The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• The FDA is facilitating access to convalescent plasma, antibody-rich blood products that are taken from blood donated by people who have recovered from the COVID-19 virus, that could shorten the length, or lessen the severity, of the illness. The agency will be using multiple pathways to support these efforts and has posted information for investigators wishing to study convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications for individual patients. The FDA also is actively engaging with researchers to discuss the possibility of collaboration on the development of a master protocol for the use of convalescent plasma, with the goal of reducing duplicative efforts.

• In response to this evolving public health emergency and continued filtering facepiece respirator (FFR or respirator) shortages, FDA has concluded based on the totality of scientific evidence available that certain imported disposable FFRs that are not NIOSH-approved are appropriate to protect the public health or safety. Under this EUA, authorized respirators listed in the letter are authorized for use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the Coronavirus Disease 2019 (COVID-19) outbreak.
  • Letter of Authorization
  • Non-NIOSH Approved Respirator EUA FAQ

• The FDA issued a Consumer Updateadvising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA is particularly concerned that deceptive and misleading products might cause Americans to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. It’s likely that the products do not do what they claim, and the ingredients in them could cause adverse effects and could interact with, and potentially interfere with, essential medications. There are no FDA-approved products to prevent COVID-19. For example, the FDA is aware of people trying to prevent COVID-19 by taking a product called chloroquine phosphate, which is sold to treat parasites in aquarium fish. Products for veterinary use or for “research use only” may have adverse effects, including serious illness and death, when taken by people. The agency warns not to take any form of chloroquine unless it has been prescribed by a health care provider and obtained from legitimate sources.

• Diagnostics update: In certain emergencies, the FDA can often quickly issue an emergency use authorization for diagnostic tests based on FDA’s rolling review of data and where the request meets certain criteria. In the COVID-19 pandemic, the FDA has worked with more than 190 test developers who have said they will be submitting applications to make tests that detect the virus. To date, 16 emergency use authorizations have been issued for nation-wide use, including one today. Under our laboratory developed test policy during COVID-19, the FDA has been notified by more than 65 laboratories.

• The FDA issued a Letter to Industry that includes steps the Center for Devices and Radiological Health (CDRH) has taken to prioritize work that advances the nation’s response during the Coronavirus Disease 2019 (COVID-19) public health emergency. These steps seek to address the impact of COVID-19 public health emergency on day-to-day operations in CDRH and in the medical device industry, while ensuring that government and private sector efforts to respond to this national emergency receive the highest priority.

• The FDA provided flexibility to veterinarians who want to utilize telemedicine to prescribe certain drugs for animals by temporarily suspending enforcement of portions of the federal veterinarian-client-patient relationship requirements. This helps veterinarians continue to care for animals while minimizing person-to-person contact between veterinary staff and the animal owner or caretaker, allowing for the social distancing that is so important in limiting the further spread of coronavirus.

• The FDA explained how the agency is working with experts around the world to find ways to prevent and treat COVID-19, including collaborating with international organizations to facilitate the development of a vaccine: FDA Voices: FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development.

• The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The agency is engaging with importers and others involved in the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S. These instructions to importers clarify the types of PPE that can be imported without engaging with FDA. They also include information about the type of information importers can submit to facilitate their entries.

• The FDA provided an update, FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19, to explain that the U.S. food supply remains safe for both people and animals. There is no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19. Additionally, overall, retail supply chains remain strong, and the FDA is working with food manufacturers and grocery stores to closely monitor the human food supply chain for any shortages. The same is true for animal food. The FDA is monitoring the availability of foods for livestock and pets. There are no shortages, and no current disruptions in the pet and livestock food supply chain.

The U.S. Food and Drug Administration reports today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway.

This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients. For the first time, a pathway will be open for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. The availability of safe and effective biosimilar and interchangeable versions of these treatments, including insulin, is expected to increase patient access, adding more choices and potentially reducing costs of these vital therapies.

Biologic drugs, including insulin, treat some of the most serious diseases and conditions. The drugs transitioning today are used in the treatment, diagnosis, and prevention of many of these conditions, including diabetes, respiratory distress syndrome, fertility conditions, Cushing’s syndrome, deep vein thrombosis, Gaucher disease and many more. But these life-saving drugs often also contribute significantly to drug costs. Historically, it was more difficult to develop generic versions of these drugs under the Federal Food, Drug and Cosmetic (FD&C) Act due to scientific challenges and limitations on the scope of data that can be relied upon in a generic drug application. This framework contributed to limited competition for these drugs, resulting in fewer choices and higher prices for patients. Today’s transition opens a new pathway for manufacturers to seek FDA approval of and bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition.

When Congress created the biosimilars pathway in the Biologics Price Competition and Innovation Act of 2009, Congress also created a 10-year timeline for stakeholders to prepare for the regulatory transition of biological products that were historically regulated under the FD&C Act; now that the day has arrived, the FDA can begin receiving applications for proposed biosimilars to these licensed transition biological products, including insulin products that millions of Americans rely on every day to maintain stable blood glucose. Approved biosimilars will be able to come to market, where there is incredible potential to reduce health care costs, as has been seen with increased generic drug offerings. On the generic drugs’ side, we know from an FDA analysis that even with one generic on the market, prices are 31 to 39% lower than before the generic competition. Similarly, biosimilars marketed in the U.S. typically have launched with initial list prices 15 to 35% lower than comparative list prices of the reference products.

Over the last 10 years, the FDA has worked hard to establish a strong framework for the biosimilar and interchangeable regulatory pathway, as well as providing clarity to all involved on what the transition means to them and how it may affect our many stakeholders. Our  Biosimilars Action Plan was established to improve the efficiency of the biosimilar and interchangeable product development and approval process and to maximize scientific and regulatory clarity for the biosimilar product development community. Through this action plan, we’ve worked to support robust competition from biosimilars, including supporting market competition and providing clear direction to industry on many relevant topics leading up to the transition.

In just the last six months, we’ve taken several important actions on biosimilars, and in preparation for this transition, including partnering with the Federal Trade Commission regarding efforts to address false or misleading statements and promotional communications by biologic product manufacturers, deter anti-competitive business practices and support a competitive marketplace for biosimilars; issuing a final rule, draft guidance and final guidances to provide clarity to industry; providing information for patients and health care providers about what the transition means to them; and expanding and digitizing the FDA’s database of FDA-licensed biological products, otherwise known as the Purple Book.

These actions, among the many others we’ve taken in this space, reflect the tireless work of our dedicated workforce to ensure a smooth regulatory transition and provide clarity for biosimilar developers. We stand ready to review incoming applications from industry. We will also continue to work closely with those interested in producing biosimilar and interchangeable products to support efficiency in the development, review, and approval of these medicines.

Today is a milestone for the future of insulin and other important treatments – potentially a new era of proposed biosimilar and interchangeable insulin products. We expect this regulatory transition to enable a vibrant competitive market for transitioning products, ultimately empowering patients by increasing choices and potentially lowering prices of safe, effective, high-quality medications.

Additional Resources:

• Information for Patients About Regulatory Changes for Certain Biological Product Medications
• Joint Statement of the Food & Drug Administration and the Federal Trade Commission Regarding a Collaboration to Advance Competition in the Biologic Marketplace
• FDA Enhances Purple Book to Support Transparency in Biosimilars

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.

We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.

Fraudulent health claims, tests, and products can pose serious health risks. They may keep some patients from seeking care or delay necessary medical treatment. The FDA reminds consumers to follow the U.S. Centers for Disease Control and Prevention’s guidelinesand speak to your medical provider if you have symptoms of COVID-19. Your medical provider will advise you about whether you should get tested and the process for being tested with an appropriate test.

The FDA will take appropriate action to protect consumers from bad actors who take advantage of a crisis to deceive the public by marketing tests that pose risks to patient health. This may include issuing warning letters, seizures or injunctions. We have already identified and issued warning letters to companies found selling and promoting fraudulent items, and we expect additional such actions will be forthcoming. Additionally, we are stepping up enforcement at ports of entry, including International Mail Facilities, to ensure these fraudulent products that originate outside the country do not enter through our borders.

If you are aware of fraudulent test kits for COVID-19, please report them to the FDA. We will continue to aggressively pursue those who place the public health at risk and hold bad actors accountable.

As a reminder, the President’s Coronavirus Guidelines for America details simple actions we can take as individuals and families to #SlowTheSpread of coronavirus.

Additional Resources:

• FDA: Novel coronavirus (COVID-19)

As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products.

FDA notes these guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

“We are aware of significant supply disruptions for alcohol-based hand sanitizers. Many manufacturers make hand sanitizers, and several have indicated that they are working to increase supply,” said FDA Commissioner Stephen M. Hahn, M.D. “In the meantime, these guidances provide flexibility to help meet demand during this outbreak. We will continue to work with manufacturers, compounders, state boards of pharmacy and the public to increase the supply of alcohol-based hand sanitizer available to Americans.”

Because of an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, there have been reports of some consumers attempting to make hand sanitizers for personal use. The agency lacks information on the methods being used to prepare such products and whether they are safe for use on human skin.

The guidance, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), is immediately in effect and outlines that the agency does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs during this ongoing public health emergency as described in the guidance.

The second guidance, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, is in effect for the temporary compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities. Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a tailor-made medication. The temporary policy outlined by the agency does not require compounders to obtain a patient-specific prescription.

The FDA’s guidance documents apply only to handrub products prepared using the United States Pharmacopoeia or Food Chemical Codex grade ingredients specifically described in the guidance, consistent with World Health Organization recommendations. The guidance documents also discuss product labeling and certain manufacturing methods and reporting requirements, such as that manufacturers must have a way to accept and submit adverse event reports to FDA for any products they manufacture.

The agency realizes that manufacturers and compounders will need time to ramp up production as they obtain the ingredients needed to make these hand sanitizers. During this time the FDA will work to assist them as they develop hand sanitizers to make available for the American public.

Additional Resources:

• FDA: Novel coronavirus (COVID-19)
• Human Drug Compounding