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

                                   643

                       2009-2010 Regular Sessions

                          I N  A S S E M B L Y

                               (PREFILED)

                             January 7, 2009
                               ___________

Introduced by M. of A. JACOBS, GOTTFRIED, ORTIZ, LENTOL, BOYLAND, CLARK,
  MARKEY,  BENEDETTO,  ENGLEBRIGHT, HOYT, KAVANAGH -- Multi-Sponsored by
  -- M. of A. BRENNAN, COLTON, HOOPER, JOHN,  LAVINE,  LIFTON,  LUPARDO,
  McENENY,  MOLINARO,  PERRY,  PHEFFER,  N. RIVERA, ROBINSON, ROSENTHAL,
  WEINSTEIN, WEISENBERG -- read once and referred to  the  Committee  on
  Health

AN  ACT  to  amend  the  public health law, in relation to requiring all
  clinical trials and studies on pharmaceuticals to be posted for public
  access; and to amend chapter 58 of the  laws  of  2005,  amending  the
  public  health  law  and other laws relating to implementing the state
  fiscal plan for the 2005-2006 fiscal year, in relation to  the  effec-
  tiveness thereof

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1.  Legislative intent. In an effort to promote  full  disclo-
sure  to  patients  about  possible  long and short term side effects of
pharmaceuticals, as well as the possible interactions with other pharma-
ceuticals, to promote patients' involvement in health care decisions and
to promote informed consultation with their physician  or  other  health
care  practitioner,  the  legislature,  in  its  role  as  purchaser  of
prescription drugs and  administrator  of  prescription  drug  programs,
hereby  deems it in the public interest to require pharmaceutical compa-
nies that market their pharmaceuticals in New York state,  to  post  the
results  of  all  clinical  trials and studies regarding such pharmaceu-
ticals on the department's website.
  S 2. Section 270 of the public health law is amended by adding two new
subdivisions 14 and 15 to read as follows:
  14. "PHARMACEUTICAL CLINICAL TRIAL"  OR  "CLINICAL  TRIAL"  MEANS  ANY
MEDICAL  AND SCIENTIFIC EVIDENCE RELATING TO THE SAFETY OR EFFICACY OF A
DRUG, WHETHER OR NOT COMPLETED IN FULL, INCLUDING BUT NOT LIMITED TO:

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

                                                           LBD02155-01-9

A. 643                              2

  (I) A CLINICAL INVESTIGATION THAT INVOLVES ANY TRIAL TO TEST THE SAFE-
TY OR EFFICACY OF A PRESCRIPTION DRUG WITH ONE OR  MORE  HUMAN  SUBJECTS
AND  THAT IS INTENDED TO BE SUBMITTED TO, OR HELD FOR INSPECTION BY, THE
FEDERAL FOOD AND DRUG ADMINISTRATION (FDA) AS PART  OF  ANY  APPLICATION
FOR A RESEARCH OR MARKETING PERMIT OR FOR ANY OTHER TYPE OF APPLICATION,
PERMIT,  PROCEDURE  OR REQUIREMENT OF THE FDA, INCLUDING BUT NOT LIMITED
TO AN ABBREVIATED NEW DRUG  APPLICATION,  AN  INVESTIGATIONAL  NEW  DRUG
APPLICATION,  A  NEW DRUG APPLICATION, NON-CONFIDENTIAL ADDITIONS TO THE
DRUG MASTER FILE, POSTMARKETING ADVERSE EVENTS RECORDING, OR  COMPLIANCE
WITH THE ELECTRONIC OR PAPER COMMON TECHNICAL DOCUMENT; AND
  (II) ANY PHARMACOLOGICAL STUDY SUBSEQUENT TO INITIAL APPROVAL FOR SALE
BY  THE  FDA,  INCLUDING  STUDIES ASSESSING POTENTIAL OFF-LABEL APPLICA-
TIONS, NEW THERAPIES, NEW WAYS OF USING KNOWN TREATMENTS AND COMPARATIVE
DRUG TRIALS ASSESSING THE EFFICACY OR SAFETY OF A DRUG COMPARED TO OTHER
THERAPIES.
  15. "MANUFACTURER" MEANS A MANUFACTURER OF PRESCRIPTION  DRUGS  OR  AN
AFFILIATE OF SUCH MANUFACTURER.
  S  3.  The public health law is amended by adding a new section 279 to
read as follows:
  S 279. CLINICAL TRIAL REGISTRY. 1. THERE  IS  HEREBY  CREATED  IN  THE
DEPARTMENT  THE  NEW  YORK STATE CLINICAL TRIAL REGISTRY (REFERRED TO IN
THIS SECTION AS THE "REGISTRY"). THE PURPOSE OF THE REGISTRY SHALL BE TO
SERVE AS A COMPREHENSIVE REPOSITORY OF INFORMATION REGARDING  ALL  CLIN-
ICAL  TRIALS  OF  PRESCRIPTION DRUGS SOLD, DELIVERED, DISPENSED, OFFERED
FOR SALE OR GIVEN AWAY IN THIS STATE, INCLUDING  INFORMATION  ABOUT  THE
RESULTS OF SUCH TRIALS, REGARDLESS OF OUTCOME.
  2.  ALL  INFORMATION IN THE REGISTRY SHALL BE MADE PUBLICLY AVAILABLE,
INCLUDING ON THE INTERNET. THE DEPARTMENT MAY  ESTABLISH  A  LINK  TO  A
WEBSITE  HOSTED  BY THE NATIONAL INSTITUTE OF HEALTH, AS LONG AS IT IS A
FREE,  NON-SUBSCRIPTION  SITE  THAT  PROVIDES  ALL  OF  THE  INFORMATION
REQUIRED  IN  SUBDIVISION FOUR OF THIS SECTION AND IS IN CONFORMITY WITH
ANY ADDITIONAL REGULATIONS ADOPTED BY THE DEPARTMENT.
  3. THE MANUFACTURER OF EVERY PHARMACEUTICAL DRUG MARKETED  OR  OFFERED
FOR  SALE  IN  NEW  YORK  STATE  SHALL SUBMIT ALL MEDICAL AND SCIENTIFIC
EVIDENCE AND INFORMATION FROM CLINICAL TRIALS REGARDING THE PRESCRIPTION
DRUG TO THE NEW YORK STATE CLINICAL TRIAL REGISTRY. TO THE  EXTENT  THAT
DISCLOSURE  IS  PERMITTED UNDER FEDERAL LAW, THE REGISTRY SHALL INCLUDE,
BUT NOT BE LIMITED TO, THE FOLLOWING INFORMATION:
  (A) NAME OF ALL MANUFACTURERS, FUNDERS AND  CLINICAL  TRIAL  SPONSORS,
INCLUDING THE NAME AND CONTACT INFORMATION, AS WELL AS THE INSTITUTIONAL
AFFILIATION OF ALL SPONSORS, CO-SPONSORS AND ADMINISTRATORS;
  (B)  SUMMARY  OF THE PURPOSE OF THE CLINICAL TRIAL, INCLUDING THE NAME
OF THE DRUG BEING TESTED AND ITS ACTIVE INGREDIENTS, OVERALL  DESIGN  OF
THE  STUDY,  INCLUDING  STATISTICAL  METHOD TO BE EMPLOYED, STATUS/PHASE
TYPE OF THE TRIAL, INCLUSION AND EXCLUSION CRITERIA,  TREATMENT  METHODS
USED,  ALL  HYPOTHESES  TESTED  BY  THE  TRIAL, THE MEDICAL CONDITION OR
CONDITIONS BEING STUDIED AND OUTCOMES THAT WERE EVALUATED;
  (C) START AND END DATE OF TRIAL;
  (D) INFORMATION PERTAINING TO  THE  RESULTS  OF  THE  CLINICAL  TRIAL,
INCLUDING,  BUT  NOT  LIMITED TO, POTENTIAL OR ACTUAL ADVERSE EFFECTS OF
THE DRUG OR BIOLOGICAL  PRODUCT  ASSOCIATED  WITH  THE  CLINICAL  TRIAL,
INCLUDING  THE FREQUENCY, SEVERITY, AND NATURE OF ADVERSE EVENTS FOR ANY
TRIAL PARTICIPANT, AND THE  NUMBERS  OF  PARTICIPANTS  WHO  DISCONTINUED
PARTICIPATION IN THE TRIAL AND THE REASONS FOR DISCONTINUANCE; AND

A. 643                              3

  (E)  ANY  OTHER INFORMATION DETERMINED BY THE COMMISSIONER TO BE RELE-
VANT TO ENSURE THE SAFETY OF PRESCRIPTION DRUGS PURCHASED BY  THE  STATE
OR WITH STATE FUNDS.
  4. THE COMMISSIONER SHALL:
  (A)  COLLECT AND HAVE POSTED SUCH RESULTS, DATING BACK TO ALL CLINICAL
TRIALS COMPLETED OR TERMINATED ON  AND  AFTER  JANUARY  FIRST,  NINETEEN
HUNDRED   NINETY,  INCLUDING  ANY  CLINICAL  TRIALS  COMPLETED  AFTER  A
PRESCRIPTION DRUG HAS BEEN APPROVED FOR SALE BY  THE  FEDERAL  FOOD  AND
DRUG ADMINISTRATION (FDA) OR ITS SUCCESSOR AGENCY;
  (B)  MONITOR  SUCH  WEBSITE  FOR  COMPLIANCE  WITH THE REQUIREMENTS OF
SUBDIVISION THREE OF THIS SECTION; AND
  (C) ENSURE PUBLIC ACCESS THROUGH PUBLIC SERVICE ANNOUNCEMENTS.
  5. NO PHARMACEUTICAL DRUG MAY BE SOLD OR  OFFERED  FOR  SALE  IN  THIS
STATE UNLESS THE MANUFACTURER OF THE PRESCRIPTION DRUG HAS COMPLIED WITH
THIS SECTION.  THIS SUBDIVISION SHALL NOT APPLY TO ANY PRESCRIPTION DRUG
THAT  HAS  BEEN SOLD IN THIS STATE PRIOR TO ONE YEAR AFTER THE EFFECTIVE
DATE OF THIS SECTION. DISCLOSURE SHALL OCCUR IN THE FOLLOWING INSTANCES:
  (A) NEW DRUG APPLICATIONS, WITHIN SIXTY DAYS OF APPROVAL BY THE FDA OR
WITHIN NINETY DAYS OF THE EFFECTIVE DATE OF THIS SECTION,  WHICHEVER  IS
LATER;
  (B)  A  DRUG THAT HAS BEEN APPROVED FOR SALE BY THE FDA, WITHIN NINETY
DAYS AFTER THE COMPLETION OR TERMINATION OF THE CLINICAL TRIAL; OR WITH-
IN NINETY DAYS OF THE EFFECTIVE  DATE  OF  THIS  SECTION,  WHICHEVER  IS
LATER;
  (C)  DISCONTINUED  TRIALS,  SUCH  AS THOSE STOPPED FOR SAFETY REASONS,
INFORMATION SHALL BE POSTED WITHIN THIRTY DAYS OF THE TERMINATION OF THE
TRIAL OR WITHIN NINETY DAYS OF  THE  EFFECTIVE  DATE  OF  THIS  SECTION,
WHICHEVER IS EARLIER.
  6. MANUFACTURERS MAY APPLY TO THE COMMISSIONER FOR AN EXTENSION OF SIX
MONTHS IF THEY CAN DOCUMENT THAT THE CLINICAL TRIAL WILL BE PUBLISHED IN
A  PEER-REVIEWED  MEDICAL  JOURNAL  AND THAT PUBLICATION ON THE CLINICAL
TRIAL REGISTRY WILL VIOLATE THE TERMS OF SUCH PUBLICATION.  THE  COMMIS-
SIONER  SHALL USE HIS OR HER DISCRETION TO APPROVE OR DENY THIS APPLICA-
TION; HOWEVER, IN THE EVENT OF INFORMATION VITAL TO THE  PUBLIC  SAFETY,
THE  APPLICATION  SHALL BE DENIED. EXTENSIONS SHALL BE RESTRICTED TO ONE
FOR EACH CLINICAL TRIAL.
  7. NOTWITHSTANDING SECTION TWELVE OF THIS CHAPTER, THE ATTORNEY GENER-
AL SHALL HAVE THE AUTHORITY TO BRING AN  ACTION  TO  ENFORCE  COMPLIANCE
WITH THIS SECTION WITHOUT REFERRAL BY THE COMMISSIONER.
  8.  THE COMMISSIONER MAY GRANT A WAIVER TO PERMIT SALE OR OFFERING FOR
SALE OF A PRESCRIPTION DRUG, WHERE THE MANUFACTURER OF THE  PRESCRIPTION
DRUG HAS NOT COMPLIED WITH THIS SECTION. A WAIVER UNDER THIS SUBDIVISION
SHALL  BE  BASED  ON  A FINDING BY THE COMMISSIONER THAT SPECIAL CIRCUM-
STANCES REQUIRE THE WAIVER IN ORDER TO PROTECT THE HEALTH OF  A  PATIENT
OR  PATIENTS.  THE  WAIVER  MAY  BE SOUGHT BY A HEALTH CARE PRACTITIONER
SEEKING TO PRESCRIBE THE PRESCRIPTION DRUG OR A PATIENT TO WHOM A HEALTH
CARE PRACTITIONER HAS PRESCRIBED THE PRESCRIPTION DRUG.  THE COMMISSION-
ER SHALL APPROPRIATELY LIMIT THE  EXTENT  OF  THE  WAIVER  AS  TO  TIME,
CIRCUMSTANCES,  CLASS OF HEALTH CARE PRACTITIONERS OR PATIENTS, OR INDI-
VIDUAL HEALTH CARE PRACTITIONER OR PATIENT. THE WAIVER SHALL BE IN WRIT-
ING, SHALL SPECIFICALLY STATE THE FINDINGS ON WHICH  IT  IS  BASED,  AND
SHALL BE A PUBLIC DOCUMENT, PROVIDED THAT ANY DISCLOSURE OF THE DOCUMENT
SHALL  INCLUDE  APPROPRIATE  REDACTION OF INDIVIDUAL PATIENT IDENTIFYING
INFORMATION AND TRADE SECRET  INFORMATION  THAT  WOULD  BE  EXEMPT  FROM
DISCLOSURE UNDER THE FEDERAL OR STATE FREEDOM OF INFORMATION LAW.

A. 643                              4

  9.  THE COMMISSIONER SHALL PROMULGATE RULES AND REGULATIONS TO PREVENT
THE  DISCLOSURE OF ANY TRADE SECRETS RESULTING FROM THE OPERATION OF THE
CLINICAL TRIAL REGISTRY.
  S  4. Reporting requirements. The commissioner of health shall make an
annual report to the legislature of his or her findings and  recommenda-
tions concerning the effectiveness, impact and benefits derived from the
posting of pharmaceutical clinical trials and studies as provided for in
this  act.  Such report shall be delivered on or before the first day of
March and shall contain evaluations of the policies and any  legislation
deemed necessary and proper.
  S  5.  Subdivision 1 of section 79 of part C of chapter 58 of the laws
of 2005, amending the public health  law  and  other  laws  relating  to
implementing  the  state  fiscal  plan for the 2005-2006 fiscal year, is
amended to read as follows:
  1. sections ten through fifteen of this act shall expire and be deemed
repealed on and after June 15, 2012; PROVIDED, HOWEVER, THAT SECTION 270
OF THE PUBLIC HEALTH LAW, AS ADDED BY SECTION TEN OF THIS ACT, SHALL NOT
EXPIRE OR BE DEEMED REPEALED;
  S 6. This act shall take effect immediately; provided,  however,  that
the  amendments  to article 2-A of the public health law made by section
three of this act shall survive the repeal of such article, as  provided
in  section  79 of part C of chapter 58 of the laws of 2005, as amended.
Effective immediately, the addition, amendment and/or repeal of any rule
or regulation necessary for the implementation of this act on its effec-
tive date are authorized and directed to be made  and  completed  on  or
before such effective date.