BILL NUMBER: S5580
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repealed.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:
2024: S.4181 - Referred to Health / A.144 - Referred to Health
2023: S.4181 - Referred to Health / A.144 - Reported to Ways & Means
2022: S.5158 - Referred to Health / A.1923 - Referred to Ways & Means
2021: S.5158 - Referred to Health / A.1923 - Reported to Ways & Means
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

Statutes affected:
S5580: 206 public health law, 206(1) public health law, 6816-a education law, 6816-a(1) education law