A00145 Summary:
| BILL NO | A00145A |
| SAME AS | SAME AS S05099-A |
| SPONSOR | Paulin |
| COSPNSR | Gottfried, Dinowitz, Galef, Hooper, Jaffee, Markey, Miller, Rivera, Weprin, Abinanti |
| MLTSPNSR | |
| Rpld §206 sub 1 ¶(o), add §280-a, Pub Health L; amd §§6810 & 6816-a, Ed L | |
| Requires the commissioner of health to establish and publish a list of generic drug products. | |
A00145 Memo:
Go to topNEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
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). Section two adds a new section 280-b, 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included in subdivision one are taken from para- graph (o) of subdivision one of section 205 of the PHL, which has been repealed.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-b) 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 manufacturers provide to the FDA is not publicly available. For most generic drugs, consumers can access such information only by going through a foLmal FOIL request. This proc- ess 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: A.8057-A, 2013 referred to health and 2014 held for consideration in ways and means. Same as S.6739-A, 2014 referred to health. FISCAL IMPLICATIONS: None. EFFECTIVE DATE: This act shall take effect on the ninetieth day after it shall have become a law.
A00145 Text:
Go to topSTATE OF NEW YORK ________________________________________________________________________ 145--A 2015-2016 Regular Sessions IN ASSEMBLY (Prefiled) January 7, 2015 ___________ Introduced by M. of A. PAULIN, GOTTFRIED, DINOWITZ, GALEF, HOOPER, JAFFEE, MARKEY, MILLER, RIVERA, WEPRIN -- read once and referred to the Committee on Health -- recommitted to the Committee on Health in accordance with Assembly Rule 3, sec. 2 -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said commit- tee 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 Assem- bly, do enact as follows: 1 Section 1. Paragraph (o) of subdivision 1 of section 206 of the public 2 health law is REPEALED. 3 § 2. The public health law is amended by adding a new section 280-b to 4 read as follows: 5 § 280-b. Generic drug products. 1. The commissioner shall establish 6 and publish a list of drug products, referred to in this section as 7 "generic drug" products, each of which shall meet the following condi- 8 tions: 9 (a) The drug product has been certified or approved by the commission- 10 er of the Federal Food and Drug Administration as being safe and effec- 11 tive for its labeled indications for use, and a new-drug application or 12 an abbreviated new-drug application approved pursuant to the Federal 13 Food, Drug, and Cosmetic Act is held for such drug product; and 14 (b) The commissioner of the Federal Food and Drug Administration has 15 evaluated such drug product as pharmaceutically and therapeutically 16 equivalent and has listed such drug product on the list of approved drug 17 products with the therapeutic equivalence evaluations, provided, howev- 18 er, that the list prepared by the commissioner shall not include any 19 drug product which the commissioner of the Federal Food and Drug Admin- EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD00283-03-6A. 145--A 2 1 istration has identified as having an actual or potential bioequivalence 2 problem. 3 2. The manufacturer of a generic drug product shall make available to 4 the department the biopharmaceutic studies and summaries, including 5 bioequivalence data and incidence of adverse events, and associated 6 analytical methods, including dissolution data and test methods provided 7 to the Federal Food and Drug Administration as part of the application 8 for such generic drug product. The department shall make such informa- 9 tion freely and publicly available on its website. 10 § 3. Paragraphs (a) and (d) of subdivision 6 of section 6810 of the 11 education law, paragraph (a) as amended by chapter 590 of the laws of 12 2011 and paragraph (d) as added by chapter 913 of the laws of 1986, are 13 amended to read as follows: 14 (a) Every prescription written in this state by a person authorized to 15 issue such prescription shall be on prescription forms containing one 16 line for the prescriber's signature. The prescriber's signature shall 17 validate the prescription. Every electronic prescription shall provide 18 for the prescriber's electronic signature, which shall validate the 19 electronic prescription. Imprinted conspicuously on every prescription 20 written in this state in eight point upper case type immediately below 21 the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED 22 GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless 23 the prescriber writes d a w in such box in the prescriber's own hand- 24 writing or, in the case of electronic prescriptions, inserts an elec- 25 tronic direction to dispense the drug as written, the prescriber's 26 signature or electronic signature shall designate approval of substi- 27 tution by a pharmacist of a generic drug product pursuant to [paragraph28(o) of subdivision one of] section [two hundred six] two hundred eight- 29 y-b of the public health law. No other letters or marks in such box 30 shall prohibit substitution. No prescription forms used or intended to 31 be used by a person authorized to issue a prescription shall have 'd a 32 w' preprinted in such box. Such box shall be placed directly under the 33 signature line and shall be three-quarters inch in length and one-half 34 inch in height, or in comparable form for an electronic prescription as 35 may be specified by regulation of the commissioner. Immediately below 36 such box shall be imprinted in six point type the words "Dispense As 37 Written". Notwithstanding any other provision of law, no state offi- 38 cial, agency, board or other entity shall promulgate any regulation or 39 guideline modifying those elements of the prescription form's contents 40 specified in this subdivision. To the extent otherwise permitted by law, 41 a prescriber may modify only those elements of the prescription form's 42 contents not specified in this subdivision. Notwithstanding any other 43 provision of this section or any other law, when a generic drug is not 44 available and the brand name drug originally prescribed is available and 45 the pharmacist agrees to dispense the brand name product for a price 46 that will not exceed the price that would have been charged for the 47 generic substitute had it been available, substitution of a generic drug 48 product will not be required. If the generic drug product is not avail- 49 able and a medical emergency situation, which for purposes of this 50 section is defined as any condition requiring alleviation of severe pain 51 or which threatens to cause disability or take life if not promptly 52 treated, exists, then the pharmacist may dispense the brand name product 53 at his regular price. In such instances the pharmacist must record the 54 date, hour and nature of the medical emergency on the back of the 55 prescription and keep a copy of all such prescriptions.A. 145--A 3 1 (d) No prescriber shall be subjected to civil liability arising solely 2 from authorizing, in accordance with this subdivision, the substitution 3 by a pharmacist of a generic drug product pursuant to [paragraph (o) of4subdivision one of] section [two hundred six] two hundred eighty-b of 5 the public health law. 6 § 4. Paragraph (b) of subdivision 1 of section 6816-a of the education 7 law, as added by chapter 776 of the laws of 1977, is amended to read as 8 follows: 9 (b) The substituted drug product is contained in the list of generic 10 drug products established pursuant to [paragraph (o) of subdivision one11of] section [two hundred six] two hundred eighty-b of the public health 12 law; and 13 § 5. This act shall take effect on the ninetieth day after it shall 14 have become a law. Effective immediately, the addition, amendment and/or 15 repeal of any rule or regulation necessary for the implementation of 16 this act on its effective date is authorized to be made and completed on 17 or before such effective date.