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

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. WHISTLEBLOWER 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:

5. 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

Fiscal implications

To be determined.

Effective date

Immediately.