debate over fda drug approval using new `animal rule

Inpharma 1379 - 22 Mar 2003 Debate over FDA drug approval using new ‘animal rule’ The US FDA utilised its ‘animal rule’ for the first time on February the 5th when it approved the use of pyridostigmine to protect military troops against the nerve gas soman. This has sparked a debate on the rule which allows the approval of certain drugs based on animal efficacy data, according to a report published in Science. The report notes that, after being given to approximately 250 000 US troops during the Gulf War, pyridostigmine was noted as being one of the possible causes of Gulf War syndrome. Critics say that the approval could lead to confusion about the safety and efficacy of pyridostigmine. Notably, animal studies suggest that the drug may adversely affect brain, muscular, and reproductive function. However, the FDA says that it reviewed the use of pyridostigmine in several animal species before approving the drug. Furthermore, the agency says that the rule is not a shortcut, is not intended to be applied broadly, and is being used to save lives. The rule is intended to apply where full-scale clinical testing would involve exposure of humans to a life- threatening disease or when the size or cost of a clinical trial make it impractical. In such cases, the FDA may allow researchers and drug development companies to forego human efficacy studies, but not human safety studies. One question regarding the rule is where to draw the line in replacing human efficacy studies with tests in animals, says the report. Couzin J. New rule triggers debate over best way to test drugs. Science 299: 1651-1653, No. 5613, 14 Mar 2003 800907279 1 Inpharma 22 Mar 2003 No. 1379 1173-8324/10/1379-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1379 - 22 Mar 2003

Debate over FDA drug approvalusing new ‘animal rule’

The US FDA utilised its ‘animal rule’ for the first timeon February the 5th when it approved the use ofpyridostigmine to protect military troops against thenerve gas soman. This has sparked a debate on the rulewhich allows the approval of certain drugs based onanimal efficacy data, according to a report published inScience.

The report notes that, after being given toapproximately 250 000 US troops during the Gulf War,pyridostigmine was noted as being one of the possiblecauses of Gulf War syndrome. Critics say that theapproval could lead to confusion about the safety andefficacy of pyridostigmine. Notably, animal studiessuggest that the drug may adversely affect brain,muscular, and reproductive function.

However, the FDA says that it reviewed the use ofpyridostigmine in several animal species beforeapproving the drug. Furthermore, the agency says thatthe rule is not a shortcut, is not intended to be appliedbroadly, and is being used to save lives.

The rule is intended to apply where full-scale clinicaltesting would involve exposure of humans to a life-threatening disease or when the size or cost of a clinicaltrial make it impractical. In such cases, the FDA mayallow researchers and drug development companies toforego human efficacy studies, but not human safetystudies.

One question regarding the rule is where to draw theline in replacing human efficacy studies with tests inanimals, says the report.Couzin J. New rule triggers debate over best way to test drugs. Science 299:1651-1653, No. 5613, 14 Mar 2003 800907279

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