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.
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.
STATE OF NEW YORK ________________________________________________________________________ 1421 2011-2012 Regular Sessions IN SENATE 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.