What's happening
This bill creates a new process and list for generic drug product approvals and public information in New York State law.
Why it matters
Creates a transparent, state-managed list of generic drugs. The bill requires the NYS Health Commissioner to publish an official list of generic drugs that have been approved by the FDA for safety, effectiveness, and therapeutic equivalence, but excludes any with known or potential bioequivalence problems. This provides prescribers, pharmacists, and the public with a clear, trusted resource for generic drug options.
Requires public access to key scientific data. Manufacturers must submit to the state detailed biopharmaceutic studies, including bioequivalence and adverse event data, as provided to the FDA. The Department of Health must make this information freely available online, allowing patients, providers, and researchers to scrutinize the safety and quality of generics dispensed in New York.
Standardizes and clarifies prescription and substitution rules. The bill updates language in prescription law to align with the new generic drug list and ensures prescribers are not held civilly liable for authorizing generic substitution according to the new process. It also maintains patient and provider choice by specifying when substitution can or cannot occur, such as in medical emergencies or when generics are unavailable.
Aims to improve drug choice, trust, and cost control. By formalizing the process and transparency around which generics can be substituted and why, the bill may increase confidence in generic drugs, potentially lower costs for consumers and the state, and reduce confusion or disputes between pharmacists, prescribers, and patients about drug substitutions.
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Who cares
Headline styles
Publish Generic Drug List
Plain English, a few words. Used as the page title.
Sponsors
1 Co-sponsor
History
- Print number 5471a
- Amend and recommit to health
- Referred to health
- Referred to health
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.
List All Generic Drugs
In Senate Committee · Health · Sponsor Amy Paulin
Full text
3 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
5471--A
2017-2018 Regular Sessions
IN SENATE
March 30, 2017
Introduced by Sen. LANZA -- read twice and ordered printed, and when printed to be committed to the Committee on Health -- recommitted to the Committee on Health in accordance with Senate Rule 6, sec. 8 -committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee
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
The People of the State of New York, represented in Senate and Assembly, do enact as follows:
Section 1. Paragraph (o) of subdivision 1 of section 206 of the public health law is REPEALED.
§ 2. The public health law is amended by adding a new section 280-c to read as follows:
§ 280-c. Generic drug products. 1. The commissioner shall establish and publish a list of drug products, referred to in this section as "generic drug" products, each of which shall meet the following conditions:
(a) The drug product has been certified or approved by the commissioner of the Federal Food and Drug Administration as being safe and effective for its labeled indications for use, and a new-drug application or an abbreviated new-drug application approved pursuant to the Federal Food, Drug, and Cosmetic Act is held for such drug product; and
(b) The commissioner of the Federal Food and Drug Administration has evaluated such drug product as pharmaceutically and therapeutically equivalent and has listed such drug product on the list of approved drug 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.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD01072-03-8
S. 5471--A 2
2. The manufacturer of a generic drug product shall make available to the department the biopharmaceutic studies and summaries, including bioequivalence data and incidence of adverse events, and associated analytical methods, including dissolution data and test methods provided to the Federal Food and Drug Administration as part of the application for such generic drug product. The department shall make such information freely and publicly available on its website.
§ 3. Paragraphs (a) and (e) of subdivision 6 of section 6810 of the education law, paragraph (a) as amended by chapter 590 of the laws of 2011 and paragraph (e) as amended by chapter 357 of the laws of 2017, are amended to read as follows:
(a) Every prescription written in this state by a person authorized to issue such prescription shall be on prescription forms containing one line for the prescriber's signature. The prescriber's signature shall validate the prescription. Every electronic prescription shall provide for the prescriber's electronic signature, which shall validate the electronic prescription. Imprinted conspicuously on every prescription written in this state in eight point upper case type immediately below the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless the prescriber writes d a w in such box in the prescriber's own handwriting or, in the case of electronic prescriptions, inserts an electronic direction to dispense the drug as written, the prescriber's signature or electronic signature shall designate approval of substitution by a pharmacist of a generic drug product pursuant to [paragraph (o) of subdivision one of] section [two hundred six] two hundred eighty-c of the public health law. No other letters or marks in such box shall prohibit substitution. No prescription forms used or intended to be used by a person authorized to issue a prescription shall have 'd a w' preprinted in such box. Such box shall be placed directly under the signature line and shall be three-quarters inch in length and one-half inch in height, or in comparable form for an electronic prescription as may be specified by regulation of the commissioner. Immediately below such box shall be imprinted in six point type the words "Dispense As Written". Notwithstanding any other provision of law, no state official, agency, board or other entity shall promulgate any regulation or guideline modifying those elements of the prescription form's contents specified in this subdivision. To the extent otherwise permitted by law, a prescriber may modify only those elements of the prescription form's contents not specified in this subdivision. Notwithstanding any other provision of this section or any other law, when a generic drug is not available and the brand name drug originally prescribed is available and the pharmacist agrees to dispense the brand name product for a price that will not exceed the price that would have been charged for the generic substitute had it been available, substitution of a generic drug product will not be required. If the generic drug 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 brand name 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.
(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 generic drug product pursuant to [paragraph (o) of
S. 5471--A 3
subdivision one of] section two hundred [six] eighty-c of the public health law.
§ 4. Paragraph (d) of subdivision 6 of section 6810 of the education law, as added by chapter 913 of the laws of 1986, is amended to read as follows:
(d) No prescriber shall be subjected to civil liability arising solely from authorizing, in accordance with this subdivision, the substitution by a pharmacist of a generic drug product pursuant to [paragraph (o) of subdivision one of] section two hundred [six] eighty-c of the public health law.
§ 5. Paragraph (b) of subdivision 1 of section 6816-a of the education law, as added by chapter 776 of the laws of 1977, is amended to read as follows:
(b) The substituted drug product is contained in the list of generic drug products established pursuant to [paragraph (o) of subdivision one of] section [two hundred six] two hundred eighty-c of the public health law; and
§ 6. This act shall take effect on the ninetieth day after it shall have become a law; provided that the amendments to paragraph (e) of subdivision 6 of section 6810 of the education law, made by section three of this act, shall not affect the expiration of such paragraph, when upon such date the provisions of section four of this act shall take effect. Effective immediately, the addition, amendment and/or repeal of any rule or regulation necessary for the implementation of this act on its effective date is authorized to be made and completed on or before such effective date.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
Title of bill
An act to amend the public health law and the educa- tion 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).
Read the full memo (925 words)
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 biopharmaceutic studies and summaries (including bioequivalence 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 information 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 differ- ences between brand and generic drugs are and decide, with their physi- cians and pharmacists, whether the generic product is appropriate for them.
Prior legislative history
2017: S.5471 - 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 Calendar 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 become a law.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.