FDA Stakeholder Update - March 27, 2020

Dear Health Professionals,

As you and other health care providers work on the front lines of the COVID-19 pandemic, we want you to know we are here to help you and your patients through this critical time. We recognize your concerns about protecting the safety of your patients, yourselves, and your families.

While our nation’s emphasis is on combatting the virus, protecting health care providers and facilitating access to critical medical supplies continue to be a top priority for the FDA.

Announcements

March 26, 2020 - Daily Roundup March 26, 2020 - FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes March 25, 2020 - Daily Roundup March 24, 2020 - FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers March 24, 2020 - FDA Helps Facilitate Veterinary Telemedicine During Pandemic

Consumer Updates

Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

While many Americans are sheltering at home to help “flatten the curve” and slow the spread of coronavirus disease (also called COVID-19), they might be tempted to buy or use questionable products that claim to help diagnose, treat, cure, and even prevent COVID-19. Because COVID-19 has never been seen in humans before, there are currently no vaccines to prevent or drugs to treat COVID-19 approved by the FDA. The FDA is working with vaccine and drug manufacturers to develop new vaccines for and find drugs to treat COVID-19 as quickly as possible. Meanwhile, some people and companies are trying to profit from this pandemic by selling unproven and illegally marketed products that make false claims, such as being effective against the coronavirus. These fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness and might be dangerous to you and your family. [03/24/2020]

Biosimilar and Interchangeable Biologics: More Treatment Choices

The FDA has approved biosimilar medications to treat conditions such as cancer, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis, and more. But what are biosimilar and interchangeable biological medications? To answer that question, it helps to first know what biological products (biologics) are. [03/23/2020]

Safety Information

FDA Letter to Stakeholders: Do Not Use Chloroquine Phosphate Intended for Fish as Treatment for COVID-19 in Humans The FDA’s Center for Veterinary Medicine has recently become aware that some consumers may mistake chloroquine phosphate used to treat disease in aquarium fish for FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans.  Unfortunately, we have learned that one person in the United States has died after he and his wife reportedly took chloroquine used to treat their fish in an attempt to prevent COVID-19; his wife also became very ill.  We are continuing to investigate this incident. While FDA is aware of the use of unapproved drugs to treat aquarium fish, our primary concern during the COVID-19 pandemic is the imminent threat to the health of consumers who may take animal drugs thinking they are interchangeable with approved human drugs. Chloroquine products sold for aquarium use have not been evaluated by the FDA to determine whether they are safe, effective, properly manufactured, and adequately labeled for use in fish--let alone humans. [03/27/2020]

Guidance Documents and Request for Comment Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency  FDA is issuing this guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the COVID-19 pandemic. This guidance does not apply to foods prepared by restaurants.   Submit Comment  Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals during this pandemic. Submit Comment Public Workshop – Artificial Intelligence in Radiological Imaging: Extension of Comment Period On February 25-26, 2020 the FDA held a public workshop to discuss the “Evolving Role of Artificial Intelligence in Radiological Imaging.” The comment period for the public workshop is extended to June 30, 2020, in response to requests for an extension to allow stakeholders additional time to submit comments. Submit Comment

FDA Voices

FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19

By: Frank Yiannas, Deputy Commissioner for Food Policy and Response

A critical part of the FDA's mission is safeguarding the human and animal food supply, helping to ensure that our food is not contaminated at any point during its journey along the supply chain. COVID-19 is a new frontier for all of us as we deal with the realities of a pandemic and the impact it is having on our lives, on our families, our communities, and on our work. The FDA is committed to protecting the health of the American people, and to facing any challenges in food safety and access that arise during this public health emergency. That has never been more true than now. [03/24/2020]

FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development

By: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

Vaccines offer a way to build immunity to a disease-causing microorganism before one has ever been exposed to it. They have been highly effective in preventing a whole range of serious infectious diseases. But there is currently no vaccine available to protect the public from the highly contagious coronavirus known as SARS-CoV-2 that is spreading globally, causing the respiratory disease COVID-19, and we know that is a major global public health concern. That’s why commercial vaccine manufacturers and other entities are aggressively working to develop vaccine candidates. So far, they’ve been able to accelerate the development timelines to enter into initial clinical trials in humans (Phase 1 studies) as expeditiously as possible. [03/23/2020]