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  • 1.  Facility fees for OTC drug manufacturers

    Posted 23-Sep-2020 08:48

    The CARES Act establishes a new program for the regulation of OTC drugs and, no surprise, establishes user fees for certain OTC drug reviews and manufacturing facilities.  The plan was for FDA to announce in the Fed Reg in May what the expected facility fees would be for the 2021 Fiscal Year, but I don't think FDA has yet announced anything about the facility fees.  Am I mistaken? 

     

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  • 2.  RE: Facility fees for OTC drug manufacturers

    Posted 24-Sep-2020 02:18


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  • 3.  RE: Facility fees for OTC drug manufacturers

    Posted 24-Sep-2020 08:40
    Hi Joy.

    Not sure that is what is being asked here - looks like Christopher is asking about facility fees.  These have not been published yet although if I remember correctly the expectation was that the FDA would collect ~$20 million per year when you include all of the fees and those fees would be divided as a "full share" from brand owner facilities and a partial (I think it was 2/3) share from contract manufacturers.  So in reality, the brand owners will ultimately pay a higher "full share" fee than the expected simple average of the total intake of fees divided by the number of registered facilities.  This is likely one of the things that is taking FDA a longer time to understand since they are now required to determine which facilities are considered "brand owners" and which are contractors.  Then you have a potential second question since there are a few facilities that perform both functions (they produce their own brands and contract fill for other companies) so you need to determine what fee structure that will involve (my guess is any "brand owner" activity will mean a full share fee but right now that is only a guess until the final fees are published).  These fees were supposed to be finalized actually I believe by July and then the invoices were to be sent out at start of fiscal but since I have not seen anything published about the fees themselves yet, invoices are likely to be late in my opinion and due date will be equivalently pushed back to accommodate.

    As for Joy's post, these are the costs for individual petitions to update the regulations and the tier is determined based on the type of information that is being asked to be updated.  For example, an editorial change in a "monograph" (I think these will ultimately be called Admin orders but again, not clear on that part yet whether they will retain the term monograph or not) or to add a warning will likely be a Tier 2 and cost you $100k but if you want to try to extend an indication, update an allowable API list with a new active, or something more substantive you are likely getting hit for a Tier 1 and $500k.  The difference is that if you need to provide clinical support for your change (and likely most, if not all, Tier 1 changes fit into this category) you will get a specified period of exclusivity where you will be the only company able to sell the product with the updated changes.

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    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
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  • 4.  RE: Facility fees for OTC drug manufacturers

    Posted 24-Sep-2020 08:57
    Thanks for the correction Victor. You are quite correct.

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  • 5.  RE: Facility fees for OTC drug manufacturers

    Posted 25-Sep-2020 17:55
    Thanks for the feedback and to clarify, Victor is correct, I was speaking of OTC Monograph User Fee Act (OMUFA) fees applying to facilities, not the fees for OTC Monograph Order Requests (OMORs).  Since my original post I did find the fees have not yet been posted.  Initially, OMUFA facility fees were expected to be published in mid-May 2020, with a payment deadline within 45 days of publication. However, when taking a closer look at Section 744M(f), fees may only be collected after the posting of the appropriations act. The appropriations act, which will specify the total amount of fees to be collected each fiscal year, shall be available starting October for the next fiscal year.  Following the publication of the appropriations act for 2021, FDA plans to publish the exact facility fee amounts in a Federal Register Notice (FRN). OTC Monograph drug facility fees for fiscal year 2021 will be due 45 days after publication of this FRN. Therefore, instead of 2020 fees being due in late June or early July 2020, they will now be dropped and 2021 fees will be due no earlier than mid-November 2020.

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    Christopher Smith, CQE, RAC
    Coastal Pharmaceutical Consultants, Inc.
    7950 Old River Road
    Burgaw, NC 28425, USA
    910.259.8877 (land)
    910.789.1232 (mobile)
    chrissmith@coastalpharmaconsultants.com
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