Source: https://www.nysenate.gov/legislation/bills/2017/s5471/amendment/original
Timestamp: 2019-03-19 04:21:21
Document Index: 113986720

Matched Legal Cases: ['§206', '§280', '§6810', '§ 2', '§  280', '§  3', '§ 4', '§ 280', '§  3', '§  4', '§ 5']

Requires the commissioner of health to establish and publish a list of generic drug products; repealer
Feb 09, 2018 print number 5471a
Feb 09, 2018 amend and recommit to health
Rpld §206 sub 1 ¶(o), add §280-c, Pub Health L; amd §§6810 & 6816-a, Ed L
2013-2014: S6739, A8057
2015-2016: S5099, A145
2019-2020: S2391, A612
Requires the commissioner of health to establish and publish a list of generic drug products.
BILL NUMBER: S5471               REVISED MEMO 01/24/2018
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
To make relevant information related to generic drugs freely and public-
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repealed.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 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.
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
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
2017: S.5471 - 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 Calendar
2014: S.6739-A - Referred to Health/ A.8057-A - Referred to Ways & Means
2013: A.8057-A - Referred to Health
to generic drug products; and to repeal paragraph (o) of subdivision 1
of section 206 of the public health law relating thereto
Section 1. Paragraph (o) of subdivision 1 of section 206 of the public
§ 2. The public health law is amended by adding a new section 280-c to
§  280-C.  GENERIC  DRUG PRODUCTS. 1. THE COMMISSIONER SHALL ESTABLISH
AND PUBLISH A LIST OF DRUG PRODUCTS, REFERRED  TO  IN  THIS  SECTION  AS
"GENERIC  DRUG"  PRODUCTS, EACH OF WHICH SHALL MEET THE FOLLOWING CONDI-
(A) THE DRUG PRODUCT HAS BEEN CERTIFIED OR APPROVED BY THE COMMISSION-
ER OF THE FEDERAL FOOD AND DRUG ADMINISTRATION AS BEING SAFE AND  EFFEC-
TIVE  FOR ITS LABELED INDICATIONS FOR USE, AND A NEW-DRUG APPLICATION OR
AN ABBREVIATED NEW-DRUG APPLICATION APPROVED  PURSUANT  TO  THE  FEDERAL
FOOD, DRUG, AND COSMETIC ACT IS HELD FOR SUCH DRUG PRODUCT; AND
(B)  THE  COMMISSIONER OF THE FEDERAL FOOD AND DRUG ADMINISTRATION HAS
EVALUATED SUCH DRUG  PRODUCT  AS  PHARMACEUTICALLY  AND  THERAPEUTICALLY
EQUIVALENT AND HAS LISTED SUCH DRUG PRODUCT ON THE LIST OF APPROVED DRUG
PRODUCTS  WITH THE THERAPEUTIC EQUIVALENCE EVALUATIONS, PROVIDED, HOWEV-
ER, THAT THE LIST PREPARED BY THE COMMISSIONER  SHALL  NOT  INCLUDE  ANY
DRUG  PRODUCT WHICH THE COMMISSIONER OF THE FEDERAL FOOD AND DRUG ADMIN-
ISTRATION HAS IDENTIFIED AS HAVING AN ACTUAL OR POTENTIAL BIOEQUIVALENCE
2. THE MANUFACTURER OF A GENERIC DRUG PRODUCT SHALL MAKE AVAILABLE  TO
THE  DEPARTMENT  THE  BIOPHARMACEUTIC  STUDIES  AND SUMMARIES, INCLUDING
BIOEQUIVALENCE DATA AND INCIDENCE  OF  ADVERSE  EVENTS,  AND  ASSOCIATED
LBD01072-02-7
S. 5471                             2
ANALYTICAL METHODS, INCLUDING DISSOLUTION DATA AND TEST METHODS PROVIDED
TO  THE  FEDERAL FOOD AND DRUG ADMINISTRATION AS PART OF THE APPLICATION
FOR SUCH GENERIC DRUG PRODUCT. THE DEPARTMENT SHALL MAKE  SUCH  INFORMA-
TION FREELY AND PUBLICLY AVAILABLE ON ITS WEBSITE.
§  3.  Paragraphs  (a) and (d) of subdivision 6 of section 6810 of the
education law, paragraph (a) as amended by chapter 590 of  the  laws  of
2011  and paragraph (d) as added by chapter 913 of the laws of 1986, are
(a) Every prescription written in this state by a person authorized to
issue such prescription shall be on prescription  forms  containing  one
line  for  the  prescriber's signature. The prescriber's signature shall
validate the prescription. Every electronic prescription  shall  provide
for  the  prescriber's  electronic  signature,  which shall validate the
electronic prescription. Imprinted conspicuously on  every  prescription
written  in  this state in eight point upper case type immediately below
GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX  BELOW".  Unless
the  prescriber  writes  d a w in such box in the prescriber's own hand-
writing or, in the case of electronic prescriptions,  inserts  an  elec-
tronic  direction  to  dispense  the  drug  as written, the prescriber's
signature or electronic signature shall designate  approval  of  substi-
tution  by a pharmacist of a GENERIC drug product pursuant to [paragraph
(o) of subdivision one of] section [two hundred six] TWO HUNDRED  EIGHT-
Y-C  of  the  public health law.   No other letters or marks in such box
shall prohibit substitution. No prescription forms used or  intended  to
be  used  by a person authorized to issue a prescription shall have 'd a
w' preprinted in such box. Such box shall be placed directly  under  the
signature  line  and shall be three-quarters inch in length and one-half
inch in height, or in comparable form for an electronic prescription  as
may  be  specified  by regulation of the commissioner. Immediately below
such box shall be imprinted in six point type  the  words  "Dispense  As
Written".    Notwithstanding  any other provision of law, no state offi-
cial, agency, board or other entity shall promulgate any  regulation  or
guideline  modifying  those elements of the prescription form's contents
specified in this subdivision. To the extent otherwise permitted by law,
a prescriber may modify only those elements of the  prescription  form's
contents  not  specified  in this subdivision. Notwithstanding any other
provision of this section or any other law, when a generic drug  is  not
the  pharmacist  agrees  to  dispense the brand name product for a price
that will not exceed the price that would  have  been  charged  for  the
product  will not be required. If the generic drug product is not avail-
able and a medical emergency  situation,  which  for  purposes  of  this
or  which  threatens  to  cause  disability or take life if not promptly
at his regular price. In such instances the pharmacist must  record  the
date,  hour  and  nature  of  the  medical  emergency on the back of the
(d) No prescriber shall be subjected to civil liability arising solely
from authorizing, in accordance with this subdivision, the  substitution
by  a pharmacist of a GENERIC drug product pursuant to [paragraph (o) of
subdivision one of] section [two hundred six] TWO  HUNDRED  EIGHTY-C  of
S. 5471                             3
§ 4. Paragraph (b) of subdivision 1 of section 6816-a of the education
law,  as added by chapter 776 of the laws of 1977, is amended to read as
(b)  The  substituted drug product is contained in the list of GENERIC
drug products established pursuant to [paragraph (o) of subdivision  one
of]  section [two hundred six] TWO HUNDRED EIGHTY-C of the public health
this act on its effective date is authorized to be made and completed on
S5471A (ACTIVE) - Details
S5471A (ACTIVE) - Summary
S5471A (ACTIVE) - Sponsor Memo
BILL NUMBER: S5471A
Section two adds a new section 280-c, named "generic drug products," to
the generic drug achieved only 75* of the maximum drug concentration
2016: S.5099-A - Referred to Health / A.145-A - Passed Assembly
2015: S.5099-A - Referred to Health / A.145-A - 3rd Reading Calendar
2014: S.6739-A - Referred to Health / A.8057-A - Referred to Ways &
S5471A (ACTIVE) - Bill Text download pdf
5471--A
§ 280-C. GENERIC DRUG PRODUCTS. 1. THE  COMMISSIONER  SHALL  ESTABLISH
AND  PUBLISH  A  LIST  OF  DRUG PRODUCTS, REFERRED TO IN THIS SECTION AS
"GENERIC DRUG" PRODUCTS, EACH OF WHICH SHALL MEET THE  FOLLOWING  CONDI-
ER  OF THE FEDERAL FOOD AND DRUG ADMINISTRATION AS BEING SAFE AND EFFEC-
TIVE FOR ITS LABELED INDICATIONS FOR USE, AND A NEW-DRUG APPLICATION  OR
AN  ABBREVIATED  NEW-DRUG  APPLICATION  APPROVED PURSUANT TO THE FEDERAL
(B) THE COMMISSIONER OF THE FEDERAL FOOD AND DRUG  ADMINISTRATION  HAS
EVALUATED  SUCH  DRUG  PRODUCT  AS  PHARMACEUTICALLY AND THERAPEUTICALLY
PRODUCTS WITH THE THERAPEUTIC EQUIVALENCE EVALUATIONS, PROVIDED,  HOWEV-
ER,  THAT  THE  LIST  PREPARED BY THE COMMISSIONER SHALL NOT INCLUDE ANY
DRUG PRODUCT WHICH THE COMMISSIONER OF THE FEDERAL FOOD AND DRUG  ADMIN-
LBD01072-03-8
S. 5471--A                          2
2.  THE MANUFACTURER OF A GENERIC DRUG PRODUCT SHALL MAKE AVAILABLE TO
THE DEPARTMENT THE  BIOPHARMACEUTIC  STUDIES  AND  SUMMARIES,  INCLUDING
BIOEQUIVALENCE  DATA  AND  INCIDENCE  OF  ADVERSE EVENTS, AND ASSOCIATED
§  3.  Paragraphs  (a) and (e) of subdivision 6 of section 6810 of the
2011  and  paragraph  (e) as amended by chapter 357 of the laws of 2017,
(e) No prescriber shall be subjected to civil liability arising solely
S. 5471--A                          3
subdivision one of] section two hundred [six]  EIGHTY-C  of  the  public
§  4.  Paragraph (d) of subdivision 6 of section 6810 of the education
law, as added by chapter 913 of the laws of 1986, is amended to read  as
from  authorizing, in accordance with this subdivision, the substitution
by a pharmacist of a GENERIC drug product pursuant to [paragraph (o)  of
subdivision  one  of]  section  two hundred [six] EIGHTY-C of the public
§ 5. Paragraph (b) of subdivision 1 of section 6816-a of the education
law, as added by chapter 776 of the laws of 1977, is amended to read  as
have  become  a  law;  provided  that the amendments to paragraph (e) of
subdivision 6 of section 6810 of the  education  law,  made  by  section
three  of  this  act, shall not affect the expiration of such paragraph,
when upon such date the provisions of section four  of  this  act  shall
take  effect.  Effective  immediately,  the  addition,  amendment and/or