senate Bill S1421

2011-2012 Legislative Session

Provides for the prescription drug reimportation protection program for the investigation of the sale of unsafe drugs including internet sales

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Archive: Last Bill Status - In Committee


  • Introduced
  • In Committee
  • On Floor Calendar
    • Passed Senate
    • Passed Assembly
  • Delivered to Governor
  • Signed/Vetoed by Governor

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Actions

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Assembly Actions - Lowercase
Senate Actions - UPPERCASE
Jan 04, 2012 referred to finance
Jan 07, 2011 referred to finance

Co-Sponsors

S1421 - Bill Details

See Assembly Version of this Bill:
A4130
Current Committee:
Law Section:
Executive Law
Laws Affected:
Add §216-e, Exec L; amd §206, Pub Health L
Versions Introduced in 2009-2010 Legislative Session:
S1572, A4708

S1421 - Bill Texts

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Provides for the prescription drug reimportation protection program to be established by the superintendent of state police, for the investigation of the sale of unsafe drugs including internet sales.

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BILL NUMBER:S1421

TITLE OF BILL:
An act
to amend the executive law and the public health law, in relation to the
prescription drug reimportation protection program

PURPOSE OR GENERAL IDEA OF THE BILL:
This bill deals with unsafe drugs being imported into the country by
requiring the State Police to investigate and act as a coordinating
agency in cases of unsafe drug reimportation by establishing common
rules of procedure, a centralized data base, using the scientific
crime detection laboratory, and coordinating with the State Health
Department;

Requiring the Health Commissioner to establish a listing on its
website of internet providers of prescription drugs, along with
complaints received by the department, convictions of the
participants, and whether the internet provider has permission
from the federal government to reimport drugs.

The Health Department is also required to provide a clear explanation
if the federal law concerning reimportation.

SUMMARY OF PROVISIONS:
Section 1 of this bill creates a new section 216-e in the executive
law in order to do the following:

1. INVESTIGATION:
Requires the superintendent of the State police to establish a
program to investigate actual and/or suspected cases of reimportation
of unsafe drugs. Specifically, it requires the state police to
investigate complaints of adulteration or mislabeling of drugs
purchased through any Internet website which offers or sells
prescription drugs to consumers in New York from another country.

2. COORDINATED STATE AND LOCAL RESPONSE:
Requires the state police to act as the coordinating agency
responding to cases of suspected adulteration or mislabeling or
otherwise in violation of law, and to establish uniform
procedures for investigation and the receipt of such complaints from
other agencies involved in such cases.

3. REGULATORY ENVIRONMENT:
Requires the superintendent, in cooperation with the department of
health, the Commissioner of the division of criminal justice
services, the department of agriculture and markets, and other
pertinent agencies, to promulgate additional rules and regulations
necessary for the program, including:

a. establishment of uniform procedures for law enforcement or
regulatory agencies involved in a suspected adulterated or
mislabeled importation or reimportation of prescription drugs. The
state police are required to provide direct investigative assistance
or support services to any law enforcement or regulatory agency upon
request;


b. establishment of a computerized central data base to function as an
information management and retrieval system for such matters;

c. authorization to use the scientific crime detection laboratory to
analyze evidence in connection with state police cases or cases that
originate with other law enforcement, regulatory agencies or other
agencies; and

d. reporting complaints to the commissioner of the department of
health for use in DOH's central registry, and to the FBI, the FDA
and/or other appropriate federal agency charged with monitoring and
prosecuting the importation or reimportation of drugs which are
mislabeled or which show evidence of tampering or adulteration or
other violations.

4. WHISTLE BLOWER PROTECTION:
Provides that good faith reporting or disclosure pursuant to the state
police and reports by the state police to the department of health
shall not constitute libel or slander or a violation of the right of
privacy or privileged communication, and provides immunity from civil
and criminal liability for any action taken in compliance with the
provisions of this section.

Section 2 of the bill amends section 206 of the public health law by
adding a new subdivision 20:

SAFE IMPORTATION SITES:
Requires the commissioner to establish a registry of web sites and
entities which offer or provide a mechanism to sell prescription
drugs to consumers in New York from another country and shall post
such registry on a health department website dedicated
to providing information for such registry.
Data to be published on such health department website include:

a) the
name of the website or entity which offers or provides a mechanism to
sell prescription drugs to consumers in New York from another
country,

b) the number of complaints concerning such website or
entity,

c) convictions, if known, of the parties operating the
website, for importing or reimporting prescription drugs which are
adulterated
or mislabeled or otherwise in violation of section 6811 of the
education law, and

d) whether the website or entity has permission
from the appropriate federal agency to import or reimport
prescription drugs into this country.

Finally, the measure provides that good faith reporting or disclosure
by the commissioner pursuant to the requirements of this subsection
shall not constitute libel or slander or a violation of the right of
privacy or privileged communication.


JUSTIFICATION:
This legislation provides appropriate oversight and protection to the
citizens of New York who are buying or who may be tempted to buy
their prescription drugs over the Internet. As was learned in the
recent hearings on pharmaceutical purchasing, there are many good,
competent providers of the drugs, but there are also unscrupulous
dealers who provide drugs that are adulterated or mislabeled. In one
case, evidence presented at the hearing, showed that drugs supposedly
imported from a Canadian website were actually manufactured in
Pakistan, shipped in adulterated containers, and the package did not
contain the drugs it was supposed to contain.

LEGISLATIVE HISTORY:
S.6784 of 2004 - Finance
S.1934 of 2006 - Finance
S.455 of 2008 - Finance
S.1572 of 2010 - Finance

FISCAL IMPLICATIONS:
To be determined.

EFFECTIVE DATE:
Immediately.

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

                                  1421

                       2011-2012 Regular Sessions

                            I N  S E N A T E

                             January 7, 2011
                               ___________

Introduced  by  Sens.  GOLDEN, LARKIN, MAZIARZ -- read twice and ordered
  printed, and when printed to be committed to the Committee on Finance

AN ACT to amend the executive law and the public health law, in relation
  to the prescription drug reimportation protection program

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

  Section  1. The executive law is amended by adding a new section 216-e
to read as follows:
  S 216-E. PRESCRIPTION DRUG REIMPORTATION PROTECTION PROGRAM. 1.    THE
SUPERINTENDENT  SHALL  ESTABLISH  A PROGRAM TO INVESTIGATE ACTUAL AND/OR
SUSPECTED CASES OF REIMPORTATION OF UNSAFE DRUGS WITHIN THIS  STATE  AND
MAY  ASSIGN  EMPLOYEES  AS  DEEMED NECESSARY FOR THE PROPER OPERATION OF
SUCH PROGRAM.
  2. THE PROGRAM SHALL PROVIDE THAT THE STATE POLICE MAY INVESTIGATE, AS
PROVIDED IN THIS SECTION, ANY INTERNET WEBSITE WHICH OFFERS OR  PROVIDES
A  MECHANISM  TO  SELL  PRESCRIPTION DRUGS TO CONSUMERS IN NEW YORK FROM
ANOTHER COUNTRY OR ANY ENTITY ACTING AS A  MIDDLEMAN  OR  AGENT  IN  THE
IMPORTATION  OR  REIMPORTATION FOR SALE OF PRESCRIPTION DRUGS FROM OTHER
COUNTRIES. THE PROGRAM SHALL PROVIDE THAT THE STATE POLICE SHALL  INVES-
TIGATE  ANY COMPLAINT FROM A GOVERNMENT OFFICIAL, OR FROM AN INDIVIDUAL,
CLAIMING THAT PRESCRIPTION DRUGS BEING IMPORTED OR  REIMPORTED  BY  SUCH
ENTITY  OR  THROUGH SUCH WEBSITE ARE ADULTERATED OR MISLABELED OR OTHER-
WISE IN VIOLATION OF SECTION SIXTY-EIGHT HUNDRED ELEVEN OF THE EDUCATION
LAW.
  3. THE PROGRAM SHALL FURTHER PROVIDE THAT THE STATE POLICE  SHALL  ACT
AS  THE COORDINATING AGENCY RESPONDING TO CASES OF SUSPECTED IMPORTATION
OR REIMPORTATION OF PRESCRIPTION DRUGS IN A MANNER THAT IS IN  VIOLATION
OF  SUCH  SECTION  SIXTY-EIGHT  HUNDRED ELEVEN OF THE EDUCATION LAW. THE
SUPERINTENDENT OF STATE POLICE SHALL  BY  REGULATION  ESTABLISH  UNIFORM
PROCEDURES  FOR  INVESTIGATION  AND  THE RECEIPT OF SUCH COMPLAINTS FROM
OTHER AGENCIES INVOLVED IN SUCH CASES.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD04386-01-1

S. 1421                             2

  4. THE SUPERINTENDENT, IN COOPERATION WITH THE DEPARTMENT  OF  HEALTH,
THE DIVISION OF CRIMINAL JUSTICE SERVICES, THE DEPARTMENT OF AGRICULTURE
AND  MARKETS,  AND OTHER PERTINENT AGENCIES, SHALL PROMULGATE SUCH ADDI-
TIONAL RULES AND REGULATIONS WHICH IN  THE  SUPERINTENDENT'S  DISCRETION
ARE  NECESSARY  FOR THE EFFICIENT OPERATION OF THIS SECTION. THESE REGU-
LATIONS SHALL INCLUDE BUT NOT BE LIMITED TO THE FOLLOWING:
  A. THE ESTABLISHMENT OF UNIFORM PROCEDURES TO BE USED WHENEVER  A  LAW
ENFORCEMENT  OR  REGULATORY AGENCY OR OTHER AGENCY BECOMES INVOLVED IN A
SUSPECTED IMPORTATION OR REIMPORTATION OF PRESCRIPTION DRUGS IN A MANNER
THAT IS IN VIOLATION OF SUCH SECTION SIXTY-EIGHT HUNDRED ELEVEN  OF  THE
EDUCATION  LAW.  SUCH  REGULATIONS  SHALL  REQUIRE THAT THE STATE POLICE
PROVIDE DIRECT INVESTIGATIVE ASSISTANCE OR SUPPORT SERVICES TO  ANY  LAW
ENFORCEMENT OR REGULATORY AGENCY UPON REQUEST;
  B.  THE  ESTABLISHMENT OF A COMPUTERIZED CENTRAL DATA BASE, LOCATED AT
DIVISION HEADQUARTERS, WHICH WILL FUNCTION AS AN INFORMATION  MANAGEMENT
AND  RETRIEVAL  SYSTEM  FOR SUCH MATTERS. NOTIFICATION OF ALL SUCH CASES
MADE TO LAW ENFORCEMENT, REGULATORY AGENCIES OR OTHER AGENCIES SHALL  BE
REPORTED  TO  THE  CENTRAL DATA BASE WITHIN FIVE HOURS OF SUCH NOTIFICA-
TION;
  C. AUTHORIZATION, UPON REQUEST, TO USE THE SCIENTIFIC CRIME  DETECTION
LABORATORY  TO ANALYZE EVIDENCE IN CONNECTION WITH STATE POLICE CASES OR
CASES THAT ORIGINATE WITH OTHER LAW ENFORCEMENT, REGULATORY AGENCIES  OR
OTHER AGENCIES; AND
  D.  REPORTING OF ALL SUCH COMPLAINTS TO THE COMMISSIONER OF HEALTH FOR
USE IN THE CENTRAL REGISTRY  WHICH  SUCH  COMMISSIONER  IS  REQUIRED  TO
DEVELOP,  AND  TO THE FEDERAL BUREAU OF INVESTIGATION, THE FOOD AND DRUG
ADMINISTRATION AND/OR OTHER  APPROPRIATE  FEDERAL  AGENCY  CHARGED  WITH
MONITORING  AND  PROSECUTING  THE  IMPORTATION OR REIMPORTATION OF DRUGS
WHICH ARE MISLABELED OR WHICH SHOW EVIDENCE OF TAMPERING OR ADULTERATION
OR OTHER VIOLATIONS OF STATE LAW.
  5. GOOD FAITH REPORTING OR DISCLOSURE PURSUANT TO THE STATE POLICE AND
REPORTS BY THE STATE POLICE  TO  THE  DEPARTMENT  OF  HEALTH  SHALL  NOT
CONSTITUTE  LIBEL  OR  SLANDER OR A VIOLATION OF THE RIGHT OF PRIVACY OR
PRIVILEGED COMMUNICATION. ANY PERSON WHO IN GOOD FAITH REPORTS CASES  OF
SUSPECTED IMPORTATION OR REIMPORTATION OF PRESCRIPTION DRUGS IN A MANNER
THAT IS IN VIOLATION OF SECTION SIXTY-EIGHT HUNDRED ELEVEN OF THE EDUCA-
TION  LAW  SHALL  BE  IMMUNE  FROM  CIVIL AND CRIMINAL LIABILITY FOR ANY
ACTION TAKEN IN COMPLIANCE WITH THE PROVISIONS OF THIS SECTION.
  S 2. Section 206 of the public health law is amended by adding  a  new
subdivision 28 to read as follows:
  28.  (A)  THE  COMMISSIONER SHALL ESTABLISH A REGISTRY OF WEBSITES AND
ENTITIES WHICH OFFER OR PROVIDE A MECHANISM TO SELL  PRESCRIPTION  DRUGS
TO CONSUMERS IN NEW YORK FROM ANOTHER COUNTRY AND SHALL POST SUCH REGIS-
TRY  ON A HEALTH DEPARTMENT WEBSITE ON THE INTERNET DEDICATED TO PROVID-
ING INFORMATION FOR SUCH REGISTRY. DATA TO BE PUBLISHED ON  SUCH  HEALTH
DEPARTMENT WEBSITE SHALL INCLUDE:
  (I) THE NAME OF THE WEBSITE OR ENTITY WHICH OFFERS OR PROVIDES A MECH-
ANISM  TO  SELL PRESCRIPTION DRUGS TO CONSUMERS IN NEW YORK FROM ANOTHER
COUNTRY,
  (II) THE NUMBER OF COMPLAINTS CONCERNING SUCH WEBSITE OR ENTITY,
  (III) CONVICTIONS, IF KNOWN, OF THE PARTIES OPERATING THE WEBSITE, FOR
IMPORTING OR REIMPORTING PRESCRIPTION DRUGS  WHICH  ARE  ADULTERATED  OR
MISLABELED  OR  OTHERWISE  IN  VIOLATION  OF SECTION SIXTY-EIGHT HUNDRED
ELEVEN OF THE EDUCATION LAW,

S. 1421                             3

  (IV) WHETHER THE WEBSITE OR ENTITY HAS PERMISSION FROM THE APPROPRIATE
FEDERAL AGENCY TO IMPORT OR REIMPORT PRESCRIPTION DRUGS INTO THIS  COUN-
TRY, AND
  (V)  THE  HEALTH DEPARTMENT WEBSITE SHALL ADDITIONALLY PROVIDE A CLEAR
EXPLANATION OF FEDERAL LAW CONCERNING IMPORTATION  OR  REIMPORTATION  OF
PRESCRIPTION DRUGS FROM ANOTHER COUNTRY INTO THIS COUNTRY.
  (B) GOOD FAITH REPORTING OR DISCLOSURE BY THE COMMISSIONER PURSUANT TO
THE REQUIREMENTS OF THIS SUBDIVISION SHALL NOT CONSTITUTE LIBEL OR SLAN-
DER OR A VIOLATION OF THE RIGHT OF PRIVACY OR PRIVILEGED COMMUNICATION.
  S 3. This act shall take effect immediately.

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