ASSEMBLY, No. 2839

 

STATE OF NEW JERSEY

 

210th LEGISLATURE

 

INTRODUCED OCTOBER 3, 2002

 

 

Sponsored by:

Assemblywoman ARLINE M. FRISCIA

District 19 (Middlesex)

Assemblyman GARY L. GUEAR, SR.

District 14 (Mercer and Middlesex)

Assemblyman JOSEPH J. ROBERTS, JR.

District 5 (Camden and Gloucester)

 

Co-Sponsored by:

Assemblymen Barnes, Chivukula, Assemblywoman Cruz-Perez, Assemblymen Egan, Green, Greenwald, Assemblywoman Watson Coleman, Assemblyman Ahearn, Assemblywoman Perez-Cinciarelli, Assemblyman Stanley, Assemblywoman Weinberg, Assemblymen Doria, Johnson, Wisniewski, Assemblywoman Greenstein, Assemblyman Payne and Assemblywoman Quigley

 

 

 

 

SYNOPSIS

    Requires pharmaceutical manufacturers to disclose gifts, fees and other economic benefits provided to health care providers for promotional and marketing purposes to DHSS.

 

CURRENT VERSION OF TEXT

    As introduced.

 

(Sponsorship Updated As Of: 1/10/2003)


An Act concerning pharmaceutical manufacturer marketing practices and supplementing Title 24 of the Revised Statutes.

 

    Be It Enacted by the Senate and General Assembly of the State of New Jersey:

 

    1. As used in this act:

    "Carrier" means an insurance company, health, hospital or medical service corporation or health maintenance organization authorized to issue health benefits plans in this State.

    "Commissioner" means the Commissioner of Health and Senior Services.

    "Health benefits plan" means a benefits plan that pays or provides hospital and medical expense benefits for covered services, which include prescription drugs, and is delivered or issued for delivery in this State by or through a carrier. Health benefits plan also includes hospital and medical expense benefits plans, which include coverage for prescription drugs, offered by the State Health Benefits Program.

    "Pharmaceutical manufacturing company" means an entity that is engaged in the production, preparation, propagation, compounding, conversion or processing of prescription drugs as follows: directly or indirectly by extraction from substances of natural origin; independently by means of chemical synthesis; or by a combination of extraction and chemical synthesis. Pharmaceutical manufacturing company also means an entity engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs, but does not include a wholesale distributor of prescription drugs or a pharmacist registered under chapter 14 of Title 45 of the Revised Statutes.

    "Pharmaceutical marketer" means a person who, while employed by or under contract to represent a pharmaceutical manufacturing company, engages in pharmaceutical detailing, promotional activities or other marketing of prescription drugs in this State to any physician, hospital, nursing home, pharmacist, administrator of a health benefits plan or any other person in the State who is authorized to prescribe, dispense or purchase prescription drugs. Pharmaceutical marketer does not include a wholesale drug distributor or the distributor's representative who promotes or otherwise markets the services of the wholesale drug distributor in connection with a prescription drug.

    "Trade secret" means the whole, or any portion or phase, of any scientific, technical or otherwise proprietary information, design, process, procedure, formula or improvement that is used in one's business and is secret and of value. A trade secret shall be presumed to be secret when the owner takes measures to prevent it from becoming available to persons other than those selected by the owner to have access thereto for limited purposes.


    2. A pharmaceutical manufacturing company whose prescription drug products are sold in this State shall, on or before January 1 of each year, disclose to the commissioner the value, nature and purpose of any gift, fee, payment, subsidy or other economic benefit provided in connection with detailing, promotional or other marketing activities by the company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, administrator of a health benefits plan or any other person in the State who is authorized to prescribe, dispense or purchase prescription drugs.

    a. A pharmaceutical manufacturing company that is subject to the provisions of this act shall disclose to the commissioner, on or before October 1, 2003 and annually thereafter, the name and address of the individual responsible for the company's compliance with the provisions of this section.

    b. The following shall be exempt from the disclosure required pursuant to this section:

    (1) free samples of prescription drugs intended to be distributed to patients;

    (2) the payment of reasonable compensation and reimbursement of expenses in connection with clinical trials. As used in this paragraph, "clinical trial" means a federally approved clinical trial conducted in connection with a research study designed to answer specific questions about vaccines, new therapies or new ways of using known treatments;

    (3) any gift, fee, payment, subsidy or economic benefit, which has a value of less than $25; and

    (4) scholarships or other support for medical students, residents and fellows to attend a significant educational, scientific or policymaking conference of a national, regional or specialty medical or other professional association, if the recipient of the scholarship or other support is selected by the association.

    c. The disclosure required pursuant to this section shall be in a form and manner prescribed by the commissioner. The initial disclosure shall be made on or before January 1, 2005 for the 12-month period ending June 30, 2004.

 

    3. The commissioner shall report annually, by March 1 of each year, to the Governor and the Legislature on the disclosures made by pharmaceutical manufacturing companies pursuant to this act.

 

    4. Any information provided by a pharmaceutical manufacturing company pursuant to the disclosure requirements of section 2 of this act that is considered a trade secret shall be confidential and shall not be considered a public record. The commissioner shall permit a pharmaceutical manufacturing company to identify the information that the company claims is a trade secret on the disclosure form established pursuant to this act.

 

    5. A pharmaceutical manufacturing company that fails to disclose the information required pursuant to section 2 of this act shall be liable to a civil penalty of up to $10,000. The action shall be brought in the name of the commissioner and shall be collected and enforced in a summary proceeding pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).

 

    6. The commissioner shall adopt rules and regulations pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), to carry out the purposes of this act.

 

    7. This act shall take effect on the 60th day after enactment.

 

 

STATEMENT

 

    This bill will require all pharmaceutical manufacturing companies whose prescription drug products are sold in this State to annually disclose to the Commissioner of Health and Senior Services the value, nature and purpose of any gift, fee, payment, subsidy or other economic benefit provided in connection with detailing, promotional or other marketing activities by the company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, administrator of a health benefits plan or any other person in the State who is authorized to prescribe, dispense or purchase prescription drugs. The initial disclosure shall be made on or before January 1, 2005 for the 12-month period ending June 30, 2004, and each subsequent disclosure shall be made by January 1 of each year.

    The bill exempts the following from the disclosure requirements:

    -- free samples of prescription drugs intended to be distributed to patients;

    -- the payment of reasonable compensation and reimbursement of expenses in connection with federally approved clinical trials;

    -- any gift, fee, payment, subsidy or economic benefit, which has a value of less than $25; and

    -- scholarships or other support for medical students, residents and fellows to attend a significant educational, scientific or policymaking conference of a national, regional or specialty medical or other professional association, if the recipient of the scholarship or other support is selected by the association.

    The bill requires the Commissioner of Health and Senior Services to report annually, by March 1 of each year, to the Governor and the Legislature on the disclosures made by pharmaceutical manufacturing companies pursuant to this bill.

    The bill provides that any required disclosure information provided by a pharmaceutical manufacturing company that the company considers to be a trade secret shall be confidential and shall not be considered a public record. The commissioner is directed to permit a pharmaceutical manufacturing company to identify the information that the company claims is a trade secret on the disclosure form established by the commissioner.

    Finally, the bill provides that a pharmaceutical manufacturing company that fails to disclose the required information shall be liable to a civil penalty of up to $10,000. The action shall be brought in the name of the commissioner and shall be collected and enforced in a summary proceeding pursuant to the "Penalty Enforcement Law of 1999," N.J.S.A.2A:58-10 et seq.