Review: ‘Totally Under Control,’ starring Rick Bright, Kathleen Sebelius, Michael Bowen, Scott Becker, Eva Lee, Taison Bell and Max Kennedy Jr.

October 13, 2020

by Carla Hay

Doctors treating COVID-19 patients in a scene from “Totally Under Control” (Photo courtesy of Neon)

“Totally Under Control”

Directed by Alex Gibney, Suzanne Hillinger and Ophelia Harutyunyan

Culture Representation: The documentary “Totally Under Control” features a predominantly white group (with a few Asians and one African American) of scientists, medical professionals, journalists and bureaucrats discussing how the U.S. government handled the COVID-19 (coronavirus) pandemic in the first several months of the pandemic.

Culture Clash: Several people in the documentary say that Donald Trump’s Republican administration, allies and other supporters frequently contradicted and ignored the advice and warnings of scientists on how to prevent the spread of the virus.

Culture Audience: “Totally Under Control” will appeal to primarily to people who want a closer look at what has already been reported in the media about the U.S. government’s response to the coronavirus pandemic.

Drive-by COVID-19 testing in a scene from “Totally Under Control” (Photo courtesy of Neon)

It’s clear from watching “Totally Under Control” that the title is a sarcastic reference to Donald Trump and his presidential administration’s “we’ve got this under control” initial response to the COVID-19 pandemic. The COVID-19 virus was first discovered in late 2019 (with origins in Wuhan, China), but it wasn’t until 2020 that the virus spread to the point it has infected and devastated millions of people around the world. It should come as no surprise that the documentary’s overwhelming conclusions are that, contrary to the movie’s title, things got out of control very quickly, and the impact will be felt for years to come.

Directed by Alex Gibney, Suzanne Hillinger and Ophelia Harutyunyan, “Totally Under Control” is a documentary that feels urgent in its message but also prone to being outdated within a short period of time because the pandemic is an ever-evolving situation. Even though “Totally Under Control” will be rendered obsolete a lot quicker than other documentaries because of rapidly developing news stories about the COVID-19 pandemic, the movie is best viewed as a time capsule for what went wrong in the first crucial months of the pandemic.

Written and narrated by Gibney, “Totally Under Control” was filmed using social-distancing guidelines: Many of the interviewees were interviewed remotely with video cameras that the filmmakers sent to them. Others who were interviewed in person were placed far-enough apart from the film crew, with plastic shielding separating people and equipment. This social-distancing is seen and mentioned in the movie.

Because there have already been copious amounts of news coverage about the COVID-19 pandemic, a lot of the information in “Totally Under Control” will not surprise people who have been closely following the news. But for everyone else, the documentary is sure to be an eye-opener in many ways, beginning with how much scientists and politicians in the United States knew about how to respond to a pandemic scenario, but U.S. government leaders were ill-prepared anyway.

It’s mentioned at the end of “Totally Under Control” that officials from the Trump administration, the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (DHHS or HHS) and the U.S. Food and Drug Administration (FDA)—the institutions that get the most criticism in the movie—declined to be interviewed or provide commentary for this documentary. Dr. Anthony Fauci, who has been the director of the National Institute of Allergy and Infectious Diseases since 1984, is not interviewed in the documentary either. However, the documentary points out that Fauci is one of the U.S. government’s few high-profile advisers in the 2020 COVID-19 pandemic who has actual medical/scientific experience, since most of Trump’s appointees who are advising him on the pandemic are people with backgrounds in business or law.

Even though “Totally Under Control” doesn’t have interviews with the highest level of U.S. government officials involved in the COVID-19 pandemic in 2020, the movie still has a good cross-section of interviewees. They include:

  • Scott Becker, CEO of the Association of Public Health Laboratories
  • Dr. Taison Bell, COVID ICU Director at the University of Virginia Medical Center
  • Michael Bowen, executive vice president of Prestige Ameritech
  • Rick Bright, former director of the Biomedical Advanced Research and Development Authority (BARDA)
  • Beth Cameron, former senior director for global health security and biodefense on the National Security Council
  • Caroline Chen, ProPublica health care reporter
  • Dr. Tom Frieden, former director of the CDC
  • Dr. Alex Greninger, assistant director of the University of Washington’s Clinical Virology Lab
  • Dr. Kim Jin Yong, infectious disease doctor at Incheon Medical Center (South Korea)
  • Max Kennedy Jr., former White House COVID-19 supply-chain volunteer
  • Victoria Kim, Seoul correspondent for Los Angeles Times,
  • Dr. James Lawler, infectious disease specialist at University of Nebraska Medical Center
  • Dr. Eva Lee, infectious disease specialist at Georgia Tech (Georgia Institute of Technology)
  • Dr. Francis Riedo, medical director of infection control and prevention at Evergreen Health (Seattle)
  • Kathleen Sebelius, former secretary of Health and Human Services
  • Michael Shear, White House correspondent for The New York Times
  • Dr. Vladimir Zelenko, family medicine doctor

Bright, who is one of the star whistleblowers in the documentary, says that there is “absolutely a playbook on how to deal with a pandemic.” It’s called the Crimson Contagion, a report that was distributed to the highest levels of U.S. government in 2019, after a series of mock pandemic drills and studies were conducted in 12 states. Bright comments on the major takeaway from these studies: “The challenge has always been ‘Who’s in charge?'” The success or failure of responding to a pandemic can be found in answering that question.

It’s a question that sounds easy to answer. But in the chaos that followed after the first reported COVID-19 patient in the United States in January 2020, it became sadly clear that no one really wanted to take charge of the problem. Before the United States was largely shut down in mid-March 2020, Trump and other officials in his administration were downplaying the spreading outbreak to the media. The documentary repeatedly holds up South Korea as an example of a country that did things correctly in containing the pandemic, by having mandatory testing, quarantines and mask wearing on a national level until the pandemic was under control in the country’s borders.

Bright says that behind the scenes, HHS assistant secretary Robert Kadlec rebuffed Bright’s request to form a disaster leadership group. And when Bright said in a meeting with HHS secretary Alex Azar that an approximate $10 billion would be needed to for the U.S. government to properly deal with a pandemic in the United States, Bright was told later by people in the meeting that this request greatly angered Azar and other officials who thought the projected cost was outrageously high.

The documentary doesn’t hesitate to make Azar and Kadlec (who are Trump appointees) two of the biggest villains in the coronavirus pandemic’s devastation of the United States. It’s noted in the movie that during his tenure, Kadlec cut spending on research for infectious diseases and eliminated a program that manufactured N-95 masks, which are crucial personal protective equipment for medical workers in the fight against highly contagious diseases like COVID-19.

And the documentary says there’s more blame to go around, besides blaming the obvious people at the top: Trump and U.S. Vice President Mike Pence, whom Trump placed in charge of a national coronavirus task force. John Bolton (former U.S. ambassador to the United Nations), who was ousted by Trump in September 2019, is also blamed for eliminating a global health security team that could’ve helped the U.S. respond better to the pandemic. And the documentary also blames Trump adviser (and Trump son-in-law) Jared Kushner, who formed his own COVID-19 task force, called the White House COVID-19 Supply Chain.

Several media reports have exposed Kushner’s task force as inept and comprised of mostly inexperienced volunteers in their 20s who received little to no training on what do. Volunteers on this task force have told the media that they were forced to get into bidding wars for PPE supplies, without being told important details, such as how high they could bid or how payment transactions would be completed. “Totally Under Control” confirms those reports about the Kushner-led task force, mainly through whistleblower Max Kennedy Jr., a former volunteer on this task force and a grandson of Robert F. Kennedy.

In the documentary, Kennedy describes in the documentary that volunteers were left to fend for themselves and figure out who to call for COVID-19 supply assistance. He also claims that Kushner and other task-force supervisors never delivered on promises, and the volunteers had to sign nondisclosure agreements (NDAs). Kennedy acknowledges that he’s breaking the NDA agreement by being interviewed for this documentary. But considering that he comes from a wealthy and powerful political family, it’s doubtful he’ll face any legal consequences.

Kennedy claims that he wanted to volunteer for Kushner’s nonpartisan task force to help any way he could. However, critics could easily accuse Kennedy of having a political agenda and being a “mole” for the Democrats by being on this task force, because the Kennedys are the most famous Democratic family in the United States. The documentary could have used more input from another person on that task force (someone not associated with a political family that’s famously opposed to Republicans), even if it that person or person didn’t want to be interviewed on camera.

Ameritech’s Bowen, who says he voted for Trump in 2016, comments that a big problem was that most mask manufacturers that were in the United States eventually left to do business in countries outside the United States. And so, when the pandemic happened and there was a shortage of masks, the U.S. was woefully unprepared and had to spend an untold higher amount of money for masks to be imported from other countries.

The American divide between political conservatives (who are usually Republicans) and political liberals (who are usually Democrats) has been the fuel behind the firestorm over requirements to wear masks during the pandemic. The documentary points out that during the pandemic, the U.S. was the only major industrial country in the world to have such a political response to wearing masks. “Totally Under Control” doesn’t reveal much that’s new, except to side with the scientists, who believe that wearing masks, social distancing, washing hands frequently and getting tested for COVID-19 are the best known ways to prevent the spread of the virus until a vaccine is found.

The documentary also has plenty of criticism for the Trump administration’s decision to let state governments create their own COVID-19 policies, compared to having a national policy that was effective for other countries that were able to contain and decrease the spread of COVID-19 within their borders. In American, state governments got into bidding wars over PPEs and testing equipment. The Trump administration feuded with state governors (almost always Democratic governors) who openly criticized Trump and his administration. These governors then accused the Trump administration of deliberately withholding federal disaster funding for their states for political reasons.

But even the U.S. system of testing failed on many levels in the first few months of the pandemic. The documentary details how the CDC had sent out flawed test kits that created a “total nightmare,” says Becker, who adds: “It was like we were flying blind, and we knew it.”

Becker, Bright and others interviewed in the film sometimes get emotional when they think about all the time wasted trying to get U.S. government approval for things that should have been quickly approved if the pandemic had been taken more seriously earlier than it was. Bright says about the shortage of N95 respirators: “I sounded the alarm every day,” but he says he was mostly ignored by the Trump administration and Trump appointees until it was too late.

And about that vaccine. The documentary mentions that one of the biggest problems is all the contradictory claims about when a vaccine is expected to be available. There’s also a lot of misinformation about what drugs work the best on COVID-19 patients. The controversial drug hydroxychloroquine, which was touted and endorsed by Trump, is inevitably mentioned as an example of a drug that has not been scientifically proven to get rid of COVID-19 in a patient, even though some people claim that it does.

One of those people is Zelenko—an ardent Trump supporter who practices medicine in Monroe, New York—and who says that hydroxychloroquine has worked on several of his COVID-19 patients, even though Zelenko admits he has no scientific proof or studies to back up that claim. None of these supposed “miracle patients” is interviewed in “Totally Under Control.” In the documentary, Zelenko seems more concerned about bragging how he was able to get the attention of Trump quickly through social media than about discussing the urgent medical issues related to COVID-19.

In his interview, Zelenko says that the day after he made a YouTube video about hydroxychloroquine, he was contacted by White House chief of staff Mark Meadows, and that led to Zelenko’s first meeting with Trump. Zelenko also seems very impressed with himself that he was able to go from being a self-described obscure doctor with a small family practice into the upper echelons of Trump medical advisers about COVID-19.

Meanwhile, Bright (who was BARDA director from 2016 to 2020) says in his “Totally Under Control” interview that his breaking point with the Trump administration was when he got email messages from several U.S. government officials—including HHS secretary Kadlec, HHS assistant director Brett Giroir and Federal Emergency Management Agency (FEMA) director Pete Gaynor—pressuring Bright to push hydroxychloroquine into as many U.S. pharmacies as possible, even though the drug had not been approved by the FDA for Emergency Use Authorization (EUA).

Bright says that he refused to go along with that plan, and he was soon removed from his BARDA position. And when he filed a whistleblower complaint and later testified in a U.S. House of Representatives hearing in May 2020, Bright was vilified by the Trump administration as a disgruntled former employee. Meanwhile, even with a vaccine, it remains to be seen how the spread of the COVID-19 virus can be contained and decreased in the U.S. when many people in the U.S. are divided over what should be required by the government and how the government should enforce those requirements in helping prevent the spread of COVID-19.

Toward the end of the documentary, Sebelius (who was HHS secretary from 2009 to 2014) comments on the billions of dollars that the U.S. spends on military defense equipment and training: “We have to take health security as seriously as we take defense security.” The one question that the documentary won’t be able to answer is what future American leaders will learn from the mistakes that were made during the COVID-19 crisis and how prepared the United States will be the next time there is a rapidly spreading, deadly pandemic.

Neon released “Totally Under Control” on digital and VOD on October 13, 2020. The movie will premiere on Hulu on October 20, 2020.

Food and Drug Administration coronavirus update: July 2, 2020

July 2, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The U.S. Food and Drug Administration (FDA) issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency’s response efforts.
  • As part of continued action to protect the American public, the FDA is warning consumers and health care professionals about hand sanitizer products that contain methanol (a.k.a. wood alcohol), a substance often used to create fuel and antifreeze. Methanol is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has seen an increase in hand sanitizer products that are labeled as containing ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. State officials have also reported recent adverse events from adults and children ingesting hand sanitizer products contaminated with methanol, including blindness, hospitalizations and death.
  • Testing updates:
    • To date, the FDA has currently authorized 162 tests under EUAs; these include 136 molecular tests, 25 antibody tests, and 1 antigen test.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

Food and Drug Administration coronavirus update: June 24, 2020

June 24, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • Today, FDA launched the first “FDA Insight” podcast, featuring FDA Commissioner Stephen Hahn, M.D., and FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D., discussing FDA’s COVID-19 efforts, including the drug development process for a COVID-19 treatment. Future FDA Insight podcasts will feature Hahn, Shah, and other FDA leaders’ insights into issues facing the agency — including the COVID-19 pandemic and other emerging topics.

  • FDA Commissioner Stephen Hahn, M.D., spoke at the German Marshall Fund’s Brussels Forum 2020. This 15th edition of the forum, live-streamed/posted on YouTube, featured a 25-minute conversation with Dr. Hahn, moderated by Axios Health Care Editor Sam Baker.

  • Today, U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen Hahn, M.D., issued the following joint USDA-FDA statement regarding food export restrictions pertaining to COVID-19:

    The United States understands the concerns of consumers here domestically and around the world who want to know that producers, processors and regulators are taking every necessary precaution to prioritize food safety especially during these challenging times. However, efforts by some countries to restrict global food exports related to COVID-19 transmission are not consistent with the known science of transmission.

    There is no evidence that people can contract COVID-19 from food or from food packaging. The U.S. food safety system, overseen by our agencies, is the global leader in ensuring the safety of our food products, including product for export.

  • Testing updates:
    • To date, there are 149 currently-authorized tests under EUAs; these include 125 molecular tests, 23 antibody tests, and 1 antigen test.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Food and Drug Administration coronavirus update: June 15, 2020

June 15, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • Today, FDA revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use. The agency issued a Press Release and posted FAQs about this action.
  • Today, FDA is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease. Based on a recently completed non-clinical laboratory study, the FDA is revising the fact sheet for health care providers that accompanies the drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended, as it may result in reduced antiviral activity of remdesivir. The agency issued a Press Release about this action.
  • On June 12, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia.
  • The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
  • To learn more about keeping your pets safe during the coronavirus (COVID-19) pandemic, watch this new video.
  • Testing updates:
    • To date, the FDA has authorized 138 tests under EUAs, which include 117 molecular tests, 20 antibody tests, and 1 antigen test.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

Food and Drug Administration coronavirus update: June 8, 2020

June 8, 2020

 

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The FDA issued a guidance, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.” The guidance addresses questions FDA has received concerning prescription drug sample distribution under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency. The guidance explains that, on a temporary basis, the FDA does not intend to object to the delivery of prescription drug samples to patients’ homes if requested by their licensed health care professional, and the guidance describes the agency’s current policy regarding the signature required at time of delivery of drug samples, to promote public health.
  • On June 8, 2020, the FDA added the BioMedInnovations SuppleVent Ventilator to the list of ventilators authorized under the March 24, 2020, EUA for certain ventilators, ventilator tubing connectors, and ventilator accessories. This ventilator provides continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes use in an intensive care unit or other hospital environments such as during intra-hospital transport and in temporary hospital facilities. Lawrence Livermore National Laboratory collaborated in the design of the ventilator.
  • FDA published two new web pages to help the public access information: (1) Innovation to Respond to COVID-19 provides an overview of FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible and (2) Educational Resources provides links to FDA-produced COVID-19-related resources that help explain FDA’s work.
  • Testing updates:
    • To date, the FDA has authorized 125 tests under EUAs, which include 107 molecular tests, 17 antibody tests, and 1 antigen test.

Additional Resources:

Media Contact: Lee.Herring@fda.hhs.gov, 240-402-6386
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

Food and Drug Administration coronavirus update: June 8, 2020

June 8, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The FDA issued a guidance, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.” The guidance addresses questions FDA has received concerning prescription drug sample distribution under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency. The guidance explains that, on a temporary basis, the FDA does not intend to object to the delivery of prescription drug samples to patients’ homes if requested by their licensed health care professional, and the guidance describes the agency’s current policy regarding the signature required at time of delivery of drug samples, to promote public health.
  • On June 8, 2020, the FDA added the BioMedInnovations SuppleVent Ventilator to the list of ventilators authorized under the March 24, 2020, EUA for certain ventilators, ventilator tubing connectors, and ventilator accessories. This ventilator provides continuous ventilatory support for adult patients who require mechanical ventilation. The ventilator is intended for institutional use by qualified, trained personnel under the direction of a doctor. Institutional use includes use in an intensive care unit or other hospital environments such as during intra-hospital transport and in temporary hospital facilities. Lawrence Livermore National Laboratory collaborated in the design of the ventilator.
  • FDA published two new web pages to help the public access information: (1) Innovation to Respond to COVID-19 provides an overview of FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible and (2) Educational Resources provides links to FDA-produced COVID-19-related resources that help explain FDA’s work.
  • Testing updates:
    • To date, the FDA has authorized 125 tests under EUAs, which include 107 molecular tests, 17 antibody tests, and 1 antigen test.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Food and Drug Administration coronavirus update: June 2, 2020

June 2, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The agency issued a new FDA Voices, titled Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety, and bylined by Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Frank Yiannas, Deputy Commissioner for Food Policy and Response. In March, the FDA was a few days away from announcing the release of the New Era of Smarter Food Safety Blueprint when the FDA’s focus turned to the COVID-19 pandemic. Plans for the New Era initiative were rightfully put on hold in order to prioritize the agency’s COVID-19 response. The FDA will release the blueprint in the coming weeks, outlining plans over the next decade to create a more digital, traceable, and safer food system.
  • The FDA published guidance, titled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators, which includes recommendations regarding procedures for single IRB member review. This is in response to physician requests for a waiver from the requirement for full IRB review. The guidance recommendations also address factors to consider when assessing potential benefits and risks for a particular patient being treated under expanded access.
  • The FDA added a second ventilator developed by NASA to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator emergency use authorization (EUA) that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. The NASA VITAL (Ventilator Intervention Technology Accessible Locally) is intended to last three to four months and is specifically tailored to provide respiratory support for COVID-19 patients who are experiencing respiratory failure or insufficiency. Where the first NASA ventilator relied on wall gas as the pressure source, the second ventilator uses an internal compressor for its energy source. The device is designed to be built with components outside the current medical device supply chain and therefore does not impact the existing supply chain of currently made ventilators.
  • The FDA added an emergency resuscitator for the Fitbit Flow to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator emergency use authorization (EUA). The Fitbit Flow is a continuous respiratory support system that includes an FDA-cleared Manual Resuscitator. The accessory is an AMBU bag with audible and visual alarms that aid the performance of the manual resuscitator for continuous breathing. This design is intended for use in treating patients with COVID-19.
  • The FDA, in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of pediatric product development plans for the treatment and prevention of COVID-19. In issuing this Common Commentary, the FDA and EMA aspire to streamline administrative processes and facilitate efficient submission of an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP).
  • The FDA recognizes the vital role of health professionals in the fight against COVID-19. In order to help health professionals quickly and easily access FDA resources, we created a new web page, titled Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals. This page contains links to FDA emergency use authorizations; information about personal protective equipment and other medical products for use during COVID-19.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 119 tests under EUAs, which include 103 molecular tests, 15 antibody tests, and 1 antigen test.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Food and Drug Administration coronavirus update: May 29, 2020

May 29, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • FDA is making its previously developed FDA MyStudies app available to investigators as a free platform to securely obtain patients’ informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. FDA MyStudies is now referred to as COVID MyStudies in the Apple App store and in the Google Play store.
  • As part of the FDA’s efforts to protect consumers, the agency issued warning letters to two companies for selling fraudulent COVID-19 products. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
    • The first seller to whom FDA sent a warning letter was Quadrant Sales & Marketing, Inc., which offers non-alcohol-based hand sanitizer products for sale in the United States with false or misleading claims including that the products maintain their effectiveness for up to 24 hours. Time-specific extended efficacy claims may give users the false impression that they need not rigorously adhere to interventions such as social distancing and engaging in good hygienic practices that have been demonstrated to curb the spread of COVID-19.
    • The second seller to whom FDA sent a warning letter was StayWell Copper Products, which offers copper “Germ Stopper” products for sale in the United States with misleading claims that the products are safe and/or effective for the prevention  of COVID-19.
  • Today, the FDA took steps to further support the development of COVID-19 tests for at-home self-collection by providing on its website a template that may be used to facilitate submission of requests for emergency use authorizations (EUA) for at-home sample collection kits. As explained in FDA’s guidance, Policy for COVID-19 Tests During the Public Health Emergency (Revised), this template reflects FDA’s current thinking on the data and information that developers should submit to facilitate the EUA process. In particular, this template includes recommendations for use by laboratories and commercial manufacturers who may choose to use it to facilitate the preparation and submission of an EUA request. Currently, developers can offer a COVID-19 test for at-home self-collection where specifically authorized under an EUA or as part of an Institutional Review Board (IRB)-approved study.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 114 tests under EUAs, which include 101 molecular tests, 12 antibody tests, and 1 antigen test.

Additional Resources:

Food and Drug Administration coronavirus update: May 18, 2020

May 18, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

  • The FDA issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
    • The first seller warned, Noetic Nutraceuticals, offers CBD products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
    • The second seller warned, The Golden Road Kratom, offers kratom products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
  • The Agency issued a new FDA Voices titled, COVID-19 Supply Chain Update: Importation of Vital Food and Medical Products. It provides details on the FDA’s work to ensure the safety and security of the U.S. supply of food and medical products. Many of the medical products our health care workers and hospitals need to battle COVID-19 come from overseas, which makes the FDA’s Office of Regulatory Affairs (ORA) work imperative to ensure legitimate products are moving as quickly as possible through the ports of entry. At the same time, ORA imports staff also screens for, and blocks the entry of, unproven products that falsely claim to prevent, diagnose, treat or cure COVID-19.
  • Over the weekend, FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit, the first standalone at-home sample collection kit that can be used with certain authorized tests. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit.
  • Last week, the FDA approved another Abbreviated New Drug Application for Hydroxychloroquine Sulfate Tablets USP, 200 mg for the treatment of: (1) Uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. (2) Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and (3) Treatment of acute and chronic rheumatoid arthritis in adults. Side effects of hydroxychloroquine include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy and neuropathy, neuropsychiatric events, and hypoglycemia. The FDA recently posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 103 tests under EUAs, which include 90 molecular tests, 12 antibody tests, and 1 antigen test.

Additional Resources:

Food and Drug Administration coronavirus update: May 9, 2020

May 9, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. The EUA was issued late Friday to Quidel Corporation for the Sofia 2 SARS Antigen FIA. This test is authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments (CLIA), as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

Diagnostic testing is one of the pillars of our nation’s response to COVID-19 and the FDA continues to take actions to help make these critical products available, including by issuing EUAs. During this pandemic, there have been two types of tests for which the FDA has issued EUAs. One type are polymerase chain reaction (PCR) tests, a molecular diagnostic testing technique that detects the genetic material from the virus and can help diagnose an active COVID-19 infection. The other type are serological tests that look for antibodies to the virus, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection (serological, or antibody, tests should not be used to diagnose active infection).

This latest FDA authorization is for an antigen test, which is a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19. Each category of diagnostic test has its own unique role in the fight against this virus. PCR tests can be incredibly accurate, but running the tests and analyzing the results can take time. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes. However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test. Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.

Antigen tests are also important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests and once multiple manufacturers enter the market, can potentially scale to test millions of Americans per day due to their simpler design, helping our country better identify infection rates closer to real time.

This is just the first antigen test to be authorized and we expect more to follow. We also anticipate providing an EUA template for antigen tests, similar to ones we’ve released for other test types, to help manufacturers streamline submissions and help expedite our review and issuance of additional EUAs.

Antigen tests will play a critical role in the fight against COVID-19 and we will continue to offer support and expertise to help with the development of accurate tests, and to review and monitor marketed tests to ensure accuracy, while balancing the urgent need for these critical diagnostics.

For More Information:
FDA: FAQs on Diagnostic Testing for SARS-CoV-2 | FDA
CMS: Clinical Laboratory Improvement Amendments (CLIA)
CDC: Testing for COVID-19