Bill Text: NY S06103 | 2019-2020 | General Assembly | Introduced


Bill Title: Relates to advertising by drug manufacturers and the disclosure of clinical trials; defines terms; regulates advertisements; requires the disclosure of clinical trials of prescription drugs; makes related provisions.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced) 2019-05-16 - REFERRED TO HEALTH [S06103 Detail]

Download: New_York-2019-S06103-Introduced.html



                STATE OF NEW YORK
        ________________________________________________________________________

                                          6103

                               2019-2020 Regular Sessions

                    IN SENATE

                                      May 16, 2019
                                       ___________

        Introduced  by Sen. CARLUCCI -- read twice and ordered printed, and when
          printed to be committed to the Committee on Health

        AN ACT to amend the public health law, in  relation  to  advertising  by
          drug manufacturers and the disclosure of clinical trials

          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:

     1    Section 1. The public health law is amended by adding  a  new  section
     2  277-a to read as follows:
     3    §  277-a.  Prohibitions  and  required  disclosures; prescription drug
     4  advertising. 1. Definitions. As used in this section, unless the context
     5  otherwise indicates, the following terms shall have the following  mean-
     6  ings:
     7    (a)  "Clinical trial" means a clinical investigation as defined by the
     8  federal Food and Drug Administration that involves any trial to test the
     9  safety or efficacy of a drug or biological  product  with  one  or  more
    10  human  subjects  and  that  is  intended to be submitted to, or held for
    11  inspection by, the federal Food and Drug Administration as  part  of  an
    12  application for a research or marketing permit.
    13    (b)  "Manufacturer  of  prescription  drugs" or "manufacturer" means a
    14  manufacturer of prescription drugs or biological products or  an  affil-
    15  iate  of  the manufacturer or a labeler that receives prescription drugs
    16  or biological products from a manufacturer or wholesaler and  repackages
    17  those  drugs or biological products for later retail sale and that has a
    18  labeler code from the federal Food and Drug Administration under 21 Code
    19  of Federal Regulations, 2027.20 (1999).
    20    (c) "Regulated advertisement" means the presentation  to  the  general
    21  public  of a commercial message regarding a prescription drug or biolog-
    22  ical product by a manufacturer of prescription drugs that is:
    23    (i) Broadcast on television or radio from a station that is physically
    24  located in the state;
    25    (ii) Broadcast over the Internet from a location in the state; or

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD11791-01-9

        S. 6103                             2

     1    (iii) Printed in magazines or newspapers that are printed, distributed
     2  or sold in the state.
     3    2.  Regulated  advertisement requirement. Beginning October fifteenth,
     4  two thousand twenty, a manufacturer may  not  present  or  cause  to  be
     5  presented in the state a regulated advertisement, unless such advertise-
     6  ment  meets the requirements concerning misbranded drugs and devices and
     7  prescription drug advertising of federal law and  regulations  under  21
     8  United States Code, Sections 331 and 352(n) and 21 Code of Federal Regu-
     9  lations, Part 202 and state rules and regulations.
    10    3.  Disclosure  of  clinical  trials  of prescription drugs. Beginning
    11  October fifteenth, two thousand twenty, a  manufacturer  or  labeler  of
    12  prescription  drugs  that  is  required  to  report  marketing costs for
    13  prescription drugs shall post, with regard to such  prescription  drugs,
    14  on  the  publicly  accessible  Internet  website of the federal National
    15  Institutes of Health or its successor agency or another publicly  acces-
    16  sible  website  the  following information concerning any clinical trial
    17  that the  manufacturer  conducted  or  sponsored  on  or  after  October
    18  fifteenth, two thousand nineteen:
    19    (a)  The  name of the entity that conducted or is conducting the clin-
    20  ical trial;
    21    (b) A summary of the purpose of the clinical trial;
    22    (c) The dates during which the trial is taking or has taken place; and
    23    (d) Information concerning the results of the clinical trial,  includ-
    24  ing potential or actual adverse effects of the drug.
    25    In order to satisfy the requirements of this subdivision, the publicly
    26  accessible  website  and  manner  of  posting shall be acceptable to the
    27  department.
    28    4. Fees. Beginning April first, two thousand twenty-one, each manufac-
    29  turer of prescription drugs that are provided to persons through a state
    30  public health plan as defined  in  subdivision  eleven  of  section  two
    31  hundred  seventy of this article shall pay a fee of one thousand dollars
    32  per calendar year to the department. Fees collected under this  subdivi-
    33  sion  shall  be  used  to cover the cost of overseeing implementation of
    34  this section, including but not limited to maintaining links to publicly
    35  accessible websites to which manufacturers are  posting  clinical  trial
    36  information  under  subdivision three of this section and other relevant
    37  sites, assessing whether and the extent to which New York residents have
    38  been harmed by the use of a particular drug and undertaking  the  public
    39  education  initiative  under  subdivision five of this section. Revenues
    40  received under this subdivision must be deposited into a general fund to
    41  be used for the purposes of this section.
    42    5. Public education  initiative.  The  department  shall  undertake  a
    43  public education initiative to inform residents of the state about clin-
    44  ical trials and drug safety information.
    45    6.  Penalties. Each day a manufacturer is in violation of this chapter
    46  is considered a separate violation. Such manufacturer shall  be  subject
    47  to the penalties prescribed in section twelve of this chapter.
    48    §  2.  Report.  By  January  15,  2021, the department of health shall
    49  report to the Legislature matters on the completeness and ease of public
    50  access to information provided by the drug manufacturers  and  the  need
    51  for further action or legislation.
    52    § 3. This act shall take effect on the one hundred eightieth day after
    53  it shall have become a law.  Effective immediately, the addition, amend-
    54  ment and/or repeal of any rule or regulation necessary for the implemen-
    55  tation  of  this act on its effective date are authorized to be made and
    56  completed on or before such effective date.
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