S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   8197
 
                        2023-2024 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             October 27, 2023
                                ___________
 
 Introduced  by M. of A. SOLAGES -- read once and referred to the Commit-
   tee on Health
 
 AN ACT to amend the public health law, in relation to requiring clinical
   trials that apply for state grant funding to make certain  information
   about such clinical trials public
 
   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 9 to read as follows:
                                  TITLE 9
                              CLINICAL TRIALS
 SECTION 269-B.   DEFINITIONS.
         269-C. GRANT REQUIREMENTS.
         269-D. POSTING REQUIREMENTS.
   § 269-B. DEFINITIONS. FOR PURPOSES OF THIS TITLE:
   1. "CLINICAL TRIAL" SHALL HAVE THE SAME MEANING AS SET FORTH IN SUBDI-
 VISION TWO-B OF SECTION FORTY-NINE HUNDRED OF THIS CHAPTER.
   2.  "HEALTH  CARE PROVIDER" SHALL MEAN A PRACTITIONER IN AN INDIVIDUAL
 PRACTICE, GROUP PRACTICE, PARTNERSHIP, PROFESSIONAL CORPORATION OR OTHER
 AUTHORIZED FORM OF ASSOCIATION, A HOSPITAL OR OTHER HEALTH CARE INSTITU-
 TION ISSUED AN OPERATING CERTIFICATE PURSUANT TO  THIS  CHAPTER  OR  THE
 MENTAL  HYGIENE  LAW,  A CERTIFIED HOME HEALTH AGENCY OR A LICENSED HOME
 CARE SERVICES AGENCY, AND ANY OTHER PURVEYOR OF HEALTH OR HEALTH RELATED
 ITEMS OR SERVICES INCLUDING BUT NOT LIMITED TO A CLINICAL LABORATORY,  A
 PHYSIOLOGICAL  LABORATORY,  A  PHARMACY,  A PURVEYOR OF X-RAY OR IMAGING
 SERVICES, A PURVEYOR OF PHYSICAL THERAPY SERVICES, A PURVEYOR OF  HEALTH
 OR  HEALTH  RELATED  SUPPLIES,  APPLIANCES OR EQUIPMENT, OR AN AMBULANCE
 SERVICE.
   § 269-C. GRANT REQUIREMENTS. 1. FOLLOWING THE EFFECTIVE DATE  OF  THIS
 SECTION,  THE COMMISSIONER SHALL REQUIRE ANY SPONSOR OF A CLINICAL TRIAL
 IN THIS STATE, INCLUDING BUT  NOT  LIMITED  TO,  A  PHARMACEUTICAL  DRUG
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD02577-01-3
              

 A. 8197                             2
 
 MANUFACTURER,  PHARMACEUTICAL  DRUG WHOLESALER, ACADEMIC MEDICAL CENTER,
 VOLUNTARY GROUP, FEDERAL AGENCY OR HEALTH CARE  PROVIDER,  THAT  APPLIES
 FOR  A STATE GRANT TO CONDUCT SUCH CLINICAL TRIAL, TO CONSPICUOUSLY POST
 CERTAIN  INFORMATION  ABOUT  SUCH  CLINICAL  TRIAL  ON  THE DEPARTMENT'S
 WEBSITE.
   2. TO THE EXTENT DISCLOSURE IS PERMITTED UNDER FEDERAL LAW, THE INFOR-
 MATION POSTED IN ACCORDANCE WITH SUBDIVISION ONE OF THIS  SECTION  SHALL
 INCLUDE, BUT SHALL NOT BE LIMITED TO, THE FOLLOWING:
   (A)  THE  NAME OF ALL CLINICAL TRIAL SPONSORS, FUNDERS AND MANUFACTUR-
 ERS, INCLUDING THE NAME AND CONTACT INFORMATION, AS WELL AS THE INSTITU-
 TIONAL AFFILIATION, OF ALL SPONSORS, CO-SPONSORS AND ADMINISTRATORS;
   (B) A SUMMARY OF THE PURPOSE OF THE CLINICAL TRIAL, INCLUDING, BUT NOT
 LIMITED TO: (I) THE NAME OF THE PHARMACEUTICAL DRUG BEING TESTED AND ITS
 ACTIVE INGREDIENTS, IF APPLICABLE; (II) THE TYPE OF CLINICAL TRIAL TO BE
 CONDUCTED; (III) THE OVERALL DESIGN OF THE STUDY, INCLUDING THE  STATIS-
 TICAL METHOD TO BE EMPLOYED; (IV) THE STATUS OR PHASE TYPE OF THE TRIAL;
 (V)  THE  INCLUSION  AND  EXCLUSION CRITERIA; (VI) THE TREATMENT METHODS
 USED; (VII) ALL HYPOTHESES TESTED BY THE TRIAL; AND (VIII)  THE  MEDICAL
 CONDITION OR CONDITIONS BEING STUDIED;
   (C) THE START DATE AND END DATE OF THE CLINICAL TRIAL; AND
   (D)  INFORMATION  PERTAINING TO THE CLINICAL TRIAL, INCLUDING, BUT NOT
 LIMITED TO POTENTIAL ADVERSE  EFFECTS  OF  THE  PHARMACEUTICAL  DRUG  OR
 BIOLOGICAL PRODUCT ASSOCIATED WITH THE CLINICAL TRIAL.
   3.  THE  COMMISSIONER SHALL PROMULGATE RULES AND REGULATIONS AS DEEMED
 NECESSARY TO AID IN THE COLLECTION AND POSTING  OF  THE  CLINICAL  TRIAL
 INFORMATION  REQUIRED  PURSUANT  TO  THIS  SECTION AND SHALL MONITOR THE
 DEPARTMENT'S WEBSITE  FOR  COMPLIANCE  WITH  THE  REQUIREMENTS  OF  THIS
 SECTION.
   § 269-D. POSTING REQUIREMENTS. 1. FOLLOWING THE EFFECTIVE DATE OF THIS
 SECTION,  THE COMMISSIONER SHALL REQUIRE ANY HEALTH CARE PROVIDER OFFER-
 ING A CLINICAL TRIAL IN THIS STATE TO CONSPICUOUSLY POST CERTAIN  INFOR-
 MATION ABOUT SUCH CLINICAL TRIAL ON THEIR WEBSITE.
   2. TO THE EXTENT DISCLOSURE IS PERMITTED UNDER FEDERAL LAW, THE INFOR-
 MATION  POSTED  IN ACCORDANCE WITH SUBDIVISION ONE OF THIS SECTION SHALL
 INCLUDE, BUT SHALL NOT BE LIMITED TO, THE FOLLOWING:
   (A) THE THERAPEUTIC INTENT OF THE CLINICAL TRIAL;
   (B) THE NAME OF ALL CLINICAL TRIAL SPONSORS, FUNDERS  AND  MANUFACTUR-
 ERS, INCLUDING THE NAME AND CONTACT INFORMATION, AS WELL AS THE INSTITU-
 TIONAL AFFILIATION, OF ALL SPONSORS, CO-SPONSORS AND ADMINISTRATORS;
   (C) A SUMMARY OF THE PURPOSE OF THE CLINICAL TRIAL, INCLUDING, BUT NOT
 LIMITED TO: (I) THE NAME OF THE PHARMACEUTICAL DRUG BEING TESTED AND ITS
 ACTIVE INGREDIENTS, IF APPLICABLE; (II) THE TYPE OF CLINICAL TRIAL TO BE
 CONDUCTED;  (III) THE OVERALL DESIGN OF THE STUDY, INCLUDING THE STATIS-
 TICAL METHOD TO BE EMPLOYED; (IV) THE STATUS OR PHASE TYPE OF THE TRIAL;
 (V) THE INCLUSION AND EXCLUSION CRITERIA;  (VI)  THE  TREATMENT  METHODS
 USED;  (VII)  ALL HYPOTHESES TESTED BY THE TRIAL; AND (VIII) THE MEDICAL
 CONDITION OR CONDITIONS BEING STUDIED;
   (D) THE START DATE AND END DATE OF THE CLINICAL TRIAL; AND
   (E) INFORMATION PERTAINING TO THE CLINICAL TRIAL, INCLUDING,  BUT  NOT
 LIMITED TO POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE CLINICAL TRIAL.
   § 2. This act shall take effect immediately.