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or services listed under paragraph A or B and those who are | | expected to so work during the coming year.__For each person | | named, the manufacturer shall also provide information on that | | person's compensation, including the cost of benefits and | | expense allotments; |
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| | | D.__The cost of all advertising distributed in or originally | | distributed from this State regarding prescription drugs | | during the past year.__For the purposes of this paragraph, | | advertising includes radio, television, Internet, magazines, | | newspapers, direct mail, telephone communications and | | electronic mail; and |
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| | | E.__For each of the 100 drugs of the manufacturer for which | | sales in this State were the highest in the prior year, the | | manufacturer's average wholesale price of the drugs, the | | lowest price for which the manufacturer sold those drugs in | | this State during the previous year and any discounts, | | rebates or other adjustments to cost that applied to sales | | of those drugs in the previous year. |
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| | | 2.__Prescription drug marketing.__The Bureau of Medical | | Services shall administer this section in order to assist the | | department in its duties as a purchaser of drugs and | | administrator of prescription drug programs. |
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| | | A.__The bureau shall collect and manage the information | | required to be provided under subsection 1. |
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| | | B.__With the exception of information protected from | | disclosure by law, rule or regulation, all information held | | by the bureau is a public record within the meaning of Title | | 1, chapter 13. |
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| | | C.__By February 5th each year, the bureau shall report to | | the Legislature on prescription drug marketing practices and | | on the cost of prescription drug marketing activities. |
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| | | 3.__Required disclosures.__Persons making informational, | | educational or sales presentations subject to the requirements of | | subsection 1, paragraph A shall disclose in the presentation | | information regarding pharmaceutical assistance programs operated | | or participated in by the manufacturer and any potential benefit | | to the person to whom the presentation is made. |
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| | | 4.__Civil violations.__The following provisions apply to | | enforcement of this section by the Attorney General. |
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| | | A.__A person who is employed to make informational, educational | | or sales presentations within this State on |
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| | | behalf of a manufacturer who is not registered under | | subsection 1, paragraph A, or who violates the disclosure | | rules adopted pursuant to subsection 3, is subject to a | | civil penalty not to exceed $5,000 per violation, plus the | | costs of suit, including necessary and reasonable | | investigative costs, reasonable expert witness fees and | | reasonable attorney's fees, payable to the State. |
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| | | B.__A manufacturer who violates this section or employs or | | causes a person to violate this section is subject to a | | civil penalty not to exceed $25,000 per violation, plus the | | costs of suit, including necessary and reasonable | | investigative costs, reasonable expert witness fees and | | reasonable attorney's fees, payable to the State. |
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| | | 5.__Application.__The requirements of this section apply to | | manufacturers, wholesalers and labelers of prescription drugs | | subject to the Maine Pharmacy Act. |
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| | | 6.__Rules.__The department shall adopt rules to implement this | | section.__Rules adopted pursuant to this section are routine | | technical rules as defined in Title 5, chapter 375, subchapter | | II-A. |
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| | | This bill requires prescription drug manufacturers, | | wholesalers and labelers to register persons employed by them to | | make informational, educational and sales presentations in this | | State. It requires the reporting of information about those | | activities. It requires reports of the average wholesale price | | of certain drugs, the lowest prices for which those drugs were | | sold and any rebates or discounts applicable to those drugs. It | | requires certain disclosures for persons making informational, | | educational and sales presentations. The bill charges the | | Bureau of Medical Services within the Department of Human | | Services with implementing the law and provides for public access | | to nonconfidential information and for an annual report. The | | bill makes a violation of the registration or the disclosure | | requirements a civil violation enforceable by the Attorney | | General. The bill authorizes the Department of Human Services to | | adopt rules as necessary to implement the law. |
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