Current through Register Vol. XLI, No. 50, December 13, 2024
Section 210-1-3 - Required Disclosures3.1. Every drug manufacturer, pharmaceutical manufacturer, and labeler of prescription drugs dispensed in this state, or to a consumer in this state via mail, who employs, directs or utilizes marketing representatives in this state must complete and file with GOHELP, the form contained in Appendix A of this rule, disclosing the reporting entity's expenditures for advertising prescription drugs to consumers in this state for the previous calendar year in full. Beginning on or before April 1, 2010, and by the first of April thereafter, the reporting entity shall annually complete and file with GOHELP the form contained in Appendix A of this rule, disclosing advertising expenses for the previous calendar year in full.3.2. The reporting entity shall disclose all expenditures for advertising and direct promotion of prescription drugs dispensed in this state, including: 3.2.a. The total amount the reporting entity spent for advertising and direct promotion of prescription drugs to consumers, prescribers, pharmacies and patient support or advocacy groups within the State of West Virginia;3.2.b. The total number of West Virginia prescribers to whom the reporting entity provided, directly or indirectly, gifts, grants or payments of any kind in excess of one hundred dollars ($100.00) for the purpose of advertising prescription drugs. Annual payments which cumulatively total more than the amount shown on the reporting form shall be reported in increments of two thousand five hundred dollars ($2,500.00) until all payments of any kind to prescribers have been reported; and3.2.c. Direct-to-consumer advertising which is directed at, received by or intended to be received by consumers in this state, the form of the advertising and the total amount expended for such advertising.3.3. If the reporting entity represents a number of entities which file a federal income tax return as a consolidated group, the reporting entity shall attach to the disclosure form a copy of the organizational chart showing all members of the consolidated group and their interrelationship.3.4. If the reporting entity does not maintain separate records of expenditures for advertising of prescription drugs within West Virginia, it may calculate the advertising expenditures directed at this state by: 3.4.a. Dividing the West Virginia population receiving the DTC advertising by the population of the nation or region for which the reporting entity does maintain records; and3.4.b. Multiplying the quotient determined pursuant to subdivision a of this subsection by the total amount the reporting entity spent on advertising in the nation or the named region.3.5. For the purposes of subsection 3.4 of this rule, the following applies: 3.5.a. The populations of this state and of the nation or region for which the reporting entity maintains records are to be determined by the most recent population data available from the United States Census Bureau.3.5.b. The reporting entity must attach the calculations to the disclosure form contained in Appendix A.3.6. The reporting entity shall file signed and verified originals of completed Appendix A forms with GOHELP.