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repealed.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.
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.
