NY State Senate Bill 2015-S6311

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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Date of Action	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 06, 2016	referred to health

co-Sponsors

2015-S6311 (ACTIVE) - Details

Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §279-a, Pub Health L

2015-S6311 (ACTIVE) - Summary

Relates to interchangeable biological products; enacts provisions relating to substitutions of biological products by pharmacists.

2015-S6311 (ACTIVE) - Sponsor Memo

                                 BILL NUMBER:  S6311

 TITLE OF BILL :

An act to amend 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 :

Section 1 adds section 279-a of the public health law to add the
definition of biological product as defined in subsection (i) of
section 351 of the Public Health Service Act 42 U.S.C. Section 262(i);
and adds the definition of interchangeable biologic product as defined
pursuant to 42 U.S.C. Section 262(k)(4) or as determined by the FDA to
be therapeutically equivalent.

The bill also extends notification to the patient by the prescriber
regarding the product prescribed to include an interchangeable
biological product, as is existing practice with a brand name or its
generic equivalent drug product and suspends the requirement that a
pharmacist substitute a biologic product when an interchangeable

biological substitute is not available; makes technical changes
necessary to reflect the substitution of an interchangeable biological
product; sets 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;
requires the Department of Health to maintain a link on its web site
to the current list of all biological products determined by the
Federal Food and Drug Administration to be an interchangeable
biological product for a specific biological product.

Section 2 provides for an immediate effective date.

 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
interchangeable biologics. This bill will update the law to reflect
the growing 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.

 PRIOR LEGISLATIVE HISTORY :

None

 FISCAL IMPLICATIONS :

None

 EFFECTIVE DATE :
Immediately.

2015-S6311 (ACTIVE) - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  6311

                            I N  S E N A T E

                               (PREFILED)

                             January 6, 2016
                               ___________

Introduced  by  Sen.  HANNON -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health

AN ACT to amend the public health law, in relation to  the  substitution
  of interchangeable biological products for prescribed products

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. The public health law is amended by adding  a  new  section
279-a to read as follows:
  S  279-A.  INTERCHANGEABLE  BIOLOGICAL  PRODUCTS.  1.  AS USED IN THIS
SECTION:
  (A) "BIOLOGICAL PRODUCT" MEANS A  BIOLOGICAL  PRODUCT  AS  DEFINED  IN
SUBSECTION (I) OF SECTION 351 OF THE PUBLIC HEALTH SERVICE ACT 42 U.S.C.
SECTION 262(I).
  (B)  "INTERCHANGEABLE  BIOLOGICAL  PRODUCT" MEANS A BIOLOGICAL PRODUCT
LICENSED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION  PURSUANT  TO
42  U.S.C.   SECTION 262(K)(4) OR A BIOLOGICAL PRODUCT DETERMINED BY THE
UNITED STATES FOOD AND DRUG ADMINISTRATION TO BE THERAPEUTICALLY  EQUIV-
ALENT  AS  SET  FORTH  IN THE LATEST EDITION OR SUPPLEMENT OF THE UNITED
STATES FOOD AND DRUG ADMINISTRATION APPROVED DRUG PRODUCTS  WITH  THERA-
PEUTIC  EQUIVALENCE  EVALUATIONS,  SOMETIMES  REFERRED TO AS THE "ORANGE
BOOK."
  2. A PHARMACIST SHALL SUBSTITUTE A BIOLOGICAL PRODUCT FOR A PRESCRIBED
BIOLOGICAL PRODUCT ONLY IF ALL OF THE FOLLOWING CONDITIONS ARE MET:
  (A) THE BIOLOGICAL PRODUCT HAS BEEN DETERMINED BY  THE  UNITED  STATES
FOOD  AND  DRUG ADMINISTRATION TO BE INTERCHANGEABLE WITH THE PRESCRIBED
PRODUCT;
  (B) THE PRESCRIBER DOES NOT DESIGNATE THAT A SUBSTITUTION IS PROHIBIT-
ED AS DESCRIBED IN SUBDIVISION SIX OF SECTION SIXTY-EIGHT HUNDRED TEN OF
THE EDUCATION LAW; AND
  (C) THE PHARMACIST INDICATES ON THE LABEL  AFFIXED  TO  THE  IMMEDIATE
CONTAINER  IN  WHICH  THE  BIOLOGICAL PRODUCT IS SOLD OR DISTRIBUTED THE
NAME AND STRENGTH OF THE PRODUCT AND ITS MANUFACTURER UNLESS  THE  PRES-
CRIBER  SPECIFICALLY STATES OTHERWISE, AND THE PHARMACIST RECORDS ON THE

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets

                      [ ] is old law to be omitted.
                                                           LBD13220-02-5

S. 6311                             2

PRESCRIPTION FORM THE BRAND NAME OR THE NAME OF THE MANUFACTURER OF  THE
DRUG PRODUCT DISPENSED.
  3.  NOTWITHSTANDING  ANY  OTHER PROVISION OF THIS SECTION OR ANY OTHER
LAW, WHEN AN INTERCHANGEABLE BIOLOGICAL PRODUCT IS NOT AVAILABLE AND THE
BIOLOGICAL PRODUCT ORIGINALLY PRESCRIBED IS AVAILABLE AND THE PHARMACIST
AGREES TO DISPENSE THE PRESCRIBED BIOLOGICAL PRODUCT FOR  A  PRICE  THAT
WILL  NOT  EXCEED  THE PRICE THAT WOULD HAVE BEEN CHARGED FOR THE INTER-
CHANGEABLE BIOLOGICAL SUBSTITUTE HAD IT BEEN AVAILABLE, SUBSTITUTION  OF
AN  INTERCHANGEABLE  BIOLOGICAL  PRODUCT  WILL  NOT  BE REQUIRED. IF THE
INTERCHANGEABLE BIOLOGICAL PRODUCT IS NOT AVAILABLE AND A MEDICAL  EMER-
GENCY  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 PRESCRIBED BIOLOGICAL PRODUCT AT THE 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.
  4.  THE  PRESCRIBER  SHALL  INFORM  THE  PATIENT WHETHER HE OR SHE HAS
PRESCRIBED A SPECIFIC BIOLOGICAL PRODUCT OR  INTERCHANGEABLE  BIOLOGICAL
PRODUCT.
  5. THE PROVISIONS OF THIS SUBDIVISION SHALL NOT APPLY TO A HOSPITAL AS
DEFINED IN ARTICLE TWENTY-EIGHT OF THIS CHAPTER.
  6.  NO PRESCRIBER SHALL BE SUBJECTED TO CIVIL LIABILITY ARISING SOLELY
FROM AUTHORIZING, IN ACCORDANCE WITH THIS SUBDIVISION, THE  SUBSTITUTION
BY  A PHARMACIST OF A DRUG PRODUCT PURSUANT TO PARAGRAPH (O) OF SUBDIVI-
SION ONE OF SECTION TWO HUNDRED SIX OF THIS CHAPTER.
  7. (A) WITHIN FIVE BUSINESS DAYS FOLLOWING THE DISPENSING OF A BIOLOG-
ICAL PRODUCT, THE DISPENSING PHARMACIST  OR  THE  PHARMACIST'S  DESIGNEE
SHALL COMMUNICATE TO THE PRESCRIBER THE SPECIFIC PRODUCT PROVIDED TO THE
PATIENT,  INCLUDING  THE  NAME  OF THE PRODUCT AND THE MANUFACTURER. THE
COMMUNICATION SHALL BE CONVEYED (I) BY MAKING AN ENTRY THAT IS ELECTRON-
ICALLY ACCESSIBLE TO THE PRESCRIBER THROUGH AN INTEROPERABLE  ELECTRONIC
MEDICAL  RECORDS SYSTEM, AN ELECTRONIC PRESCRIBING TECHNOLOGY OR A PHAR-
MACY RECORD; OR (II) BY USING FACSIMILE,  TELEPHONE,  ELECTRONIC  TRANS-
MISSION, OR OTHER PREVAILING MEANS.
  (B) COMMUNICATION UNDER PARAGRAPH (A) OF THIS SUBDIVISION SHALL NOT BE
REQUIRED WHERE:
  (I)  THERE IS NO FDA-APPROVED INTERCHANGEABLE BIOLOGIC FOR THE PRODUCT
PRESCRIBED; OR
  (II) A REFILL PRESCRIPTION IS NOT CHANGED FROM THE  PRODUCT  DISPENSED
ON THE PRIOR FILLING OF THE PRESCRIPTION.
  8. THE DEPARTMENT SHALL MAINTAIN A LINK ON ITS WEB SITE TO THE CURRENT
LIST  OF ALL BIOLOGICAL PRODUCTS DETERMINED BY THE FEDERAL FOOD AND DRUG
ADMINISTRATION TO BE AN INTERCHANGEABLE BIOLOGICAL PRODUCT FOR A SPECIF-
IC BIOLOGICAL PRODUCT.
  S 2. This act shall take effect immediately.

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Senate Bill S6311

Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee

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co-Sponsors

2015-S6311 (ACTIVE) - Details

2015-S6311 (ACTIVE) - Summary

2015-S6311 (ACTIVE) - Sponsor Memo

2015-S6311 (ACTIVE) - Bill Text download pdf

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Sponsored By

Kemp Hannon

Archive: Last Bill Status - In Senate Committee Health Committee

Actions

co-Sponsors

Tony Avella

Andrew J. Lanza

George Latimer

2015-S6311 (ACTIVE) - Details

2015-S6311 (ACTIVE) - Summary

2015-S6311 (ACTIVE) - Sponsor Memo

2015-S6311 (ACTIVE) - Bill Text download pdf

Comments