FDA does not support the Memorandum of Understanding that @HHSGov signed with @USDA announced today. FDA has no intention of abdicating our public health mandate. We’ll continue to stay focused on executing our vital public health mission entrusted to us by the American people. FDA remains undeterred in our steadfast commitment to ensure that animal agricultural biotechnology products undergo independent and science and risk-based evaluation by our career experts.

Today, I am reaffirming FDA’s commitment to transparency around the EUA process and sharing some updates on our plan to provide more information about FDA’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines. fda.gov/news-events/pr… The EUA process allows the Secretary of Health and Human Services, in appropriate circumstances, to declare that EUAs are justified for products to respond to certain types of threats.

One of the agency’s highest priorities is ensuring the quality, safety and effectiveness of vaccines. This deep and abiding commitment is something that we consider essential to engendering the public’s trust in vaccines. #FDAVoices #FDAVaccineFacts fda.gov/news-events/fd… Vaccines are one of the most significant public health interventions ever implemented. They have been largely responsible for the dramatic reduction in serious adverse consequences and death related to infectious diseases

FDA scientific reviewers who have long experience with vaccine development are encouraged by the rapid rate of enrollment in the ongoing clinical trials for a #COVID19 vaccine. They are looking forward to the completion of the trials so that they can evaluate data and decide whether to approve or authorize its use.

Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago. They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined.

Hydroxychloroquine (HCQ) remains a safe drug for approved indications. Patients with rheumatoid arthritis and lupus should continue taking this for their conditions if prescribed by a doctor While we at FDA wait for data from controlled trials to determine the safety and efficacy of HCQ for the treatment of #COVID19, physicians should make the decision about prescribing HCQ while assessing the risks and benefits in the context of the doctor-patient relationship.

FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences, Inc. for the investigational antiviral drug remdesivir – which has been shown to shorten recovery time in some #COVID19 clinical trial patients – to treat suspected or confirmed #COVID19. fda.gov/news-events/pr… This EUA allows for remdesivir to be distributed in the U.S. & administered intravenously in adults & children with severe #COVID19 disease, defined as low blood oxygen levels or needing oxygen therapy or more intensive breathing support, like a ventilator.

While clinical trials are ongoing to determine the safety and effectiveness of hydroxychloroquine and chloroquine for #COVID19, there are known side effects of these medications that should be considered. fda.gov/news-events/pr… FDA issued a Drug Safety Communication regarding known side effects of hydroxychloroquine & chloroquine, including potentially life-threatening heart rhythm problems, reported with their use for treatment or prevention of #COVID19, for which they are not FDA-approved.

Based on prior experience with respiratory viruses & on data from China, convalescent plasma – the plasma from the blood of recovered #COVID19 patients – may potentially lessen severity or shorten the illness caused by #COVID19. fda.gov/news-events/pr… FDA is facilitating access to convalescent plasma to treat #COVID19 using multiple pathways. Our initial effort focused on emergency investigational new drug applications (eINDs), & we provided info to help health care providers submit applications to treat individual patients.

Consumers should be extremely cautious of products claiming to treat #COVID19. While FDA is working with medical product developers to quickly advance the development & availability of a #COVID19 treatment, no FDA-approved treatment currently exists. fda.gov/consumers/cons… Some people and companies are trying to profit from the pandemic by selling unproven/illegally marketed products claiming to diagnose, cure, treat or prevent #COVID19 -- these have NOT been evaluated by FDA for safety and effectiveness & might be dangerous to you and your family.

Sometimes science moves faster than the regulatory process, & in times of public health emergency like the #COVID19 pandemic, it is paramount that we be flexible in getting potentially life-saving investigational medicines to patients who need them most. fda.gov/vaccines-blood… Convalescent plasma—or plasma collected from the blood of fully recovered #COVID19 patients & given as treatment to very ill #COVID19 patients—is being studied as a potential investigational treatment for #coronavirus.

FDA is working closely with partners across the U.S. government & regulated industry to expedite the development & availability of medical products to prevent & treat #COVID19, including repurposing existing therapies that may help treat #COVID19 patients. fda.gov/news-events/pr… While there are no FDA-approved therapeutics or drugs to treat, cure, or prevent #COVID19, there are several FDA-approved treatments that may help ease symptoms from a supportive care perspective.

Since January 24, @US_FDA has been reaching out to more than 180 drug manufacturers and reminding them of their applicable legal requirements to notify FDA of any anticipated supply disruptions as a result of the #coronavirus outbreak. We have also asked them to evaluate their entire supply chain, including active pharmaceutical ingredients and other components manufactured in China. At this time, no firm has reported a shortage is anticipated for any drug due to #COVID19.