FDA Emergency Use Authorization For Bioterror Drugs Includes HHS Consultation

FDA will consult with an HHS panel when making decisions on which drug candidates could be authorized for emergency use.

The HHS Emergency Use Authorization Working Group will be headed by the assistant secretary of public health emergency preparedness and will include representatives from FDA, the Centers for Disease Control & Prevention, the National Institutes of Health, the Departments of Defense, Homeland Security and Veterans Affairs, and other agencies as appropriate.

FDA announced the establishment of the working group and outlined the agency's policies for authorizing the use of unapproved drugs or indications during a declared emergency in a ^FDL-1 draft guidance published in the July 5 Federal Register.

FDA's powers to grant emergency use authorization (EUA) were created by two laws in 2004: the National Defense Authorization Act and the Project BioShield Act (¹ (Also see "“BioShield” Law Nears Passage; FDA Proposes “Pre-Pre-IND” Meetings" - Pink Sheet, 7 Jun, 2004.), p. 35). The agency can take steps against biological, chemical, radiological and nuclear agents by allowing unapproved therapies or uses to treat life-threatening diseases in an emergency when no alternatives are available.

Eligibility for an EUA will be based on four criteria: the disease can cause a serious or life-threatening disease or condition; available scientific evidence suggests that the product could effectively diagnose, treat or prevent the disease or condition; known and potential benefits outweigh the risks; and no adequate approved alternatives are available.

Eligible products will be granted authorization if they "may be effective." The standard "provides for a lower level of evidence than the 'effectiveness' standard that FDA uses for product approvals," the draft guidance states. FDA will evaluate the potential effectiveness of an EUA product on a case-by-case basis.

Requests for EUA consideration "will be acted upon within a matter of hours or days" in an emergency situation, FDA said.

The agency will be required to expedite requests for consideration quickly during an emergency. However, the length of time required for action will vary depending upon several factors, including the product profile, the existence of pending applications and the nature of the emergency.

An EUA will not be issued until after an emergency has been declared by the HHS secretary, which is based on a determination by DHS (domestic emergency), DoD (military emergency) or HHS itself (public health emergency). To facilitate review, the agency requests that entities with a possible candidate product, "particularly one at an advanced stage of development," contact FDA before an emergency arises.

Any person or entity with a candidate product should "discuss with the agency at the earliest possible time...the nature and type of safety data that might be appropriate to submit to FDA," the guidance states.

The guidance highlights both "emergency" and "pre-emergency" recommendations for submitting an EUA request. Pre-emergency activities should include discussing with FDA an appropriate format for submission, such as an IND, investigational device exemption or Master File.

"If, prior to the declaration of an emergency, FDA believes that a candidate product may meet the criteria for an EUA, the agency may share appropriate information on such product" with the EUA Working Group, the guidance states.

The draft also discusses the data requirements for an EUA request. The amount of safety data required will differ depending on "whether the product is approved for another indication and, in the case of an unapproved product, the product's stage of development."

The guidance also discusses conditions of authorization, and revocation or termination of an EUA. Comments on the draft guidance are due Sept. 6.

FDA has exercised its emergency use authorization powers once. The agency agreed earlier this year to allow DoD to use anthrax vaccine adsorbed to inoculate military personnel on a voluntary basis.

[Editor's note: In-depth coverage of that decision appeared in ² "The Pink Sheet" DAILY in January. Visit our website, www.ThePinkSheetDAILY.com to sign up for a free trial.]