The U.S. now has the most confirmed coronavirus cases in the world, and the FDA and state boards of pharmacy are issuing daily guidance on how to stop the spread or join in the fight through relaxed standards or expedited market entry. The essential ammo necessary to fight COVID-19 includes respirators and personal protective equipment that protect the wearer from airborne particles and liquid. The FDA made strides in increasing the supply of both this week.
FDA Actions
Reports surfaced of doctors and nurses making their own face masks in response to the Centers for Disease Control and Prevention recommendation that healthcare providers use homemade masks as a last resort. Homemade face masks are not useful in preventing COVID-19 transmission. The desired N95 masks filter at least 95% of airborne particles. With widespread shortages of personal protective equipment even after the FDA sent a letter to healthcare providers on surgical mask and gown conservation strategies, there were two big developments this week regarding PPE: 1) the FDA issued an Emergency Use Authorization (EUA) for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, followed by 2) the FDA issued guidance on its Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease Public Health Emergency.
First, for an overview of EUAs, please check out our prior article describing how EUAs cut regulatory red tape. This EUA allows non-FDA-approved, non-NIOSH-approved face masks to be imported for use in the healthcare setting. In doing this, the EUA outlines two ways in which products could be eligible for importation. Of course, manufacturers or importers will have to request that the FDA add the eligible product to a list of face masks that the FDA will allow to be imported under the EUA. To be eligible for inclusion on the list, the products must meet specified performance standards from Australia, Brazil, Europe, Japan, Korea or Mexico. In the alternative, the face masks could bear any of the following marketing authorizations: European CE Mark, Australian Register of Therapeutic Goods Certificate of Inclusion, Health Canada License, Japan Pharmaceuticals, and Medical Device/Ministry of Health Labour and Welfare. Allowing manufacturers and importers to source product from other countries is a step in the right direction for arming our healthcare providers with the tools necessary to defend against COVID-19.
Second, in guidance, the FDA provided more flexibility for face mask and respirator manufacturers. The FDA confirmed that face masks and respirators that are not intended for a medical purpose do not require the FDA approval. In determining whether a face mask or respirator is intended for a medical purpose, the FDA particularly looks at the claims on the label. For face masks that are intended for a medical purpose, such as surgical masks, which are class II devices that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials, the FDA will not object to such masks being distributed without submission of a premarket notification. Lastly, the FDA seeks communication with firms interested in reprocessing and recycling single-use face masks as well as with firms that can manufacture face masks or respirators that are not currently legally marketed in the U.S. EUAs may be issued for reprocessors that can demonstrate their process adequately disinfects single-use face masks while maintaining the face mask filtration performance. Additionally, EUAs may be issued for firms that can produce face masks that protect frontline personnel during the public health emergency.
Again using the EUA tool the FDA has at its disposal, FDA issued an EUA authorizing the emergency use of ventilators, anesthesia gas machines modified for use as ventilators and positive pressure breathing devices modified for use as ventilators (collectively referred to as “ventilators”), as well as of ventilator tubing connectors and ventilator accessories. As with the other EUAs it has issued to increase medical supplies to combat COVID-19, FDA will add a ventilator, ventilator tubing connector or ventilator accessory to the list of authorized products upon submission of a request from a sponsor. The request must confirm that the safety, performance and labeling of the device meet the conditions set forth in the EUA. Additionally, in this EUA, the FDA waived certain current good manufacturing practice requirements and registration and listing requirements for authorized ventilators, ventilator tubing connectors and ventilator accessories.
The FDA is now also issuing guidance related to food during COVID-19. Under this guidance, the FDA does not intend to object to the sale by restaurants of packaged food (both perishable and nonperishable) that lacks a Nutrition Facts label, provided the food does not have any nutrition claims and contains other required information on the label. Manufacturers may also distribute packaged food that is labeled for use in restaurants without a Nutrition Facts label if the food does not have any nutrition claims and contains other required information. The other required information for both restaurants and manufacturers is a statement of identity; an ingredients statement; the name and place of business of the food manufacturer, packer or distributor; net quantity of contents; and allergen information.
Telemedicine has been popular with the DEA and states during COVID-19, and now the FDA has announced that it is temporarily suspending enforcement of portions of the federal veterinarian-client-patient relationship (VCPR) requirements relevant to the FDA regulations governing Extralabel Drug Use in Animals and Veterinary Feed Directive (VFD) drugs. Using telemedicine, veterinarians can prescribe drugs in an extralabel manner or authorize the use of VFD drugs without direct examination of or making visits to their patients.
$2 trillion coronavirus stimulus package passed by the Senate and expected to be passed by the House, and then signed into law, makes changes to over-the-counter drug regulation as well as drug and medical device shortage reporting. Stay tuned to our updates, as we will provide an overview once the all-encompassing stimulus package becomes law.
State Boards of Pharmacy
Ohio continues to be a leader in response to COVID-19. Earlier this week, Ohio issued an emergency rule for dispensing chloroquine and hydroxychloroquine. This rule follows an uptick in the number of prescriptions being written for chloroquine and hydroxychloroquine, which indicated unnecessary hoarding of the drugs. Under the Ohio rule, no prescription for chloroquine or hydroxychloroquine may be dispensed by a pharmacist unless the prescription contains a diagnosis code. If the diagnosis code is for COVID-19, then the prescription is limited to a 14-day supply and no refills. The rule was revised on March 26 to allow the dispensing of chloroquine or hydroxychloroquine for presumptive positive patients – originally, the rule prohibited this practice. Ohio also authorized pharmacists, pharmacy interns and pharmacy technicians licensed in other states to work in Ohio pharmacies under certain conditions.
Restricting dispensing of chloroquine and hydroxychloroquine is not unique to Ohio. New York, North Carolina and Nevada are among many of the other states that have restrictions in place. North Carolina may be the most innovative state in its restrictions. The North Carolina Board of Pharmacy passed an emergency rule that created a list of “restricted drugs”: hydroxychloroquine, chloroquine, lopinavir-ritonavir, ribavirin, oseltamivir, darunavir and azithromycin. While no drug is FDA-approved for COVID-19, the drugs on this list, approved for other indications, have been mentioned in research circles as potential treatments. For a pharmacist to fill or refill any of these restricted drugs, the prescription must include a diagnosis code unless the patient was already prescribed the restricted drug prior to March 10.
Takeaways
Rapid response in the life sciences and pharmacy sector continues to occur at both the federal and state levels to address the threat of the new coronavirus. We expect to see continued activity in this space and will keep you updated as we become aware of developments.
