV-2 test. ContagionLive. https://www.contagionlive.com/news/fda-issues-emergency-authorization-for-cobas-sarscov2-test. Published March 13, 2020. Accessed March 13, 2020.
  • Coronavirus Disease 2019 (COVID-19) in the U.S. CDC. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html. Updated March 13, 2020. Accessed March 13, 2020.
  • Pharmacy Readiness for Coronavirus Disease 2019- Recommendations for Federal Policymakers. ASHP. https://www.ashp.org/-/media/assets/advocacy-issues/docs/Pharmacy-Readiness-for-Coronavirus-Disease-2019-COVID-19-FEDERAL.ashx?utm_source=030620-GRD-Coronavirus. Published March 2020. Accessed March 13, 2020.
  • Pharmacy Readiness for Coronavirus Disease 2019- Recommendations for State Policymakers. ASHP. https://www.ashp.org/-/media/assets/advocacy-issues/docs/Pharmacy-Readiness-for-Coronavirus-Disease-2019-COVID-19-STATE.ashx. Published March 2020. Accessed March 13, 2020.
  • CMS publishes FAQs to ensure individuals, issuers and states have clear information on coverage benefits for COVID-19. CMS.gov. https://www.cms.gov/newsroom/press-releases/cms-publishes-faqs-ensure-individuals-issuers-and-states-have-clear-information-coverage-benefits. Published March 13, 2020. Accessed March 13, 2020.