What's happening
This bill allows pharmacists to substitute FDA-approved interchangeable biological products for prescribed biologics, with specific conditions and prescriber notification requirements.
Why it matters
Expands patient access to lower-cost therapies. By allowing pharmacists to substitute FDA-approved interchangeable biological products (biosimilars), patients may benefit from more affordable treatment options without sacrificing efficacy or safety.
Enhances transparency and safety in prescribing. The bill requires pharmacists to notify prescribers within five business days of any substitution, ensuring that doctors remain informed about exactly which product their patient receives, which could be critical in tracking outcomes or managing adverse effects.
Defines clear conditions and limitations. Substitution is only permitted if the FDA has designated the biosimilar as interchangeable, the prescriber has not expressly prohibited substitution, and the pharmacist properly labels the dispensed product. This balances cost savings with prescriber and patient choice.
Supports informed healthcare decisions. The law mandates that the state maintain an up-to-date online list of interchangeable biological products, empowering both healthcare providers and patients with current information about available alternatives.
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Who cares
Pharmacists and pharmacies
The bill would require lower-cost biological product substitution when specified conditions are met, with labeling requirements and notice to prescribers within five business days, subject to exceptions.
Biologic prescribers
Prescribers could prohibit substitution and would have to inform patients whether they prescribed a brand-name product or an interchangeable biological product.
Patients prescribed biological products
Patients could receive less expensive interchangeable products, with provisions allowing the prescribed product to be dispensed when a substitute is unavailable.
New York State Education Department
The department would have to maintain a website link to the FDA’s current list of interchangeable biological products.
Headline styles
Allow Cheaper Biologic Substitutions
Plain English, a few words. Used as the page title.
Sponsors
History
- Substituted by A7509A
- Ordered to third reading cal.2161
- Committee discharged and committed to rules
- Print number 4788a
- Amend (t) and recommit to higher education
- Referred to higher education
Companion bill
The same bill in the other chamber. A bill becomes law when one version passes both houses and the governor signs it, so either number can carry it.
Allow Swapping Biologic Drugs
Signed by Governor · Sponsor Richard Gottfried
Full text
3 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
4788--A
2017-2018 Regular Sessions
IN SENATE
March 1, 2017
Introduced by Sens. HANNON, DeFRANCISCO, GRIFFO, HELMING, LATIMER, VALE- SKY -- read twice and ordered printed, and when printed to be committed to the Committee on Higher Education -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee
AN ACT to amend the education law and the public health law, in relation to the substitution of interchangeable biological products for prescribed products; and providing for the expiration of such provisions
The People of the State of New York, represented in Senate and Assembly, do enact as follows:
Section 1. Section 6802 of the education law is amended by adding two new subdivisions 27 and 28 to read as follows:
27. "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).
28. "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) as set forth in the latest edition or supplement of the United States Food and Drug Administration Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, sometimes referred to as the "Purple Book," or a biological product determined by the United States Food and Drug Administration to be therapeutically equivalent as set forth in the latest edition or supplement of the United States Food and Drug Administration Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as the "Orange Book."
§ 2. Paragraphs (b), (c) and (d) of subdivision 6 of section 6810 of the education law, paragraph (b) as amended and paragraph (d) as added by chapter 913 of the laws of 1986, paragraph (c) as added by chapter 776 of the laws of 1977, are amended to read as follows:
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD02608-03-7
S. 4788--A 2
(b) 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 interchangeable 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 emergency 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 his 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.
(c) The prescriber shall inform the patient whether he or she has prescribed a brand name or its generic equivalent drug product or interchangeable biological product.
[(c)] (d) The provisions of this subdivision shall not apply to a hospital as defined in article twenty-eight of the public health law.
[(d)] (e) 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 subdivision one of section two hundred six of the public health law.
§ 3. Section 6816-a of the education law is amended by adding three new subdivisions 3, 4 and 5 to read as follows:
3. A pharmacist shall substitute a less expensive biological product for a prescribed biological product provided that all of the following conditions are met:
(a) the substituted biological product is either an interchangeable biological product for the prescribed product or the substituted biological product is one for which the prescribed product is an interchangeable biological product;
(b) the prescriber does not designate that a substitution is prohibited as described in subdivision six of section sixty-eight hundred ten of this article; 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 prescriber specifically states otherwise.
4. (a) Within five business days following the dispensing of a substituted biological 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 to the prescriber (i) by making an entry that is electronically accessible to the prescriber through an interoperable electronic medical records system, an electronic prescribing technology or a pharmacy record; or (ii) by using facsimile, electronic transmission or other electronic means. If an electronic means described in this paragraph is not available to the pharmacist at the time of communication, the dispensing pharmacist or the pharmacist's designee may communicate the information by telephone.
(b) Communication under paragraph (a) of this subdivision shall not be required where:
(i) there is no FDA-approved interchangeable biological product for the product prescribed; or
S. 4788--A 3
(ii) a refill prescription is not changed from the product dispensed on the prior filling of the prescription.
5. 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 specific biological product.
§ 4. Subparagraph 2 of paragraph (o) of subdivision 1 of section 206 of the public health law, as amended by chapter 913 of the laws of 1986, is amended to read as follows:
(2) The commissioner of the Federal Food and Drug Administration has evaluated such drug product as:
(i) pharmaceutically and therapeutically equivalent and has listed such drug product on the list of approved drugs products with the therapeutic equivalence evaluations, provided, however, that the list prepared by the commissioner shall not include any drug product which the commissioner of the Federal Food and Drug Administration has identified as having an actual or potential bioequivalence problem; or
(ii) as an interchangeable biological product and has listed such product on the list of approved drug products with interchangeability.
§ 5. This act shall take effect immediately and shall expire five years after having become a law.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
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; and providing for the expiration of such provisions
Purpose
This bill would establish requirements for pharmacies to substitute and dispense biological products.
Summary of provisions
Section 1 amends section 6802 of the education 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.
Sections 2 and 3 amend sections 6810 and 6816-a of the education law to extend 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 4 makes conforming amendments to section 206 of the public health law.
Section 5 provides for an 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
Similar to S6311 of 2016
Fiscal implications
None
Effective date
Immediately, provided that it shall expire five years after having become a law.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.