2009S0006-1 10/24/08
By: Lucio S.B. No. 553
A BILL TO BE ENTITLED
AN ACT
relating to the disclosure of certain economic benefits provided by
manufacturers or repackagers of prescription drugs; providing
penalties.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Chapter 431, Health and Safety Code, is amended
by adding Subchapter O to read as follows:
SUBCHAPTER O. PRESCRIPTION DRUG MARKETING
Sec. 431.451. DEFINITIONS. In this subchapter:
(1) "Pharmaceutical marketer" means a person who,
while employed by or under contract to represent a manufacturer or
repackager, engages in pharmaceutical detailing, promotional
activity, or other marketing of prescription drugs in this state to
a physician, hospital, nursing home, pharmacist, health benefit
plan administrator, or other person authorized by law to dispense
or prescribe prescription drugs in this state.
(2) "Repackager" has the meaning assigned by Section
431.401.
Sec. 431.452. ANNUAL REPORT; DISCLOSURE OF CERTAIN ECONOMIC
BENEFITS. (a) Not later than January 1 of each year, a
manufacturer or repackager that sells or repackages prescription
drugs in this state shall submit to the department the name and
address of the individual responsible for the manufacturer's or
repackager's compliance with this section.
(b) Not later than February 1 of each year, a manufacturer
or repackager that sells or repackages prescription drugs in this
state shall submit to the department a report that discloses any
gift, fee, payment, subsidy, or other economic benefit received by
a physician, physician's office, hospital, nursing home,
pharmacist, health benefit plan administrator, or other person
authorized by law to dispense or prescribe prescription drugs in
this state in connection with detailing, promotional, or marketing
activities of the manufacturer or repackager, directly or through
its pharmaceutical marketers.
(c) The report required under Subsection (b) must cover the
preceding calendar year and must be submitted on a form, including
any electronic form, prescribed by the department. The report must
include:
(1) the name and address of each recipient of an
economic benefit;
(2) the value and a description of the economic
benefit; and
(3) the date of receipt of the economic benefit.
(d) The department shall make available to the public on
request a report submitted under this section.
(e) Not later than March 1 of each year, the department
shall make all reports submitted under this section available on
the department's Internet website.
Sec. 431.453. EXEMPTIONS. The following economic benefits
are exempt from disclosure under Section 431.452:
(1) a gift, fee, payment, subsidy, or other economic
benefit with a fair market value that is less than $75;
(2) free samples of prescription drugs intended for
distribution to patients;
(3) payment of reasonable compensation and
reimbursement of expenses in connection with bona fide clinical
trials conducted in relation to a research study designed to answer
specific questions about vaccines, new therapies, or new ways of
using known treatments;
(4) a scholarship or other support for a medical
student, resident, or fellow to attend a bona fide educational,
scientific, or policy-making conference of an established
professional association if the recipient of the scholarship or
other support is selected by the association; and
(5) a grant or other support for the development,
production, or presentation of a bona fide educational, scientific,
or policy-making program or conference of an established
professional association if the professional association
independently selects, develops, produces, or presents the
educational, scientific, or policy-making program or conference.
Sec. 431.454. PENALTIES; INJUNCTION. (a) The
commissioner may, in accordance with the procedures applicable to
administrative penalties assessed under Subchapter C, assess an
administrative penalty against a person who does not file a report
required under this subchapter.
(b) The attorney general may bring an action:
(1) for injunctive relief to compel a person to file a
report required under this subchapter; and
(2) to impose a civil penalty of not more than $10,000
for a failure to file a report required under this subchapter.
(c) Each failure to file a report required under this
subchapter constitutes a separate violation.
(d) The court may award to the attorney general reasonable
court costs and attorney's fees in connection with an action
brought under Subsection (b).
SECTION 2. (a) Not later than January 1, 2010, the
executive commissioner of the Health and Human Services Commission
shall adopt the rules and procedures necessary to implement
Subchapter O, Chapter 431, Health and Safety Code, as added by this
Act, including rules defining bona fide clinical trials and bona
fide programs and conferences under Subdivisions (3), (4), and (5),
Section 431.453, Health and Safety Code, as added by this Act.
(b) Not later than January 1, 2010, the Department of State
Health Services shall develop the form required by Section 431.452,
Health and Safety Code, as added by this Act.
(c) Notwithstanding Section 431.452, Health and Safety
Code, as added by this Act, a manufacturer or repackager of
prescription drugs is not required to submit the report required by
that section before February 1, 2011.
SECTION 3. (a) Except as provided by Subsection (b) of
this section, this Act takes effect September 1, 2009.
(b) Section 431.454, Health and Safety Code, as added by
this Act, takes effect January 1, 2011.