S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   4562
 
                        2017-2018 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             February 3, 2017
                                ___________
 
 Introduced by M. of A. DiPIETRO -- read once and referred to the Commit-
   tee on Health
 
 AN  ACT  to  amend  the  public health law, in relation to disclosure of
   certain gifts provided by drug manufacturers or wholesalers to  health
   care providers
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Article 2 of the public health law is amended by  adding  a
 new title 7 to read as follows:
 
                                 TITLE VII
            NEW YORK STATE PHARMACEUTICAL DRUG MANUFACTURER AND
                         WHOLESALER DISCLOSURE ACT
 SECTION 267.   LEGISLATIVE INTENT.
         267-A. DEFINITIONS.
         267-B. DISCLOSURE REQUIREMENTS.
         267-C. ANNUAL CONSUMER GUIDE ON PHARMACEUTICAL DRUG MANUFACTURER
                  AND WHOLESALER GIFTS TO HEALTH CARE PROVIDERS.
         267-D. PENALTIES.
         267-E. RULES AND REGULATIONS.
   § 267. LEGISLATIVE  INTENT.    THE  LEGISLATURE FINDS THAT THE COST OF
 PRESCRIPTION DRUGS IN THE UNITED STATES HAS GROWN DRAMATICALLY.  ACCORD-
 ING TO THE CENTERS FOR DISEASE CONTROL, SPENDING ON RETAIL  PRESCRIPTION
 DRUGS  IN  THE  UNITED  STATES  MORE  THAN  TRIPLED FROM FIFTEEN BILLION
 DOLLARS IN  NINETEEN  HUNDRED  EIGHTY-TWO  TO  FORTY-EIGHT  BILLION  TWO
 HUNDRED  MILLION  DOLLARS IN NINETEEN HUNDRED NINETY-TWO, THEN MORE THAN
 TRIPLED AGAIN TO ONE HUNDRED  SIXTY-TWO  BILLION  FOUR  HUNDRED  MILLION
 DOLLARS  IN  TWO  THOUSAND TWO. IN PER CAPITA TERMS, RETAIL PRESCRIPTION
 DRUGS SPENDING INCREASED FROM SIXTY-FOUR  DOLLARS  IN  NINETEEN  HUNDRED
 EIGHTY-TWO  TO  FIVE  HUNDRED SIXTY-NINE DOLLARS IN TWO THOUSAND TWO. IN
 TWO THOUSAND FIVE, SPENDING  ON  PHARMACEUTICALS  ROSE  TO  TWO  HUNDRED

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

                                                            LBD05869-01-7

 A. 4562                             2
 
 FIFTY-ONE  BILLION EIGHT HUNDRED MILLION DOLLARS. WHILE THE AVAILABILITY
 OF USEFUL NEW DRUGS TO TREAT CHRONIC CONDITIONS SUCH AS  HEART  DISEASE,
 HYPERTENSION AND DEPRESSION ACCOUNTS FOR MUCH OF THE INCREASED SPENDING,
 THERE  IS  WIDESPREAD  CONCERN  ABOUT THE IMPACT AGGRESSIVE MARKETING BY
 DRUG MANUFACTURERS AND WHOLESALERS HAS HAD ON DRUG COSTS AND PRESCRIBING
 PATTERNS. IN ADDITION TO  THE  EXPLOSIVE  GROWTH  IN  DIRECT-TO-CONSUMER
 ADVERTISING,  THESE  MARKETING EFFORTS ARE OFTEN DIRECTED AT HEALTH CARE
 PROVIDERS AND INCLUDE GIFTS, PARAPHERNALIA, TRIPS AND TRAVEL,  FOOD  AND
 ENTERTAINMENT.  A  COMPETITIVE  MEDIA  REPORTING  STUDY  FOUND THAT DRUG
 COMPANIES PROVIDED SEVEN BILLION TWO HUNDRED MILLION  DOLLARS  WORTH  OF
 FREE SAMPLES TO PHYSICIANS' OFFICES IN NINETEEN HUNDRED NINETY-NINE. THE
 DRUG INDUSTRY SPONSORED MORE THAN THREE HUNDRED FOURTEEN THOUSAND PHYSI-
 CIAN  "EVENTS"  IN  TWO  THOUSAND  ONE,  RANGING FROM CATERED LUNCHES IN
 HOSPITAL CONFERENCE ROOMS TO WEEKEND GETAWAYS AT RESORTS, NEARLY  DOUBLE
 THE  NUMBER  FOUR  YEARS  EARLIER.  DRUG COMPANIES SPENT SOME TWENTY-TWO
 BILLION DOLLARS IN MARKETING IN TWO THOUSAND  THREE.  ACCORDING  TO  THE
 JOURNAL  OF  THE  AMERICAN  MEDICAL  ASSOCIATION, NINETY PERCENT OF DRUG
 COMPANY MARKETING IS DIRECTED AT PHYSICIANS. ESTEEMED  MEDICAL  PUBLICA-
 TIONS  SUCH  AS  THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION AND THE
 BRITISH MEDICAL JOURNAL PRODUCED STUDIES THAT  SUGGEST  THESE  MARKETING
 ACTIVITIES DO INFLUENCE HEALTH CARE PROVIDERS' DECISIONS ON PRESCRIPTION
 DRUGS, AND IN WAYS THAT ARE NOT THE BEST FOR PATIENTS OR THE HEALTH CARE
 SYSTEM  ITSELF.  THE  LEGISLATURE RECOGNIZES THAT DRUG MANUFACTURERS AND
 WHOLESALERS ARE FREE TO USE ANY LEGAL SALES AND MARKETING TECHNIQUES  TO
 PROMOTE  THEIR PRODUCTS. BUT THE LEGISLATURE ALSO FINDS THAT THE CONSUM-
 ERS HAVE A RIGHT TO KNOW WHAT GIFTS, IF ANY, THEIR HEALTH CARE PROVIDERS
 ARE RECEIVING FROM MANUFACTURERS AND WHOLESALERS,  IN  ORDER  THAT  THEY
 MIGHT   MAKE   INFORMED   AND   COST-EFFECTIVE   DECISIONS  ABOUT  THEIR
 PRESCRIPTION DRUG EXPENDITURES.
   § 267-A. DEFINITIONS. AS USED IN THIS TITLE, THE FOLLOWING TERMS SHALL
 HAVE THE FOLLOWING MEANINGS:
   1. "APPROVED CLINICAL TRIAL" MEANS A  CLINICAL  TRIAL  THAT  HAS  BEEN
 APPROVED  BY  THE  U.S.  FOOD  AND DRUG ADMINISTRATION (FDA) OR HAS BEEN
 APPROVED BY A DULY CONSTITUTED INSTITUTIONAL REVIEW  BOARD  (IRB)  AFTER
 REVIEWING  AND  EVALUATING  IT  IN  ACCORDANCE  WITH  THE  HUMAN SUBJECT
 PROTECTION STANDARDS SET FORTH AT 21 C.F.R. PART 50, 45 C.F.R. PART  46,
 OR AN EQUIVALENT SET OF STANDARDS OF ANOTHER FEDERAL AGENCY.
   2.  "BONA  FIDE  CLINICAL TRIAL" MEANS AN APPROVED CLINICAL TRIAL THAT
 CONSTITUTES "RESEARCH" AS THAT TERM IS DEFINED IN  45  C.F.R.  §  46.102
 WHEN THE RESULTS OF THE RESEARCH CAN BE PUBLISHED FREELY BY THE INVESTI-
 GATOR  AND  REASONABLY CAN BE CONSIDERED TO BE OF INTEREST TO SCIENTISTS
 OR MEDICAL PRACTITIONERS WORKING IN THE PARTICULAR FIELD OF INQUIRY.
   3. "CLINICAL TRIAL" MEANS ANY STUDY ASSESSING THE SAFETY  OR  EFFICACY
 OF  DRUGS ADMINISTERED ALONE OR IN COMBINATION WITH OTHER DRUGS OR OTHER
 THERAPIES, OR ASSESSING THE RELATIVE SAFETY  OR  EFFICACY  OF  DRUGS  IN
 COMPARISON WITH OTHER DRUGS OR OTHER THERAPIES.
   4.  "DRUGS"  SHALL  HAVE  THE SAME MEANING AS SET FORTH IN SUBDIVISION
 SEVEN OF SECTION SIX THOUSAND EIGHT HUNDRED TWO OF THE EDUCATION LAW.
   5. "HEALTH CARE PROVIDER" MEANS ANY PHYSICIAN OR OTHER PERSON  WHO  IS
 LEGALLY AUTHORIZED TO PRESCRIBE DRUGS.
   6.  "PHARMACEUTICAL  DRUG  MANUFACTURER" MEANS A PERSON WHO COMPOUNDS,
 MIXES, PREPARES, PRODUCES AND BOTTLES OR PACKS DRUGS FOR THE PURPOSE  OF
 DISTRIBUTING  OR  SELLING TO PHARMACIES OR TO OTHER CHANNELS OF DISTRIB-
 UTION.
   7. "PHARMACEUTICAL DRUG WHOLESALER" MEANS A PERSON WHOSE PRIMARY BUSI-
 NESS PURPOSE IS TO BOTTLE, PACK OR PURCHASE DRUGS  FOR  THE  PURPOSE  OF

 A. 4562                             3
 
 SELLING  OR  RESELLING TO PHARMACIES OR TO OTHER CHANNELS AS PROVIDED IN
 THIS TITLE.
   8.  "PHARMACY" SHALL HAVE THE SAME MEANING AS SET FORTH IN SUBDIVISION
 ONE OF SECTION SIX THOUSAND EIGHT HUNDRED TWO OF THE EDUCATION LAW.
   9. "UNRESTRICTED GRANT" MEANS ANY GIFT,  PAYMENT,  SUBSIDY,  OR  OTHER
 ECONOMIC  BENEFIT  TO  AN  EDUCATIONAL INSTITUTION, PROFESSIONAL ASSOCI-
 ATION, HEALTH CARE FACILITY,  OR  GOVERNMENTAL  ENTITY  WHICH  DOES  NOT
 IMPOSE  ANY  RESTRICTIONS  ON  THE  USE  OF THE GRANT, SUCH AS FAVORABLE
 TREATMENT OF A CERTAIN PRODUCT OR AN ABILITY OF THE MARKETER TO  CONTROL
 OR INFLUENCE THE PLANNING, CONTENT, OR EXECUTION OF THE EDUCATION ACTIV-
 ITY.
   §  267-B. DISCLOSURE REQUIREMENTS. 1. ANY PHARMACEUTICAL DRUG MANUFAC-
 TURER OR PHARMACEUTICAL DRUG WHOLESALER, INCLUDING ANY EMPLOYEE OR AGENT
 OF SUCH MANUFACTURER OR WHOLESALER, THAT MAKES ANY GIFT WHETHER  IN  THE
 FORM  OF MONEY, SERVICE, LOAN, TRAVEL, ENTERTAINMENT, HOSPITALITY, THING
 OR PROMISE, OR IN ANY OTHER FORM, TO A HEALTH CARE PROVIDER SHALL REPORT
 THE GIFT TO THE COMMISSIONER IN THE MANNER SET FORTH IN SUBDIVISION  TWO
 OF THIS SECTION.
   2.  ANY PHARMACEUTICAL DRUG MANUFACTURER OR PHARMACEUTICAL DRUG WHOLE-
 SALER WHO MAKES AT LEAST ONE GIFT UNDER SUBDIVISION ONE OF THIS  SECTION
 SHALL  FILE  WITH  THE  COMMISSIONER AN ANNUAL REPORT, DUE NO LATER THAN
 JUNE FIRST OF EACH YEAR, BEGINNING IN TWO THOUSAND FIFTEEN, OF ALL GIFTS
 MADE BY THE MANUFACTURER OR WHOLESALER TO HEALTH CARE PROVIDERS.
   3. SUCH ANNUAL REPORT SHALL CONTAIN: (A) THE NAME, ADDRESS  AND  TELE-
 PHONE  NUMBER OF THE PHARMACEUTICAL DRUG MANUFACTURER OR WHOLESALER; (B)
 AN ITEMIZED LIST CONTAINING A DESCRIPTION OF  EACH  GIFT  FALLING  UNDER
 SUBDIVISION  ONE  OF  THIS  SECTION  AND THE NAME, ADDRESS AND TELEPHONE
 NUMBER OF THE HEALTH CARE PROVIDER WHO RECEIVED EACH GIFT; (C) THE MONE-
 TARY VALUE OF EACH GIFT; AND (D) SUCH OTHER INFORMATION AS DEEMED NECES-
 SARY BY THE COMMISSIONER FOR COMPLIANCE WITH THIS ARTICLE.
   4. THE FOLLOWING SHALL BE EXEMPT FROM DISCLOSURE:
   (A) THE  PAYMENT  OF  REASONABLE  COMPENSATION  AND  REIMBURSEMENT  OF
 EXPENSES IN CONNECTION WITH BONA FIDE CLINICAL TRIALS;
   (B) ANY GIFT THE VALUE OF WHICH IS LESS THAN SEVENTY-FIVE DOLLARS;
   (C)  SCHOLARSHIP  OR OTHER SUPPORT FOR MEDICAL STUDENTS, RESIDENTS AND
 FELLOWS TO ATTEND A SIGNIFICANT EDUCATIONAL, SCIENTIFIC, OR  POLICY-MAK-
 ING  CONFERENCE  OF  A NATIONAL, REGIONAL, OR SPECIALTY MEDICAL OR OTHER
 PROFESSIONAL ASSOCIATION IF THE RECIPIENT OF THE  SCHOLARSHIP  OR  OTHER
 SUPPORT IS SELECTED BY THE ASSOCIATION;
   (D) UNRESTRICTED GRANTS FOR CONTINUING MEDICAL EDUCATION PROGRAMS;
   (E) PRESCRIPTION DRUG REBATES AND DISCOUNTS; AND
   (F) FREE SAMPLES OF DRUGS.
   § 267-C. ANNUAL CONSUMER GUIDE ON PHARMACEUTICAL DRUG MANUFACTURER AND
 WHOLESALER  GIFTS  TO  HEALTH CARE PROVIDERS. 1. NO LATER THAN SEPTEMBER
 FIRST OF EACH YEAR, BEGINNING IN TWO THOUSAND FIFTEEN, THE  COMMISSIONER
 SHALL  PUBLISH  AND  MAKE  AVAILABLE,  FREE  OF  CHARGE TO THE PUBLIC, A
 CONSUMER GUIDE ON GIFTS PROVIDED BY  PHARMACEUTICAL  DRUG  MANUFACTURERS
 AND  WHOLESALERS  TO HEALTH CARE PROVIDERS. SUCH GUIDE SHALL CONTAIN ALL
 OF THE INFORMATION PROVIDED IN THE ANNUAL REPORT REQUIRED BY SECTION TWO
 HUNDRED SIXTY-SEVEN-B OF THIS TITLE AND THE INFORMATION SHALL BE WRITTEN
 IN PLAIN LANGUAGE IN A CLEAR AND UNDERSTANDABLE FORMAT.
   2. THE COMMISSIONER SHALL PROVIDE FOR THE  ADEQUATE  DISTRIBUTION  AND
 AVAILABILITY  OF  THE CONSUMER GUIDE ON PHARMACEUTICAL DRUG MANUFACTURER
 AND WHOLESALER GIFTS TO HEALTH CARE PROVIDERS.   APPROPRIATE  COPIES  OF
 THE  GUIDE SHALL BE TRANSMITTED TO THE OFFICE FOR THE AGING FOR DISTRIB-
 UTION AT EVERY OFFICE FOR THE AGING IN THE STATE, TO EVERY COUNTY OFFICE

 A. 4562                             4

 FOR THE AGING IN THE STATE AND TO  THE  COMMISSIONER  OF  EDUCATION  FOR
 DISTRIBUTION  TO  EVERY  PUBLIC LIBRARY IN THE STATE WHERE COPIES OF THE
 GUIDE SHALL BE MADE AVAILABLE FREE OF CHARGE TO THE PUBLIC. THE  COMMIS-
 SIONER SHALL ALSO POST THE GUIDE ON THE DEPARTMENT'S INTERNET WEBSITE.
   §  267-D.  PENALTIES.   1. THE COMMISSIONER MAY IMPOSE A CIVIL PENALTY
 FOR FAILURE TO FILE A TIMELY REPORT AS REQUIRED BY SECTION  TWO  HUNDRED
 SIXTY-SEVEN-B OF THIS TITLE IN AN AMOUNT UP TO FIFTY DOLLARS A DAY UNTIL
 SUCH REPORT IS FILED OR THREE THOUSAND DOLLARS, WHICHEVER IS LESS.
   2.  ANY PERSON WHO VIOLATES ANY OTHER PROVISION OF THIS TITLE SHALL BE
 SUBJECT TO A CIVIL PENALTY IN AN AMOUNT NOT  TO  EXCEED  THREE  THOUSAND
 DOLLARS FOR EACH VIOLATION. THE COMMISSIONER IS AUTHORIZED TO ASSESS THE
 CIVIL  PENALTY  UNDER  THIS  SECTION  PURSUANT TO SECTION TWELVE OF THIS
 CHAPTER.
   § 267-E. RULES AND REGULATIONS.  THE  COMMISSIONER  IS  AUTHORIZED  TO
 PROMULGATE  RULES  AND  REGULATIONS AS DEEMED NECESSARY TO CARRY OUT AND
 ENFORCE THE PROVISIONS OF THIS TITLE.
   § 2. This act shall take effect on the first of January next  succeed-
 ing the date on which it shall have become a law.