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A01923 Summary:

BILL NOA01923
 
SAME ASSAME AS S05158
 
SPONSORPaulin
 
COSPNSRGottfried, Dinowitz, Galef, Rivera J, Weprin, Abinanti
 
MLTSPNSR
 
Rpld 206 sub 1 (o), add 280-d, Pub Health L; amd 6810 & 6816-a, Ed L
 
Requires the commissioner of health to establish and publish a list of generic drug products.
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A01923 Actions:

BILL NOA01923
 
01/13/2021referred to health
01/26/2021reported referred to ways and means
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A01923 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A1923
 
SPONSOR: Paulin
  TITLE OF BILL: An act to amend the public health law and the education law, in relation to generic drug products; and to repeal paragraph (o) of subdivision 1 of section 206 of the public health law relating thereto   PURPOSE OR GENERAL IDEA OF BILL: To make relevant information related to generic drugs freely and public- ly available.   SUMMARY OF SPECIFIC PROVISIONS: Section one repeals paragraph (o) of subdivision 1 of section 206 of the public health law (PHL). Section two adds a new section 280-c, named "generic drug products," to the PHL. The provisions included in subdivision one are taken from para- graph (o) of subdivision one of section 205 of the PHL, which has been repealed. This new subdivision provides that the health commissioner shall establish a list of drug products, which must be certified or approved and evaluated as therapeutically and pharmaceutically equiv- alent by the Federal Food and Drug Administration. Subdivision two provides that the manufacturer of a generic drug product shall make available to the department of health the studies and summaries (includ- ing bioequivalence data, therapeutic equivalence data, and incidence of adverse events) and associated analytical methods (including dissolution data and test methods) provided to the FDA as part of the application for such generic drug product. The department shall make such informa- tion freely and publicly available on its website. Section 3 and section 4 change the references to paragraph (o) of subdi- vision 1 of section 206 of the PHL in the Education Law. Section 5 provides the effective date.   JUSTIFICATION: New York State Law (paragraph (o) of subdivision 1 of section 206 of the PHL) provides that the health commissioner shall establish and maintain a list of generic drug products, which must meet specified conditions. The bill repeals this paragraph and transfers its language to a new section (280-b) of the PHL, named "generic drug products." This way, the provisions related to generic drugs are easily accessible. The bill also introduces a new provision (subdivision 2 of the new section 280-c) to make relevant information related to generic drug products freely and publicly available. The Center for Drug Evaluation and Research defines a generic drug as a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and perform- ance characteristics, and intended use. Generic drugs are approved by the FDA and represent an affordable option for users. To receive approval by the FDA, generic drug manufacturers have to submit specified documents and reports, proving that their drug is bioequivalent to the respective brand name drug. The information that producers and manufac- turers provide to the FDA is not publicly available. For most generic drugs, consumers can access such information only by going through a formal FOIL request. This process can be extremely difficult and time consuming. Moreover, the availability of such information is extremely valuable. The FDA has to process thousands of drug applications and mostly relies on studies submitted by the drug producers or manufacturers when making bioequivalence assessments. Even when FDA procedures are precisely followed, differences between generic and brand name drugs can occur. For example, in 2008, the FDA declared a particular generic version of a brand name antidepressant drug as safe and effective. However, shortly thereafter it was discov- ered that the generic drug's side effects were different than those of the brand name drug. In 2012, the FDA reevaluated and announced that the generic drug is not the bioequivalent to the brand name drug. The reversal was based on a FDA bioequivalence study which found that the generic drug achieved only 75% of the maximum drug concentration attained by the brand name product (potentially explaining the return of depression in patients switched to the generic product). The generic manufacturer's product released much of its drug earlier than the brand's product. The dissolution rate greatly affects how a drug is released in the human body. This ultimately impacts the drug effects. The new results obtained by the FDA closely matched the results of inde- pendent organizations that tested the two drugs for bioequivalence. If the information that this bill makes public was available immediately, the time for a correction to be made may have been less than four years. The biopharmaceutic studies and summaries, dissolution data, and test methods provided to the FDA by generic drugs producers must be avail- able. This way, such information can be reviewed and analyzed by experts who can conduct independent evaluations of the drugs. The intent of the bill is to encourage transparency in order to protect consumers. Certainly, consumers should have the option to have their prescription filled with a generic product, particularly since generics often cost less than brand name drugs. However, consumers must be informed of the drawbacks, if any, of taking a generic drug instead of the brand name drug. Consumers have the right to know what the differences between brand and generic drugs are and decide, with their physicians and phar- macists, whether the generic product is appropriate for them.   PRIOR LEGISLATIVE HISTORY: 2020: A.612A, Referred to Ways and Means / S.2391A, Referred to Health. 2019: A.612A, Reported Referred to Ways and Means / S.2391A, Amended and Recommitted to Health. 2018: S.5471-A 5.5471 -- Referred to Health / A.236-A Passed Assembly 2017: Referred to Health / A.236 - Passed Assembly 2016: S.5099-A- Referred to Health/A.145-A -Passed Assembly 2015: S.5099-A- Referred to Health/A.145-A -3rd Reading 2014: S.6739-A- Referred to Health/A.8057-A- Referred to Ways & Means 2013: A.8057-A- Referred to Health   FISCAL IMPLICATIONS: None.   EFFECTIVE DATE: This act shall take effect on the ninetieth day after it shall have become a law.
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A01923 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          1923
 
                               2021-2022 Regular Sessions
 
                   IN ASSEMBLY
 
                                    January 13, 2021
                                       ___________
 
        Introduced  by  M.  of A. PAULIN, GOTTFRIED, DINOWITZ, GALEF, J. RIVERA,
          WEPRIN, ABINANTI -- read once and referred to the Committee on Health
 
        AN ACT to amend the public health law and the education law, in relation
          to generic drug products; and to repeal paragraph (o) of subdivision 1
          of section 206 of the public health law relating thereto

          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section 1. Paragraph (o) of subdivision 1 of section 206 of the public
     2  health law is REPEALED.
     3    § 2. The public health law is amended by adding a new section 280-d to
     4  read as follows:
     5    §  280-d.  Generic  drug products. 1. The commissioner shall establish
     6  and publish a list of drug products, referred  to  in  this  section  as
     7  "generic  drug"  products, each of which shall meet the following condi-
     8  tions:
     9    (a) The drug product has been certified or approved by the commission-
    10  er of the Federal Food and Drug Administration as being safe and  effec-
    11  tive  for its labeled indications for use, and a new-drug application or
    12  an abbreviated new-drug application approved  pursuant  to  the  Federal
    13  Food, Drug, and Cosmetic Act is held for such drug product; and
    14    (b)  The  commissioner of the Federal Food and Drug Administration has
    15  evaluated such drug product as: (i) pharmaceutically and therapeutically
    16  equivalent and has listed such drug product on the list of approved drug
    17  products with the therapeutic equivalence evaluations, provided,  howev-
    18  er,  that  the  list  prepared by the commissioner shall not include any
    19  drug product which the commissioner of the Federal Food and Drug  Admin-
    20  istration has identified as having an actual or potential bioequivalence
    21  problem  or (ii) as an interchangeable biological product and has listed
    22  such product on the list of approved drug products with interchangeabil-
    23  ity.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD01823-01-1

        A. 1923                             2
 
     1    2. The manufacturer of a generic drug product shall make available  to
     2  the department the studies and summaries, including bioequivalence data,
     3  therapeutic equivalence data, and incidence of adverse events, and asso-
     4  ciated  analytical  methods, including dissolution data and test methods
     5  provided  to  the  Federal  Food  and Drug Administration as part of the
     6  application for such generic drug product.  The  department  shall  make
     7  such information freely and publicly available on its website.
     8    §  3.  Paragraphs  (a) and (e) of subdivision 6 of section 6810 of the
     9  education law, paragraph (a) as amended by chapter 590 of  the  laws  of
    10  2011  and  paragraph  (e) as amended by chapter 357 of the laws of 2017,
    11  are amended to read as follows:
    12    (a) Every prescription written in this state by a person authorized to
    13  issue such prescription shall be on prescription  forms  containing  one
    14  line  for  the  prescriber's signature. The prescriber's signature shall
    15  validate the prescription. Every electronic prescription  shall  provide
    16  for  the  prescriber's  electronic  signature,  which shall validate the
    17  electronic prescription. Imprinted conspicuously on  every  prescription
    18  written  in  this state in eight point upper case type immediately below
    19  the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED
    20  GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX  BELOW".  Unless
    21  the  prescriber  writes  d a w in such box in the prescriber's own hand-
    22  writing or, in the case of electronic prescriptions,  inserts  an  elec-
    23  tronic  direction  to  dispense  the  drug  as written, the prescriber's
    24  signature or electronic signature shall designate  approval  of  substi-
    25  tution  by a pharmacist of a generic drug product pursuant to [paragraph
    26  (o) of subdivision one of] section [two hundred six] two hundred  eight-
    27  y-d  of  the  public health law.   No other letters or marks in such box
    28  shall prohibit substitution. No prescription forms used or  intended  to
    29  be  used  by a person authorized to issue a prescription shall have 'd a
    30  w' preprinted in such box. Such box shall be placed directly  under  the
    31  signature  line  and shall be three-quarters inch in length and one-half
    32  inch in height, or in comparable form for an electronic prescription  as
    33  may  be  specified  by regulation of the commissioner. Immediately below
    34  such box shall be imprinted in six point type  the  words  "Dispense  As
    35  Written".    Notwithstanding  any other provision of law, no state offi-
    36  cial, agency, board or other entity shall promulgate any  regulation  or
    37  guideline  modifying  those elements of the prescription form's contents
    38  specified in this subdivision. To the extent otherwise permitted by law,
    39  a prescriber may modify only those elements of the  prescription  form's
    40  contents  not  specified  in this subdivision. Notwithstanding any other
    41  provision of this section or any other law, when a generic drug  is  not
    42  available and the brand name drug originally prescribed is available and
    43  the  pharmacist  agrees  to  dispense the brand name product for a price
    44  that will not exceed the price that would  have  been  charged  for  the
    45  generic substitute had it been available, substitution of a generic drug
    46  product  will not be required. If the generic drug product is not avail-
    47  able and a medical emergency  situation,  which  for  purposes  of  this
    48  section is defined as any condition requiring alleviation of severe pain
    49  or  which  threatens  to  cause  disability or take life if not promptly
    50  treated, exists, then the pharmacist may dispense the brand name product
    51  at his regular price. In such instances the pharmacist must  record  the
    52  date,  hour  and  nature  of  the  medical  emergency on the back of the
    53  prescription and keep a copy of all such prescriptions.
    54    (e) No prescriber shall be subjected to civil liability arising solely
    55  from authorizing, in accordance with this subdivision, the  substitution
    56  by  a pharmacist of a generic drug product pursuant to [paragraph (o) of

        A. 1923                             3

     1  subdivision one of] section two hundred [six]  eighty-d  of  the  public
     2  health law.
     3    §  4.  Paragraph (d) of subdivision 6 of section 6810 of the education
     4  law, as added by chapter 913 of the laws of 1986, is amended to read  as
     5  follows:
     6    (d) No prescriber shall be subjected to civil liability arising solely
     7  from  authorizing, in accordance with this subdivision, the substitution
     8  by a pharmacist of a generic drug product pursuant to [paragraph (o)  of
     9  subdivision  one  of]  section  two hundred [six] eighty-d of the public
    10  health law.
    11    § 5. Paragraph (b) of subdivision 1 of section 6816-a of the education
    12  law, as added by chapter 776 of the laws of 1977, is amended to read  as
    13  follows:
    14    (b)  The  substituted drug product is contained in the list of generic
    15  drug products established pursuant to [paragraph (o) of subdivision  one
    16  of]  section [two hundred six] two hundred eighty-d of the public health
    17  law; and
    18    § 6. This act shall take effect on the ninetieth day  after  it  shall
    19  have  become  a  law;  provided  that the amendments to paragraph (e) of
    20  subdivision 6 of section 6810 of the  education  law,  made  by  section
    21  three  of  this  act, shall not affect the expiration of such paragraph,
    22  when upon such date the provisions of section four  of  this  act  shall
    23  take  effect.  Effective  immediately,  the  addition,  amendment and/or
    24  repeal of any rule or regulation necessary  for  the  implementation  of
    25  this  act  on its effective date are authorized to be made and completed
    26  on or before such effective date.
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