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.

 

24 Hour Fitness files for bankruptcy, announces about 130 gym closures

June 15, 2020

by Ken Bradley

On June 15, 2020, gym company 24 Hour Fitness Worldwide Inc. filed for Chapter 11 bankruptcy and announced the permanent closures of about 130 locations in the United States, mostly in California and Texas. The company was forced to close its locations nationwide in March 2020, due to the COVID-19 pandemic. Approximately 400 of the remaining 24 Hour Fitness locations are expected to re-open by the end of June or early July 2020, depending on gym re-opening policies of the state, county or city where each gym is located.

The re-opening of these 24 Hour Fitness gyms includes new policies for health precautions during the COVID-19 pandemic, such as requiring appointments, with each appointment limiting gym use to one hour per person; social distancing of people and equipment (at least 6 feet apart) throughout each location; no longer providing childcare and fitness done in groups; and discontinuing the use of showers, swimming pools, saunas and basketball courts.

Customer complaints about 24 Hour Fitness are flooding social media, with people claiming that they have not been able to obtain refunds for pre-paid or automatically paid gym membership during the period of time that 24 Hour Fitness locations have been closed. There are also concerns about getting refunds for locations that will be permanently closed. 24 Hour Fitness has not publicly addressed these complaints.

In a statement on the 24 Hour Fitness website and social-media accounts, the company announced the bankruptcy and restructuring:

“On June 15, 2020, we announced an important step to strengthen 24 Hour Fitness for the long-term. We are implementing a financial restructuring, through a voluntary Chapter 11 filing. This process gives us the opportunity to reposition 24 Hour Fitness by eliminating debt and closing clubs that were either out-of-date or in close proximity with other 24 Hour Fitness clubs.

“Removing these financial and operational constraints allows us to focus entirely on transforming our business and the club experience for the better. We will have the financial flexibility and resources to upgrade equipment and expand and improve our fitness offerings to best serve our members and continue our transformational journey.

“We have refreshed the club environment for the health and safety of our club members. As we continue to reopen clubs in a phased approach, you can learn more about the club environment here.

“While we reopen clubs, all members will have access to any available 24 Hour Fitness club through the end of 2020, regardless of membership level. For updates and further news about our phased club reopenings and locations, please visit us at https://www.24hourfitness.com/health_clubs/gyms-open-near-me.

“We are deeply grateful for your continued loyalty to 24 Hour Fitness. You provide the inspiration for what we do, and we are excited to continue supporting you along your fitness journey well into the future.”

Here is the list of 24 Hour Fitness locations that will be permanently closed:

California

  • 850 Tennant Station, Morgan Hill, CA 95037
  • 1519 Gateway Blvd, Fairfield, CA 94533
  • 4300 Sonoma Blvd, Vallejo, CA 94589
  • 140A Alamo Plaza, Alamo, CA 94507
  • 3951 Alemany Blvd, San Francisco, CA 94132
  • 1775 Solano Avenue, Berkeley, CA 94707
  • 375A North Capitol Avenue, San Jose, CA 95133
  • 35630 Fremont Boulevard, Fremont, CA 94536
  • 2145 Market Street, San Francisco, CA 94114
  • 301 Jacklin Road, Milpitas, CA 95035
  • 3800 24th Street, San Francisco, CA 94114
  • 350 Bay Street, San Francisco, CA 94133
  • 2033 N. Main Street, Walnut Creek, CA 94596
  • 3633 Rosedale Highway, Bakersfield, CA 93308
  • 4302 Gosford Road, Bakersfield, CA 93313
  • 505 S. Flower Street, Los Angeles, CA 90071
  • 240 North Brand Blvd, Glendale, CA 91203
  • 12120 Carson Street, Hawaiian Gardens, CA 90716
  • 9750 Central Avenue, Montclair, CA 91763
  • 23750 Alessandro Blvd, Moreno Valley, CA 92553
  • 1335 Rancho Vista Blvd, Palmdale, CA 93551
  • 465 North Halstead Street, Pasadena, CA 91107
  • 2350 Tapo Street, Simi Valley, CA 93063
  • 1422 Azusa Avenue, West Covina, CA 91791
  • 1417 Second Street, Santa Monica, CA 90401
  • 16200 Bear Valley Road, Victorville, CA 92395
  • 400 W. Disney Way, Suite 94, Anaheim, CA 92802
  • 1600 Adams Avenue, Costa Mesa, CA 92626
  • 18305 Brookhurst Street, Fountain Valley, CA 92708
  • 517 Spectrum Center Drive, Irvine, CA 92618
  • 25252 McIntyre Street, Suite A, Laguna Hills, CA 92653
  • 18007 Von Karman Avenue, Irvine, CA 92612
  • 6731 Westminster Blvd., Westminster, CA 92683
  • 3137 West Benjamin Holt Drive, Stockton, CA 95219
  • 1090 North Main Street, Manteca, CA 95336
  • 5114 Arden Way, Carmichael, CA 95608
  • 40396 Murrieta Hot Springs Road, Murrieta, CA 92563
  • 27520 Ynez Road, Temecula, CA 92591
  • 320 Third Avenue, Chula Vista, CA 91910
  • 7680 Girard Avenue, La Jolla, CA 92037
  • 641 S. Rancho Sante Fe Road, San Marcos, CA 92078
  • 324 Sycamore Avenue, Vista, CA 92083

Colorado

  • 7720 N. Academy Blvd., Colorado Springs, CO 80920
  • 3001 South 23rd Avenue, Greeley, CO 80631
  • 4100 South Parker Road, Aurora, CO 80014
  • 1450 South Abilene Street, Aurora, CO 80012
  • 360 South Teller Street, Lakewood, CO 80226
  • 4650 W 120th Avenue, Broomfield, CO 80020
  • 2770 South Colorado Blvd, Denver, CO 80222
  • 3435 S. Inca Street, Englewood, CO 80110
  • 460 South College Avenue, Fort Collins, CO 80524
  • 333 Dad Clark Drive, Highlands Ranch, CO 80126
  • 2650 W. Belleview Avenue, Suite #100, Littleton, CO 80123
  • 11798 Oswego Street, Englewood, CO 80112
  • 6839 South Vine Street, Centennial, CO 80122

Florida

  • 1775 North Congress Avenue, Boynton Beach, FL 33426
  • 6846 Forest Hills Blvd., Greenacres, FL 33413
  • 20851 Dixie Drive Highway, Miami, FL 33189
  • 8400 Mills Drive, Miami, FL 33183
  • 2982 Grand Avenue, Miami, FL 33133
  • 8333 Pines Blvd., Pembroke Pines, FL 33024
  • 15 West Crystal Lake Street, Orlando, FL 32806

Hawaii

  • 150 Hana Highway, Kahului, HI 96732

Illinois

  • 560 S. Schmale Road, Carol Stream, IL 60188
  • 141 N Barrington Road Schaumburg, Schaumburg, IL 60194

Maryland

  • 200 Harker Place, Annapolis, MD 21401
  • 9450 Ruby Lockhart Blvd, Lanham, MD 20706

New Jersey

  • 918 Bergen Avenue, Jersey City, NJ 7306
  • 459 Route 17, Hasbrouck Heights, NJ 7604
  • 1327 Centennial Avenue, Piscataway, NJ 8854
  • 189 US Highway 46, Saddle Brook, NJ 7663
  • 133 Route 23, Wayne, NJ 7470
  • 30 Sylvan Way, Parsippany, NJ 7054
  • 1624 Saint Georges Avenue, Avenel, NJ 7001

Nevada

  • 4480 E. Charleston Blvd., Las Vegas, NV 89104
  • 2893 North Green Valley Parkway, Henderson, NV 89014
  • 4440 E. Tropicana Avenue, Las Vegas, NV 89121
  • 100 City Parkway, Las Vegas, NV 89106
  • 2106 W. Craig Road, North Las Vegas, NV 89032
  • 601 S. Rainbow Blvd., Las Vegas, NV 89145
  • 9875 S. Maryland Parkway, Las Vegas, NV 89183
  • 5035 W. Tropicana Avenue, Las Vegas, NV 89103
  • 6155 Neil Road, Reno, NV 89511

New York

  • 1675 Sunrise Hwy, Bay Shore, NY 11706
  • 1921 86th Street, Brooklyn, NY 11214
  • 945 Kings Highway, Brooklyn, NY 11223
  • 225 Fifth Avenue, New York, NY 10010
  • 941 Carmans Road, Massapequa, NY 11758
  • 153 East 53rd Street, New York, NY 10022
  • 1728 Sheepshead Bay Road, Brooklyn, NY 11235
  • 2503 Grand Concourse, Bronx, NY 10468
  • 298 West 231st, Bronx, NY 10463
  • 589 Tuckahoe Road, Yonkers, NY 10710

Oregon

  • 4145 SW Watson Ave, Beaverton, OR 97005

Texas

  • 13802 N Hwy 183, Austin, TX 78750
  • 12400 N IH- 35 Svc. Road Southbound, Austin, TX 78753
  • 1208 N Interstate 35 Ste 300, Round Rock, TX 7868
  • 213 North Highway 67, Cedar Hill, TX 75104
  • 2100 Plaza Parkway, Bedford, TX 76021
  • 3050 North Josey Lane, Suite 110, Carrollton, TX 75007
  • 7622 Campbell Road, Dallas, TX 75248
  • 3865 Preston Road, Frisco, TX 75034
  • 2407 West Airport Freeway, Irving, TX 75062
  • 5901 Golden Triangle, Fort Worth, TX 76244
  • 724 West Main Street, Lewisville, TX 75067
  • 5706 E. Mockingbird Lane, Dallas, TX 75206
  • 6601 Northeast Loop 820, North Richland Hills, TX 76180
  • 4600 West Park Blvd., Plano, TX 75093
  • 7068 FM-1960 East, Humble, TX 77346
  • 12708 Northwest Freeway, Houston, TX 77092
  • 130 West Parkwood Avenue, Friendswood, TX 77546
  • 19734 Saums Road, Houston, TX 77084
  • 21614 Tomball Parkway, Houston, TX 77070
  • 4425 FM 1960 West, Houston, TX 77068
  • 1550 S. Mason Road, Katy, TX 77450
  • 2765 Gulf Freeway South, League City, TX 77573
  • 5946 Fairmont Parkway, Pasadena, TX 77505
  • 5721 Westheimer Road, Houston, TX 77057
  • 25632 Highway 290, Cypress, TX 77429
  • 10860 Kuykendahl Road, The Woodlands, TX 77381

Utah

  • 1121 East Ashton Ave, Salt Lake City, UT 84106
  • 5684 South 900 East, Murray, UT 84121
  • 5766 South 1900 West, Taylorsville, UT 84129
  • 10365 South 1300 East, Sandy, UT 84094

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