Alerts

FDA and State Boards of Pharmacy React to Coronavirus – March 19, 2020 Update

Alerts / March 19, 2020

The Food and Drug Administration (FDA) and the state boards of pharmacy continue to issue guidance and policy daily. Now, the Drug Enforcement Administration (DEA) has joined in to provide guidance to industry and healthcare professionals related to COVID-19.

FDA Commissioner Stephen Hahn spoke at the White House Coronavirus Task Force press briefing on Mar. 19, stating that the FDA is providing “regulatory flexibility but at the same time scientific oversight” for developing treatments for COVID-19.

DEA

DEA published a COVID-19 information webpage that provides information on the drug supply, electronic prescribing, telemedicine and medication-assisted treatment. Most noteworthy is DEA’s affirmation that for the duration of the public health emergency, “DEA-registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation”, provided three conditions are met:

  1. The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice.
  2. The telemedicine communication is conducted using an audiovisual, real-time, two-way interactive communication system.
  3. The practitioner is acting in accordance with applicable federal and state law.

DEA explains that the practitioner may issue a prescription either electronically (for schedules II-V) or by calling in an emergency schedule II prescription to the pharmacy, or by calling in a schedule III-V prescription to the pharmacy.

Additionally, DEA is relaxing dispensing requirements for narcotic treatment programs. DEA is allowing alternative delivery methods for narcotic treatment program patients who may be quarantined because of COVID-19. Likewise, the Substance Abuse and Mental Health Services Administration provided guidance on opioid treatment programs. The guidance recognizes the need for states to request exceptions for opioid treatment program patients to be able to take home increased supplies of medication.

FDA Actions

Postponing and temporary non-enforcement is FDA’s default for all things not related to COVID-19. Most FDA meetings involving the Center for Drug Evaluation and Research from Mar. 10 through Apr. 30 are postponed, canceled or modified to take place remotely. Because of President Donald Trump’s Coronavirus Guidelines for America recommendation to avoid social gathering in groups of 10 or more people and Centers for Disease Control and Prevention recommendations, speculation remains that all FDA meetings will be canceled, postponed or modified. Just last week, FDA remote webinars unrelated to COVID-19 were canceled, likely due to finite agency resources.

As speculated, FDA confirmed that it is scaling back domestic inspections. Previously, FDA announced that it was postponing most foreign facility inspections through April. Now, FDA is temporarily postponing all domestic routine surveillance facility inspections. These postponed inspections “are facility inspections the FDA traditionally conducts every few years based on a risk analysis.” FDA stated that domestic for-cause inspection assignments will be evaluated and will proceed if they are mission-critical. In the current state of the COVID-19 outbreak, speculation remains that it is likely no FDA inspections will be occurring in the upcoming weeks.

FDA also announced that it “will temporarily not enforce FSMA [Food Safety Modernization Act] supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead.” Independent of FDA oversight, FSMA requires certain entities in the food industry to verify that their suppliers are meeting FDA food safety standards. This on-site audit requirement will not be enforced if other verification methods are used.

FDA issued guidance for conducting clinical trials during the COVID-19 pandemic. FDA clarified that patient safety is a priority. Sponsors and investigators may make “changes to the protocol or investigational plan to minimize or eliminate immediate hazards or to protect the life and well-being of research participants (e.g., to limit exposure to COVID-19),” and such changes “may be implemented without IRB approval or before filing an amendment to the IND or IDE.” Ongoing trials may need to be modified at this time, and sponsors should look to the guidance to determine next steps.

State Boards of Pharmacy

Many state boards of pharmacy have now issued specific guidance or policy regarding COVID-19; those that have not are Colorado, Connecticut, Delaware, District of Columbia, Hawaii, Illinois, Indiana, Maine, Michigan, Montana, Nebraska, New Mexico, New York, North Dakota, Oklahoma, Rhode Island, South Dakota, Tennessee, Washington, Wisconsin and Wyoming.

As of yesterday, 48 states have declared a state of emergency. Many state Pharmacy Practice Acts or state board of pharmacy regulations provide for exceptions during a declared state of emergency. Therefore, we note that even if your state board of pharmacy has not issued COVID-19 guidance or policy, flexibility in regulations may be provided based on a declared state of emergency.

Takeaways

Rapid response in the life sciences and pharmacy sectors continue to occur at both the federal and state levels to address the threat of the new COVID-19. We expect to see continued activity in this space and will keep you updated as we become aware of developments.

Authorship Credit: Lee Rosebush, Lindsay Holmes and Marc Wagner

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