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