Bill Text: NY A05777 | 2009-2010 | General Assembly | Introduced


Bill Title: An act to amend the public health law, in relation to requiring the manufacturer or labeler of each prescription drug to annually report the marketing costs of such drug to the department of health

Spectrum: Bipartisan Bill

Status: (Introduced - Dead) 2010-01-06 - referred to health [A05777 Detail]

Download: New_York-2009-A05777-Introduced.html
                           S T A T E   O F   N E W   Y O R K
       ________________________________________________________________________
                                         5777
                              2009-2010 Regular Sessions
                                 I N  A S S E M B L Y
                                   February 20, 2009
                                      ___________
       Introduced  by  M. of A. BRODSKY, SPANO -- read once and referred to the
         Committee on Health
       AN ACT to amend the public health law,  in  relation  to  requiring  the
         manufacturer  or  labeler of each prescription drug to annually report
         the marketing costs of such drug to the department of health
         THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
       BLY, DO ENACT AS FOLLOWS:
    1    Section  1.  Legislative  intent.  The  legislature  hereby  finds and
    2  declares that the price of prescription drugs in this state  and  across
    3  the nation has been increasing at an alarming rate over the past decade.
    4  Prescription  drug  costs are increasing at a faster rate than any other
    5  component of health care and are driving the increase in overall  health
    6  care  cost. As is apparent by the ubiquitous nature of the marketing and
    7  public information campaigns relating to prescription drugs,  pharmaceu-
    8  tical  manufacturers  put a great deal of resources into marketing their
    9  products. This has been especially true since  the  1997  relaxation  of
   10  federal  laws  relating  to  prescription drug advertising. It is in the
   11  interest of  assisting  this  state  in  its  role  as  a  purchaser  of
   12  prescription  drugs  and administrator of prescription drug programs, to
   13  enable the state to determine the scope of prescription  drug  marketing
   14  costs  and  their effect on the cost, utilization and delivery of health
   15  care services, and thus further the role of this state  as  guardian  of
   16  the public interest.
   17    S  2.  Section 206 of the public health law is amended by adding a new
   18  subdivision 26 to read as follows:
   19    26. THE COMMISSIONER IS AUTHORIZED AND DIRECTED TO REQUIRE MANUFACTUR-
   20  ERS OR LABELERS OF PRESCRIPTION DRUGS, WHICH DISPENSE SUCH DRUGS IN THIS
   21  STATE AND WHICH EMPLOY, DIRECT OR UTILIZE MARKETING  REPRESENTATIVES  IN
   22  THE  STATE,  TO  REPORT  THE MARKETING COSTS OF EACH OF ITS PRESCRIPTION
   23  DRUGS DISPENSED IN THIS STATE.
        EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                             [ ] is old law to be omitted.
                                                                  LBD08592-01-9
       A. 5777                             2
    1    (A) DEFINITIONS. AS USED  IN  THIS  SUBDIVISION,  UNLESS  THE  CONTEXT
    2  CLEARLY  INDICATES OTHERWISE, THE FOLLOWING TERMS SHALL HAVE THE FOLLOW-
    3  ING MEANINGS:
    4    (I)  "LABELER"  MEANS ANY PERSON OR ENTITY, HAVING A LABELER CODE FROM
    5  THE FEDERAL FOOD AND DRUG ADMINISTRATION, THAT RECEIVES  A  PRESCRIPTION
    6  DRUG  FROM THE MANUFACTURER OR A WHOLESALER OF SUCH DRUG, AND REPACKAGES
    7  SUCH DRUG TO BE DISPENSED IN THIS STATE.
    8    (II)  "MANUFACTURER"  MEANS  A  MANUFACTURER  OF  PRESCRIPTION   DRUGS
    9  DISPENSED  IN  THIS STATE, AND SHALL INCLUDE THE SUBSIDIARY OR AFFILIATE
   10  OF SUCH MANUFACTURER.
   11    (III) "MARKETING" MEANS ADVERTISING  AND  PROMOTIONAL  ACTIVITIES  FOR
   12  PRESCRIPTION  DRUGS  DISPENSED  IN THIS STATE INCLUDING, BUT NOT LIMITED
   13  TO, THOSE ACTIVITIES DESCRIBED IN PARAGRAPH (B) OF THIS SUBDIVISION.
   14    (B) MANNER OF REPORTING. ON OR  BEFORE  JULY  FIRST  EACH  YEAR  EVERY
   15  MANUFACTURER  AND LABELER SHALL FILE A REPORT WITH THE DEPARTMENT ON ITS
   16  MARKETING ACTIVITIES CONDUCTED IN  THIS  STATE.  SUCH  REPORT  SHALL  BE
   17  SUBMITTED IN SUCH FORM AND MANNER, AND INCLUDE THE PAYMENT OF SUCH A FEE
   18  AS  SHALL  BE  DETERMINED  BY  THE  COMMISSIONER. EACH SUCH REPORT SHALL
   19  INCLUDE THE VALUE, NATURE, PURPOSE AND RECIPIENT OF  MARKETING  EXPENSES
   20  INCLUDING, BUT NOT LIMITED TO:
   21    (I)  ALL  EXPENSES  ASSOCIATED  WITH ADVERTISING, MARKETING AND DIRECT
   22  PROMOTION OF PRESCRIPTION DRUGS THROUGH  RADIO,  TELEVISION,  MAGAZINES,
   23  NEWSPAPERS,  DIRECT MAIL AND TELEPHONE COMMUNICATIONS AS THEY PERTAIN TO
   24  RESIDENTS OF THIS STATE;
   25    (II) WITH REGARD TO ALL PROVIDERS OF HEALTHCARE SERVICES REGULATED  BY
   26  THE  DEPARTMENT UNDER THE PROVISIONS OF ARTICLE TWENTY-EIGHT, THIRTY-SIX
   27  OR FORTY-FOUR OF THIS CHAPTER, INCLUDING  HEALTH  MAINTENANCE  ORGANIZA-
   28  TIONS  ESTABLISHED PURSUANT TO ARTICLE FORTY-THREE OF THE INSURANCE LAW,
   29  THE FOLLOWING INFORMATION:
   30    (A)  ALL  EXPENSES  ASSOCIATED  WITH  EDUCATIONAL   OR   INFORMATIONAL
   31  PROGRAMS,  MATERIALS  AND  SEMINARS,  AND  REMUNERATION FOR PROMOTING OR
   32  PARTICIPATING IN EDUCATIONAL OR INFORMATIONAL  SESSIONS,  REGARDLESS  OF
   33  WHETHER THE MANUFACTURER OR LABELER PROVIDES THE EDUCATIONAL OR INFORMA-
   34  TIONAL SESSIONS OR MATERIALS,
   35    (B)  ALL EXPENSES ASSOCIATED WITH FOOD, ENTERTAINMENT AND GIFTS VALUED
   36  AT MORE THAN SEVENTY-FIVE DOLLARS, AND ANYTHING  PROVIDED  TO  A  HEALTH
   37  CARE PROFESSIONAL FOR LESS THAN MARKET VALUE,
   38    (C) ALL EXPENSES ASSOCIATED WITH TRIPS AND TRAVEL, AND
   39    (D)  ALL  EXPENSES ASSOCIATED WITH PRODUCT SAMPLES, EXCEPT FOR SAMPLES
   40  THAT WILL BE DISTRIBUTED FREE OF CHARGE TO PATIENTS; AND
   41    (III) THE AGGREGATE COST OF  ALL  EMPLOYEES  AND  CONTRACTORS  OF  THE
   42  MANUFACTURER  OR LABELER WHO DIRECTLY OR INDIRECTLY ENGAGE IN THE ADVER-
   43  TISING OR PROMOTIONAL ACTIVITIES LISTED IN SUBPARAGRAPHS (I) AND (II) OF
   44  THIS PARAGRAPH, INCLUDING ALL FORMS OF PAYMENT  TO  SUCH  EMPLOYEES  AND
   45  CONTRACTORS.  THE  COST  REPORTED  PURSUANT  TO  THIS SUBPARAGRAPH SHALL
   46  REFLECT ONLY THAT PORTION OF PAYMENT TO EMPLOYEES AND  CONTRACTORS  THAT
   47  PERTAINS  TO ACTIVITIES WITHIN THIS STATE OR TO RECIPIENTS OF THE ADVER-
   48  TISING OR PROMOTIONAL ACTIVITIES WHO ARE RESIDENTS OF OR ARE EMPLOYED IN
   49  THIS STATE.
   50    (C) EXCEPTIONS. THE FOLLOWING MARKETING EXPENSES SHALL NOT BE  SUBJECT
   51  TO THE REPORTING REQUIREMENTS OF THIS SUBDIVISION:
   52    (I) EXPENSES OF SEVENTY-FIVE DOLLARS OR LESS;
   53    (II)   REASONABLE  COMPENSATION  AND  REIMBURSEMENT  FOR  EXPENSES  IN
   54  CONNECTION WITH A BONA FIDE CLINICAL TRIAL OF A NEW VACCINE, THERAPY  OR
   55  TREATMENT; AND
       A. 5777                             3
    1    (III)  SCHOLARSHIPS  AND  REIMBURSEMENT  OF  EXPENSES  FOR ATTENDING A
    2  SIGNIFICANT EDUCATIONAL, SCIENTIFIC OR POLICY-MAKING CONFERENCE OR SEMI-
    3  NAR OF A NATIONAL, REGIONAL OR SPECIALTY MEDICAL OR  OTHER  PROFESSIONAL
    4  ASSOCIATION IF THE RECIPIENT OF THE SCHOLARSHIP IS CHOSEN BY THE ASSOCI-
    5  ATION SPONSORING THE CONFERENCE OR SEMINAR.
    6    (D)  DEPARTMENT REPORTS. ANNUALLY ON OR BEFORE NOVEMBER THIRTIETH, THE
    7  DEPARTMENT SHALL SUBMIT A REPORT,  PROVIDING  INFORMATION  IN  AGGREGATE
    8  FORM, ON PRESCRIPTION DRUG MARKETING EXPENSES TO THE GOVERNOR, TEMPORARY
    9  PRESIDENT  OF THE SENATE AND SPEAKER OF THE ASSEMBLY. ON OR BEFORE JANU-
   10  ARY FIRST, TWO THOUSAND TEN AND EVERY TWO YEARS THEREAFTER, THE  DEPART-
   11  MENT  SHALL PROVIDE A REPORT TO THE GOVERNOR, TEMPORARY PRESIDENT OF THE
   12  SENATE AND SPEAKER OF THE ASSEMBLY, PROVIDING INFORMATION  IN  AGGREGATE
   13  FORM,  CONTAINING  AN  ANALYSIS OF THE DATA SUBMITTED TO THE DEPARTMENT,
   14  INCLUDING THE  SCOPE  OF  PRESCRIPTION  DRUG  MARKETING  ACTIVITIES  AND
   15  EXPENSES  AND  THEIR  EFFECT  ON  THE  COST, UTILIZATION AND DELIVERY OF
   16  HEALTH CARE SERVICES AND ANY RECOMMENDATIONS WITH  REGARD  TO  MARKETING
   17  ACTIVITIES OF PRESCRIPTION DRUG MANUFACTURERS AND LABELERS.
   18    (E) CONFIDENTIALITY; PUBLIC INFORMATION. NOTWITHSTANDING ANY PROVISION
   19  OF  LAW  TO  THE  CONTRARY,  ALL INFORMATION SUBMITTED TO THE DEPARTMENT
   20  PURSUANT TO THIS SUBDIVISION SHALL BE  CONFIDENTIAL  AND  NOT  A  PUBLIC
   21  RECORD AS DEFINED IN SECTION EIGHTY-SIX OF THE PUBLIC OFFICERS LAW. DATA
   22  COMPILED IN AGGREGATE FORM BY THE DEPARTMENT FOR THE PURPOSES OF REPORT-
   23  ING  REQUIRED BY THIS SUBDIVISION SHALL BE A PUBLIC RECORD AS DEFINED IN
   24  SECTION EIGHTY-SIX OF THE PUBLIC OFFICERS LAW, AS LONG AS  IT  DOES  NOT
   25  REVEAL TRADE INFORMATION THAT IS PROTECTED BY STATE OR FEDERAL LAW.
   26    (F) VIOLATIONS. ANY PERSON WHO VIOLATES ANY PROVISION OF THIS SUBDIVI-
   27  SION  SHALL  BE LIABLE TO THE PEOPLE OF THE STATE FOR A CIVIL PENALTY OF
   28  TEN THOUSAND DOLLARS, PLUS COURT COSTS AND ATTORNEYS' FEES, WHICH  SHALL
   29  BE ENFORCED PURSUANT TO TITLE TWO OF THIS ARTICLE.
   30    (G)  RULES.  ANY  AND ALL RULES AND REGULATIONS NECESSARY TO IMPLEMENT
   31  THE PROVISIONS OF THIS SUBDIVISION SHALL BE PROMULGATED BY  THE  COMMIS-
   32  SIONER.
   33    S 3. This act shall take effect on the one hundred eightieth day after
   34  it  shall  have become a law. Effective immediately, any rules and regu-
   35  lations necessary to implement the provisions of this act on its  effec-
   36  tive date are authorized to be made on or before such effective date.
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