Bill Text: OH SB91 | 2013-2014 | 130th General Assembly | Introduced

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Bill Title: Regarding prescription drug marketing disclosures.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Introduced - Dead) 2013-03-19 - To Medicaid, Health & Human Services [SB91 Detail]

Download: Ohio-2013-SB91-Introduced.html

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As Introduced

130th General Assembly Regular Session 2013-2014

S. B. No. 91

Senator Skindell 

Cosponsor: Senator Tavares 

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A BILL

To amend section 3715.99 and to enact section 3715.93

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of the Revised Code regarding prescription drug

2

marketing disclosures.

3

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

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