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78R7739 YDB-D
By: Deshotel H.B. No. 2046
A BILL TO BE ENTITLED
AN ACT
relating to a prescription drug cost control education program and
disclosure of certain expenditures by prescription drug
manufacturers.
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 168 to read as follows:
CHAPTER 168. PRESCRIPTION DRUGS
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 168.001. 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) "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.
(3) "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. 168.002. RULES. The board, in consultation with the
Texas State Board of Pharmacy, shall adopt the rules necessary to
implement this chapter.
[Sections 168.003–168.050 reserved for expansion]
SUBCHAPTER B. PHARMACEUTICAL MANUFACTURING COMPANIES
Sec. 168.051. 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 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.
(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. 168.052. CONFIDENTIALITY. (a) Information identified
as trade secret information under Section 168.051(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 and available
for inspection on request.
Sec. 168.053. DEPARTMENT DISCLOSURE OF REPORT. Except as
provided by Section 168.052, the department shall review and make
available to the public on request an annual report submitted under
Section 168.051.
Sec. 168.054. 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.
[Sections 168.055–168.100 reserved for expansion]
SUBCHAPTER C. PRESCRIPTION DRUG COST CONTROL EDUCATION PROGRAM
Sec. 168.101. ESTABLISHMENT. (a) The department shall
establish, promote, and maintain a prescription drug cost control
education program that:
(1) provides independent information and education on
the therapeutic and cost-effective use of prescription drugs; and
(2) does not compromise the quality of care of
physicians, pharmacists, and health care providers authorized to
prescribe or dispense prescription drugs.
(b) The department shall develop and provide independent
informational materials related to:
(1) the therapeutic and cost-effective use of
prescription drugs by patients;
(2) the fiscal impact of prescribing expensive and
nationally advertised drugs; and
(3) the relative costs and benefits of a variety of
prescription drugs, with an emphasis on:
(A) substituting generic prescription drugs for
brand name prescription drugs when available and appropriate;
(B) prescribing established, less costly drugs
instead of newer, more expensive prescription drugs when available
and appropriate;
(C) prescribing lower dosages of prescription
drugs when available and appropriate; and
(D) providing information about potentially
harmful drug combinations, drug recalls, and drug studies.
Sec. 168.102. IMPLEMENTATION. The department shall:
(1) provide sufficient staff to implement the program;
(2) provide appropriate training for program staff;
(3) identify the appropriate persons to carry out the
program;
(4) base the program on the most up-to-date
information and findings; and
(5) identify and, when appropriate, replicate or use
successful prescription drug cost control education programs and
obtain related materials and services from organizations with
appropriate expertise and knowledge of therapeutic and
cost-effective use of prescription drugs without compromising the
quality of care.
Sec. 168.103. PROFESSIONAL EDUCATION. The department shall
use the following strategies to educate physicians and health
professionals and training community service providers on the most
up-to-date and accurate scientific and medical information
concerning the therapeutic and cost-effective use of prescription
drugs without compromising quality:
(1) identify and obtain education materials for the
professional that translates the latest scientific and medical
information into clinical applications;
(2) raise awareness among physicians and health and
human services professionals as to the importance of prescribing a
cost-effective prescription drug without sacrificing quality of
care; and
(3) conduct a statewide conference on therapeutic and
cost-effective use of prescription drugs without compromising
quality of care at appropriate intervals.
Sec. 168.104. GRANTS AND GIFTS. The department may accept
grants of money, services, or property from the federal government,
a foundation, organization, medical school, or other person to
implement this subchapter.
SECTION 2. (a) The Texas State Board of Pharmacy shall
develop the form required by Section 168.051, Health and Safety
Code, as added by this Act, not later than October 1, 2003.
(b) The Texas Board of Health shall adopt the rules required
and establish the education program required by Chapter 168, Health
and Safety Code, as added by this Act, not later than March 1, 2004.
(c) Notwithstanding Section 168.051, 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, 2004.
SECTION 3. This Act takes effect September 1, 2003.