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  1. Safety & Availability (Biologics)

Countering Bioterrorism Questions and Answers

Has the Center for Biologics Evaluation and Research had any involvement in countering bioterrorism?

CBER continues to be very active in supporting US Government’s initiatives to develop medical countermeasures and counter bioterrorism and emerging infectious diseases, including pandemic influenza. CBER staff have participated in numerous meetings, briefings, and conferences representing FDA with staff from the Department of Defense, the Department of Health and Human Services (DHHS), Department of Homeland Security, and the Office of Management and Budget as well as other DHHS Agencies including the Biomedical Advanced Research and Development Authority (BARDA), National Institutes of Health and the Centers for Disease Control and Prevention. The Center has also engaged in the development of new regulatory models to accommodate the need for preparedness in the case of an emergency attack. Procedures and protocols have been developed to enable the use of investigational new drugs in a highly controlled, safe manner for particular emergency situations, such as responding to a bioterrorist attack that exposes individuals to the agents that cause anthrax, smallpox and botulism.

What types of medical countermeasures are currently available in the event of a terrorist attack?

We have licensed vaccines for both anthrax and smallpox. In addition, we have a licensed treatment for complications from smallpox vaccination. Since 9/11 and the anthrax attacks of late 2001, CBER has worked with numerous manufacturers to develop and bring to licensure countermeasures against many potential biological agents. There are products in development that include new vaccines or treatments for anthrax, smallpox, botulism, plague, and others.

What regulations or guidance documents exist that would help with the development of safe and effective new products that might be used in countering bioterrorism?

In May 2002, the FDA published "Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible" [21 CFR 601 Subpart H, as well as 21 CFR 314 Subpart I for New Drugs]. This rule, known simply as the "Animal Rule," was designed to permit approval or licensing of drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions caused by exposure to biological, chemical, radiological, or nuclear substances. This rule amends the new drug and biological product regulations to identify the information needed to provide substantial evidence of the efficacy of new drug and biological products only when human efficacy studies are not ethical and field trials are not feasible. The new rule does not address the need for safety data which still must be established through human clinical trials.

In January 2009, a draft guidance was published “Animal Models – Essential Elements to Address Efficacy Under the Animal Rule.” After opening the docket for comments twice and holding a public meeting to hear comments on the guidance, this document is under revision by a CDER/CBER team and will be re-published as a draft guidance for comment in the future.

In December 2007, an interim final rule was published “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile” to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be held in the Strategic National Stockpile (SNS). This rule was issued to facilitate the safety, effectiveness, and availability of appropriate medical countermeasures stored in the SNS in the event of a public health emergency. In February 2012, the final rule was published in the Federal Register without change from the interim final rule.

Has CBER approved any new biologics under the Animal Rule so far?

CBER hasn't approved any new products under the Animal Rule to date. However, several products in development and on the licensure path are moving towards approval through this mechanism. The Center for Drugs Evaluation and Research (CDER) has approved two products to date using the Animal Rule, Pyridostigmine Bromide and Cyanokit.

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