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Industry news, page-196

  1. 4,327 Posts.
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    @Greenwave17

    Not worried in the slightest - sometimes a collective or selective (either or) argument pops up that the outcomes derived through the FDA processes are comensurate with the funding that particular drug company/s has provided as per their application to the authority for a process to occur, in whatever appraisal/approval capacity has been applied for....nothing could be further from the truth of the process
    https://hotcopper.com.au/data/attachments/3695/3695201-935fb300ad2ba3aa91d25745e3334566.jpg
    every cent of appropriation is transparently accounted for and reported to treasury who have oversight of the allocation of those 'fee' appropriations - all budgetary spends associated with all such appropriations are then 'commercially' reported ....no such thing as commercial in confidence = denial or non disclosure, the administration would be be immediately audited and against all unaccounted discretionary spending

    'Funding Sources
    FDA’s total program level, the amount that FDA can spend, is composed of discretionary
    appropriations from two different sources.
    First, FDA is appropriated funding out of the
    Treasury’s General Fund. (This is the usual source of funding for discretionary appropriations, and, in keeping with the conventions used in FDA budget documents, is referred to in this report'

    Second, FDA also is allowed to collect and obligate user fees.
    FDA’s annual appropriation sets both the amount of budget authority and the amount of user fees that the agency is authorized to collect and obligate for that fiscal year.
    The budget authority appropriations are largely for the Salaries and Expenses account, with a smaller amount for the
    Buildings and Facilities account, which is used for any changes to or purchase of fixed equipment
    and facilities used by FDA.
    The appropriations of the several different user fees contribute only to the Salaries and Expenses account.

    to discover the appropriation distribution of 'user fees ' is relatively, simple, yet no one bothers....why? (rhetorical - if you have an agenda its a good idea not to disclose the facts of the situation ...you may end up with nothing to argue for)

    et al. Generally, the medical product user fees have been authorized in legislation on a five-year cycle.
    Each five-year authorization sets a total amount of fee revenue for the first year and provides a formula for
    annual adjustments to that total based on inflation and other adjustments. In contrast, the nonmedical product user fee programs do not require reauthorization and, with the exception of the tobacco product user fee program, are indefinite. Table A-1 presents the list of user fees that contribute to FDA’s budget, sorted by the dollar amount they contribute to the agency’s FY2021
    budget. The table also includes the authorizing legislation for each current user fee, specifies whether the user fee program requires reauthorization, and provides the most recentre authorization, if applicable.

    in other words congress and treasury scrutinise all of the appropriations

    https://hotcopper.com.au/data/attachments/3695/3695235-361a863892f49612303b4ebd9c4902b5.jpg
    https://hotcopper.com.au/data/attachments/3695/3695239-f59ed8c0a5c4a91c6d7a61bd77d11f36.jpg

    and of course
    https://hotcopper.com.au/data/attachments/3695/3695244-7dbeb2fab4fc121941378ee6b7b12972.jpg
    https://hotcopper.com.au/data/attachments/3695/3695245-2f0566059c74a0d7dd5c814c15b81d8f.jpg
    https://hotcopper.com.au/data/attachments/3695/3695249-b60c61231366e64b8cdcc2958f81084c.jpg

    https://hotcopper.com.au/data/attachments/3695/3695256-0fec9c8807c8ff813c1501cda74688b4.jpg
    have a read

    i think you'll agree its extensive, comprehensive and transparent

    The Food and Drug Administration (FDA) Budget: Fact Sheet (congress.gov)

    GLA smile.png

    Last edited by Flectional: 17/10/21
 
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