81R1611 JSC-D
By: Ellis S.B. No. 151
A BILL TO BE ENTITLED
AN ACT
relating to the disclosure of certain expenditures by prescription
drug manufacturers; imposing a penalty.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle H, Title 2, Health and Safety Code, is
amended by adding Chapter 173 to read as follows:
CHAPTER 173. PRESCRIPTION DRUG MARKETING
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 173.001. DEFINITIONS. In this chapter:
(1) "Clinical trial" means an approved 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.
(2) "Department" means the Department of State Health
Services.
(3) "Executive commissioner" means the executive
commissioner of the Health and Human Services Commission.
(4) "Pharmaceutical manufacturing company" means a
person that produces, prepares, propagates, compounds, converts,
or processes prescription drugs, either directly or indirectly, by
extraction from substances of natural origin, by chemical
synthesis, or by a combination of extraction and chemical
synthesis, or packages, repackages, labels, relabels, or
distributes prescription drugs. The term does not include a
wholesale drug distributor or a pharmacist.
(5) "Pharmaceutical representative" means a person
who is employed by or under contract to represent a pharmaceutical
manufacturing company and who 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 to
prescribe or dispense prescription drugs. The term does not include
a wholesale prescription drug distributor or the distributor's
representative who promotes or otherwise markets the services of
the wholesale drug distributor in connection with a prescription
drug.
Sec. 173.002. RULES. The executive commissioner, in
consultation with the Texas State Board of Pharmacy, shall adopt
the rules necessary to implement this chapter.
[Sections 173.003-173.050 reserved for expansion]
SUBCHAPTER B. PHARMACEUTICAL MANUFACTURING COMPANIES
Sec. 173.051. ANNUAL REPORT. (a) A pharmaceutical
manufacturing company doing business in this state shall submit an
annual report to the department and the Texas State Board of
Pharmacy that discloses:
(1) the value, nature, and purpose of any gift, fee,
payment, subsidy, or other economic benefit received in connection
with detailing, promotional, or other marketing activities of the
company, directly or through its representatives, by a physician,
hospital, nursing home, pharmacist, pharmacy, health benefit plan
administrator, or other person authorized to prescribe or dispense
prescription drugs in this state; and
(2) the name and address of each gift recipient.
(b) The annual report must be on the form and submitted in
the manner prescribed by the Texas State Board of Pharmacy. The
form must allow a company to identify trade secret information.
(c) A pharmaceutical manufacturing company annually shall
disclose to the Texas State Board of Pharmacy and to the department
the name and address of the individual responsible for the
company's compliance with this section.
Sec. 173.052. CONFIDENTIALITY. (a) Information identified
as trade secret information under Section 173.051(b) is
confidential and exempt from disclosure under Chapter 552,
Government Code.
(b) Information relating to the following economic benefits
is confidential and exempt from disclosure under Chapter 552,
Government Code:
(1) free samples of prescription drugs intended for
distribution to patients;
(2) payment of reasonable compensation and
reimbursement of expenses in connection with bona fide clinical
trials;
(3) a gift, payment, fee, subsidy, or other economic
benefit valued at less than $25; and
(4) a scholarship or other support for a medical
student, resident, or fellow to attend a significant educational,
scientific, or policy-making conference of a national, regional, or
specialty medical or other professional association if the
recipient of the scholarship or other support is selected by the
association.
(c) Except as provided by Subsection (a) or (b), information
provided in an annual report is public information.
Sec. 173.053. DEPARTMENT DISCLOSURE OF REPORT. (a) Except
as provided by Section 173.052, the department shall review and
make available to the public an annual report submitted under
Section 173.051.
(b) The department shall publish the annual report on the
department's website and shall make printed copies of the report
available on request.
Sec. 173.054. VIOLATION: INJUNCTION OR CIVIL PENALTY. (a)
The attorney general may bring an action:
(1) for injunctive relief to compel a person to file an
annual report required under this subchapter; and
(2) to impose a civil penalty of not more than $10,000
for a failure to file an annual report required under this
subchapter.
(b) The court may award to the attorney general reasonable
court costs and attorney's fees in connection with an action
brought under Subsection (a).
(c) Each failure to file an annual report constitutes a
separate violation.
SECTION 2. (a) The Texas State Board of Pharmacy shall
develop the form required by Section 173.051, Health and Safety
Code, as added by this Act, not later than October 1, 2009.
(b) Notwithstanding Section 173.051, Health and Safety
Code, as added by this Act, a pharmaceutical manufacturing company
is not required to submit the annual report required by that section
before June 30, 2010.
SECTION 3. This Act takes effect September 1, 2009.