Senate Bill S6103

2019-2020 Legislative Session

Relates to advertising by drug manufacturers and the disclosure of clinical trials

download bill text pdf

Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Date of Action	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 08, 2020	referred to health
May 16, 2019	referred to health

2019-S6103 (ACTIVE) - Details

Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §277-a, Pub Health L

2019-S6103 (ACTIVE) - Summary

Relates to advertising by drug manufacturers and the disclosure of clinical trials; defines terms; regulates advertisements; requires the disclosure of clinical trials of prescription drugs

2019-S6103 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S6103

SPONSOR: CARLUCCI
 
TITLE OF BILL:

An act to amend the public health law, in relation to advertising by
drug manufacturers and the disclosure of clinical trials

 
PURPOSE OR GENERAL IDEA OF BILL:

Establishes regulations regarding the advertising of pharmaceutical
drugs and requires that the Department of Health submit a report to the
Legislature.

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1: This bill requires the Department of Health to adopt rules
incorporating by reference federal laws and regulations concerning
misbranded drugs and devices and prescription drug advertising.

The bill also requires drug manufacturers to provide information

concerning clinical trials of prescription drugs advertised in the
State, provides immunity for disclosure of that information, directs the
department to maintain this information on an Internet website and
enables the department to collect a fee from manufacturers to support a
clinical trial database.

Section 2: Report. By January 15, 2021, the department of health shall
report to the Legislature matters on the completeness and ease of public
access to information provided by the drug manufacturers and the need
for further action or legislation.

Section 3: Effective Date.

 
JUSTIFICATION:

Direct-to-consumer pharmaceutical advertising (DTCPA) has grown rapidly
during the past several decades and is now the most prominent type of
health communication that the public encounters. The FDA regulates
DTCPA, but critics say that the rules are too relaxed and inadequately
enforced. Although only limited data exist, research suggests that DTCPA
is both beneficial and detrimental to the public health. The number of
arguments that favor or oppose DTCPA is fairly evenly balanced, and
viewpoints presented by both sides can he supported with evidence.
Although there have been calls to ban or severely curtail consumer drug
advertising, remedies to maximize the benefits and minimize the risks of
DTCPA are more frequently suggested.

 
PRIOR LEGISLATIVE HISTORY:

New Legislation

 
FISCAL IMPLICATIONS:

 
EFFECTIVE DATE:
This act shall take effect on the one hundred eightieth day after it
shall have become a law. Effective immediately, the addition, amendment
and/or repeal of any rule or regulation necessary for the implementation
of this act on its effective date are authorized to be made and
completed on or before such effective date.

2019-S6103 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   6103
 
                        2019-2020 Regular Sessions
 
                             I N  S E N A T E
 
                               May 16, 2019
                                ___________
 
 Introduced  by Sen. CARLUCCI -- read twice and ordered printed, and when
   printed to be committed to the Committee on Health
 
 AN ACT to amend the public health law, in  relation  to  advertising  by
   drug manufacturers and the disclosure of clinical trials
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. The public health law is amended by adding  a  new  section
 277-a to read as follows:
   §  277-A.  PROHIBITIONS  AND  REQUIRED  DISCLOSURES; PRESCRIPTION DRUG
 ADVERTISING. 1. DEFINITIONS. AS USED IN THIS SECTION, UNLESS THE CONTEXT
 OTHERWISE INDICATES, THE FOLLOWING TERMS SHALL HAVE THE FOLLOWING  MEAN-
 INGS:
   (A)  "CLINICAL TRIAL" MEANS A CLINICAL INVESTIGATION AS DEFINED BY THE
 FEDERAL FOOD AND DRUG ADMINISTRATION THAT INVOLVES ANY TRIAL TO TEST THE
 SAFETY OR EFFICACY OF A DRUG OR BIOLOGICAL  PRODUCT  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 AS  PART  OF  AN
 APPLICATION FOR A RESEARCH OR MARKETING PERMIT.
   (B)  "MANUFACTURER  OF  PRESCRIPTION  DRUGS" OR "MANUFACTURER" MEANS A
 MANUFACTURER OF PRESCRIPTION DRUGS OR BIOLOGICAL PRODUCTS OR  AN  AFFIL-
 IATE  OF  THE MANUFACTURER OR A LABELER THAT RECEIVES PRESCRIPTION DRUGS
 OR BIOLOGICAL PRODUCTS FROM A MANUFACTURER OR WHOLESALER AND  REPACKAGES
 THOSE  DRUGS OR BIOLOGICAL PRODUCTS FOR LATER RETAIL SALE AND THAT HAS A
 LABELER CODE FROM THE FEDERAL FOOD AND DRUG ADMINISTRATION UNDER 21 CODE
 OF FEDERAL REGULATIONS, 2027.20 (1999).
   (C) "REGULATED ADVERTISEMENT" MEANS THE PRESENTATION  TO  THE  GENERAL
 PUBLIC  OF A COMMERCIAL MESSAGE REGARDING A PRESCRIPTION DRUG OR BIOLOG-
 ICAL PRODUCT BY A MANUFACTURER OF PRESCRIPTION DRUGS THAT IS:
   (I) BROADCAST ON TELEVISION OR RADIO FROM A STATION THAT IS PHYSICALLY
 LOCATED IN THE STATE;
   (II) BROADCAST OVER THE INTERNET FROM A LOCATION IN THE STATE; OR
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.

                                                            LBD11791-01-9

 S. 6103                             2
 
   (III) PRINTED IN MAGAZINES OR NEWSPAPERS THAT ARE PRINTED, DISTRIBUTED
 OR SOLD IN THE STATE.
   2.  REGULATED  ADVERTISEMENT REQUIREMENT. BEGINNING OCTOBER FIFTEENTH,
 TWO THOUSAND TWENTY, A MANUFACTURER MAY  NOT  PRESENT  OR  CAUSE  TO  BE
 PRESENTED IN THE STATE A REGULATED ADVERTISEMENT, UNLESS SUCH ADVERTISE-
 MENT  MEETS THE REQUIREMENTS CONCERNING MISBRANDED DRUGS AND DEVICES AND
 PRESCRIPTION DRUG ADVERTISING OF FEDERAL LAW AND  REGULATIONS  UNDER  21
 UNITED STATES CODE, SECTIONS 331 AND 352(N) AND 21 CODE OF FEDERAL REGU-
 LATIONS, PART 202 AND STATE RULES AND REGULATIONS.
   3.  DISCLOSURE  OF  CLINICAL  TRIALS  OF PRESCRIPTION DRUGS. BEGINNING
 OCTOBER FIFTEENTH, TWO THOUSAND TWENTY, A  MANUFACTURER  OR  LABELER  OF
 PRESCRIPTION  DRUGS  THAT  IS  REQUIRED  TO  REPORT  MARKETING COSTS FOR
 PRESCRIPTION DRUGS SHALL POST, WITH REGARD TO SUCH  PRESCRIPTION  DRUGS,
 ON  THE  PUBLICLY  ACCESSIBLE  INTERNET  WEBSITE OF THE FEDERAL NATIONAL
 INSTITUTES OF HEALTH OR ITS SUCCESSOR AGENCY OR ANOTHER PUBLICLY  ACCES-
 SIBLE  WEBSITE  THE  FOLLOWING INFORMATION CONCERNING ANY CLINICAL TRIAL
 THAT THE  MANUFACTURER  CONDUCTED  OR  SPONSORED  ON  OR  AFTER  OCTOBER
 FIFTEENTH, TWO THOUSAND NINETEEN:
   (A)  THE  NAME OF THE ENTITY THAT CONDUCTED OR IS CONDUCTING THE CLIN-
 ICAL TRIAL;
   (B) A SUMMARY OF THE PURPOSE OF THE CLINICAL TRIAL;
   (C) THE DATES DURING WHICH THE TRIAL IS TAKING OR HAS TAKEN PLACE; AND
   (D) INFORMATION CONCERNING THE RESULTS OF THE CLINICAL TRIAL,  INCLUD-
 ING POTENTIAL OR ACTUAL ADVERSE EFFECTS OF THE DRUG.
   IN ORDER TO SATISFY THE REQUIREMENTS OF THIS SUBDIVISION, THE PUBLICLY
 ACCESSIBLE  WEBSITE  AND  MANNER  OF  POSTING SHALL BE ACCEPTABLE TO THE
 DEPARTMENT.
   4. FEES. BEGINNING APRIL FIRST, TWO THOUSAND TWENTY-ONE, EACH MANUFAC-
 TURER OF PRESCRIPTION DRUGS THAT ARE PROVIDED TO PERSONS THROUGH A STATE
 PUBLIC HEALTH PLAN AS DEFINED  IN  SUBDIVISION  ELEVEN  OF  SECTION  TWO
 HUNDRED  SEVENTY OF THIS ARTICLE SHALL PAY A FEE OF ONE THOUSAND DOLLARS
 PER CALENDAR YEAR TO THE DEPARTMENT. FEES COLLECTED UNDER THIS  SUBDIVI-
 SION  SHALL  BE  USED  TO COVER THE COST OF OVERSEEING IMPLEMENTATION OF
 THIS SECTION, INCLUDING BUT NOT LIMITED TO MAINTAINING LINKS TO PUBLICLY
 ACCESSIBLE WEBSITES TO WHICH MANUFACTURERS ARE  POSTING  CLINICAL  TRIAL
 INFORMATION  UNDER  SUBDIVISION THREE OF THIS SECTION AND OTHER RELEVANT
 SITES, ASSESSING WHETHER AND THE EXTENT TO WHICH NEW YORK RESIDENTS HAVE
 BEEN HARMED BY THE USE OF A PARTICULAR DRUG AND UNDERTAKING  THE  PUBLIC
 EDUCATION  INITIATIVE  UNDER  SUBDIVISION FIVE OF THIS SECTION. REVENUES
 RECEIVED UNDER THIS SUBDIVISION MUST BE DEPOSITED INTO A GENERAL FUND TO
 BE USED FOR THE PURPOSES OF THIS SECTION.
   5. PUBLIC EDUCATION  INITIATIVE.  THE  DEPARTMENT  SHALL  UNDERTAKE  A
 PUBLIC EDUCATION INITIATIVE TO INFORM RESIDENTS OF THE STATE ABOUT CLIN-
 ICAL TRIALS AND DRUG SAFETY INFORMATION.
   6.  PENALTIES. EACH DAY A MANUFACTURER IS IN VIOLATION OF THIS CHAPTER
 IS CONSIDERED A SEPARATE VIOLATION. SUCH MANUFACTURER SHALL  BE  SUBJECT
 TO THE PENALTIES PRESCRIBED IN SECTION TWELVE OF THIS CHAPTER.
   §  2.  Report.  By  January  15,  2021, the department of health shall
 report to the Legislature matters on the completeness and ease of public
 access to information provided by the drug manufacturers  and  the  need
 for further action or legislation.
   § 3. This act shall take effect on the one hundred eightieth day after
 it shall have become a law.  Effective immediately, the addition, amend-
 ment and/or repeal of any rule or regulation necessary for the implemen-
 tation  of  this act on its effective date are authorized to be made and
 completed on or before such effective date.

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Senate Bill S6103

Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee

Actions

2019-S6103 (ACTIVE) - Details

2019-S6103 (ACTIVE) - Summary

2019-S6103 (ACTIVE) - Sponsor Memo

2019-S6103 (ACTIVE) - Bill Text download pdf

Comments

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Sponsored By

David Carlucci

Archive: Last Bill Status - In Senate Committee Health Committee

Actions

2019-S6103 (ACTIVE) - Details

2019-S6103 (ACTIVE) - Summary

2019-S6103 (ACTIVE) - Sponsor Memo

2019-S6103 (ACTIVE) - Bill Text download pdf

Comments