NY State Senate Bill 2021-S5158

Senate Bill S5158

2021-2022 Legislative Session

Requires the commissioner of health to establish and publish a list of generic drug products; repealer

download bill text pdf

Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 05, 2022	referred to health
Feb 25, 2021	referred to health

2021-S5158 (ACTIVE) - Details

See Assembly Version of this Bill:: A1923
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Rpld §206 sub 1 ¶(o), add §280-d, Pub Health L; amd §§6810 & 6816-a, Ed L
Versions Introduced in Other Legislative Sessions:: 2013-2014: S6739, A8057
2015-2016: S5099, A145
2017-2018: S5471, A236
2019-2020: S2391, A612
2023-2024: S4181, A144

2021-S5158 (ACTIVE) - Summary

Requires the commissioner of health to establish and publish a list of generic drug products.

2021-S5158 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S5158

SPONSOR: LANZA
 
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repealed.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: S.2391- Referred to Health / A.612-A Referred to Ways and Means

2019: S.2391-A-Print Number 2391A/A.612-A Reported Referred to Ways and
Means

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

2021-S5158 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   5158
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                             February 25, 2021
                                ___________
 
 Introduced  by  Sen.  LANZA  -- read twice and ordered printed, and when
   printed to be committed 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:
 
   Section 1. Paragraph (o) of subdivision 1 of section 206 of the public
 health law is REPEALED.
   § 2. The public health law is amended by adding a new section 280-d to
 read as follows:
   §  280-D.  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-
 TIONS:
   (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: (I) 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
 PROBLEM  OR (II) AS AN INTERCHANGEABLE BIOLOGICAL PRODUCT AND HAS LISTED
 SUCH PRODUCT ON THE LIST OF APPROVED DRUG PRODUCTS WITH INTERCHANGEABIL-
 ITY.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD01823-01-1

 S. 5158                             2
 
   2. THE MANUFACTURER OF A GENERIC DRUG PRODUCT SHALL MAKE AVAILABLE  TO
 THE DEPARTMENT THE STUDIES AND SUMMARIES, INCLUDING BIOEQUIVALENCE DATA,
 THERAPEUTIC EQUIVALENCE DATA, AND INCIDENCE OF ADVERSE EVENTS, AND ASSO-
 CIATED  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 INFORMATION FREELY AND PUBLICLY AVAILABLE ON ITS WEBSITE.
   §  3.  Paragraphs  (a) and (e) of subdivision 6 of section 6810 of the
 education law, paragraph (a) as amended by chapter 590 of  the  laws  of
 2011  and  paragraph  (e) as amended by chapter 357 of the laws of 2017,
 are amended to read as follows:
   (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
 the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED
 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-D  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
 available and the brand name drug originally prescribed is available and
 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
 generic substitute had it been available, substitution of a generic drug
 product  will not be required. If the generic drug product is not avail-
 able and a medical emergency  situation,  which  for  purposes  of  this
 section is defined as any condition requiring alleviation of severe pain
 or  which  threatens  to  cause  disability or take life if not promptly
 treated, exists, then the pharmacist may dispense the brand name product
 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
 prescription and keep a copy of all such prescriptions.
   (e) 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

 S. 5158                             3

 subdivision one of] section two hundred [six]  EIGHTY-D  of  the  public
 health law.
   §  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
 follows:
   (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] EIGHTY-D of the public
 health law.
   § 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
 follows:
   (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-D of the public health
 law; and
   § 6. This act shall take effect on the ninetieth day  after  it  shall
 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
 repeal of any rule or regulation necessary  for  the  implementation  of
 this  act  on its effective date are authorized to be made and completed
 on or before such effective date.

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