NY State Senate Bill 2015-S5338A

Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Date of Action	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 20, 2016	print number 5338a
Jan 20, 2016	amend (t) and recommit to health
Jan 06, 2016	referred to health
May 13, 2015	referred to health

Bill Amendments

Original

A (Active)

co-Sponsors

2015-S5338 - Details

Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §278-a, Pub Health L
Versions Introduced in 2017-2018 Legislative Session:: S4986

2015-S5338 - Summary

Enacts the pharmaceutical cost transparency act requiring prescription drug manufacturers to file a report disclosing certain financial information pertaining to prescription drugs which have a wholesale acquisition cost of $10,000 or more annually or per course of treatment.

2015-S5338 - Sponsor Memo

                                BILL NUMBER:S5338

TITLE  OF  BILL:   An act to amend the public health law, in relation to
establishing the pharmaceutical cost transparency act of 2015

PURPOSE:  To make information available to the public about the cost  of
ultra-high-priced pharmaceuticals

SUMMARY OF PROVISIONS:

Section 1. Establishes the pharmaceutical transparency act of 2015.

Section  2  Amends the public health law by adding a new section, 278-a.
Legislative intent, including annual cost reporting on the  most  expen-
sive  drugs  Provides that each manufacturer of a prescription drug that
is made available in New York State, that has  a  wholesale  acquisition
cost  of  ten  thousand  dollars  shall  file  an annual report with the
department no later than May 1 of each year on a form prescribed by  the
department.  Specifies  the  content  of  such report, including but not
limited to the total cost for the production of  each  drug;  the  total
research  and  development  costs  for each drug; and the total costs of
clinical trials and other regulatory costs for each drug. Requires  that
all  of  the information in the report shall be itemized by manufacturer
and audited by a fully independent third party prior to filing. Provides
that the department shall issue an annual report to the legislature  and
that  such  report shall be posted on the department's website. Requires

the department to convene an advisory panel to develop the required form
Describes the members of such panel.

Section 3. Effective date

EXISTING LAW: None

JUSTIFICATION:  The New York Times Editorial on  May,  5  2015  entitled
"Runaway  Drug Prices" described the outrageous costs charged to consum-
ers for prescription drugs. When the Medicare Part D  prescription  drug
plan was signed into law, it specifically prohibited the federal govern-
ment  from  negotiating  for the best prices with the drug manufacturers
According   to   the   Editorial,   "Spending   on   all    prescription
drugs..accounts for a tenth of the nation's total health spending."

Pharmaceutical companies have long maintained that the exorbitant prices
are  needed in order to cover the costs associated with research, devel-
opment and clinical trials. However,  neither  the  consumers  who  need
these  prescriptions,  or  insurance  companies,  including Medicare nor
Medicaid who pay for them, have any idea  if  what  the  pharmaceuticals
contend is actually true.

This  bill  would  bring transparency to an area of health care spending
that for too long has been hidden from the  public.  If  a  prescription
drug  demands an outrageous price tag, the public, insurers and federal,

state and local governments, should have access to the information  that
supposedly justifies the cost

This  legislation would require that each manufacturer of a prescription
drug that is made available in New York  State,  that  has  a  wholesale
acquisition  cost  of  ten  thousand dollars shall file an annual report
with the department no later than May 1 of each year.   The report  will
include  information  regarding  the  total  costs  for  each  drug for:
production; research and development; clinical trials and other  regula-
tory  costs;  materials, manufacturing and administration; costs paid by
other entities, including federal, state or other governmental programs;
other costs to acquire the drug; total marketing and advertising  costs;
a  cumulative  annual  history  of  the  average  wholesale price; total
profits derived from the sale of the  drug;  and  the  total  amount  of
financial assistance provided by the manufacturer, if available.

LEGISLATIVE HISTORY: New Bill

FISCAL IMPLICATIONS: None to State

LOCAL FISCAL IMPLICATIONS: To be determined

EFFECTIVE DATE: Immediately

2015-S5338 - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  5338

                       2015-2016 Regular Sessions

                            I N  S E N A T E

                              May 13, 2015
                               ___________

Introduced  by  Sen.  DIAZ  --  read twice and ordered printed, and when
  printed to be committed to the Committee on Health

AN ACT to amend the public health law, in relation to  establishing  the
  pharmaceutical cost transparency act of 2015

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. This act shall be cited and may be known as the "pharmaceu-
tical cost transparency act of 2015".
  S 2. The public health law is amended by adding a new section 278-a to
read as follows:
  S 278-A. PRESCRIPTION DRUG COST TRANSPARENCY. 1.  LEGISLATIVE  INTENT.
A.  IT IS THE INTENT OF THE LEGISLATURE TO MAKE INFORMATION AVAILABLE TO
THE PUBLIC ABOUT THE COST OF ULTRA-HIGH-PRICED PHARMACEUTICALS, IN ORDER
TO MAKE PHARMACEUTICAL PRICING AS TRANSPARENT AS THE  PRICING  IN  OTHER
SECTORS OF THE HEALTH CARE INDUSTRY.
  B. THE LEGISLATURE FINDS THAT THERE SHOULD BE ANNUAL COST REPORTING ON
THE  MOST  EXPENSIVE DRUGS THAT WOULD BE OF USE TO POLICYMAKERS, GOVERN-
MENT AGENCIES, AND  OTHERS  TO  UNDERSTAND  COSTS  FOR  THESE  IMPORTANT
PRODUCTS.
  2.  EACH  MANUFACTURER  OF  A PRESCRIPTION DRUG, MADE AVAILABLE IN NEW
YORK, THAT HAS A WHOLESALE ACQUISITION  COST  OF  TEN  THOUSAND  DOLLARS
($10,000)  OR  MORE  ANNUALLY  OR  PER COURSE OF TREATMENT, SHALL FILE A
REPORT PURSUANT TO THIS SECTION ON THE COSTS FOR EACH QUALIFYING DRUG.
  3. THE REPORT REQUIRED PURSUANT TO SUBDIVISION  TWO  OF  THIS  SECTION
SHALL INCLUDE ALL OF THE FOLLOWING FOR EACH DRUG:
  A.  THE  TOTAL  COSTS FOR THE PRODUCTION OF THE DRUG, INCLUDING ALL OF
THE FOLLOWING:
  (I) THE TOTAL RESEARCH AND DEVELOPMENT COSTS PAID BY THE MANUFACTURER,
AND SEPARATELY, THE TOTAL RESEARCH AND DEVELOPMENT  COSTS  PAID  BY  ANY
PREDECESSOR IN THE DEVELOPMENT OF THE DRUG.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11025-02-5

S. 5338                             2

  (II)  THE  TOTAL  COSTS  OF CLINICAL TRIALS AND OTHER REGULATORY COSTS
PAID BY THE MANUFACTURER, AND SEPARATELY, THE TOTAL  COSTS  OF  CLINICAL
TRIALS  AND OTHER REGULATORY COSTS PAID BY ANY PREDECESSOR IN THE DEVEL-
OPMENT OF THE DRUG.
  (III) THE TOTAL COSTS FOR MATERIALS, MANUFACTURING, AND ADMINISTRATION
ATTRIBUTABLE TO THE DRUG.
  (IV) THE TOTAL COSTS PAID BY ANY ENTITY OTHER THAN THE MANUFACTURER OR
PREDECESSOR  FOR  RESEARCH  AND  DEVELOPMENT,  INCLUDING ANY AMOUNT FROM
FEDERAL, STATE, OR OTHER GOVERNMENTAL PROGRAMS OR ANY FORM OF SUBSIDIES,
GRANTS, OR OTHER SUPPORT.
  (V) ANY OTHER COSTS TO ACQUIRE  THE  DRUG,  INCLUDING  COSTS  FOR  THE
PURCHASE  OF  PATENTS,  LICENSING OR ACQUISITION OF ANY CORPORATE ENTITY
OWNING ANY RIGHTS TO THE DRUG WHILE IN DEVELOPMENT, OR ALL OF THESE.
  (VI) THE TOTAL MARKETING AND ADVERTISING COSTS FOR  THE  PROMOTION  OF
THE  DRUG  DIRECTLY  TO  CONSUMERS, INCLUDING, BUT NOT LIMITED TO, COSTS
ASSOCIATED WITH DIRECT TO CONSUMER COUPONS AND  AMOUNT  REDEEMED,  TOTAL
MARKETING  AND  ADVERTISING  COSTS FOR PROMOTION OF THE DRUG DIRECTLY OR
INDIRECTLY TO PRESCRIBERS, AND ANY OTHER ADVERTISING FOR THE DRUG.
  B. A CUMULATIVE ANNUAL HISTORY OF AVERAGE WHOLESALE PRICE  AND  WHOLE-
SALE ACQUISITION COST INCREASES FOR THE DRUG (EXPRESSED AS PRECENTAGES),
INCLUDING  THE  MONTHS  EACH INCREASE IN EACH CATEGORY, AVERAGE WHOLSALE
PRICE AND WHOLESALE ACQUISITION COST, TOOK EFFECT.
  C. THE TOTAL PROFIT ATTRIBUTABLE TO THE DRUG AS REPRESENTED  IN  TOTAL
DOLLARS  AND  REPRESENTED  AS  A PERCENTAGE OF THE TOTAL COMPANY PROFITS
THAT WERE DERIVED FROM THE SALE OF THE DRUG.
  D. THE TOTAL AMOUNT  OF  FINANCIAL  ASSISTANCE  THE  MANUFACTURER  HAS
PROVIDED THROUGH PATIENT PRESCRIPTION ASSISTANCE PROGRAMS, IF AVAILABLE.
  4.  ALL  OF THE INFORMATION IN SUBDIVISION THREE OF THIS SECTION SHALL
BE ITEMIZED AND DOCUMENTED BY THE MANUFACTURER, AND AUDITED BY  A  FULLY
INDEPENDENT THIRD-PARTY AUDITOR PRIOR TO FILING.
  5.  THE  INFORMATION  REQUIRED BY THIS SECTION SHALL BE FILED ANNUALLY
WITH THE DEPARTMENT ON A FORM PRESCRIBED BY THE DEPARTMENT AND SHALL  BE
SUBMITTED NO LATER THAN MAY FIRST OF EACH YEAR.
  6.  NOTWITHSTANDING  ANY  OTHER  SECTION  OF  LAW TO THE CONTRARY, THE
DEPARTMENT SHALL ISSUE A REPORT ANNUALLY TO  THE  LEGISLATURE  OUTLINING
THE  INFORMATION  SUBMITTED PURSUANT TO THIS SECTION, AND THE DEPARTMENT
SHALL POST THE REPORT PUBLICLY ON ITS WEBSITE.
  7. THE DEPARTMENT SHALL CONVENE AN ADVISORY PANEL TO DEVELOP THE  FORM
REQUIRED  BY  THIS  SECTION.  THE  PANEL  SHALL INCLUDE, BUT NEED NOT BE
LIMITED TO, REPRESENTATIVES FROM  THE  PHARMACEUTICAL  INDUSTRY,  HEALTH
CARE SERVICE PLANS AND INSURERS, PHARMACY BENEFIT MANAGERS, GOVERNMENTAL
AGENCIES, CONSUMER ADVOCATES, AND PHYSICIANS.
  S 3. This act shall take effect immediately.

co-Sponsors

2015-S5338A (ACTIVE) - Details

Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §278-a, Pub Health L
Versions Introduced in 2017-2018 Legislative Session:: S4986

2015-S5338A (ACTIVE) - Summary

2015-S5338A (ACTIVE) - Sponsor Memo

                                 BILL NUMBER:  S5338A

 TITLE OF BILL :

An act to amend the public health law, in relation to establishing the
pharmaceutical cost transparency act of 2016

 PURPOSE :

To make information available to the public about the cost of
ultra-high-priced pharmaceuticals

 SUMMARY OF PROVISIONS :

Section 1. Establishes the pharmaceutical transparency act of 2016.

Section 2 Amends the public health law by adding a new section, 278-a.
Legislative intent, including annual cost reporting on the most
expensive drugs Provides that each manufacturer of a prescription drug
that is made available in New York State, that has a wholesale
acquisition cost of ten thousand dollars shall file an annual report
with the department no later than May 1 of each year on a form
prescribed by the department. Specifies the content of such report,
including but not limited to the total cost for the production of each
drug; the total research and development costs for each drug; and the
total costs of clinical trials and other regulatory costs for each

drug. Requires that all of the information in the report shall be
itemized by manufacturer and audited by a fully independent third
party prior to filing. Provides that the department shall issue an
annual report to the legislature and that such report shall be posted
on the department's website. Requires the department to convene an
advisory panel to develop the required form Describes the members of
such panel.

Section 3. Effective date

 EXISTING LAW :

None

 JUSTIFICATION :

The New York Times Editorial on May, 5 2016 entitled "Runaway Drug
Prices" described the outrageous costs charged to consumers for
prescription drugs. When the Medicare Part D prescription drug plan
was signed into law, it specifically prohibited the federal government
from negotiating for the best prices with the drug manufacturers
According to the Editorial, "Spending on all prescription
drugs..accounts for a tenth of the nation's total health spending."

Pharmaceutical companies have long maintained that the exorbitant
prices are needed in order to cover the costs associated with
research, development and clinical trials. However, neither the
consumers who need these prescriptions, or insurance companies,
including Medicare nor Medicaid who pay for them, have any idea if
what the pharmaceuticals contend is actually true.

This bill would bring transparency to an area of health care spending
that for too long has been hidden from the public. If a prescription
drug demands an outrageous price tag, the public, insurers and
federal, state and local governments, should have access to the
information that supposedly justifies the cost

This legislation would require that each manufacturer of a
prescription drug that is made available in New York State, that has a
wholesale acquisition cost of ten thousand dollars shall file an
annual report with the department no later than May 1 of each year.
The report will include information regarding the total costs for each
drug for: production; research and development; clinical trials and
other regulatory costs; materials, manufacturing and administration;
costs paid by other entities, including federal, state or other
governmental programs; other costs to acquire the drug; total
marketing and advertising costs; a cumulative annual history of the
average wholesale price; total profits derived from the sale of the
drug; and the total amount of financial assistance provided by the
manufacturer, if available.

 LEGISLATIVE HISTORY :

New Bill

 FISCAL IMPLICATIONS :

None to State

 LOCAL FISCAL IMPLICATIONS :

To be determined

 EFFECTIVE DATE :
Immediately

2015-S5338A (ACTIVE) - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 5338--A

                       2015-2016 Regular Sessions

                            I N  S E N A T E

                              May 13, 2015
                               ___________

Introduced by Sens. DIAZ, PERKINS -- 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, in relation to  establishing  the
  pharmaceutical cost transparency act of 2016

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. This act shall be cited and may be known as the "pharmaceu-
tical cost transparency act of 2016".
  S 2. The public health law is amended by adding a new section 278-a to
read as follows:
  S 278-A. PRESCRIPTION DRUG COST TRANSPARENCY. 1.  LEGISLATIVE  INTENT.
A.  IT IS THE INTENT OF THE LEGISLATURE TO MAKE INFORMATION AVAILABLE TO
THE PUBLIC ABOUT THE COST OF ULTRA-HIGH-PRICED PHARMACEUTICALS, IN ORDER
TO MAKE PHARMACEUTICAL PRICING AS TRANSPARENT AS THE  PRICING  IN  OTHER
SECTORS OF THE HEALTH CARE INDUSTRY.
  B. THE LEGISLATURE FINDS THAT THERE SHOULD BE ANNUAL COST REPORTING ON
THE  MOST  EXPENSIVE DRUGS THAT WOULD BE OF USE TO POLICYMAKERS, GOVERN-
MENT AGENCIES, AND  OTHERS  TO  UNDERSTAND  COSTS  FOR  THESE  IMPORTANT
PRODUCTS.
  2.  EACH  MANUFACTURER  OF  A PRESCRIPTION DRUG, MADE AVAILABLE IN NEW
YORK, THAT HAS A WHOLESALE ACQUISITION  COST  OF  TEN  THOUSAND  DOLLARS
($10,000)  OR  MORE  ANNUALLY  OR  PER COURSE OF TREATMENT, SHALL FILE A
REPORT PURSUANT TO THIS SECTION ON THE COSTS FOR EACH QUALIFYING DRUG.
  3. THE REPORT REQUIRED PURSUANT TO SUBDIVISION  TWO  OF  THIS  SECTION
SHALL INCLUDE ALL OF THE FOLLOWING FOR EACH DRUG:
  A.  THE  TOTAL  COSTS FOR THE PRODUCTION OF THE DRUG, INCLUDING ALL OF
THE FOLLOWING:

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11025-03-6

S. 5338--A                          2

  (I) THE TOTAL RESEARCH AND DEVELOPMENT COSTS PAID BY THE MANUFACTURER,
AND SEPARATELY, THE TOTAL RESEARCH AND DEVELOPMENT  COSTS  PAID  BY  ANY
PREDECESSOR IN THE DEVELOPMENT OF THE DRUG.
  (II)  THE  TOTAL  COSTS  OF CLINICAL TRIALS AND OTHER REGULATORY COSTS
PAID BY THE MANUFACTURER, AND SEPARATELY, THE TOTAL  COSTS  OF  CLINICAL
TRIALS  AND OTHER REGULATORY COSTS PAID BY ANY PREDECESSOR IN THE DEVEL-
OPMENT OF THE DRUG.
  (III) THE TOTAL COSTS FOR MATERIALS, MANUFACTURING, AND ADMINISTRATION
ATTRIBUTABLE TO THE DRUG.
  (IV) THE TOTAL COSTS PAID BY ANY ENTITY OTHER THAN THE MANUFACTURER OR
PREDECESSOR FOR RESEARCH AND  DEVELOPMENT,  INCLUDING  ANY  AMOUNT  FROM
FEDERAL, STATE, OR OTHER GOVERNMENTAL PROGRAMS OR ANY FORM OF SUBSIDIES,
GRANTS, OR OTHER SUPPORT.
  (V)  ANY  OTHER  COSTS  TO  ACQUIRE  THE DRUG, INCLUDING COSTS FOR THE
PURCHASE OF PATENTS, LICENSING OR ACQUISITION OF  ANY  CORPORATE  ENTITY
OWNING ANY RIGHTS TO THE DRUG WHILE IN DEVELOPMENT, OR ALL OF THESE.
  (VI)  THE  TOTAL  MARKETING AND ADVERTISING COSTS FOR THE PROMOTION OF
THE DRUG DIRECTLY TO CONSUMERS, INCLUDING, BUT  NOT  LIMITED  TO,  COSTS
ASSOCIATED  WITH  DIRECT  TO CONSUMER COUPONS AND AMOUNT REDEEMED, TOTAL
MARKETING AND ADVERTISING COSTS FOR PROMOTION OF THE  DRUG  DIRECTLY  OR
INDIRECTLY TO PRESCRIBERS, AND ANY OTHER ADVERTISING FOR THE DRUG.
  B.  A  CUMULATIVE ANNUAL HISTORY OF AVERAGE WHOLESALE PRICE AND WHOLE-
SALE ACQUISITION COST INCREASES FOR THE DRUG (EXPRESSED AS PRECENTAGES),
INCLUDING THE MONTHS EACH INCREASE IN EACH CATEGORY,  AVERAGE  WHOLESALE
PRICE AND WHOLESALE ACQUISITION COST, TOOK EFFECT.
  C.  THE  TOTAL PROFIT ATTRIBUTABLE TO THE DRUG AS REPRESENTED IN TOTAL
DOLLARS AND REPRESENTED AS A PERCENTAGE OF  THE  TOTAL  COMPANY  PROFITS
THAT WERE DERIVED FROM THE SALE OF THE DRUG.
  D.  THE  TOTAL  AMOUNT  OF  FINANCIAL  ASSISTANCE THE MANUFACTURER HAS
PROVIDED THROUGH PATIENT PRESCRIPTION ASSISTANCE PROGRAMS, IF AVAILABLE.
  4. ALL OF THE INFORMATION IN SUBDIVISION THREE OF THIS  SECTION  SHALL
BE  ITEMIZED  AND DOCUMENTED BY THE MANUFACTURER, AND AUDITED BY A FULLY
INDEPENDENT THIRD-PARTY AUDITOR PRIOR TO FILING.
  5. THE INFORMATION REQUIRED BY THIS SECTION SHALL  BE  FILED  ANNUALLY
WITH  THE DEPARTMENT ON A FORM PRESCRIBED BY THE DEPARTMENT AND SHALL BE
SUBMITTED NO LATER THAN MAY FIRST OF EACH YEAR.
  6. NOTWITHSTANDING ANY OTHER SECTION  OF  LAW  TO  THE  CONTRARY,  THE
DEPARTMENT  SHALL  ISSUE  A REPORT ANNUALLY TO THE LEGISLATURE OUTLINING
THE INFORMATION SUBMITTED PURSUANT TO THIS SECTION, AND  THE  DEPARTMENT
SHALL POST THE REPORT PUBLICLY ON ITS WEBSITE.
  7.  THE DEPARTMENT SHALL CONVENE AN ADVISORY PANEL TO DEVELOP THE FORM
REQUIRED BY THIS SECTION. THE PANEL  SHALL  INCLUDE,  BUT  NEED  NOT  BE
LIMITED  TO,  REPRESENTATIVES  FROM  THE PHARMACEUTICAL INDUSTRY, HEALTH
CARE SERVICE PLANS AND INSURERS, PHARMACY BENEFIT MANAGERS, GOVERNMENTAL
AGENCIES, CONSUMER ADVOCATES, AND PHYSICIANS.
  S 3. This act shall take effect immediately.

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Senate Bill S5338A

Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee

Actions

Bill Amendments

co-Sponsors

2015-S5338 - Details

2015-S5338 - Summary

2015-S5338 - Sponsor Memo

2015-S5338 - Bill Text download pdf

co-Sponsors

2015-S5338A (ACTIVE) - Details

2015-S5338A (ACTIVE) - Summary

2015-S5338A (ACTIVE) - Sponsor Memo

2015-S5338A (ACTIVE) - Bill Text download pdf

Comments

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Sponsored By

Ruben Diaz

Archive: Last Bill Status - In Senate Committee Health Committee

Actions

Bill Amendments

co-Sponsors

Bill Perkins

2015-S5338 - Details

2015-S5338 - Summary

2015-S5338 - Sponsor Memo

2015-S5338 - Bill Text download pdf

co-Sponsors

Bill Perkins

2015-S5338A (ACTIVE) - Details

2015-S5338A (ACTIVE) - Summary

2015-S5338A (ACTIVE) - Sponsor Memo

2015-S5338A (ACTIVE) - Bill Text download pdf

Comments