The FDA has implemented several measures to curb the COVID-19 pandemic and ease the burden on health systems across the country.
Seven updates:
Editor's note: This is not an exhaustive list. Updates are listed in order of most recent to least.
- FDA is allowing providers to skip some protocols so they can give patients access to drugs while remaining self-isolated or quarantined. Some drugs require patients to undergo risk evaluation and mitigation strategy tests, or REMS, which are lab tests or imaging requirements, before they are given access to the treatments. For drugs subject to REMS, healthcare providers prescribing and dispensing these drugs should consider whether there are compelling reasons not to complete the tests during the COVID-19 pandemic. The FDA advised providers to use their "best medical judgment" in weighing the benefits and risks of continuing to provide drugs without lab tests or imaging studies.
- FDA is allowing hospitals to repurpose existing machines as ventilators. As hospitals face a critical shortage of ventilators, the FDA said it is being flexible in speeding up the regulatory process for acquiring the devices. Hospitals will also be allowed to use ventilators typically used for other environments in hospital settings, such as a ventilator normally used in an ambulance. The agency suggests hospitals look into other devices that may help patients, such as continuous positive airway pressure, or CPAP, devices typically used to treat sleep apnea.
- FDA authorized COVID-19 diagnostic tests that can give results within hours, rather than days. The tests are point-of-care tests, meaning they can produce results at hospitals rather than having to be sent to an outside laboratory. They are made by a molecular diagnostics company called Cepheid, and the company plans to roll them out by March 30.
- FDA warns the public of fake COVID-19 tests marketed to be used by consumers at home. The agency said it hasn't approved any at-home COVID-19 tests and that fake tests could pose serious health risks, including keeping some people from seeking necessary medical treatment if the result is inaccurate.
- FDA said it won't punish temporary manufacturers of alcohol-based hand sanitizer to deal with supply shortages. It outlined steps manufacturers will have to take to make unregulated hand sanitizer, including having to find a way to submit any potential adverse events reports related to the hand sanitizer to the FDA.
- FDA expanded use of some vital sign-measuring devices to allow providers to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure. The goal is to reduce the number of people who come into the hospital and minimize potential coronavirus exposure.
- FDA is urging the public to donate blood to help offset shortages during the COVID-19 pandemic. The agency said the number of donations has been dramatically reduced because of social distancing and canceled blood drives, but it said coming to blood donation centers is safe.