H. B. No. 39 As Introduced

As Introduced

127th General Assembly

Regular Session

2007-2008

H. B. No. 39

Representative Skindell

Cosponsors: Representatives Stewart, D., Foley, Koziura, Ujvagi, Strahorn, Lundy, Hagan, R., Bolon, Brady, Beatty

A BILL

To amend section 3715.99 and to enact sections 1
3715.88, 3715.89, and 3715.90 of the Revised Code 2
to require manufacturers and labelers of dangerous 3
drugs to disclose to the Director of Health the 4
value, nature, and purpose of certain gifts, fees, 5
payments, subsidies, and other economic benefits 6
they provide in connection with pharmaceutical 7
detailing, marketing, or promotion. 8

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

       Section 1. That section 3715.99 be amended and sections 9
3715.88, 3715.89, and 3715.90 of the Revised Code be enacted to 10
read as follows: 11

       Sec. 3715.88. (A) As used in this section and section 12
3715.89 of the Revised Code: 13

       (1) "Detailing" means the marketing or promotion of dangerous 14
drugs by or on behalf of a manufacturer or labeler. 15

       (2) "Labeler" means a person to whom both of the following 16
apply: 17

       (a) The person receives dangerous drugs from a manufacturer 18
or wholesaler and repackages them for retail sale. 19

       (b) The person has a labeler code from the United States food 20
and drug administration under 21 C.F.R. 207.20. 21

       (3) "Marketer" means a person who, while employed by or under 22
contract to represent a manufacturer or labeler, engages in 23
pharmaceutical detailing or other marketing or promotion of 24
dangerous drugs. 25

       (4) "Sample drug" has the same meaning as in section 2925.01 26
of the Revised Code. 27

       (5) "Wholesaler" means a person who, on official written 28
orders other than prescriptions, supplies dangerous drugs that the 29
person has not manufactured, produced, or prepared personally and 30
includes a "wholesale distributor of dangerous drugs" as defined 31
in section 4729.01 of the Revised Code. 32

       (B) On or before the first day of January of each year, each 33
manufacturer and labeler that sells dangerous drugs shall disclose 34
to the director of health the name and address of the individual 35
responsible for the manufacturer's or labeler's compliance with 36
this section. 37

       (C) Subject to division (E) of this section, no manufacturer 38
or labeler that sells dangerous drugs shall fail, on or before the 39
first day of February of each year, to disclose to the director 40
the value, nature, and purpose of any gift, fee, payment, subsidy, 41
or other economic benefit provided in connection with detailing, 42
promotion, or other marketing activities by the manufacturer or 43
labeler, directly or through a marketer, to any licensed health 44
professional authorized to prescribe drugs, hospital, nursing 45
home, residential care facility, adult care facility, pharmacist, 46
or health plan administrator. Disclosure shall cover the prior 47
calendar year and be made on a form and in a manner prescribed by 48
the director in rules adopted under section 3715.89 of the Revised 49
Code. No manufacturer or labeler shall fail to comply with this 50
division. 51

       (D) On or before the first day of June of each year, the 52
director shall submit to the governor and members of the general 53
assembly a report summarizing the disclosures made in that year 54
under this section. 55

       (E) All of the following are exempt from disclosure under 56
this section: 57

       (1) Any gift, fee, payment, subsidy, or other economic 58
benefit the value of which does not exceed twenty-five dollars; 59

       (2) Sample drugs that are given with the intent that they be 60
distributed to patients; 61

       (3) The payment of reasonable compensation and reimbursement 62
of expenses in connection with a bona fide clinical trial 63
conducted in connection with a research study designed to answer 64
specific questions about vaccines, new therapies, or new ways of 65
using known treatments; 66

       (4) Scholarship or other support for medical students, 67
residents, and fellows to attend bona fide educational, 68
scientific, or policy-making conferences of an established 69
professional association if the recipient of the scholarship or 70
other support is selected by the association. 71

       Sec. 3715.89. The director of health shall adopt rules under 72
Chapter 119. of the Revised Code to do both of the following: 73

       (A) Prescribe the form and manner in which each manufacturer 74
and labeler is to make the disclosures required by division (C) of 75
section 3715.88 of the Revised Code; 76

       (B) Define the terms "bona fide clinical trial" and "bona 77
fide educational, scientific, or policy-making conference" for 78
purposes of divisions (E)(3) and (4) of section 3715.88 of the 79
Revised Code. 80

       Sec. 3715.90. In addition to the penalty prescribed by 81
section 3715.99 of the Revised Code, whoever violates section 82
3715.88 of the Revised Code may be subject to an action by the 83
attorney general in the Franklin county court of common pleas for 84
injunctive relief. The court may issue an injunction and also may 85
award costs and attorney's fees associated with the action. 86

       Sec. 3715.99. (A) Whoever violates sections 3715.13 to 87
3715.19, or 3715.38 of the Revised Code is guilty of a minor 88
misdemeanor. 89

       (B) Whoever violates section 3715.22, 3715.25, 3715.27, or 90
3715.34 of the Revised Code is guilty of a misdemeanor of the 91
fourth degree. 92

       (C) Whoever violates section 3715.23 or 3715.36 of the 93
Revised Code is guilty of a misdemeanor of the second degree. 94

       (D) Whoever violates section 3715.52 or 3715.65 of the 95
Revised Code is guilty of a misdemeanor of the fourth degree on a 96
first offense; on each subsequent offense, the person is guilty of 97
a misdemeanor of the second degree. 98

       (E) Whoever violates section 3715.521 of the Revised Code is 99
guilty of a minor misdemeanor. A violation of that section occurs 100
on a daily basis, not according to the number of times per day 101
that an expired drug, baby food, or infant formula is sold, 102
offered for sale, or delivered at retail or to the consumer. Each 103
day of violation is a separate offense. 104

       (F) Whoever violates division (C) of section 3715.88 of the 105
Revised Code shall be fined not more than ten thousand dollars per 106
violation. Each unlawful failure to disclose under that section 107
constitutes a separate violation. 108

       Section 2. That existing section 3715.99 of the Revised Code 109
is hereby repealed. 110

Section 1. That section 3715.99 be amended and sections	9
3715.88, 3715.89, and 3715.90 of the Revised Code be enacted to	10
read as follows:	11

Sec. 3715.88. (A) As used in this section and section	12
3715.89 of the Revised Code:	13

(1) "Detailing" means the marketing or promotion of dangerous	14
drugs by or on behalf of a manufacturer or labeler.	15

(2) "Labeler" means a person to whom both of the following	16
apply:	17

(a) The person receives dangerous drugs from a manufacturer	18
or wholesaler and repackages them for retail sale.	19

(b) The person has a labeler code from the United States food	20
and drug administration under 21 C.F.R. 207.20.	21

(3) "Marketer" means a person who, while employed by or under	22
contract to represent a manufacturer or labeler, engages in	23
pharmaceutical detailing or other marketing or promotion of	24
dangerous drugs.	25

(4) "Sample drug" has the same meaning as in section 2925.01	26
of the Revised Code.	27

(5) "Wholesaler" means a person who, on official written	28
orders other than prescriptions, supplies dangerous drugs that the	29
person has not manufactured, produced, or prepared personally and	30
includes a "wholesale distributor of dangerous drugs" as defined	31
in section 4729.01 of the Revised Code.	32

(B) On or before the first day of January of each year, each	33
manufacturer and labeler that sells dangerous drugs shall disclose	34
to the director of health the name and address of the individual	35
responsible for the manufacturer's or labeler's compliance with	36
this section.	37

(C) Subject to division (E) of this section, no manufacturer	38
or labeler that sells dangerous drugs shall fail, on or before the	39
first day of February of each year, to disclose to the director	40
the value, nature, and purpose of any gift, fee, payment, subsidy,	41
or other economic benefit provided in connection with detailing,	42
promotion, or other marketing activities by the manufacturer or	43
labeler, directly or through a marketer, to any licensed health	44
professional authorized to prescribe drugs, hospital, nursing	45
home, residential care facility, adult care facility, pharmacist,	46
or health plan administrator. Disclosure shall cover the prior	47
calendar year and be made on a form and in a manner prescribed by	48
the director in rules adopted under section 3715.89 of the Revised	49
Code. No manufacturer or labeler shall fail to comply with this	50
division.	51

(D) On or before the first day of June of each year, the	52
director shall submit to the governor and members of the general	53
assembly a report summarizing the disclosures made in that year	54
under this section.	55

(E) All of the following are exempt from disclosure under	56
this section:	57

(1) Any gift, fee, payment, subsidy, or other economic	58
benefit the value of which does not exceed twenty-five dollars;	59

(2) Sample drugs that are given with the intent that they be	60
distributed to patients;	61

(3) The payment of reasonable compensation and reimbursement	62
of expenses in connection with a bona fide clinical trial	63
conducted in connection with a research study designed to answer	64
specific questions about vaccines, new therapies, or new ways of	65
using known treatments;	66

(4) Scholarship or other support for medical students,	67
residents, and fellows to attend bona fide educational,	68
scientific, or policy-making conferences of an established	69
professional association if the recipient of the scholarship or	70
other support is selected by the association.	71

Sec. 3715.89. The director of health shall adopt rules under	72
Chapter 119. of the Revised Code to do both of the following:	73

(A) Prescribe the form and manner in which each manufacturer	74
and labeler is to make the disclosures required by division (C) of	75
section 3715.88 of the Revised Code;	76

(B) Define the terms "bona fide clinical trial" and "bona	77
fide educational, scientific, or policy-making conference" for	78
purposes of divisions (E)(3) and (4) of section 3715.88 of the	79
Revised Code.	80

Sec. 3715.90. In addition to the penalty prescribed by	81
section 3715.99 of the Revised Code, whoever violates section	82
3715.88 of the Revised Code may be subject to an action by the	83
attorney general in the Franklin county court of common pleas for	84
injunctive relief. The court may issue an injunction and also may	85
award costs and attorney's fees associated with the action.	86

Sec. 3715.99. (A) Whoever violates sections 3715.13 to	87
3715.19, or 3715.38 of the Revised Code is guilty of a minor	88
misdemeanor.	89

(B) Whoever violates section 3715.22, 3715.25, 3715.27, or	90
3715.34 of the Revised Code is guilty of a misdemeanor of the	91
fourth degree.	92

(C) Whoever violates section 3715.23 or 3715.36 of the	93
Revised Code is guilty of a misdemeanor of the second degree.	94

(D) Whoever violates section 3715.52 or 3715.65 of the	95
Revised Code is guilty of a misdemeanor of the fourth degree on a	96
first offense; on each subsequent offense, the person is guilty of	97
a misdemeanor of the second degree.	98

(E) Whoever violates section 3715.521 of the Revised Code is	99
guilty of a minor misdemeanor. A violation of that section occurs	100
on a daily basis, not according to the number of times per day	101
that an expired drug, baby food, or infant formula is sold,	102
offered for sale, or delivered at retail or to the consumer. Each	103
day of violation is a separate offense.	104

(F) Whoever violates division (C) of section 3715.88 of the	105
Revised Code shall be fined not more than ten thousand dollars per	106
violation. Each unlawful failure to disclose under that section	107
constitutes a separate violation.	108

Section 2. That existing section 3715.99 of the Revised Code	109
is hereby repealed.	110