NY State Senate Bill 2017-S4986

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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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Mar 03, 2017	referred to health

2017-S4986 (ACTIVE) - Details

Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §278-a, Pub Health L
Versions Introduced in 2015-2016 Legislative Session:: S5338

2017-S4986 (ACTIVE) - 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.

2017-S4986 (ACTIVE) - Sponsor Memo

                                 BILL NUMBER:  S4986

 TITLE OF BILL :  An act to amend the public health law, in relation
to establishing the pharmaceutical cost transparency act of 2017

 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 2017.

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 :

2016: S.5338A-AMEND (T) AND RECOMMIT TO HEALTH
2015: S.5338- REFERRED TO HEALTH

 FISCAL IMPLICATIONS :

None to State

 LOCAL FISCAL IMPLICATIONS :

To be determined

 EFFECTIVE DATE :
Immediately

2017-S4986 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   4986
 
                        2017-2018 Regular Sessions
 
                             I N  S E N A T E
 
                               March 3, 2017
                                ___________
 
 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 2017
 
   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 2017".
   § 2. The public health law is amended by adding a new section 278-a to
 read as follows:
   § 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.
                                                            LBD07382-01-7

 S. 4986                             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 PERCENTAGES),
 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.
   § 3. This act shall take effect immediately.

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Senate Bill S4986

Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee

2017-S4986 (ACTIVE) - Details

2017-S4986 (ACTIVE) - Summary

2017-S4986 (ACTIVE) - Sponsor Memo

2017-S4986 (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S4986

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Sponsored By

Ruben Diaz

Archive: Last Bill Status - In Senate Committee Health Committee

2017-S4986 (ACTIVE) - Details

2017-S4986 (ACTIVE) - Summary

2017-S4986 (ACTIVE) - Sponsor Memo

2017-S4986 (ACTIVE) - Bill Text download pdf

Comments