Alerts

FDA and State Boards of Pharmacy React to Coronavirus

Alerts / March 16, 2020

The new coronavirus continues to be the leading global news headline. We have established a comprehensive online resource center to help address and answer legal questions about coronavirus disease 2019 (COVID-19). Here, we provide you an overview of important actions in the life sciences sector that the FDA and state boards of pharmacy are taking to address the pandemic so far. We will continue to keep you updated as new information becomes available.

FDA Actions

FDA took steps to correct misinformation being spread about the coronavirus with its joint work with the Federal Trade Commission to issue seven joint letters to a variety of companies that allegedly are taking advantage of fears surrounding the pandemic and making advertising claims related to the coronavirus. For more in-depth coverage of these warning letters, see our colleagues’ AD-ttorneys Law Blog.

FDA is focusing on ensuring the availability of personal protective equipment for healthcare workers and providing ample diagnostic tests for COVID-19. FDA is utilizing its Emergency Use Authorization (EUA) authority to allow unapproved medical products or unapproved uses of approved medical products to be employed in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions. On Jan. 31, the Secretary of Health and Human Services determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. That declaration allows FDA to issue EUAs. So far, FDA is allowing healthcare workers to wear disposable filtering facepiece respirators (e.g., N95s) to prevent exposure to pathogenic biological airborne particles during the coronavirus outbreak that were approved by the National Institute for Occupational Safety and Health. The Occupational Safety and Health Administration similarly issued guidance providing enforcement discretion in regard to supply shortages of N95 filtering facepiece respirators due to the COVID-19 outbreak. In addition, FDA sent a letter to healthcare providers on surgical mask and gown conservation strategies. FDA is working to avoid any widespread shortages of these products. Like the EUAs for personal protective equipment, FDA has issued multiple EUAs for various diagnostic testing products. In addition to increasing the number of diagnostic tests available, FDA set up a hotline to help labs with diagnostic test issues. Labs may call FDA’s 24/7 hotline (1-888-INFO-FDA) regarding difficulties obtaining supplies for collecting patient samples for COVID-19 testing, including swabs and media needed for transport and conservation of the samples.

Also, FDA announced that it does not intend to object to the compounding of ethyl alcohol- or isopropyl alcohol-based hand sanitizers. The Centers for Disease Control and Prevention recommends washing hands with soap and water whenever possible, but if soap and water are not available, a hand sanitizer with at least 60% alcohol should be used. Alcohol-based hand sanitizers help us fight the spread of the coronavirus, but they have been in short supply. Under the guidance, both pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities may compound alcohol-based hand sanitizers. FDA provided compounders with a recipe of ingredients and labeling that must be used to fall within FDA’s enforcement discretion. Compounders can assist with public health efforts during the COVID-19 pandemic like they do in times of drug shortage. FDA has already been alerted of the first drug shortage connected to the coronavirus.

Further, FDA is proactively looking after its employees by postponing most foreign inspections through April. There is speculation that FDA may decrease travel for domestic inspections; however, this remains unconfirmed at this time.

While there are no FDA-approved drugs to treat COVID-19 or other coronavirus-related diseases, FDA is working with product sponsors to expedite the development of treatments and is using expedited initial review and preinvestigational new drug discussions. Through these pathways, the National Institutes of Health initiated a randomized controlled trial for the treatment of COVID-19. Clinical trials are also underway for a vaccine for COVID-19. Reports indicate that the first experimental dose is scheduled to be given on Monday, Mar. 16.

State Boards of Pharmacy

State boards of pharmacy are following suit in an attempt to address the new coronavirus. We expect more activity from the states as more localities are affected.

Florida declared a State of Emergency that allows a pharmacist to refill prescriptions early. Under Florida law, a pharmacist may dispense up to a 30-day supply of maintenance medication for a chronic condition.

Recognizing the need to conserve supplies, the North Carolina Board of Pharmacy, the State of Ohio Board of Pharmacy and the Texas State Board of Pharmacy provided guidance regarding sterile compounding compliance under conditions related to coronavirus concerns. Texas is providing for the extended use of face masks, gowns and shoe covers, and inspectors will take that into account when inspecting pharmacies. Ohio issued guidance allowing for the reuse of sterile compounding garb.

Facilitating the practice of social distancing to prevent the spread of the coronavirus, the State of Ohio Board of Pharmacy issued remote processing guidance for pharmacy professionals. This is a temporary policy that allows for the remote processing of a medication order or prescription but does not allow remote dispensing. Under the guidance, remote processing includes the provision of many common pharmacy services such as receiving, interpreting, evaluating, clarifying and approval of medication orders and prescriptions. Additionally, remote processing may include entering orders, entering other data, performing prospective drug utilization review, interpreting clinical data, processing insurance, performing therapeutic interventions, providing drug information services, and authorizing release of medication for administration.

Takeaways

Rapid response in the life sciences and pharmacy sector is occurring at both the federal and state levels to address the threat of the new coronavirus. We expect to see continued activity in this space.

Authorship Credit: Lee H. Rosebush, Lindsay P. Holmes, Marc N. Wagner

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