FDA Issues Health Care Provider Information on Antibody Testing

Food and Drug Administration (FDA) is recommending that health care providers continue to use serological (antibody) tests intended to identify people who have been exposed to or recovered from coronavirus disease 2019 (COVID-19). FDA specifically recommended the following for health care providers:

  • Continue to use serological (antibody) tests, as appropriate, however, be aware of their limitations,
  • Do not use serological (antibody) tests as the sole basis to diagnose COVID-19 but instead as information about whether a person may have been exposed, and
  • Be aware that not all marketed serological tests have been evaluated by FDA. The agency’s authorized tests, including serological tests, are listed on its Emergency Use Authorization (EUA) web page.

To help ensure that health care providers have access to accurate tests, FDA is working with the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) on a validation project to help identify the most promising serological tests. Providers are encouraged to report any adverse events or suspected adverse events experienced with serological tests via the MedWatch Adverse Event Reporting Program.

Experts Voice Concern of Additional Pandemic Waves As States Begin Easing Restrictions

Health experts throughout the country are warning that additional waves of the COVID-19 pandemic could emerge in the fall or winter, even as some states begin reducing restrictions to keep residents at home. For example, in an interview with The Washington Post, CDC Director Robert Redfield said, “There’s a possibility that the assault of the virus on our nation next winter will actually be even more difficult than the one we just went through.” He later clarified that statement during a daily COVID-19 task force briefing, noting that seasonal influenza will be back in the fall. “The issue I was talking about was that it will be more difficult in that we will have two viruses circulating at one time.”

Other developments over the last few days include:

  • FDA has re-issued an EUA to permit testing for COVID-19 from samples self-collected by patients at home;
  • FDA issued a face mask EUA in response to insufficient supplies of available face masks for use by both the general public and health care providers; and
  • The United States Department of Health and Human Services has awarded nearly $165 million to combat the COVID-19 pandemic in rural communities.

Daily updates on the spread of the virus, including a state-by-state breakdown of known infections and fatalities, are available from CDC. International information is available from World Health Organization.

NABP continues to collect information about how boards of pharmacy are responding to COVID-19 in the Coronavirus Updates section of the NABP website. Pharmacists are also encouraged to check their state board(s) of pharmacy websites for jurisdiction-specific information. Additional resources for pharmacists and other health care providers are available from the American Pharmacists Association’s Pharmacists’ Guide to Coronavirus.

Seventy-Two Clinical Trials for COVID-19 Therapies Underway Via FDA’s Special Emergency Program

Recognizing the COVID-19 pandemic as an unprecedented event in modern history, FDA launched the Coronavirus Treatment Acceleration Program to make it easier for patients and their providers to have access to new treatments as soon as possible. According to a new FDA Voices article written by FDA Commissioner Stephen M. Hahn, MD, 72 clinical trials of potential COVID-19 treatments are currently underway. These include direct-acting antiviral drugs, medication designed to decrease the inflammation of the lungs associated with COVID-19, and treatments derived from blood plasma taken from people who have recovered from the virus. FDA is also actively supporting efforts to facilitate vaccine development by working with developers, researchers, and manufacturers to help expedite the development and availability of vaccines that may prevent COVID-19.

In the article, Hahn further emphasizes that his agency is working with others, including NIH and the Foundation for NIH to develop a national strategy for the coordinated response to the pandemic. The Accelerating COVID-19 Therapeutic Interventions and Vaccines Partnership will aim to develop a collaborative framework for prioritizing vaccine and drug candidates, streamline clinical trials, coordinate regular processes, and/or leverage assets among all partners to rapidly respond to the pandemic.

“We’re all in this together and will continue to do everything we can to expedite the development of innovative prevention and treatment approaches,” Hahn wrote. “The FDA will use science and data to drive our decisions and will remain steadfast in our efforts to bring treatments to patients.”

DEA Launches Secure Your Meds Awareness Campaign, Reminds Americans to Keep Medications Safe During Pandemic

During the COVID-19 pandemic, Drug Enforcement Administration (DEA) launched the Secure Your Meds awareness campaign, which calls on Americans to keep their prescription medications safe and secure until they can be properly disposed. The goal of this campaign is to also prompt families to discuss the topic of controlled prescription drug abuse to keep everyone safe.

“Protecting the health and safety of our communities is DEA’s top priority, especially during the unprecedented public health emergency,” said DEA Acting Administrator Uttam Dhillon in a press release. “With Americans at home, families need to be even more vigilant and keep prescription medications safe, secure, and out of reach of children and others in the household.”

Many studies show that abused prescription drugs are often obtained from the family medicine cabinet. DEA is asking Americans to clean out their cabinets, making sure to secure any unused, unwanted, and expired prescriptions until the next National Prescription Drug Take-Back Day.

National Prescription Drug Take-Back Days are held twice a year, once in the spring and once in the fall. However, due to COVID-19, DEA’s spring 2020 take-back day event was postponed and will be rescheduled after emergency guidelines are lifted. For more information about the National Prescription Drug Take-Back Days, visit takebackday.dea.gov.