S T A T E   O F   N E W   Y O R K
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                                  1636

                       2011-2012 Regular Sessions

                          I N  A S S E M B L Y

                            January 11, 2011
                               ___________

Introduced by M. of A. COLTON -- 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:

  Section 1.  Legislative  intent.  The  legislature  hereby  finds  and
declares  that  the price of prescription drugs in this state and across
the nation has been increasing at an alarming rate over the past decade.
Prescription drug costs are increasing at a faster rate than  any  other
component  of health care and are driving the increase in overall health
care cost. As is apparent by the ubiquitous nature of the marketing  and
public  information campaigns relating to prescription drugs, pharmaceu-
tical manufacturers put a great deal of resources into  marketing  their
products.  This  has  been  especially true since the 1997 relaxation of
federal laws relating to prescription drug advertising.  It  is  in  the
interest  of  assisting  this  state  in  its  role  as  a  purchaser of
prescription drugs and administrator of prescription drug  programs,  to
enable  the  state to determine the scope of prescription drug marketing
costs and their effect on the cost, utilization and delivery  of  health
care  services,  and  thus further the role of this state as guardian of
the public interest.
  S 2.  Section 206 of the public health law is amended by adding a  new
subdivision 28 to read as follows:
  28. THE COMMISSIONER IS AUTHORIZED AND DIRECTED TO REQUIRE MANUFACTUR-
ERS OR LABELERS OF PRESCRIPTION DRUGS, WHICH DISPENSE SUCH DRUGS IN THIS
STATE  AND  WHICH EMPLOY, DIRECT OR UTILIZE MARKETING REPRESENTATIVES IN
THE STATE, TO REPORT THE MARKETING COSTS OF  EACH  OF  ITS  PRESCRIPTION
DRUGS DISPENSED IN THIS STATE.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD02419-01-1

              

A. 1636                             2

  (A)  DEFINITIONS.  AS  USED  IN  THIS  SUBDIVISION, UNLESS THE CONTEXT
CLEARLY INDICATES OTHERWISE, THE FOLLOWING TERMS SHALL HAVE THE  FOLLOW-
ING MEANINGS:
  (I)  "LABELER"  MEANS ANY PERSON OR ENTITY, HAVING A LABELER CODE FROM
THE FEDERAL FOOD AND DRUG ADMINISTRATION, THAT RECEIVES  A  PRESCRIPTION
DRUG  FROM THE MANUFACTURER OR A WHOLESALER OF SUCH DRUG, AND REPACKAGES
SUCH DRUG TO BE DISPENSED IN THIS STATE.
  (II)  "MANUFACTURER"  MEANS  A  MANUFACTURER  OF  PRESCRIPTION   DRUGS
DISPENSED  IN  THIS STATE, AND SHALL INCLUDE THE SUBSIDIARY OR AFFILIATE
OF SUCH MANUFACTURER.
  (III) "MARKETING" MEANS ADVERTISING  AND  PROMOTIONAL  ACTIVITIES  FOR
PRESCRIPTION  DRUGS  DISPENSED  IN THIS STATE INCLUDING, BUT NOT LIMITED
TO, THOSE ACTIVITIES DESCRIBED IN PARAGRAPH (B) OF THIS SUBDIVISION.
  (B) MANNER OF REPORTING. ON OR  BEFORE  JULY  FIRST  EACH  YEAR  EVERY
MANUFACTURER  AND LABELER SHALL FILE A REPORT WITH THE DEPARTMENT ON ITS
MARKETING ACTIVITIES CONDUCTED IN  THIS  STATE.  SUCH  REPORT  SHALL  BE
SUBMITTED IN SUCH FORM AND MANNER, AND INCLUDE THE PAYMENT OF SUCH A FEE
AS  SHALL  BE  DETERMINED  BY  THE  COMMISSIONER. EACH SUCH REPORT SHALL
INCLUDE THE VALUE, NATURE, PURPOSE AND RECIPIENT OF  MARKETING  EXPENSES
INCLUDING, BUT NOT LIMITED TO:
  (I)  ALL  EXPENSES  ASSOCIATED  WITH ADVERTISING, MARKETING AND DIRECT
PROMOTION OF PRESCRIPTION DRUGS THROUGH  RADIO,  TELEVISION,  MAGAZINES,
NEWSPAPERS,  DIRECT MAIL AND TELEPHONE COMMUNICATIONS AS THEY PERTAIN TO
RESIDENTS OF THIS STATE;
  (II) WITH REGARD TO ALL PROVIDERS OF HEALTHCARE SERVICES REGULATED  BY
THE  DEPARTMENT UNDER THE PROVISIONS OF ARTICLE TWENTY-EIGHT, THIRTY-SIX
OR FORTY-FOUR OF THIS CHAPTER, INCLUDING  HEALTH  MAINTENANCE  ORGANIZA-
TIONS  ESTABLISHED PURSUANT TO ARTICLE FORTY-THREE OF THE INSURANCE LAW,
THE FOLLOWING INFORMATION:
  (A)  ALL  EXPENSES  ASSOCIATED  WITH  EDUCATIONAL   OR   INFORMATIONAL
PROGRAMS,  MATERIALS  AND  SEMINARS,  AND  REMUNERATION FOR PROMOTING OR
PARTICIPATING IN EDUCATIONAL OR INFORMATIONAL  SESSIONS,  REGARDLESS  OF
WHETHER THE MANUFACTURER OR LABELER PROVIDES THE EDUCATIONAL OR INFORMA-
TIONAL SESSIONS OR MATERIALS,
  (B)  ALL EXPENSES ASSOCIATED WITH FOOD, ENTERTAINMENT AND GIFTS VALUED
AT MORE THAN SEVENTY-FIVE DOLLARS, AND ANYTHING  PROVIDED  TO  A  HEALTH
CARE PROFESSIONAL FOR LESS THAN MARKET VALUE,
  (C) ALL EXPENSES ASSOCIATED WITH TRIPS AND TRAVEL, AND
  (D)  ALL  EXPENSES ASSOCIATED WITH PRODUCT SAMPLES, EXCEPT FOR SAMPLES
THAT WILL BE DISTRIBUTED FREE OF CHARGE TO PATIENTS; AND
  (III) THE AGGREGATE COST OF  ALL  EMPLOYEES  AND  CONTRACTORS  OF  THE
MANUFACTURER  OR LABELER WHO DIRECTLY OR INDIRECTLY ENGAGE IN THE ADVER-
TISING OR PROMOTIONAL ACTIVITIES LISTED IN SUBPARAGRAPHS (I) AND (II) OF
THIS PARAGRAPH, INCLUDING ALL FORMS OF PAYMENT  TO  SUCH  EMPLOYEES  AND
CONTRACTORS.  THE  COST  REPORTED  PURSUANT  TO  THIS SUBPARAGRAPH SHALL
REFLECT ONLY THAT PORTION OF PAYMENT TO EMPLOYEES AND  CONTRACTORS  THAT
PERTAINS  TO ACTIVITIES WITHIN THIS STATE OR TO RECIPIENTS OF THE ADVER-
TISING OR PROMOTIONAL ACTIVITIES WHO ARE RESIDENTS OF OR ARE EMPLOYED IN
THIS STATE.
  (C) EXCEPTIONS. THE FOLLOWING MARKETING EXPENSES SHALL NOT BE  SUBJECT
TO THE REPORTING REQUIREMENTS OF THIS SUBDIVISION:
  (I) EXPENSES OF SEVENTY-FIVE DOLLARS OR LESS;
  (II)   REASONABLE  COMPENSATION  AND  REIMBURSEMENT  FOR  EXPENSES  IN
CONNECTION WITH A BONA FIDE CLINICAL TRIAL OF A NEW VACCINE, THERAPY  OR
TREATMENT; AND

A. 1636                             3

  (III)  SCHOLARSHIPS  AND  REIMBURSEMENT  OF  EXPENSES  FOR ATTENDING A
SIGNIFICANT EDUCATIONAL, SCIENTIFIC OR POLICY-MAKING CONFERENCE OR SEMI-
NAR OF A NATIONAL, REGIONAL OR SPECIALTY MEDICAL OR  OTHER  PROFESSIONAL
ASSOCIATION IF THE RECIPIENT OF THE SCHOLARSHIP IS CHOSEN BY THE ASSOCI-
ATION SPONSORING THE CONFERENCE OR SEMINAR.
  (D)  DEPARTMENT REPORTS. ANNUALLY ON OR BEFORE NOVEMBER THIRTIETH, THE
DEPARTMENT SHALL SUBMIT A REPORT,  PROVIDING  INFORMATION  IN  AGGREGATE
FORM, ON PRESCRIPTION DRUG MARKETING EXPENSES TO THE GOVERNOR, TEMPORARY
PRESIDENT  OF THE SENATE AND SPEAKER OF THE ASSEMBLY. ON OR BEFORE JANU-
ARY FIRST, TWO THOUSAND TWELVE  AND  EVERY  TWO  YEARS  THEREAFTER,  THE
DEPARTMENT  SHALL  PROVIDE A REPORT TO THE GOVERNOR, TEMPORARY PRESIDENT
OF THE SENATE AND SPEAKER OF  THE  ASSEMBLY,  PROVIDING  INFORMATION  IN
AGGREGATE  FORM,  CONTAINING  AN  ANALYSIS  OF THE DATA SUBMITTED TO THE
DEPARTMENT, INCLUDING THE SCOPE OF PRESCRIPTION  DRUG  MARKETING  ACTIV-
ITIES  AND EXPENSES AND THEIR EFFECT ON THE COST, UTILIZATION AND DELIV-
ERY OF HEALTH CARE SERVICES  AND  ANY  RECOMMENDATIONS  WITH  REGARD  TO
MARKETING ACTIVITIES OF PRESCRIPTION DRUG MANUFACTURERS AND LABELERS.
  (E) CONFIDENTIALITY; PUBLIC INFORMATION. NOTWITHSTANDING ANY PROVISION
OF  LAW  TO  THE  CONTRARY,  ALL INFORMATION SUBMITTED TO THE DEPARTMENT
PURSUANT TO THIS SUBDIVISION SHALL BE  CONFIDENTIAL  AND  NOT  A  PUBLIC
RECORD AS DEFINED IN SECTION EIGHTY-SIX OF THE PUBLIC OFFICERS LAW. DATA
COMPILED IN AGGREGATE FORM BY THE DEPARTMENT FOR THE PURPOSES OF REPORT-
ING  REQUIRED BY THIS SUBDIVISION SHALL BE A PUBLIC RECORD AS DEFINED IN
SECTION EIGHTY-SIX OF THE PUBLIC OFFICERS LAW, AS LONG AS  IT  DOES  NOT
REVEAL TRADE INFORMATION THAT IS PROTECTED BY STATE OR FEDERAL LAW.
  (F) VIOLATIONS. ANY PERSON WHO VIOLATES ANY PROVISION OF THIS SUBDIVI-
SION  SHALL  BE LIABLE TO THE PEOPLE OF THE STATE FOR A CIVIL PENALTY OF
TEN THOUSAND DOLLARS, PLUS COURT COSTS AND ATTORNEYS' FEES, WHICH  SHALL
BE ENFORCED PURSUANT TO TITLE TWO OF THIS ARTICLE.
  (G)  RULES.  ANY  AND ALL RULES AND REGULATIONS NECESSARY TO IMPLEMENT
THE PROVISIONS OF THIS SUBDIVISION SHALL BE PROMULGATED BY  THE  COMMIS-
SIONER.
  S 3. This act shall take effect on the one hundred eightieth day after
it  shall  have become a law. Effective immediately, any rules and regu-
lations necessary to implement the provisions of this act on its  effec-
tive date are authorized to be made on or before such effective date.