Regulations and Laws That May Apply During a Pandemic

During a pandemic, certain legal authorities, policies and regulations may apply and serve as the foundation for the US Department of Health and Human Services (HHS) to respond.

Public Health Service Act

The Public Health Service (PHS) Act forms the foundation of the HHS’ legal authority for responding to public emergencies by authorizing the HHS Secretary to take key actions, such as lead all federal public health and medical response, declare a public health emergency, assist states in meeting health emergencies, maintain the Strategic National Stockpile, and control communicable diseases.  The PHS Act was amended by the Pandemic and All-Hazards Preparedness Act (PAHPA) of 2006 and the Pandemic and All-Hazards Reauthorization Act (PAHPRA) of 2013.

Issuing Declarations

Under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, the President may declare an emergency at the request of the Governor of an affected State, or a Chief Executive of an affected Indian Tribe.  The president can also declare an emergency without a Gubernatorial request if the primary responsibility for response rests with the Federal Government in order to provide expedited Federal assistance and support necessary.

The HHS Secretary may, under section 319 of the PHS Act determine that a disease or disorder presents a public health emergency; or that a public health emergency, including significant outbreaks of infectious disease or bioterrorist attacks, otherwise exists.  Following a section 319 declaration, the Secretary can take many actions during an influenza pandemic, including making grants; entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder, and waiving or modifying  certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP) and Health Insurance Portability Accountability Act (HIPAA) requirements. These waivers or modifications are permitted under Section 1135 of the Social Security Act to ensure sufficient health care items and services are available during a public health emergency.

Under the Public Readiness and Emergency Preparedness Act (PREP Act) of the PHS Act, the HHS Secretary is also authorized to issue a PREP Act declaration that provides immunity from liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.  A PREP Act declaration is different from and not dependent on other emergency declarations.

Visit the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) website for a comprehensive overview of the HHS legal authorities, policies and committees for responding to public health emergencies. Read the “Public Health Emergency Declarations Q&A” and the “PREP Act Frequently Asked Questions” for more information about the legal authorities of the HHS Secretary.

Federal Food, Drug and Cosmetic Act

The Federal Food, Drug and Cosmetic (FD&C) Act is the foundation for Food and Drug Administration’s (FDA’s) authority and responsibility to protect and promote the public health by, among other things, ensuring the safety and effectiveness of human and veterinary drugs, biological products, and medical devices; and ensuring the safety and security of our nation’s food supply. Section 564 of the FD&C Act, authorizes the HHS Secretary to declare an emergency justifying the emergency use authorization (EUA) of medical countermeasures (MCMs) during public health emergencies. When an EUA is declared, the FDA Commissioner can allow either (a) the use of an unapproved medical product (e.g., drug, vaccine, or diagnostic device) or (b) the unapproved use of an approved medical product during an emergency to diagnose, treat, or prevent a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear (CBRN) agent. For example, during the 2009 H1N1 influenza pandemic, the FDA approved the emergency use of antivirals for certain patients and health care settings.

An EUA declaration can be made only when certain legal criteria are met and when scientific evidence is available to support the use during an emergency. For more information, please visit the following Food and Drug Administration web pages.

• FDA Medical Countermeasure (MCM) Legal, Regulatory and Policy Framework
• FDA Emergency Use Authorities
• FDA PAPHRA Q&A for Public Health Preparedness and Response Stakeholders
• FDA Emergency Use Authority of Medical Products and Related Authorities (April 2016)
• FDA Emergency use of an Investigational Drug or Biologic

Isolation and Quarantine

Under section 361 of the PHS Act, the HHS Secretary is authorized to take measures to prevent the entry and spread of communicable diseases from foreign countries into the US and between states.  The authority for carrying out these functions on a daily basis is delegated to the Centers for Disease Control and Prevention (CDC), Division of Global Migration and Quarantine. More information about legal authorities for isolation and quarantine is available on the CDC Quarantine and Isolation web page.