Requires the commissioner of health to establish and publish a list of generic drug products.
TITLE OF BILL: 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
PURPOSE OR GENERAL IDEA OF BILL: To make relevant information related to generic drugs freely and publicly 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-a, named "generic drug products", to the PHL. The provisions included in subdivision one are taken from paragraph (o) of subdivision one of section 205 of the PHL, which has been repealed.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 equivalent 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 subdivision 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 Public Health Law) 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-a) 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 208-a) 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 performance 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 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.
In 2008, the FDA declared Teva's Budeprion XL 300 (generic version of the antidepressant Wellbutrin XL 300 mg) as safe and effective. However, consumers started to complain about the generic version of Wellbutrin: after switching to the generic formulation, many reported symptoms such as headaches, irritability, nausea, and return of depression.
In 2012, the FDA announced that the Teva's generic drug is NOT bioequivalent to the brand name drug. The reversal was based on a FDA bioequivalence study which found Budeprion XL 300 achieved only 75%. of the maximum drug concentration attained with Wellbutrin XL 300 mg (potentially explaining the return of depression in patients switched to Budeprion XL 300). Teva's product released much of its drug earlier than Wellbutrin. The dissolution rate greatly affects how a drug is released in the human body. This ultimately affects the drug effectiveness. The new results obtained by the FDA closely matched the results of independent organizations that tested the two drugs for bioequivalence.
The biopharmaceutic studies and summaries, dissolution data, and test methods provided to the FDA by generic drugs producers must be available. 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 differences between brand and generic drugs are and decide, with their physicians and pharmacists, whether the generic product is appropriate for them.
PRIOR LEGISLATIVE HISTORY: This is a new bill.
FISCAL IMPLICATIONS: None to the State.
EFFECTIVE DATE: This act shall take effect on the ninetieth day after it shall have become a law.
STATE OF NEW YORK ________________________________________________________________________ 6739--A IN SENATE March 5, 2014 ___________Introduced by Sen. LANZA -- read twice and ordered printed, and when printed to be committed to the Committee on Health -- 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 ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. Paragraph (o) of subdivision 1 of section 206 of the public health law is REPEALED. S 2. The public health law is amended by adding a new section 280-a to read as follows: S 280-A. 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 CONDI- TIONS: (A) THE DRUG PRODUCT HAS BEEN CERTIFIED OR APPROVED BY THE COMMISSION- ER OF THE FEDERAL FOOD AND DRUG ADMINISTRATION AS BEING SAFE AND EFFEC- TIVE 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, HOWEV- ER, THAT THE LIST PREPARED BY THE COMMISSIONER SHALL NOT INCLUDE ANY DRUG PRODUCT WHICH THE COMMISSIONER OF THE FEDERAL FOOD AND DRUG ADMIN- ISTRATION HAS IDENTIFIED AS HAVING AN ACTUAL OR POTENTIAL BIOEQUIVALENCE PROBLEM. 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 PROVIDEDEXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD11513-03-4 S. 6739--A 2
TO THE FEDERAL FOOD AND DRUG ADMINISTRATION AS PART OF THE APPLICATION FOR SUCH GENERIC DRUG PRODUCT. THE DEPARTMENT SHALL MAKE SUCH INFORMA- TION FREELY AND PUBLICLY AVAILABLE ON ITS WEBSITE. S 3. Paragraphs (a) and (d) of subdivision 6 of section 6810 of the education law, paragraph (a) as amended by chapter 590 of the laws of 2011 and paragraph (d) as added by chapter 913 of the laws of 1986, 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 hand- writing or, in the case of electronic prescriptions, inserts an elec- tronic direction to dispense the drug as written, the prescriber's signature or electronic signature shall designate approval of substi- tution by a pharmacist of a GENERIC drug product pursuant to
[paragraph (o) of subdivision one of]section [two hundred six]TWO HUNDRED EIGHT- Y-A 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 offi- cial, 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 avail- able 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. (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]TWO HUNDRED EIGHTY-A of the public health law.S. 6739--A 3
S 4. 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-A of the public health law; and S 5. This act shall take effect on the ninetieth day after it shall have become a law. 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.