NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A5029
SPONSOR: Jacobson TITLE OF BILL:
An act to amend the education law, in relation to the substitution of
brand name epinephrine auto-injectors with alternate epinephrine auto-
injectors for dispensation by pharmacists
PURPOSE OR GENERAL IDEA OF BILL:
This legislation will help to ensure affordable access to epinephrine
SUMMARY OF PROVISIONS:
Section 1 adds a new subdivision 6 to Education Law § 6816-a to author-
ize a pharmacist to substitute an alternate generic epinephrine auto-in-
jector containing the same active ingredients, dosage, form and strength
as the brand name product prescribed, provided: 1 The prescriber does
not indicate that the prescription must be dispensed as written;
2. The alternate epinephrine auto-injector available would cost less;
3. The pharmacist has advised the purchaser of the availability of an
alternate epinephrine auto-injector and obtained consent to dispense the
alternate; and
4. The pharmacist has counseled the patient or person authorized to act
on the patient's behalf on the proper usage and operating features of
the alternate epinephrine auto-injector.
Section 2 sets forth the effective date which is immediately.
JUSTIFICATION:
Epinephrine auto-injectors save lives. After ingesting or being other-
wise exposed to a life-threatening allergen (e.g. nuts, shellfish,
latex), a person who suffers from catastrophic allergies will immediate-
ly experience anaphylaxis and can die within minutes unless they are
injected with epinephrine. There are many auto-injectors that deliver
epinephrine on the market, but EpiPen is practically synonymous with the
device and Mylan Pharmaceutical has come to dominate the market.
In 2007, Mylan acquired EpiPen and spent billions of dollars marketing
it while also increasing the price 600%, bringing the cost to over $600.
Yet, epinephrine auto-injectors only cost around $30 to produce. Less
expensive epinephrine auto-injector alternatives are available. For
example, Impax Laboratorie's Adrenaclick can be purchased for as little
as $140 and CVS has also announced plans for an alternate epinephrine
auto-injector that will sell for a fraction of the price of an EpiPen.
There are other companies and pharmacies which charge about $110 for a
two pack and this not include possible available coupons. However, since
there is technically no generic version of the EpiPen, a pharmacist is
only permitted to dispense a less expensive version if the prescription
is written for an epinephrine auto-injector rather than for EpiPen.
Today, many of those who suffer from catastrophic allergies are still
paying as much as $600 to fill an EpiPen prescription. (A single
prescription usually includes two injectors in case the first injection
proves insufficient and a second injection is required to save a
sufferer's life.) Families of children with catastrophic allergies are
also required to keep a set of two epinephrine auto-injectors with their
school nurse or daycare center, potentially doubling the cost to $1,200,
Epinephrine auto-injectors are the only treatment to reverse the effects
of a catastrophic allergic reaction, making them a life-or-death neces-
sity. And since epinephrine auto-injectors expire and must be replaced
annually, EpiPens are a recurring financial burden to the allergy
sufferer and their family. Even with insurance coverage, theocost can be
prohibitive. On a broader level, all consumers are impacted by increased
insurance premiums and taxpayer dollars spent on EpiPens by EMTs and the
State Medicaid program. As a result of Mylan's marketing efforts, most
prescribers issue prescriptions specifying EpiPens unaware that they
should or could write epinephrine auto-injector instead. Many families
don't realize it either.
While New York generic substitution law permits pharmacists to dispense
a lower cost generic drug for a brand name prescription drug unless the
prescriber writes "dispense as written," questions have arisen about
whether the current law covers epinephrine auto-injectors, which are a
combination drug and a device for administering the drug, or whether an
alternate brand name injector may be substituted where the prescribed
injector is not available.
This bill would authorize a pharmacist to substitute an alternate
epinephrine auto-injector containing the same active ingredients, where:
(1) the prescriber does not indicate that the prescription must be
dispensed as written; (2) the alternate epinephrine auto-injector avail-
able would cost less; (3) the pharmacist has advised the purchaser of
the availability of an alternate epinephrine auto-injector and obtained
consent to dispense the alternate; and (4) The pharmacist has counseled
the patient or person authorized to act on the patient's behalf on the
proper usage and operating features of the alternate epinephrine auto-
injector. 2 In passing this legislation, New York would be joining more
than a dozen states that allow for this substitution. We cannot let a
technicality come betwe en New Yorkers and affordable access to this
life saving medication.
PRIOR LEGISLATIVE HISTORY:
2023-2024: A6988 - Referred to Assembly Higher Education Committee
S4447 - Passed Senate
FISCAL IMPLICATIONS FOR STATE AND LOCAL GOVERNMENTS:
None
EFFECTIVE DATE:
This act shall take effect immediately.
STATE OF NEW YORK
________________________________________________________________________
5029
2025-2026 Regular Sessions
IN ASSEMBLY
February 11, 2025
___________
Introduced by M. of A. JACOBSON -- read once and referred to the Commit-
tee on Higher Education
AN ACT to amend the education law, in relation to the substitution of
brand name epinephrine auto-injectors with alternate epinephrine auto-
injectors for dispensation by pharmacists
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Section 6816-a of the education law is amended by adding a
2 new subdivision 6 to read as follows:
3 6. (a) Notwithstanding subdivision two of this section or any other
4 section of law to the contrary, when a patient is prescribed a brand
5 name epinephrine auto-injector, a pharmacist may substitute an alternate
6 epinephrine auto-injector containing the same active ingredients, dosage
7 form and strength as the brand name product prescribed, ordered or
8 demanded, regardless of whether the alternate epinephrine auto-injector
9 is included in the latest list of interchangeable drug products for the
10 prescribed epinephrine auto-injector device, provided that:
11 (i) the prescriber does not indicate that the prescription therefor
12 shall be dispensed as written pursuant to paragraph (a) of subdivision
13 six of section sixty-eight hundred ten of this article;
14 (ii) the alternate epinephrine auto-injector available would reflect a
15 lower unit cost to the purchaser;
16 (iii) the pharmacist has advised the purchaser of the availability of
17 an alternate epinephrine auto-injector and obtained consent to dispense
18 the alternate epinephrine auto-injector; and
19 (iv) the pharmacist has counseled the patient or person authorized to
20 act on the patient's behalf on the proper usage and operating features
21 of the alternate epinephrine auto-injector.
22 (b) For purposes of this subdivision "epinephrine auto-injector" shall
23 have the same meaning as provided in paragraph (b) of subdivision one of
24 section three thousand-c of the public health law.
25 § 2. This act shall take effect immediately.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD03148-01-5
