S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2939
 
                        2017-2018 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 23, 2017
                                ___________
 
 Introduced by M. of A. McDONALD -- read once and referred to the Commit-
   tee on Health
 
 AN  ACT to amend the public health law, in relation to prescription drug
   cost transparency
 
   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:

   Section  1. Legislative intent. It is the intent of the legislature to
 make information available to the public about the cost and  utilization
 of  pharmaceutical  drugs.  To  fulfill this goal, the legislature finds
 that there should be annual reporting of drug costs and use  that  would
 be  of use by policymakers, government agencies and others to understand
 pharmacy cost trends.
   § 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. EACH MANUFACTURER  OF
 A  BRAND AND GENERIC MEDICATION THAT IS MADE AVAILABLE IN NEW YORK STATE
 SHALL FILE A REPORT ON PHARMACEUTICAL COSTS AS OUTLINED IN THIS SECTION.
   2. THE MANUFACTURER OF A PHARMACEUTICAL  DRUG  THAT  HAS  A  WHOLESALE
 ACQUISITION  COST  OF ONE THOUSAND DOLLARS FOR A THIRTY DAY SUPPLY SHALL
 FILE A REPORT PURSUANT TO THIS SECTION ON THE COSTS FOR EACH  QUALIFYING
 DRUG. WHOLESALE ACQUISITION COST SHALL HAVE THE SAME MEANING AS FOUND IN
 SUBSECTION (C) OF 42 U.S. CODE SECTION 1395W-3A.
   3.  THE  MANUFACTURER  OF  A  PHARMACEUTICAL DRUG WHICH DURING A THREE
 MONTH PERIOD HAS A CUMULATIVE PRICE INCREASE OF THREE TIMES THE CONSUMER
 PRICE INDEX SHALL FILE A REPORT PURSUANT TO THIS SECTION  ON  THE  COSTS
 FOR EACH QUALIFYING DRUG.
   4.  THE  REPORT SHALL INCLUDE THE FOLLOWING FOR EACH DRUG DESCRIBED IN
 SUBDIVISIONS TWO AND THREE OF THIS SUBDIVISION:
   (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.
                                                            LBD07661-01-7
              

 A. 2939                             2
 
   (1) THE TOTAL RESEARCH AND DEVELOPMENT COSTS INCLUDING BUT NOT LIMITED
 TO:
   (I) THE TOTAL COSTS OF ANY STUDY DRUG MANUFACTURED DURING THIS REPORT-
 ING  PERIOD IN SUPPORT OF THE U.S. FOOD AND DRUG ADMINISTRATION APPROVED
 USE OF THE DRUG;
   (II) THE TOTAL COSTS OF ANY PRECLINICAL STUDIES CONDUCTED DURING  THIS
 REPORTING PERIOD;
   (III)  THE  TOTAL  COSTS  OF ANY CLINICAL TRIALS CONDUCTED DURING THIS
 REPORTING PERIOD;
   (IV) THE TOTAL COSTS ASSOCIATED WITH THE PREPARATION AND SUBMISSION OF
 ANY REGULATORY DOCUMENTS SUBMITTED TO THE U.S. FOOD  AND  DRUG  ADMINIS-
 TRATION DURING THIS REPORTING PERIOD;
   (V)  THE TOTAL COSTS OF POST APPROVAL CLINICAL STUDIES MANDATED BY THE
 U.S. FOOD AND DRUG ADMINISTRATION DURING THIS REPORTING PERIOD; AND
   (VI) THE TOTAL COSTS OF POST APPROVAL STUDIES EARMARKED  FOR  PUBLICA-
 TION USING EXTERNAL PROVIDERS OF DATA DURING THIS REPORTING PERIOD;
   (2)  THE  TOTAL  COSTS FOR MATERIALS, MANUFACTURING AND ADMINISTRATION
 ATTRIBUTABLE TO THE DRUG FOR THIS REPORTING PERIOD;
   (3) THE TOTAL COSTS PAID BY ANY ENTITY OTHER THAN THE MANUFACTURER  OR
 PREDECESSOR  FOR RESEARCH AND DEVELOPMENT, INCLUDING AN ITEMIZED LIST OF
 ANY AMOUNT FROM FEDERAL, STATE, OR OTHER GOVERNMENTAL  PROGRAMS  OR  ANY
 FORM  OF  SUBSIDIES, GRANTS, OR OTHER SUPPORT FOR THIS REPORTING PERIOD;
 AND
   (4) 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.
   (B) THE TOTAL ADMINISTRATIVE COSTS FOR  THE  PROMOTION  OF  THE  DRUG,
 INCLUDING BUT NOT LIMITED TO:
   (I) MARKETING AND ADVERTISING COSTS;
   (II) DIRECT TO CONSUMER ADVERTISING COSTS;
   (III) PRESCRIBER EDUCATION COSTS;
   (IV) PROFESSIONAL EDUCATION COSTS;
   (V) LOBBYING COSTS; AND
   (VI)  FINANCIAL ASSISTANCE TO PATIENT GROUPS, DISEASE ASSOCIATIONS, OR
 OTHER CONSUMER ORGANIZATIONS.
   (C) THE TOTAL PROFIT AS REPRESENTED IN TOTAL DOLLARS AND A  PERCENTAGE
 OF TOTAL COMPANY PROFIT DERIVED FROM THE SALE OF THE DRUG.
   (D)  THE  TOTAL  AMOUNT  OF  FINANCIAL ASSISTANCE THE MANUFACTURER HAS
 PROVIDED  THROUGH  PATIENT  PRESCRIPTION  ASSISTANCE  PROGRAMS  IF  SUCH
 PROGRAMS ARE AVAILABLE, INCLUDING BUT NOT LIMITED TO:
   (I)  COSTS  ASSOCIATED  WITH  DIRECT  TO  CONSUMER  COUPONS AND AMOUNT
 REDEEMED;
   (II) COSTS ASSOCIATED WITH COPAYMENT ASSISTANCE PROGRAMS; AND
   (III) COSTS ASSOCIATED WITH SAMPLE DOSES, TRIAL DOSES,  OR  WHERE  THE
 DRUG PRODUCT IS PROVIDED BUT NOT SOLD.
   (E)  THE  WHOLESALE  ACQUISITION COST OF THE DRUG AS PUBLICLY REPORTED
 FOR EACH DRUG, INCLUDING A FIVE-YEAR HISTORY  OF  WHOLESALE  ACQUISITION
 COST PRICE INCREASES, EXPRESSED AS A PERCENTAGE, AND THE MONTH OR MONTHS
 EACH INCREASE TOOK EFFECT AND ANY EXPLANATION FOR THE PRICE INCREASE.
   5. INFORMATION SHALL BE FILED WITH THE DEPARTMENT ANNUALLY, CONSISTENT
 WITH SUBDIVISIONS TWO AND THREE OF THIS SECTION, ON A FORM PRESCRIBED BY
 THE DEPARTMENT AND SHALL BE SUBMITTED NO LATER THAN MAY FIRST, TWO THOU-
 SAND EIGHTEEN. SUCH INFORMATION SHALL BE UPDATED QUARTERLY.
   6.  THE  DEPARTMENT  SHALL  ISSUE  A  REPORT OUTLINING THE INFORMATION
 SUBMITTED PURSUANT TO THIS SECTION BY DECEMBER THIRTY-FIRST,  TWO  THOU-
 SAND  EIGHTEEN  AND  ISSUE ADDENDUMS ON A QUARTERLY BASIS REFLECTING THE

 A. 2939                             3
 
 REQUIREMENTS OF PARAGRAPH (D) OF SUBDIVISION FOUR OF THIS SECTION TO THE
 LEGISLATURE. SUCH INFORMATION SHALL BE MADE PUBLICLY  AVAILABLE  ON  THE
 DEPARTMENT'S WEBSITE.
   7.  THE  DEPARTMENT SHALL CONVENE AN ADVISORY WORKGROUP TO DEVELOP THE
 FORMS REQUIRED BY THIS SECTION. THE WORKGROUP SHALL INCLUDE, BUT IS  NOT
 LIMITED  TO,  REPRESENTATIVES  FROM  THE PHARMACEUTICAL INDUSTRY, HEALTH
 INSURANCE  PLANS,  PHARMACY  BENEFIT  MANAGERS,  GOVERNMENTAL  AGENCIES,
 CONSUMER ADVOCATES, AND PHYSICIANS.
   8.  THE  DEPARTMENT SHALL MAINTAIN THE CONFIDENTIALITY OF ANY INFORMA-
 TION SUBMITTED PURSUANT TO THIS SECTION THAT THE COMMISSIONER  DEEMS  TO
 BE  CONFIDENTIAL,  PROPRIETARY  INFORMATION  OF  THE  PRESCRIPTION  DRUG
 MANUFACTURER AND THE DISCLOSURE OF WHICH WOULD  CAUSE  THE  MANUFACTURER
 COMPETITIVE HARM. THIS CONFIDENTIAL PROPRIETARY INFORMATION SHALL NOT BE
 MADE  PUBLIC  BY  THE DEPARTMENT AND IS EXEMPT FORM DISCLOSURE UNDER THE
 STATE FREEDOM OF INFORMATION LAW.
   § 3. This act shall take effect immediately.