Johnson Johnson Vol 6/25 by FDADocs

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        OFFICE    OF                                                      ONE JOHNSON    & JOHNS%4      PLAZA
GENERAL          COUNSEL                                                  NEW BRUNSWICK,     N.J. 08&3-7001




   VIA FEDERAL                 EXPRESS

   Dockets Management Branch, (HFA               0%
   Food and Drug Administration
   5630 Fishers Lane, Room 1061
   Rockville, Maryland 20852

   Re:            Comments to Docket No.         IN-1269
                  Proposed Rule; Requiremc       !tson co e            Format of Labeling for Human
                  Prescription Drugs and Bi      ogics; Rc 1:         Its for Prescription Drug
                  Product Labels    .

   Dear Sir or Madam:

           These comments are submiti            1 on beha               larmaceutical companies of the
   Johnson &Johnson family of camp:              ies.. With              ately 99,000 employees, Johnson
   &Johnson, is the world’s most corn1           ehensive                y based manufacturer of health
   care products, as’well as a provider c        related se              the consumer, pharmaceutical and
   professional markets. Johnson &Jo             lson has 1              190 operating companies in 51
   countries around the world, selling p         bducts in I             175 countries. In the year 2000,
   Johnson &Johnson invested $1.9 bi             lnofatc            bh lion research and development
   spent on pharmaceutical developma             , which re         ;iil 1 18.6% increase from 1999.
   Johnson &Johnson is the seventh la            pt pharn           da md the second largest
   biotechnology company in the work              Its subsic        an ufacture and sell prescription
   medicines include antifungals and an          infective!            ‘Iarming products, and drugs for
   psychiatry and mental health, pain n:         iagement            9’ c&r disease, cancer, arthritis and
                                                                    pap
   gastrointestinal disorders.

            We are keenly interested in F        IA’S prop            :nd its regulations governing the
   format and content of labeling for p:         scription            biologic products and agree with
   the Agency’s stated objectives of ma          ng the   lat         er for health care practitioners to
   access, read, and use.” We agree wit          and suPP             nments of the Pharmaceutical
   Research and Manufacturers of Ame             ca (“PhR             lis subject dated June 14,2001,
   and would like to expand upon two I           ecific iter          : comments as follows.

   I.             Highlights    of Prescribing   lformatic

          We join PhRMA in strongly ‘posing tl                  a      of a ‘TIighlights” section to the
   approved product labeling. The app lved prod                 t     ; is a distillation of complex data
                                                                       June 21,200l



    designed to provide curr
    products to health care pr
    negotiations with FDA, sp
    the available data to ensure
    current knowledge about a product.
    make the labeling easier to access, re    and most appropriately served by
    the adoption of a standardized                  of the labeling sections to
    place more critical information                  of key text through special
    formatting, which are all attributes

             In contradistin                            of important prescribing
    information in an additional “
    proposed rule and +ll have a                          believe that cognitive
    theory and actual research
    section would encourage practition
    the crucial information contained
    cognitive theory supports the prop0
    information and .ignore comprehens
    itself acknowledges in its proposed ‘
    all of the information needed to
    rule would structure labeling in a
    prescribing information and lead
    that is needed for safe



              In addition, we join PhRMA         concern over the product
    liability implications of FDA’s prop      harmaceutical product liability case
    involves allegations that important       from the labeling or that risk or
    other information disclosed was not
    significantly increased by inclusion o
,   alleged inadequacy of that section           ties between the information
    condensed for that section and the              information. This concern is
    not merely “speculative” as the
    analogous situations. For ex
    in the Physicians Desk Referen                      e “Highlights” section
    proposed by FDA) did not                   regarding certain side effects, was
    misleading when compared to the
    practitioners to ignore the actual p

    II.     Proposed Restrictions on         in the “‘Indications   and Usage”
            and “Dosage and Admini
                                                                        June 21,200l




and Usage” and “Dosage an
scientifkally valid and po
FDA should not depart
horn studies that are scientitically s
Inappropriate use of this data in
authority and not at the expense                  cling scientific information that
                                               from a public policy perspective
FDA stands on fkmer ground                       sure of truthful and non-
misleading information in a come         health care professional to make an
appropriate and independent ju               ante of the information. we
respectfully submit that eliminann              ignificant information from the
labeling runs counter to FDA’s st              ore informative labeling for
practitioners and patients.

              For instance, FDA pro
data have not been shown to be
clinical studies, only be included
specifically granted a waker. C             anti-infective drug products contains
two lists of organisms: (a) thos            buate and well-controlled clinical
studies (commonly known as the
there are insufficient clinical data
pathogens associated with app                  d are documented to be >90%
susceptible in the United States (c
to delete fi-om labeling the ‘“in v&v
of valuable information on less fr




                unusual infection

            Echo&g our view about         truthful and non-misleading data with
the appropriate contextual informa                                                     /
                                                                                       j
                                                  I




                                         i@       I


Dockets Management Branch (ElFA-.305)             ’
Food and Drug Administration                  4                                    June21,2001



                In our view, this &z
                excluded horn the



            FDA can address the p
otherwise through its existing legal                  ?!?bints to Consider in the Clinical
Development and Labeling of Anti
clear statement of the Agency’s
product for specific infections
the product labeling. PTC at 9.
mechanism for keeping the lab                              that microorganism susceptibility
patterns can change with time.

                                                             the impact of this proposed
policy shift on the Agency’s                                      s for commercial in 2?&0
susceptibility testing devices                                    of in vitro data in the
labeling. As reflected in the comme                     elepak, Microbiology Reviewer,
Center for Devices, and Radiologic
“clinically indicated organisms” an
infective drug products to select or
organisms, and interpretative crit
test devices.’ The FDA reviewer

                The removal from
                data would be too


                evaluable data since



                                                              not be able to
                                                              device to detect
                resistance or even
                resistance is of high
                antimicrobial resistan




’ Seealso, Food and Drug Admin., G&&me
(March 8,200O).
Dockets Management Branch @-IFA
Food and Drug Administration                                                    June21,200l



          Based on the foregoing ~&CL     3n, we r   qy request that the proposal for a
“Highlights” section be eliminated it     efinalr    I that FDA abandon consideration of
restrictions on the inclusion in the la   ing of b   ata and other data on indications, uses,
and dosing that are not included in t     “Indicat   td +a,”     and “Dosage and
Administration” sections. We apprc        te the o   nity to comment on the proposed rule
and look forward to your thought&xl       nsiderat   th!z issues raised here and in the
comments of,PhRMA.




                                                         Iohnson

								
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