NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A8648A
SPONSOR: Gottfried TITLE OF BILL:
An act to amend the education law and the public health law, in relation
to the substitution of interchangeable biological products for
prescribed products
PURPOSE:
This bill would establish requirements for pharmacies to substitute and
dispense biological products.
SUMMARY OF PROVISIONS:
The bill amends section 6802 of the Education law to add the definitions
of biological product and interchangeable biologic product. The bill
amends 6810 and 6816 of the education law to set forth the conditions
under which the substitution of a biologic product is required; provides
for the appropriate method of communication by the pharmacist to the
prescriber notifying the prescriber of the substitution of the biologic
product dispensed, and makes conforming amendment to section 206 of the
public health law.
JUSTIFICATION:
Biologic products represent the cutting edge of medical science and
research. They successfully treat patients with difficult to treat
diseases including cancer, heart disease, arthritis, multiple sclerosis,
HIV/AIDS, among others. Biologics are often used to treat patients with
complex chronic disease and/or critically ill patients that have not
been responsive to traditional medical treatments alone.
There are currently more than 200 FDA approved biologic therapies,
including some of the most innovative new treatments for patients
suffering from debilitating diseases and conditions. While New York
State law governs the substitution by pharmacists of generic drugs for
their branded counterparts, the existing law has not been updated to
allow for the substitution of biologic products with FDA approved inter-
changeable biologics. This bill will update the law to reflect the grow-
ing market of biologic products and increased availability of biosimilar
products that are designated as interchangeable by the FDA. Without this
change to current law, automatic substitution of biologic products will
be prohibited.
LEGISLATIVE HISTORY:
None
FISCAL IMPLICATIONS:
None.
EFFECTIVE DATE:
Immediately
