The U.S. Food and Drug Administration is working in many ways to protect our nation’s public health during the COVID-19 public health emergency. Our Center for Drug Evaluation and Research (CDER), responsible for the regulation of drug therapies, engages in many activities to support much of the FDA’s work during this unprecedented time.
CDER’s key priorities during this public health emergency include:
- Making safe and effective drugs to treat COVID-19 patients available as soon as possible
- Monitoring the nation’s supply of medicines and taking action to mitigate or prevent drug shortages
- Working to help ensure the health of all patients
Below summarizes CDER’s actions towards achieving these critical goals.
Recognizing the urgent need for safe and effective drugs, CDER is working closely with researchers to accelerate the study of potentially beneficial drugs to treat COVID-19. Some of these drugs are already approved by FDA for other conditions, while others are experimental. Our goal is to help these researchers generate evidence to determine which proposed drugs are safe and effective.
Our actions include:
- Launching a new FDA Coronavirus Treatment Acceleration Program to:
- Expedite the regulatory review process for therapeutics in clinical trials for COVID-19 including review of clinical trial protocols and development programs
- Accelerate development and publication of guidance for industry on developing drugs to treat and prevent COVID-19, including two detailed guidances: one to provide general considerations for meeting requests for drugs in development and another to assist with the clinical development of drugs with direct antiviral activity or immunomodulatory activity
- Establish a single point of contact to facilitate COVID-19 product development reachable at: COVID19firstname.lastname@example.org, where a multidisciplinary team provides advice to sponsors and other parties with the intent of moving a promising therapy into clinical trials as rapidly as possible
- Collaborate with industry and academic groups working together to advance potential therapies
- Utilize regulatory flexibility in the review of manufacturing specifications during product development to facilitate scale-up of manufacturing capacity
- Evaluating newly identified safety signals associated with the use of repurposed drugs to treat COVID-19 patients.
Some key measures of progress to date:
- On October 22, 2020, FDA approved the first treatment for COVID-19 in certain populations, the antiviral drug remdesivir.
- More than 350 trials have been reviewed by FDA.
- Issuing more than 22 guidance documents for industry related to therapeutic development since the start of the COVID-19 outbreak
- Expediting, when necessary, Emergency Use Authorizations (EUAs) for potential drug and biological therapies.
- Received more than 1,400 expanded access requests to support access to therapies with the potential to help patients.
The public health emergency is placing extraordinary demands on our nation’s drug supply. CDER is working to address drug shortages and to proactively prevent future shortages of needed drugs. We are conducting this work in close collaboration with manufacturers, compounders, distributors, health care professionals, health care associations, and the National Association of Boards of Pharmacy (NABP) and government counterparts such as the Federal Emergency Management Agency (FEMA), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), and state regulators. We are also working to enable new suppliers of critical products to safely supply the market.
Our actions to-date include:
- Monitoring the quality and security of the nation’s drug supply chain
- Monitoring potential disruptions across the drug supply chain, expediting new guidance to bolster drug supply (including manufacturing and inspections), and proactively working with manufacturers to evaluate supply chains and exercise appropriate regulatory discretion(s), without compromising safety
- Actively monitoring potential shortages of medicines – using a combination of methods – and working collaboratively to make sure shortages don’t impede patient care
- Providing registration and listing assistance for companies who want to provide critical products – to help ensure FDA knows the manufacturers and sources of drugs during the pandemic
- Offering temporary regulatory flexibility for certain critically needed drugs compounded by outsourcing facilities and non-outsourcing facilities for hospitalized patients with COVID-19, and for the compounding and manufacturing of alcohol-based hand sanitizer during the COVID-19 pandemic
- Issuing new guidance to help reduce risk when pharmacies are not able to obtain standard equipment used in drug compounding
- Monitoring imported products and taking action to ensure active pharmaceutical ingredients and medicines sourced from abroad are appropriate for patients and access to such products is not delayed unnecessarily
- Innovating CDER's facility assessment approach given the reduced ability to conduct on-site inspections to help ensure continued drug quality and support approval of new drugs to treat a range of conditions
- Taking action against sellers of fraudulent products for the treatment or prevention of COVID-19, including issuing more than 99 warning letters and alerting consumers to risks associated with these products
- Working to keep potentially harmful drugs out of the U.S. by issuing warning letters to internet pharmacies offering for sale unapproved and misbranded drugs that claim to prevent, cure or treat COVID-19
- Issuing a guidance noting that legal requirements related to certain product tracing and product identification activities, and wholesale distribution, do not apply to qualifying distribution activities during the emergency
- Approving, as of October 27, 2020, more than 300 manufacturing supplements (requests by manufacturers to modify their manufacturing methods) for generic and brand name products, often to change their supply chain, process, or facility, to help ensure adequate supply
- Prioritizing the assessment of generic drug submissions for products that could help address COVID-19 in recognition of the public health emergency
- Launching a range of surveillance studies using the Sentinel system to monitor drug usage during COVID-19 – both to deepen understanding of COVID-19 and to strengthen safety surveillance of the overall drug market
Some key measures of progress to-date:
- Assisting new and established manufacturers producing alcohol-based hand sanitizers and ethanol for use in hand sanitizers: Since March 1, 2020, about 3,000 new hand sanitizers manufacturers have registered with FDA
- Since January 1, 2020, CDER fielded more than 49,000 inquiries from the general public, including health care providers, consumers and manufacturers, regarding medications; this included more than 16,000 specifically related to COVID-19
- Continuing outreach to over 90 manufacturers relating to manufacturing capacity and supply chain for both COVID-19 and non-COVID-19 treatments
- Warned consumers they should not use over 200 hand sanitizer products with serious safety concerns, including contamination with toxic ingredients, sub-potent levels of alcohol, or labeled with false, misleading, or unproven claims.
While the COVID-19 public health emergency requires intense focus across the health care landscape on the acute needs of patients infected with COVID-19, CDER maintains a continuing commitment to the full scope of its public health mandate in the interests of all patients. CDER continues critical activities related to:
- safeguarding against unsafe drugs
- maintaining surveillance of the safety of all prescription and over-the-counter drugs
- reviewing applications to investigate or market new and generic drugs
- engaging with industry in numerous ways to ensure clinical research for a range of diseases continues
In short, CDER has kept a keen focus on balancing our COVID-19 priorities with our other critical work needed to protect the health of the American public.
Our actions include:
- Rapidly responding to drug developers regarding changes they are making to help keep non-COVID-19 related clinical and bioequivalence trials on track and promote patient safety, including issuing and updating a key guidance on the conduct of clinical trials during this public health crisis and a dedicated email (clinicaltrialconduct-COVID19@fda.hhs.gov) for stakeholder inquiries, which we have utilized to regularly update the guidance
- Continuing critical review and approval work to help ensure that safe and effective treatments for patients with other diseases can still be delivered
- Continuing our ongoing assessment, surveillance, compliance and pharmaceutical quality efforts across every product area, and continuing to work with drug manufacturers to help ensure safe, effective and high-quality drugs for the American public
- Helping to ensure access to cost saving drugs and other needed medications through continued review and approval of generic drugs and biosimilars
- Making available for public viewing, as part of the regulatory process, a standard memorandum of understanding addressing certain distributions of compounded drug products between the FDA and states
- Warned companies illegally selling unapproved cannabidiol (CBD) products with false claims of being able to treat medical conditions, including opioid addiction and reminded consumers of the dangers of using unapproved products to treat conditions or diseases with existing, approved treatment options
- Requiring labeling changes for the widely-used prescription and over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs), which include aspirin, ibuprofen, naproxen, diclofenac, and celecoxib. These changes include new product information to explain that if women take the medications around 20 weeks or later in their pregnancy, the drugs can cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid (the protective cushion surrounding the unborn baby) and the potential for pregnancy-related complications.
Some key measures of progress to-date:
- As of October 22, 2020, CDER has approved more than 42 novel drugs and therapeutic biologics (those never before approved or marketed in the U.S.), including the first treatment for COVID-19, the first drug therapy to treat patients with Ebola virus, many innovative therapies to treat a variety of cancers, a first treatment for thyroid eye disease, a new drug to treat patients with growth hormone deficiency, a new treatment for multiple sclerosis and a new therapy for Cushing’s disease.
- Approved more than 558 generic drug applications since January 1, 2020, including at least 53 “first generics.”