MessageFrom: Sadove, Elizabeth
Sent: Monday, September 15, 2003 3:44 PM
To: Dockets, FDA; Butler, Jennie C
Subject: FW: MedDRA costs - FR posting in error?

This comment, sent to the dockets division regarding a posting in the FR, found its way to me after a long series of referrals.  It needs to be included as a submission to Docket 00N-1484, as a comment to the proposed rule on Safety Reporting Requirements for Human Drug and Biological Products (68 FR 12406).   Please let me know if there's anything I need to do to make sure it gets included.  Thank you, Liz Sadove 
(301) 594-5645, 
sadovee@cder.fda.gov

   From: Butler, Jennie C 
  Sent: Monday, September 08, 2003 4:36 PM
  To: CDER DRUGINFO; Hill (Banks), Lanessa; Meyer, Mary
  Subject: FW: MedDRA costs - FR posting in error?



        -----Original Message-----
        From: Jennifer Assinck [mailto:jassinck@sympatico.ca]
        Sent: Monday, September 08, 2003 4:31 PM
        To: FDADockets@oc.fda.gov
        Subject: MedDRA costs - FR posting in error?


        To Whom It May Concern:

         

        I am a regulatory affairs consultant with a client that is a very small business (8 employees) manufacturing one "orphan" biologic drug.  I am looking into having clinical legacy data (100 COSTART terms) converted from COSTART to MedDRA terms and having the correct MedDRA codes for any future ADR reporting.

         

        I contacted a CRO who does have a MedDRA license, but was told that they are not allowed to code ADRs into MedDRA terms/codes unless their client also has a MedDRA license.  They have confirmed this with the MedDRA MSSO, as it will significantly impact on their own practices.

         

        There is a comment in the recent Federal Register that would seem to indicate that it is possible for small firms to contract with CROs for such a service in order to avoid the subscription costs of MedDRA.  I wish to point out that this may not be true.  It appears that the MedDRA MSSO is exerting a monopoly and it will not be possible for small firms to save money by going through a CRO.  Indeed, on top of the subscription cost paid to MedDRA, the firm will also have to pay a CRO for their time.

         

        I will quote here from the Federal Register:

         

        Food and Drug Administration

        21 CFR Parts 310, 312, 314, 320, 600,

        601, and 606

        [Docket No. 00N-1484]

        RIN 0910-AA97

        Safety Reporting Requirements for

        Human Drug and Biological Products

         

         

        V.D.2.b. Recurring costs

        V.D.2.b.i. MedDRA core subscription.

        Companies must pay subscription costs

        on an annual basis to the MedDRA

        MSSO. Core subscription costs vary

        with the size of the company and with

        the level of services. Estimates of costs

        range from $5,000 to $40,000 for drug

        and biologics firms. ERG judged that

        blood facilities would incur only

        modest annual costs associated with

        MedDRA subscription and updates

        because of the limited range of

        terminology describing medical

        outcomes. ERG assumed that blood

        facilities would either work through

        industry associations to negotiate lower

        per firm subscription costs or,

        alternatively, contract with contract

        research organizations to obtain the

        necessary MedDRA codes.

         

        I look forward to a response from you, clarifying whether companies can indeed approach CROs for conversion work without having to take out a subscription to MedDRA themselves.  If it turns out that small companies will have to subscribe, is it possible for the FDA to pressure the MedDRA MSSO to change this restriction.

         

        Sincerely, 

        Jennifer Assinck

        PharmaCompliance Consulting Services