Shortages of gloves, gowns, face masks, respirators, ventilators, drugs and hand sanitizer continue to be reported. The crackdowns on prescribing of chloroquine and hydroxychloroquine, currently being studied to treat COVID-19, could not stop the inevitable shortage of these two drugs. Both chloroquine and hydroxychloroquine were placed on the Food and Drug Administration (FDA) drug shortage list on March 31. Find out below what that means for patients and industry. Like all healthcare professionals, the FDA and states continue to work around the clock to attempt to curb the impact of COVID-19.
DEA Actions (Exceptions)
The Drug Enforcement Administration (DEA) is taking major steps to ensure an uninterrupted drug supply and to preserve patient access to needed controlled substances. The DEA granted numerous regulatory exceptions and is accepting communications via email for registering emergency or temporary off-site locations that use controlled substances.
In the absence of COVID-19, DEA regulations require a practitioner to obtain a separate DEA registration in each state in which he or she dispenses a controlled substance. In response to COVID-19, the DEA granted an exception for practitioners. Under the exception, for the duration of the public health emergency, DEA-registered practitioners are not required to obtain additional registrations with the DEA in the additional states where the dispensing (including prescribing and administering) occurs. Additionally, DEA-registered practitioners may prescribe controlled substances via telemedicine to patients in states in which they are not registered with the DEA. This will increase patient access during the COVID-19 pandemic in states that have declared public emergencies and granted reciprocity to neighboring states and their practitioners for medical licensing requirements.
Practitioners and pharmacists received two more exceptions from the DEA regarding emergency oral Schedule II prescriptions. Typically, a pharmacist may dispense a Schedule II controlled substance upon receiving oral authorization from the prescriber, provided that the pharmacist received a written prescription for the amount dispensed within seven days. The DEA extended that time frame to 15 days during the public health emergency. Additionally, because getting a paper prescription to the pharmacy may be difficult because of social distancing and stay-at-home orders, the DEA will allow the prescriber to send the follow-up prescription to the pharmacy via facsimile or to take a photograph or scan of this follow-up prescription and send the photograph or scan to the pharmacy in place of the paper prescription. The DEA is embracing technology to increase patient access during the public health crisis.
The DEA waived the 65 percent inventory limit for DEA-registered bulk manufacturers in response to COVID-19. The DEA explained that “all DEA registered bulk manufacturers are allowed to exceed the 65 percent ceiling in order to supply dosage form manufacturers with the active pharmaceutical ingredient(s); this may be necessary to manufacture specific products to avoid existing or potential shortages. This exception does not authorize any manufacturer to exceed his previously established annual manufacturing quota.”
The DEA previously announced that practitioners may prescribe controlled substances to patients using telemedicine without first conducting an in-person evaluation, as we discussed in a prior alert. The DEA made additional strides in telemedicine by providing practitioners additional flexibility during the “public health emergency to prescribe buprenorphine to new and existing patients with OUD [opioid use disorder] via telephone by otherwise authorized practitioners without requiring such practitioners to first conduct an examination of the patient in person or via telemedicine.”
FDA Actions
March 28, the FDA issued an emergency use authorization (EUA) for the distribution of chloroquine phosphate and hydroxychloroquine sulfate from the Strategic National Stockpile to treat patients hospitalized with COVID-19 for whom a clinical trial is not available or participation is not feasible. Although neither drug is FDA-approved for the treatment of COVID-19, the FDA issued this EUA because “[b]ased upon limited in-vitro and anecdotal clinical data in case series, chloroquine phosphate and hydroxychloroquine sulfate are currently recommended for treatment of hospitalized COVID-19 patients in several countries, and a number of national guidelines report incorporating recommendations regarding use of chloroquine phosphate or hydroxychloroquine sulfate in the setting of COVID-19.” The topic of how the FDA uses EUAs to quickly ease regulations in response to an emergency is discussed in our earlier alert.
The FDA issued a guidance for industry on notifying the FDA of drug shortages. In this guidance, the FDA reminds industry of the obligation to notify “FDA of a permanent discontinuance in the manufacture of covered drugs and biological products or an interruption in the manufacture of covered drugs and biological products that is likely to lead to a meaningful disruption (or, in the case of blood or blood components intended for transfusion, a significant disruption) in the supply of such products in the United States.” A critical component of preventing or mitigating drug shortages is manufacturers notifying the FDA as soon as possible so that the FDA can maintain the lists of drugs and biologics that are in short supply.
Then, chloroquine and hydroxychloroquine were added to the FDA drug shortage list. We previously reported the increase in hospital purchases of hydroxychloroquine weeks ago, in addition to chloroquine and hydroxychloroquine being on the American Society of Health-System Pharmacists drug shortage list. Now that chloroquine and hydroxychloroquine are recognized on the FDA drug shortage list, certain statutory safeguards of the nation’s drug supply are activated. For example, FDA-registered 503B outsourcing facilities may now compound essential copies of the commercially available products for the duration of time the drugs appear on the FDA drug shortage list. This allows these facilities that operate under the same current good-manufacturing practices as drug manufacturers use to produce drug products to increase patient access. Similar to how these facilities have compounded hand sanitizer under the FDA’s Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer, these facilities may now begin compounding chloroquine and hydroxychloroquine from bulk drug substances or raw material.
The FDA also updated the Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer. The ingredient list was updated to include Food Chemical Codex-grade ethanol and glycerin. There are also various formulas that may be followed to provide compounders more flexibility and options to compound hand sanitizer for consumers or healthcare personnel during the public health emergency.
With respect to EUAs, the FDA issued a new EUA and reissued two EUAs on respirators. The newest EUA on respirators is for a system used to decontaminate compatible N95 respirators for reuse by healthcare personnel during the COVID-19 pandemic. N95 respirators filter out at least 95 percent of airborne particles and are essential to protect healthcare personnel caring for COVID-19 patients. N95 respirators are in short supply, and the FDA already had issued two EUAs to increase the supply of N95 for healthcare personnel. These two EUAs have been updated to include respirators decontaminated using the decontamination system. Additionally, the FDA clarified that under the EUA NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings, manufacturers of authorized respirators do not need to submit attestation to the FDA to request authorization. Under the EUA Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, however, manufacturers need to submit a request to the FDA for authorization even if the respirator meets the eligibility criteria outlined in the EUA. The FDA will add authorized respirators as “Exhibit 1” once a request is submitted and approved. As of March 31, the FDA has not authorized any respirators for importation. The FDA also is accepting requests for authorization of respirators not eligible under the EUA, but the request follows a slightly different process. We expect the FDA will publish a list of authorized respirators any day now.
The FDA’s Enforcement Policy for Gowns, Other Apparel, and Gloves During COVID-19 attempts to expand the availability of gowns, gloves and other apparel to protect healthcare workers. The FDA is waiving various regulatory requirements to increase the supply of necessary personal protective equipment (PPE). The FDA recommends that healthcare providers follow current Centers for Disease Control and Prevention guidance regarding PPE that should be used during the COVID-19 outbreak. Healthcare employers also must comply with standards of the Occupational Safety and Health Administration that require PPE to protect workers and that apply to infectious disease hazards. Manufacturers and those in a position to increase the supply of PPE should consult the enforcement policy for specifics, but examples of waived regulatory requirements include premarket notification requirements, registration and listing requirements, unique device identification requirements, and quality system regulation requirements.
Continuing attempts to expand access to much-needed supplies, the FDA also issued the Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During COVID-19. Under the policy, the FDA does not intend to object to certain noncompliance with regulatory requirements for limited modifications to the indications or functionality of FDA-cleared or FDA-approved sterilizers, disinfectant devices and air purifiers pertaining to a device’s viricidal effectiveness against SARS-CoV-2, the name of the virus that causes COVID-19. Additionally, the FDA is providing enforcement discretion for the distribution and use of sterilizers, disinfectant devices and air purifiers that are intended to be effective at killing the SARS-CoV-2 virus but do not already have marketing authorization. This policy will help expand the availability and capability of sterilizers, disinfectant devices and air purifiers during the COVID-19 pandemic.
In a highly anticipated update to the guidance titled Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, the FDA added an appendix of questions and answers. Specific issues addressed in the questions and answers include submitting protocol amendments, documenting protocol deviations, initiating virtual clinical trial visits for monitoring patients, making changes to ship investigational products directly to patients, and obtaining and documenting informed consent from patients in isolation due to COVID-19.
The FDA continues to aggressively warn firms who market unapproved products related to COVID-19. The FDA sent five new warnings to firms selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19. The FDA warned that these products are unapproved and misbranded. There currently are no vaccines, pills, potions, lotions, lozenges or over-the-counter products available to treat or cure COVID-19.
Last, the FDA continues to innovate to use every available tool it has available to assist in fighting COVID-19. The FDA created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program. Currently, there are 10 therapeutic agents in active trials and another 15 agents in the planning stages. The FDA requests developers engage with the agency as soon as possible to expedite developing therapies.
State Boards of Pharmacy
We previously mentioned state boards of pharmacy, including those in Ohio, New York, North Carolina and Nevada, that have implemented restrictions on dispensing of chloroquine or hydroxychloroquine. Now reports indicate that major pharmacies are implementing measures to prevent hoarding.
The Michigan Department of Licensing and Regulatory Affairs sent a letter to licensed prescribers and dispensers notifying them of their continued obligation to adhere to the standards of practice and to exercise the professional judgment applicable to their professions. The letter was intended to deter stockpiling of chloroquine and hydroxychloroquine, citing statements from the Michigan State Medical Society, the Michigan Pharmacists Association, the American Medical Association, the American Pharmacists Association and the American Society of Health-System Pharmacists, all disapproving of the practice of stockpiling.
The Missouri Board of Pharmacy updated its supplemental guidance on COVID-19 waivers. Missouri allows Missouri-licensed pharmacies to use individuals licensed as pharmacists or pharmacy technicians in another U.S. state or territory to provide pharmacy services during the state of emergency. Pharmacists and pharmacy technicians must submit an emergency practice notification form. Additionally, Missouri-licensed pharmacies may use entities licensed as a pharmacy in another U.S. state or territory to assist with providing pharmacy services during the state of emergency. Missouri is also allowing a pharmacy technician to prepare a prescription without a pharmacist physically present at the pharmacy if a pharmacist cannot be physically present at the pharmacy due to COVID-19 and the state of emergency. This practice is allowed only if it is in the best interest of the patient’s health and safety and the final product is remotely verified by a pharmacist.
Takeaways
Rapid response in the life sciences and pharmacy sectors continues to occur at both the federal and state levels to address the threat of the pandemic. We expect to see continued activity in this space and will keep you updated as we become aware of developments.
