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| To amend section 3715.99 and to enact section 3715.93 | 1 |
| of the Revised Code regarding prescription drug | 2 |
| marketing disclosures. | 3 |
| Section 1. That section 3715.99 be amended and section | 4 |
| 3715.93 of the Revised Code be enacted to read as follows: | 5 |
| Sec. 3715.93. (A) As used in this section: | 6 |
| (1) "Detailing" means the marketing or promotion of dangerous | 7 |
| drugs by or on behalf of a manufacturer or labeler. | 8 |
| (2) "Labeler" means a person to whom both of the following | 9 |
| apply: | 10 |
| (a) The person receives dangerous drugs from a manufacturer | 11 |
| or wholesaler and repackages them for retail sale. | 12 |
| (b) The person has a labeler code from the United States food | 13 |
| and drug administration under 21 C.F.R. 207.20. | 14 |
| (3) "Marketer" means a person who, while employed by or under | 15 |
| contract to represent a manufacturer or labeler, engages in | 16 |
| pharmaceutical detailing or other marketing or promotion of | 17 |
| dangerous drugs. | 18 |
| (4) "Sample drug" has the same meaning as in section 2925.01 | 19 |
| of the Revised Code. | 20 |
| (5) "Wholesaler" means a person who, on official written | 21 |
| orders other than prescriptions, supplies dangerous drugs that the | 22 |
| person has not manufactured, produced, or prepared personally and | 23 |
| includes a "wholesale distributor of dangerous drugs" as defined | 24 |
| in section 4729.01 of the Revised Code. | 25 |
| (B)(1) On or before the first day of January of each year, | 26 |
| each manufacturer and labeler that sells dangerous drugs shall | 27 |
| report to the director of health the name and address of the | 28 |
| individual responsible for the manufacturer's or labeler's | 29 |
| compliance with this section. | 30 |
| (2) On or before the first day of February of each year, each | 31 |
| manufacturer or labeler that sells dangerous drugs shall submit to | 32 |
| the director a report that discloses, except as provided in | 33 |
| division (E) of this section, the value, nature, and purpose of | 34 |
| any gift, fee, payment, subsidy, or other economic benefit | 35 |
| provided in connection with detailing, promotion, or other | 36 |
| marketing activities by the manufacturer or labeler, directly or | 37 |
| through a marketer, to any licensed health professional authorized | 38 |
| to prescribe drugs, hospital, nursing home, residential care | 39 |
| facility, adult care facility, pharmacist, or health benefit plan | 40 |
| administrator. The report shall cover the prior calendar year and | 41 |
| be made on a form and in a manner prescribed by the director in | 42 |
| rules adopted under this section. When submitting the report, the | 43 |
| manufacturer or labeler shall pay a fee in an amount and in a | 44 |
| manner prescribed by the director in rules adopted under this | 45 |
| section. | 46 |
| (C) No manufacturer or labeler shall fail to make a | 47 |
| disclosure in the report required by division (B)(2) of this | 48 |
| section with respect to a particular licensed health professional | 49 |
| authorized to prescribe drugs, hospital, nursing home, residential | 50 |
| care facility, adult care facility, pharmacist, or health benefit | 51 |
| plan administrator that is provided a gift, fee, payment, subsidy, | 52 |
| or other economic benefit in connection with detailing, promotion, | 53 |
| or other marketing activities. | 54 |
| (D) On or before the first day of June of each year, the | 55 |
| director shall submit a report to the governor and, in accordance | 56 |
| with section 101.68 of the Revised Code, the general assembly. The | 57 |
| report shall summarize the reports received in that year under | 58 |
| division (B)(2) of this section. | 59 |
| (E) All of the following are exempt from disclosure under | 60 |
| this section: | 61 |
| (1) Any gift, fee, payment, subsidy, or other economic | 62 |
| benefit the value of which does not exceed twenty-five dollars; | 63 |
| (2) Sample drugs that are given with the intent that they be | 64 |
| distributed to patients; | 65 |
| (3) The payment of reasonable compensation and reimbursement | 66 |
| of expenses in connection with a bona fide clinical trial | 67 |
| conducted in connection with a research study designed to answer | 68 |
| specific questions about vaccines, new therapies, or new ways of | 69 |
| using known treatments; | 70 |
| (4) Scholarships or other support for medical students, | 71 |
| residents, and fellows to attend bona fide educational, | 72 |
| scientific, or policy-making conferences of an established | 73 |
| professional association if the recipients of the scholarships or | 74 |
| other support are selected by the association. | 75 |
| (F) The director shall adopt rules in accordance with Chapter | 76 |
| 119. of the Revised Code to do all of the following: | 77 |
| (1) Prescribe the form and manner in which each manufacturer | 78 |
| and labeler is to make the report required by division (B)(2) of | 79 |
| this section; | 80 |
| (2) Prescribe the amount and manner in which each | 81 |
| manufacturer and labeler is to pay the fee required by division | 82 |
| (B)(2) of this section; | 83 |
| (3) Define the terms "bona fide clinical trial" and "bona | 84 |
| fide educational, scientific, or policy-making conference" for | 85 |
| purposes of divisions (E)(3) and (4) of this section. | 86 |
| (G) In addition to the penalty prescribed by section 3715.99 | 87 |
| of the Revised Code, whoever violates division (C) of this section | 88 |
| may be subject to an action by the attorney general in the | 89 |
| Franklin county court of common pleas for injunctive relief. The | 90 |
| court may issue an injunction and also may award costs and | 91 |
| attorney's fees associated with the action. | 92 |
| Sec. 3715.99. (A) Whoever violates sections 3715.13 to | 93 |
| 3715.19, or 3715.38 of the Revised Code is guilty of a minor | 94 |
| misdemeanor. | 95 |
| (B) Whoever violates section 3715.22, 3715.25, 3715.27, or | 96 |
| 3715.34 of the Revised Code is guilty of a misdemeanor of the | 97 |
| fourth degree. | 98 |
| (C) Whoever violates section 3715.23 or 3715.36 of the | 99 |
| Revised Code is guilty of a misdemeanor of the second degree. | 100 |
| (D) Whoever violates section 3715.52 or 3715.65 of the | 101 |
| Revised Code is guilty of a misdemeanor of the fourth degree on a | 102 |
| first offense; on each subsequent offense, the person is guilty of | 103 |
| a misdemeanor of the second degree. | 104 |
| (E) Whoever violates section 3715.521 of the Revised Code is | 105 |
| guilty of a minor misdemeanor. A violation of that section occurs | 106 |
| on a daily basis, not according to the number of times per day | 107 |
| that an expired drug, baby food, or infant formula is sold, | 108 |
| offered for sale, or delivered at retail or to the consumer. Each | 109 |
| day of violation is a separate offense. | 110 |
| (F) Whoever violates division (C) of section 3715.93 of the | 111 |
| Revised Code shall be fined not more than ten thousand dollars. | 112 |
| Each violation is a separate offense. | 113 |
| Section 2. That existing section 3715.99 of the Revised Code | 114 |
| is hereby repealed. | 115 |