A07196 Summary:

BILL NOA07196A
 
SAME ASSAME AS UNI. S05169-A
 
SPONSORDenDekker
 
COSPNSRMosley, Jacobson, Colton, Buttenschon, Hevesi, Stirpe, Reyes, Barron, Pichardo, Seawright, Carroll, Lentol, LiPetri, Ashby, Weprin, Simon, Lifton, Benedetto, D'Urso, Hunter, Montesano, Gottfried, Cruz, Niou, DeStefano, Dinowitz, Jean-Pierre
 
MLTSPNSR
 
Add 396-rrr, Gen Bus L
 
Enacts the manufacturer disclosure and transparency act requiring prescription drug manufacturers to notify the attorney general of arrangements between pharmaceutical manufacturers resulting in the delay of the introduction of generic medications.
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A07196 Actions:

BILL NOA07196A
 
04/12/2019referred to consumer affairs and protection
01/08/2020referred to consumer affairs and protection
02/05/2020amend (t) and recommit to consumer affairs and protection
02/05/2020print number 7196a
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A07196 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A7196A
 
SPONSOR: DenDekker
  TITLE OF BILL: An act to amend the general business law, in relation to requiring prescription drug manufacturers to notify the attorney general of arrangements between pharmaceutical manufacturers resulting in the delay of the introduction of generic drugs   PURPOSE OF BILL: Enacts the "Manufacturer Disclosure and Transparency Act" to bring disclosure and transparency to the pay-for-delay deals that harm consum- ers by delaying generic drug competition with brand-name drugs.   SUMMARY OF SPECIFIC PROVISIONS: Section 1 establishes the title of the bill. Section 2 requires each pharmaceutical manufacturer doing business in this state that manufactures a brand-name prescription drug and enters into an agreement with another pharmaceutical manufacturer for the purpose of delaying or preventing another manufacturer from introducing a generic substitute for a brand-name drug to, no later than thirty days after entering into such agreement, send notice to the Attorney General with the name of the drug, the wholesale price, the disease it is commonly prescribed to treat, the manufacturer of such drug, the name of the generic manufacturer and the length of the delay. The Attorney General is then required to share that information with the New York State Drug Utilization Review Board, all Medicaid managed care plans, health carriers and pharmacy benefit managers doing business in the state. The Attorney General's office shall also post on its website all the notices required in section 2 searchable by drug, cost, disease and manufacturer both for the brand-name and generic drug for public review. A manufacturer of a brand-name drug who fails to notify the Attorney General of any agreement specified in the act shall be fined by the Attorney General no less than five-thousand dollars for a first violation and no less than ten-thousand dollars for each violation ther- eafter for each day such manufacturer fails to properly notify the attorney general pursuant to the requirements of the section. Additionally, the Attorney General is authorized to promulgate rules and regulations necessary for the implementation of this section. Section 3 establishes the effective date.   JUSTIFICATION: The Manufacturer Disclosure and Transparency Act would bring transparen- cy and disclosure to the pay-for-delay deals that harm consumers by delaying generic drug competition with brand-name drugs. Rising prescription drug prices have been devastating to New Yorkers who depend on prescription drugs to keep them healthy. The growing number of brand- name and specialty drugs with prices of $100,000 or more has led many to question whether the costs associated with these products are defensible or sustainable. The timely availability of generic and biosimilar drugs, which will increase competition and help lower prices - will play an important role in addressing these concerns. Brand-name drug manufacturers often file patent infringement lawsuits against the first generic drug manufacturers to seek FDA approval for competing generic drugs. Rather than face the costs and uncertainty associated with litigation, some brand-name and generic drug manufactur- ers choose to enter into what is known as a "pay-for-delay" agreement where the brand-name drug manufacturers compensates the generic drug manufacturer for keeping its product off the market for a certain amount of time. Such agreements can be particularly problematic when they involve the first-to-file generic manufacturer, because no other generic manufacturer can enter the market until the first-to-file manufacturer has marketed its product for 180 days. These pay-for-delay agreements provide financial benefits to drug manufacturers at the expense of consumers; the brand-name manufacturer can continue to charge monopoly prices, and the generic company is compensated for its inaction. The Federal Trade Commission (FTC) esti- mates that pay-for delay agreements cost American consumers $3.5 billion per year. The FTC has found that pay-for-delay agreements prohibit generic entry for an average of nearly 17 months longer than patent settlement agree- ments without such payments. In the meantime, consumers must continue paying brand-name drug prices, which can be as much as 85 percent higher than the prices of their generic drug counterparts. Any delay in gener- ic entry results in a longer period of purchases at the full brand price and correspondingly fewer purchases at less expensive generic prices. This negatively impacts both consumers and other payers, including taxpayer-funded health programs such as Medicaid. Generic drugs have proven to be one of the safest and most effective ways for consumers to lower their prescription drug costs, and the use of generic drugs has been steadily increasing. These drugs should not be delayed from entering the marketplace.   PRIOR LEGISLATIVE HISTORY: New bill.   FISCAL IMPLICATIONS: None.   EFFECTIVE DATE: This act shall take effect on the one hundred eightieth day after it shall have become a law.
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A07196 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
            S. 5169--A                                            A. 7196--A
 
                               2019-2020 Regular Sessions
 
                SENATE - ASSEMBLY
 
                                     April 12, 2019
                                       ___________
 
        IN  SENATE  -- Introduced by Sens. BIAGGI, BENJAMIN, CARLUCCI, GAUGHRAN,
          HOYLMAN, JACKSON, MAY,  MYRIE,  PARKER,  SALAZAR  --  read  twice  and
          ordered  printed, and when printed to be committed to the Committee on
          Consumer Protection  --  recommitted  to  the  Committee  on  Consumer
          Protection  in  accordance  with  Senate  Rule  6, sec. 8 -- committee
          discharged, bill amended, ordered reprinted as amended and recommitted
          to said committee
 
        IN ASSEMBLY -- Introduced by  M.  of  A.  DenDEKKER,  MOSLEY,  JACOBSON,
          COLTON,   BUTTENSCHON,   HEVESI,   STIRPE,  REYES,  BARRON,  PICHARDO,
          SEAWRIGHT, CARROLL, LENTOL, LiPETRI,  ASHBY,  WEPRIN,  SIMON,  LIFTON,
          BENEDETTO, D'URSO, HUNTER, MONTESANO, GOTTFRIED, CRUZ -- read once and
          referred to the Committee on Consumer Affairs and Protection -- recom-
          mitted  to the Committee on Consumer Affairs and Protection in accord-
          ance 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 general  business  law,  in  relation  to  requiring
          prescription  drug  manufacturers  to  notify  the attorney general of
          arrangements between pharmaceutical  manufacturers  resulting  in  the
          delay of the introduction of generic drugs
 
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
 
     1    Section 1. This act shall be known and may be cited as  the  "manufac-
     2  turer disclosure and transparency act".
     3    §  2. The general business law is amended by adding a new section 396-
     4  rrr to read as follows:
     5    § 396-rrr. Delay of introduction of generic medications. 1.  (a)  Each
     6  pharmaceutical  manufacturer  doing business in this state that manufac-
     7  tures a brand name prescription drug and  enters  into  an  arrangement,
     8  through agreement or otherwise, with another pharmaceutical manufacturer

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD11037-02-0

        S. 5169--A                          2                         A. 7196--A
 
     1  that  has  the  purpose  or  effect of delaying or preventing such other
     2  manufacturer from introducing a generic substitute for  such  drug  into
     3  the  marketplace  shall,  not later than thirty days after entering into
     4  such  arrangement,  send  notice  to the attorney general, in a form and
     5  manner prescribed by the attorney general, disclosing the name  of  such
     6  drug,  the wholesale price, the disease such drug is commonly prescribed
     7  to treat, the manufacturer  of  such  drug,  the  name  of  the  generic
     8  manufacturer, and the length of the delay.
     9    (b)  The  attorney  general  shall,  no  later  than thirty days after
    10  receiving a notice pursuant to paragraph (a) of this subdivision,  share
    11  the information with the drug utilization review board established under
    12  section  three  hundred  sixty-nine-bb  of  the social services law, all
    13  medicaid managed care  plans,  health  carriers  and  pharmacy  benefits
    14  managers  doing  business in the state in a format and manner prescribed
    15  by the attorney general.
    16    2. The office of the attorney general shall post on  its  website  all
    17  the  notices  required  pursuant  to paragraph (a) of subdivision one of
    18  this section in a format and manner developed by  the  attorney  general
    19  that is searchable by drug, cost, disease, and manufacturer both for the
    20  brand and generic drug for public review.
    21    3. For a violation by a manufacturer of a brand name drug who knowing-
    22  ly  or  negligently  fails to notify the attorney general as required in
    23  paragraph (a) of subdivision one of this section, the  attorney  general
    24  shall  fine such manufacturer no less than five thousand dollars for the
    25  first violation for each day such manufacturer fails to properly  notify
    26  the attorney general pursuant to the requirements of this section and no
    27  less  than  ten  thousand dollars for each violation thereafter for each
    28  day such manufacturer fails to  properly  notify  the  attorney  general
    29  pursuant to the requirements of this section.
    30    4.  The  attorney  general is authorized to promulgate rules and regu-
    31  lations necessary for the implementation of this section.
    32    § 3. This act shall take effect on the one hundred eightieth day after
    33  it shall have become a law.
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