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S. B. No. 79 As IntroducedAs Introduced
129th General Assembly | Regular Session | 2011-2012 |
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Cosponsors:
Senators Cafaro, Tavares, Smith
A BILL
To amend section 3715.99 and to enact section 3715.93
of the Revised Code regarding prescription drug
marketing disclosures.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That section 3715.99 be amended and section
3715.93 of the Revised Code be enacted to read as follows:
Sec. 3715.93. (A) As used in this section:
(1) "Detailing" means the marketing or promotion of dangerous
drugs by or on behalf of a manufacturer or labeler.
(2) "Labeler" means a person to whom both of the following
apply:
(a) The person receives dangerous drugs from a manufacturer
or wholesaler and repackages them for retail sale.
(b) The person has a labeler code from the United States food
and drug administration under 21 C.F.R. 207.20.
(3) "Marketer" means a person who, while employed by or under
contract to represent a manufacturer or labeler, engages in
pharmaceutical detailing or other marketing or promotion of
dangerous drugs.
(4) "Sample drug" has the same meaning as in section 2925.01
of the Revised Code.
(5) "Wholesaler" means a person who, on official written
orders other than prescriptions, supplies dangerous drugs that the
person has not manufactured, produced, or prepared personally and
includes a "wholesale distributor of dangerous drugs" as defined
in section 4729.01 of the Revised Code.
(B)(1) On or before the first day of January of each year,
each manufacturer and labeler that sells dangerous drugs shall
report to the director of health the name and address of the
individual responsible for the manufacturer's or labeler's
compliance with this section.
(2) On or before the first day of February of each year, each
manufacturer or labeler that sells dangerous drugs shall submit to
the director a report that discloses, except as provided in
division (E) of this section, the value, nature, and purpose of
any gift, fee, payment, subsidy, or other economic benefit
provided in connection with detailing, promotion, or other
marketing activities by the manufacturer or labeler, directly or
through a marketer, to any licensed health professional authorized
to prescribe drugs, hospital, nursing home, residential care
facility, adult care facility, pharmacist, or health benefit plan
administrator. The report shall cover the prior calendar year and
be made on a form and in a manner prescribed by the director in
rules adopted under this section. When submitting the report, the
manufacturer or labeler shall pay a fee in an amount and in a
manner prescribed by the director in rules adopted under this
section.
(C) No manufacturer or labeler shall fail to make a
disclosure in the report required by division (B)(2) of this
section with respect to a particular licensed health professional
authorized to prescribe drugs, hospital, nursing home, residential
care facility, adult care facility, pharmacist, or health benefit
plan administrator that is provided a gift, fee, payment, subsidy,
or other economic benefit in connection with detailing, promotion,
or other marketing activities.
(D) On or before the first day of June of each year, the
director shall submit a report to the governor and, in accordance
with section 101.68 of the Revised Code, the general assembly. The
report shall summarize the reports received in that year under
division (B)(2) of this section.
(E) All of the following are exempt from disclosure under
this section:
(1) Any gift, fee, payment, subsidy, or other economic
benefit the value of which does not exceed twenty-five dollars;
(2) Sample drugs that are given with the intent that they be
distributed to patients;
(3) The payment of reasonable compensation and reimbursement
of expenses in connection with a bona fide clinical trial
conducted in connection with a research study designed to answer
specific questions about vaccines, new therapies, or new ways of
using known treatments;
(4) Scholarships or other support for medical students,
residents, and fellows to attend bona fide educational,
scientific, or policy-making conferences of an established
professional association if the recipients of the scholarships or
other support are selected by the association.
(F) The director shall adopt rules in accordance with Chapter
119. of the Revised Code to do all of the following:
(1) Prescribe the form and manner in which each manufacturer
and labeler is to make the report required by division (B)(2) of
this section;
(2) Prescribe the amount and manner in which each
manufacturer and labeler is to pay the fee required by division
(B)(2) of this section;
(3) Define the terms "bona fide clinical trial" and "bona
fide educational, scientific, or policy-making conference" for
purposes of divisions (E)(3) and (4) of this section.
(G) In addition to the penalty prescribed by section 3715.99
of the Revised Code, whoever violates division (C) of this section
may be subject to an action by the attorney general in the
Franklin county court of common pleas for injunctive relief. The
court may issue an injunction and also may award costs and
attorney's fees associated with the action.
Sec. 3715.99. (A) Whoever violates sections 3715.13 to
3715.19, or 3715.38 of the Revised Code is guilty of a minor
misdemeanor.
(B) Whoever violates section 3715.22, 3715.25, 3715.27, or
3715.34 of the Revised Code is guilty of a misdemeanor of the
fourth degree.
(C) Whoever violates section 3715.23 or 3715.36 of the
Revised Code is guilty of a misdemeanor of the second degree.
(D) Whoever violates section 3715.52 or 3715.65 of the
Revised Code is guilty of a misdemeanor of the fourth degree on a
first offense; on each subsequent offense, the person is guilty of
a misdemeanor of the second degree.
(E) Whoever violates section 3715.521 of the Revised Code is
guilty of a minor misdemeanor. A violation of that section occurs
on a daily basis, not according to the number of times per day
that an expired drug, baby food, or infant formula is sold,
offered for sale, or delivered at retail or to the consumer. Each
day of violation is a separate offense.
(F) Whoever violates division (C) of section 3715.93 of the
Revised Code shall be fined not more than ten thousand dollars.
Each violation is a separate offense.
Section 2. That existing section 3715.99 of the Revised Code
is hereby repealed.
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