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Emerging Viral Infections
In addition to diseases such as HIV/AIDS,
herpesvirus infections, and viral hepatitis, the Division of
Antiviral Products reviews submissions and applications for
antiviral products (including antiviral drugs and certain types of biologic products) directed against a range of infections that have
recently emerged or re-emerged, or could emerge under certain
conditions of public health crisis, as major causes of human
illness. This category of emerging viral infections includes (but is
not limited to) the following:
- Infections that may spread widely due to
genetic changes in existing viral pathogens (such as novel strains
of influenza);
- Infections appearing in new settings due to
movement of human populations or of animal reservoirs (such as
West Nile virus or monkeypox);
- Infections newly recognized as causes of
human disease (such as SARS or hantavirus pulmonary syndrome);
- Infections that are rare or nonexistent
under normal circumstances but that could be sources of
significant concern in the context of potential bioterrorism/biowarfare
threats (such as smallpox, serious vaccinia infections
complicating smallpox vaccination, or certain viral hemorrhagic
fevers).
Approaches to drug development for emerging
viral infections
Development of drugs for emerging viral
infections poses distinctive challenges because many of these
illnesses are rare but may be life-threatening, and have the
potential to change rapidly in incidence and/or virulence, such that
a serious public health threat could arise with little advance
opportunity for study. Thus, although developing treatment and
control measures is a high priority, the traditional sequence of
nonclinical and clinical studies may be very difficult to implement.
In order to facilitate progress without compromising scientific
standards, careful attention to the following possible approaches
may be desirable. Prospective sponsors should discuss these with the
review division:
- Consideration of potential applicability to
emerging infections during development of antivirals for other
purposes;
- Assembly and analysis of treatment
experience for related products and diseases that may have
indirect relevance to the product and disease of interest;
- Prospective design of nonclinical studies
(including shared discussion of planned animal studies across all
review disciplines) to provide as much supplemental information as
possible in support of potentially limited clinical data;
- Prospective design of clinical trials to
maximize the amount of useful information that may be gained from
sparse experience, and to address both the importance of
adequately controlled and monitored trials and the constraints of
study conduct under emergency conditions;
- Regulatory mechanisms for facilitation of
timely interactions.
Sponsors seeking to develop antiviral drugs for
emerging infections are urged to communicate with the Division as
early in the development process as possible. Typically the
Pre-IND consultation program
will provide an appropriate mechanism for such early consultations.
For some drug development programs for emerging infections, repeated
Pre-IND interactions may be desirable.
Useful links for additional information on
emerging infections and drug development
The following links provide access to
additional information on general issues related to emerging viral
infections and drug development for such infections. Listing is for
informational purposes and may not imply endorsement. Relevance of
the listed resources will vary for specific development
proposals. Potential sponsors or investigators are encouraged to
contact the
DAVP pre-IND contact  with questions.
- Pre-IND website (FDA/CDER/Office of
Antimicrobial Products, including DAVP):
http://www.fda.gov/cder/ode4/preind/default.htm. Sponsors are
urged to contact DAVP early in the development process to discuss
the most efficient design and potential uses of nonclinical as
well as clinical studies.
- FDA/CDER website for Influenza Antiviral
Drugs and Related Information:
http://www.fda.gov/cder/drug/antivirals/influenza/default.htm.
This site provides summaries and links to information regarding
influenza control public health measures, pandemic influenza
preparedness, and approved drugs for treatment and prevention of
influenza.
- FDA Counterterrorism website:
http://www.fda.gov/oc/opacom/hottopics/bioterrorism.html.
This site provides links to general information on
counterterrorism-related activities at FDA including some related
to viral emerging infections.
- Selected FDA regulations, guidance, announcements/notices, and
policy
related to facilitating development of and access to drugs for
serious life-threatening infections with limited therapeutic
options, including (but not limited to) potential threat agents:
- 21 CFR 312 Subpart E (312.80-312.88), Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
- 21 CFR 312.36, Emergency use of an investigational new drug
- 21 CFR 312.34, Treatment use of an investigational new drug
- Proposed Rule, Expanded Access to Investigational Drugs for Treatment Use [HTML] [PDF]
- Guidance, Emergency Use Authorization of Medical Products
- Draft Guidance for Industry, Vaccinia Virus — Developing Drugs to Mitigate Complications from Smallpox Vaccination
- Draft Guidance for Industry, Smallpox (Variola) Infection: Developing Drugs for Prevention and Treatment
- Priority Review Policy
- 21 CFR 314 Subpart H (314.500-314.560), Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
- 21 CFR 314 Subpart I (314.600-314.650), Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible (“Animal Rule”)
- 21 CFR 601 Subpart H (601.90-601.95), Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible (“Animal Rule” for biologic products)
- Guidance for Industry, Fast Track Drug Development Programs - Designation, Development, and Application Review [HTML] or [PDF]
- National Institutes of Health, National
Institute of Allergy and Infectious Diseases, Division of
Microbiology and Infectious Diseases, Virology Branch, website
with links to antiviral drug screening program:
http://www.niaid.nih.gov/dmid/viral. Sponsors of antiviral
drugs that might have applicability to treatment of emerging
infections are encouraged to contact the NIH/NIAID/DMID/Virology
Branch to discuss screening drugs for antiviral activity against
emerging pathogens.
- Centers for Disease Control and Prevention
Emerging Infectious Diseases website:
http://www.cdc.gov/ncidod/diseases/eid/index.htm. This site
contains information and additional links for a range of emerging
infections and related topics.
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Date created: November 17, 2004, updated March 19, 2008 |
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