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Prescription Drug Reform

Here is the CTCPS pharmaceutical legislation for this year (2007).

OFFICE OF THE ATTORNEY GENERAL
2007 GENERAL ASSEMBLY SESSION
PUBLIC HEALTH COMMITTEE

TITLE: An Act Concerning Pharmaceutical Company Disclosures of Incentives Provided to Health Care Providers

SUMMARY: Beginning on July 1, 2008 and annually thereafter, this proposal requires pharmaceutical companies to disclose to the Commissioner of Public Health, gifts and other financial incentives provided to health care providers and health benefit administrators by such companies or their marketers as part of their marketing of pharmaceutical drugs. Free samples for patients, compensation for clinical trials, scholarship payments for students and resident physicians are excluded from this report. Any information that would be a trade secret must be kept confidential by the Commissioner. The Commissioner shall issue an annual report. Failure to provide such information results in a civil fine of not more than $10,000 per violation.

TEXT:

Section 1. (NEW) (Effective October 1, 2007) (a) As used in this section:

(1) "Commissioner" means the Commissioner of Public Health.

(2) "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, health benefit plan administrator or a prescribing practitioner, as defined in subdivision (22) of subsection (a) of section 20-571 of the general statutes, located in this state. "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.

(3) "Pharmaceutical manufacturing company" means any entity that engages in the production, preparation, propagation, compounding, conversion or processing of prescription drugs, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or any entity engaging in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs. "Pharmaceutical manufacturing company" does not include a pharmacist licensed pursuant to part II of chapter 400j of title 20 of the general statutes.

(b) (1) On or before July 1, 2008, and annually thereafter, every pharmaceutical manufacturing company shall disclose to the commissioner the value, nature and purpose of any gift, fee, payment, subsidy or other economic benefit provided by it in connection with detailing, or promotional or other marketing activities by the company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator or prescribing practitioner, as defined in subdivision (22) of subsection (a) of section 20-571 of the general statutes, located in this state. Disclosure shall be made on a form and in a manner prescribed by the commissioner. Such disclosure shall be for the twelve-month period ending December 31, 2007. On or before March 1, 2009, and annually thereafter, the commissioner shall report to the General Assembly, in accordance with section 11-4a of the general statutes, on the disclosures made under this section.

(2) Every pharmaceutical manufacturing company shall disclose to the commissioner, on or before July 1, 2008, and annually thereafter, the name and address of the individual responsible for the company's compliance with the provisions of this section.

(3) All information disclosed to or otherwise obtained by the commissioner pursuant to this section which might reveal a trade secret shall be considered confidential and shall not be disclosed by the commissioner unless ordered by a court of competent jurisdiction.

(4) The following are exempt from disclosure under this section:

(A) Free samples of prescription drugs intended to be distributed to patients;

(B) The payment of reasonable compensation and reimbursement of expenses in connection with a bona fide clinical trial. As used in this subparagraph, "clinical trial" means a 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;

(C) Any gift, fee, payment, subsidy or other economic benefit the value of which is less than twenty-five dollars; and

(D) Scholarship or other support for medical students, residents or fellows to attend an educational, scientific or policy-making conference of a national, regional or specialty medical or other professional association, if the recipient of the scholarship or other support is selected by such association.

(c) A pharmaceutical manufacturing company that fails to disclose as required by subsection (b) of this section shall be liable for a civil fine of not more than ten thousand dollars. Each failure to disclose shall constitute a separate violation. Upon referral by the commissioner, the Attorney General may bring an action in the superior court for the Judicial District of Hartford to recover such civil fine and obtain such equitable relief as the court deems appropriate.


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