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S. 1335
STATUS INFORMATION
General Bill
Sponsors: Senator Short
Document Path: l:\council\bills\nbd\12388ac06.doc
Introduced in the Senate on April 11, 2006
Currently residing in the Senate Committee on Medical Affairs
Summary: Prescription drug manufacturers and labelers
HISTORY OF LEGISLATIVE ACTIONS
Date Body Action Description with journal page number ------------------------------------------------------------------------------- 4/11/2006 Senate Introduced and read first time SJ-7 4/11/2006 Senate Referred to Committee on Medical Affairs SJ-7
View the latest legislative information at the LPITS web site
VERSIONS OF THIS BILL
TO AMEND THE CODE OF LAWS OF SOUTH CAROLINA, 1976, BY ADDING SECTION 44-6-60 SO AS TO REQUIRE PRESCRIPTION DRUG MANUFACTURERS AND LABELERS TO SUBMIT MARKETING ACTIVITIES AND EXPENSE REPORTS TO THE DEPARTMENT OF HEALTH AND HUMAN SERVICES ANNUALLY, TO SPECIFY THE CONTENTS OF THESE REPORTS, AND TO REQUIRE THE DEPARTMENT TO ANALYZE THE IMPACT OF THESE ACTIVITIES AND EXPENSES ON COST, UTILIZATION, AND DELIVERY OF HEALTH CARE IN THIS STATE AND TO SUBMIT THIS INFORMATION TO THE GOVERNOR AND GENERAL ASSEMBLY.
Whereas, the General Assembly finds that the price of prescription drugs in this State and across the nation has been increasing at an alarming rate over the past decade; and
Whereas, prescription drug costs are increasing at a faster rate than any other component of health care and are driving the increase in overall health care costs, as is apparent by the ubiquitous nature of the marketing and public information campaigns relating to prescription drugs, pharmaceutical manufacturers put a great deal of resources into marketing their products; and
Whereas, it is in the interest of assisting this State in its role as a purchaser of prescription drugs and administrator of prescription drug programs, to enable the State to determine the scope of prescription drug marketing costs and their effect on the cost, utilization, and delivery of health care services, and thus, further the role of the State as guardian of the public interest. Now, therefore,
Be it enacted by the General Assembly of the State of South Carolina:
SECTION 1. Article 1, Chapter 6, Title 44 of the 1976 Code is amended by adding:
"Section 44-6-60. (A) As used in this section:
(1) 'Labeler' means a person or entity, having a labeler code from the Federal Food and Drug Administration, that receives a prescription drug from the manufacturer or a wholesaler of the drug, and repackages the drug to be dispensed in this State.
(2) 'Manufacturer' means a manufacturer of prescription drugs dispensed in this State, and includes the subsidiary or affiliate of the manufacturer.
(3) 'Marketing' means advertising and promotional activities for prescription drugs dispensed in this State including, but not limited to, those activities described in subsection (B).
(B) On or before July first of each year, every manufacturer and labeler shall file a report with the department on its marketing activities conducted in this State. The report must be submitted in such form and manner, and include the payment of a fee as is established by the department. Each report must include the value, nature, purpose, and recipient of marketing expenses including, but not limited to:
(1) all expenses associated with advertising, marketing, and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail, internet, and telephone communications as they pertain to residents of this State;
(2) with regard to all health care providers including health insurers and health maintenance organizations, the following information:
(a) all expenses associated with educational or informational programs, materials and seminars, and remuneration for promoting or participating in educational or informational sessions, regardless of whether the manufacturer or labeler provides the educational or informational sessions or materials;
(b) all expenses associated with food, entertainment, and gifts valued at more than seventy-five dollars and anything provided to a health care provider for less than market value;
(c) all expenses associated with trips and travel; and
(d) all expenses associated with product samples, except for samples that will be distributed free of charge to patients; and
(3) the aggregate cost of all employees and contractors of the manufacturer or labeler who directly or indirectly engage in the advertising or promotional activities listed in items (1) and (2), including all forms of payment to these employees and contractors. The cost reported pursuant to this item shall reflect only that portion of payment to employees and contractors that pertains to activities within this State or to recipients of the advertising or promotional activities who are residents of or are employed in this State.
(C) The following marketing expenses are not subject to the reporting requirements of this section:
(1) expenses of seventy-five dollars or less;
(2) reasonable compensation and reimbursement for expenses in connection with a bona fide clinical trial of a new vaccine, therapy, or treatment; and
(3) scholarships and reimbursement of expenses for attending a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship is chosen by the association sponsoring the conference or seminar.
(D) Annually before January first, the department shall submit a report, providing information in aggregate form, on prescription drug marketing expenses, reported pursuant to this section, to the Governor, and the General Assembly. Beginning January 1, 2008, and every two years thereafter, the department shall provide a report to the Governor and General Assembly providing information in aggregate form, containing an analysis of the data submitted to the department, including the scope of prescription drug marketing activities and expenses and their effect on the cost, utilization, and delivery of health care services and any recommendations with regard to marketing activities of prescription drug manufacturers and labelers.
(E) Notwithstanding any other provision of law, all information submitted to the department pursuant to this section is confidential and is not subject to disclosure under the Freedom of Information Act. However, data compiled in aggregate form by the department for the purposes of reporting required by this section is subject to disclosure, as long as it does not reveal trade information that is protected by state or federal law.
(F) A person who violates any provision of this section is subject to a civil penalty of ten thousand dollars, plus court costs and attorney's fees.
(G) The department shall promulgate regulations necessary to carryout the provisions of this section."
SECTION 2. Section 44-6-60(G) of the 1976 Code, as added by Section 1 of this act takes effect upon approval of the Governor and the remainder of the bill takes effect January 1, 2007.
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