NY State Senate Bill S4986

Archive: Last Bill Status - In Senate Committee Health Committee

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

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

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.

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

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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The New York State Senate

senate Bill S4986

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Archive: Last Bill Status - In Senate Committee Health Committee

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S4986 (ACTIVE) - Details

S4986 (ACTIVE) - Summary

S4986 (ACTIVE) - Sponsor Memo

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

Your Voice

Actions

S4986 (ACTIVE) - Details

S4986 (ACTIVE) - Summary

S4986 (ACTIVE) - Sponsor Memo

S4986 (ACTIVE) - Bill Text download pdf

Comments