New York State Assembly

 
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A00145 Summary:

A00145 Actions:

A00145 Committee Votes:

Committee:WAYS AND MEANS   Chair:Farrell      
DATE:05/25/2016AYE/NAY:34/0  Action: Favorable         
Farrell
Aye
Oaks
Aye
Lentol
Aye
Crouch
Aye
Schimminger
Excused
Barclay
Aye
Gantt
Aye
Fitzpatrick
Aye
Weinstein
Aye
Saladino
Aye
Glick
Aye
Hawley
Aye
Nolan
Aye
Duprey
Aye
Pretlow
Aye
Corwin
Aye
Perry
Aye
Malliotakis
Aye
Colton
Aye
Walter
Aye
Cook
Aye
Cahill
Aye
Aubry
Aye
Hooper
Aye
Thiele
Aye
Wright
Aye
Cusick
Aye
Ortiz
Aye
Benedetto
Aye
Markey
Aye
Moya
Aye
Weprin
Aye
Rodriguez
Aye
Ramos
Aye
Braunstein
Aye

A00145 Floor Votes:

A00145 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
 submitted in accordance with Assembly Rule III, Sec 1(f)



 
BILL NUMBER: A145A
 
SPONSOR: Paulin (MS)

 
TITLE OF BILL:  An act to amend the public health law and the educa-
tion 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-b, 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repealed.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 biopharmaceutic studies and
summaries (including bioequivalence 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 information
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-b) 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 manufacturers provide to the FDA is
not publicly available. For most generic drugs, consumers can access
such information only by going through a foLmal FOIL request. This proc-
ess 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 differ-
ences between brand and generic drugs are and decide, with their physi-

cians and pharmacists, whether the generic product is appropriate for
them.
 
 
PRIOR LEGISLATIVE HISTORY:
 
A.8057-A, 2013 referred to health and 2014 held for consideration in
ways and means. Same as S.6739-A, 2014 referred to health.
 
 
FISCAL IMPLICATIONS:
 
None.
 
 
EFFECTIVE DATE:
This act shall take effect on the ninetieth day after it shall have
become a law.

A00145 Text:

 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         145--A
 
                               2015-2016 Regular Sessions
 
                   IN ASSEMBLY
 
                                       (Prefiled)
 
                                     January 7, 2015
                                       ___________
 
        Introduced  by  M.  of  A.  PAULIN,  GOTTFRIED, DINOWITZ, GALEF, HOOPER,
          JAFFEE, MARKEY, MILLER, RIVERA, WEPRIN -- read once  and  referred  to
          the  Committee  on Health -- recommitted to the Committee on Health in
          accordance with Assembly Rule 3, sec. 2 -- committee discharged,  bill
          amended,  ordered reprinted as amended and recommitted to said commit-
          tee
 
        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-b to
     4  read as follows:
     5    §  280-b.  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  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-
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD00283-03-6
        A. 145--A                           2
 
     1  istration has identified as having an actual or potential bioequivalence
     2  problem.
     3    2.  The manufacturer of a generic drug product shall make available to
     4  the department the  biopharmaceutic  studies  and  summaries,  including
     5  bioequivalence  data  and  incidence  of  adverse events, and associated
     6  analytical methods, including dissolution data and test methods provided
     7  to the Federal Food and Drug Administration as part of  the  application
     8  for  such  generic drug product. The department shall make such informa-
     9  tion freely and publicly available on its website.
    10    § 3. Paragraphs (a) and (d) of subdivision 6 of section  6810  of  the
    11  education  law,  paragraph  (a) as amended by chapter 590 of the laws of
    12  2011 and paragraph (d) as added by chapter 913 of the laws of 1986,  are
    13  amended to read as follows:
    14    (a) Every prescription written in this state by a person authorized to
    15  issue  such  prescription  shall be on prescription forms containing one
    16  line for the prescriber's signature. The  prescriber's  signature  shall
    17  validate  the  prescription. Every electronic prescription shall provide
    18  for the prescriber's electronic  signature,  which  shall  validate  the
    19  electronic  prescription.  Imprinted conspicuously on every prescription
    20  written in this state in eight point upper case type  immediately  below
    21  the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED
    22  GENERICALLY  UNLESS  PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless
    23  the prescriber writes d a w in such box in the  prescriber's  own  hand-
    24  writing  or,  in  the case of electronic prescriptions, inserts an elec-
    25  tronic direction to dispense  the  drug  as  written,  the  prescriber's
    26  signature  or  electronic  signature shall designate approval of substi-
    27  tution by a pharmacist of a generic drug product pursuant to  [paragraph
    28  (o)  of subdivision one of] section [two hundred six] two hundred eight-
    29  y-b of the public health law.  No other letters or  marks  in  such  box
    30  shall  prohibit  substitution. No prescription forms used or intended to
    31  be used by a person authorized to issue a prescription shall have  'd  a
    32  w'  preprinted  in such box. Such box shall be placed directly under the
    33  signature line and shall be three-quarters inch in length  and  one-half
    34  inch  in height, or in comparable form for an electronic prescription as
    35  may be specified by regulation of the  commissioner.  Immediately  below
    36  such  box  shall  be  imprinted in six point type the words "Dispense As
    37  Written".  Notwithstanding any other provision of law,  no  state  offi-
    38  cial,  agency,  board or other entity shall promulgate any regulation or
    39  guideline modifying those elements of the prescription  form's  contents
    40  specified in this subdivision. To the extent otherwise permitted by law,
    41  a  prescriber  may modify only those elements of the prescription form's
    42  contents not specified in this subdivision.  Notwithstanding  any  other
    43  provision  of  this section or any other law, when a generic drug is not
    44  available and the brand name drug originally prescribed is available and
    45  the pharmacist agrees to dispense the brand name  product  for  a  price
    46  that  will  not  exceed  the  price that would have been charged for the
    47  generic substitute had it been available, substitution of a generic drug
    48  product will not be required. If the generic drug product is not  avail-
    49  able  and  a  medical  emergency  situation,  which for purposes of this
    50  section is defined as any condition requiring alleviation of severe pain
    51  or which threatens to cause disability or  take  life  if  not  promptly
    52  treated, exists, then the pharmacist may dispense the brand name product
    53  at  his  regular price. In such instances the pharmacist must record the
    54  date, hour and nature of the  medical  emergency  on  the  back  of  the
    55  prescription and keep a copy of all such prescriptions.
        A. 145--A                           3
 
     1    (d) No prescriber shall be subjected to civil liability arising solely
     2  from  authorizing, in accordance with this subdivision, the substitution
     3  by a pharmacist of a generic drug product pursuant to [paragraph (o)  of
     4  subdivision  one  of]  section [two hundred six] two hundred eighty-b of
     5  the public health law.
     6    § 4. Paragraph (b) of subdivision 1 of section 6816-a of the education
     7  law,  as added by chapter 776 of the laws of 1977, is amended to read as
     8  follows:
     9    (b) The substituted drug product is contained in the list  of  generic
    10  drug  products established pursuant to [paragraph (o) of subdivision one
    11  of] section [two hundred six] two hundred eighty-b of the public  health
    12  law; and
    13    §  5.  This  act shall take effect on the ninetieth day after it shall
    14  have become a law. Effective immediately, the addition, amendment and/or
    15  repeal of any rule or regulation necessary  for  the  implementation  of
    16  this act on its effective date is authorized to be made and completed on
    17  or before such effective date.