Animal Models for Assessing Countermeasures to Bioterrorism Agents (2011) / Chapter Skim
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3 Ethical and Regulatory Challenges in the Development of Countermeasures
3 Ethical and Regulatory Challenges in the Development of Countermeasures
Pages 39-50
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From page 39... ...
A short discussion of the two products approved to date under the Animal Rule is also offered, as well as a short description of the FDA's drug development regulatory process. HISTORY OF THE ANIMAL RULE AND ETHICAL CONSIDERATIONS To respond effectively to potential biological and chemical threats, drugs and biological products are being developed and produced for which it is neither ethical nor legal to conduct efficacy studies with humans because of the unacceptably high risk of harm that testing itself would pose.
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From page 40... ...
. Three years later, in 2002, the final rule provided for "approval of certain new drug and biological products based on animal data when adequate and well-controlled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers and field trials are not feasible prior to approval.
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From page 41... ...
. A perceived medical crisis, such as a bioterroristic attack, could easily create an undue and arguably inappropriate public demand for drugs, vaccines, or other biological products under development or approved under For example, during a public health emergency such a consultative process might not be feasible.
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From page 42... ...
The DoD's waiver of informed-consent requirements for combat use of PB and botulinum toxoid vaccine became a lightning rod for controversy in the 1990s (Rettig 1999, 2000) , even though their use fell within the battlefield exceptions to informed consent requirements for INDs (e.g., 21 CFR 50.23)
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From page 43... ...
The draft announced that "when human efficacy studies are neither ethical nor feasible, animal efficacy studies may be relied on under the Animal Rule to support approval or licensure of a drug or biological product. This guidance identifies and discusses the critical characteristics of an animal model" (FDA 2009a, p 3610)
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From page 44... ...
. Cyanokit Dog and Human Data Indicates Effectiveness The Cyanokit package insert indicates "that hydroxocobalamin is likely to produce clinical benefit in humans" (FDA 2009b, p 5)
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From page 45... ...
As a result of animal efficacy studies, in April 2009, HGS delivered 20,000 doses of raxibacumab to the stockpile to treat inhalational anthrax in an emergency. Three months later, "HGS received a second order for 45,000 doses to be delivered over a period of three years, beginning near the end of 2009.
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From page 46... ...
is primarily Section 351 of the Public Health Service Act, 42 USC 201 et seq., and specific sections of the FFDC.6 Drugs and biological products have the same general development pathway. Both drugs and biological products are subject to the IND application regulations (21 CFR Parts 312, 314 and 316)
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From page 47... ...
The committee provides advice to the FDA regarding the safety and efficacy of the product for the proposed indication as well as what postmarketing clinical trials should be considered, if applicable. As part of the approval process, the FDA works with the applicant on the product package insert and other labeling.
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From page 48... ...
1999a. New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot be Conducted.
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From page 49... ...
2000. Waiving Informed Consent: Military Use of Non-FDA-Approved Drugs in Combat.
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