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Given that the administration would occur incident to a physician service (that is, the product is not self-administered), the differing mechanism of action from replacing deficient factors (that is, triggering the body to make clotting factors rather than infusing clotting factors into the body), and the requirement of close monitoring by a healthcare professional post-infusion, these gene therapies do not have the characteristics described in the January 2003 report that is referenced in section 1842(o)(5) of the Act, which the Secretary relied on in drafting 410.63(c)

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Were exposed to so many different things that its difficult to tease them apart, says Adam Lacy-Hulbert, an immunologist at the Benaroya Research Institute in Seattle, Washington