COVID-19 Updates from the FDA

With COVID-19 continuing to impact the nation, the FDA has regularly communicated various updates regarding diagnostic testing, clinical trials, and policy regarding supposed treatments. Further information regarding the following updates, as well as new developments as they occur, can be found on the FDA’s Press Announcements page.

FDA Diagnostic Testing Update

In mid-March, the FDA updated regulations to expedite the delivery of diagnostic tests for COVID-19, allowing states to set up a system in which laboratories developing tests can engage directly with the appropriate state authorities, instead of with the FDA. Furthermore, the FDA does not intend to object to commercial manufacturers distributing these newly developed tests.

The FDA is also utilizing their power of Emergency Use Authorization (EUA), a system in which they may allow the use of unapproved medical products or unapproved uses of approved products in a crisis when there are no adequate or approved alternatives. Currently the FDA is working with over 380 developers in the hope of granting EUAs for diagnostic tests to detect COVID-19, with 50 such tests receiving EUAs.

Several COVID-19 tests are being utilized; some take days, hours, or minutes, but they employ different methods. An antibody test has recently been approved. However, the FDA has reiterated again and again that at this time, no at-home diagnostic tests exist for COVID-19. Any product claiming to do so is fraudulent, and the FDA is currently investigating such products. The FDA did grant an EUA for one diagnostic test that permits the testing of samples self-collected by patients at home, but samples must be sent of to a lab for testing.

The Use of Chloroquine and Hydroxychloroquine

Many media outlets have reported on the potential use of chloroquine, an anti-malaria drug, to reduce symptoms of COVID-19. The FDA has not issued an official approval of the use of chloroquine for COVID-19, however they have taken several actions regarding such products.

This includes issuing an emergency use authorization (EUA), a system in which they may allow the use of unapproved medical products or unapproved uses of approved products in a crisis when there are no adequate or approved alternatives. This specific EUA allows for hydroxychloroquine sulfate and chloroquine phosphate products donated to Strategic National Stockpile to be distributed and used for certain hospital patients infected with COVID-19.

Furthermore, the FDA approved an abbreviated new drug application (ANDA) for hydroxychloroquine sulfate tablets. While the ANDA does not cover COVID-19 in its indications, it does allow for more generic manufacturing.

And finally, the FDA is working with manufacturers to expedite the production of these products. However, the FDA warned that chloroquine phosphate products created to treat diseases in aquarium fish are not exchangeable with other formulations of chloroquine. Furthermore, the FDA is reporting serious heart rhythm problems in COVID-19 patients treated with hydroxychloroquine or chloroquine. These drugs should only be used in limited circumstances in hospitalized patients as outlined by the FDA.


Tags: FDA, COVID-19, diagnostic test, chloroquine, hydroxychloroquine


Sandy Shtab: Regulatory Acceleration in Response to COVID-19

Healthesystems’ AVP of Advocacy & Compliance, Sandy Shtab, was featured in WorkCompWire’s Leaders Speak Series, discussing regulatory acceleration in response to COVID-19.

In the article, Sandy covers federal and state responses, the relaxing of requirements to ease access to injured worker care, telehealth, disaster recovery plans, and more.

Read the article in full online at WorkCompWire.


Tags: WorkCompWire, Sandy Shtab, Leaders Speak, COVID-19


Could Convalescent Plasma Treat COVID-19?

In mid-March, the FDA expressed interest in evaluating if convalescent plasma taken from blood donated by people who have recovered from COVID-19 could shorten the length or lessen the severity of the virus. The agency now leads a cross-government initiative to facilitate the development of antibody-rich blood products.

The FDA claims that prior experience with respiratory viruses, and data from China, indicates that such products could be useful in the fight against COVID-19, and a recent article from the Journal of the American Medical Association (JAMA) shows potential.

The JAMA study documents the results of convalescent plasma transfusions for five patients with critical illness from COVID-19, all of whom had high viral loads and suffered acute respiratory distress syndrome (ARDS), requiring mechanical ventilation.

Convalescent plasma was administered to these patients 10-22 days after hospital admission. Body temperature normalized within three days for four out of the five patients, and their sequential organ failure assessment (SOFA) scores decreased, indicating a lower likelihood of organ failure. Furthermore, ARDS resolved in four patients after 12 days, with three patients weaned off ventilators after two weeks. Three patients were discharged, and the other two were in stable condition 37 days after the transfusion.

While this study and others like it show promise, they require evaluation in randomized clinical trials, as this case was an uncontrolled case study with a very small sample size.

However, the potential of studies like this is encouraging the FDA to facilitate access to convalescent plasma for treating COVID-19, using multiple pathways. This includes emergency investigational new drug applications (eIND). The FDA is proving healthcare providers information on how to submit eINDs to treat individual patients with convalescent plasma. Furthermore, the FDA is working with healthcare industry, academic, and government partners to develop and implement protocols surrounding convalescent plasma.

And finally, the FDA is encouraging those who have fully recovered from COVID-19 for at least two weeks to consider donating plasma, which could potentially help save lives. Potential donors are encouraged to visit the Red Cross online, or contact their local blood donor or plasma collection center.


Tags: blood, convalescent plasma, plasma, transfusion, FDA, JAMA


More States Make COVID-19 Compensable in Workers’ Comp

While most of the country self isolates to flatten the curve of COVID-19 infections, various essential workers face infection while helping to keep the nation running.

Depending on a state’s definitions of occupational illnesses and/or diseases that may arise out of employment, coronavirus could be considered a reasonable occupational risk that warrants workers’ comp coverage. However, with a lack of clarity surrounding such language, several state governments have expanded workers’ comp coverage for COVID-19 to certain workers who may be exposed to the virus in the line of duty.

In early March, the Washington Department of Labor began providing benefits to quarantined healthcare workers and first responders. Coverage includes medical testing, treatment expenses if a worker becomes ill or injured, and indemnity payments for those who cannot work if they are sick or quarantined.

A week later, North Dakota Governor Doug Burgum issued Executive Order 2020-12, which also expanded coverage to first responders and healthcare workers, making them eligible for 14 days of wage replacement and medical coverage if quarantined. This measure applied to volunteer first responders as well.

In early April, the Florida Office of Insurance Regulation issued a memo expressing that first responders, healthcare workers, and others that contract COVID-19 due to work-related exposure would be eligible for workers’ comp benefits under Florida law. The memo states that “insurers licensed to provide workers’ compensation coverage in Florida are reminded of this statutory requirement, which must be applied on a non-discriminatory basis.” With no clarification on “others” and “non-discriminatory basis,” several other occupations could possibly receive similar benefits.

Meanwhile in Minnesota, Governor Tim Walz signed House Bill 4537, which provides workers’ comp coverage for COVID-19 due to workplace exposure for first responders, correctional officers, healthcare workers, home health workers, and childcare workers providing care to first responders. Employees who contract COVID-19 but do not fall into these categories are not precluded from claiming COVID-19 as an occupational disease.

Kentucky Governor Andy Beshear issued Executive Order 2020-277, expanding coverage to first responders, healthcare workers, grocery store workers, postal workers, childcare workers, domestic violence shelter workers, and child advocacy workers.

Missouri issued an emergency rule to cover first responders, while the Illinois Workers’ Compensation Commission issued an emergency ruling that offers coverage to first responders, healthcare workers, and other front-line workers, assuming COVID-19 arises out of the course of employment. The ruling’s definition of “front-line workers” covers several and other occupations. However, now it is reported that the Workers’ Compensation Commission is repealing this emergency rule.


Tags: COVID-19, healthcare worker, first responders, coverage, compensable, grocery, Washington, North Dakota, Kentucky, Missouri, Illinois. Florida, Minnesota


Silvia Sacalis: 3 Evolving Clinical Trends in Workers’ Comp

Healthesystems’ VP of Clinical Services, Silvia Sacalis, BS, PharmD, was featured in WorkCompWire’s Leaders Speak Series, discussing clinical trends in workers’ comp, including changing populations, shifts in chronic pain drug therapy, and comorbidities.

Read the article in full online at WorkCompWire.


Tags: Silvia Sacalis, WorkCompWire, clinical, population trends, population management, chronic pain, drug therapy, comorbidities