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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 economic benefits provided by |
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manufacturers or repackagers of prescription drugs; providing |
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penalties. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Chapter 431, Health and Safety Code, is amended |
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by adding Subchapter O to read as follows: |
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SUBCHAPTER O. PRESCRIPTION DRUG MARKETING |
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Sec. 431.451. DEFINITIONS. In this subchapter: |
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(1) "Pharmaceutical marketer" means a person who, |
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while employed by or under contract to represent a manufacturer or |
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repackager, engages in pharmaceutical detailing, promotional |
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activity, or other marketing of prescription drugs in this state to |
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a physician, hospital, nursing home, pharmacist, health benefit |
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plan administrator, or other person authorized by law to dispense |
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or prescribe prescription drugs in this state. |
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(2) "Repackager" has the meaning assigned by Section |
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431.401. |
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Sec. 431.452. ANNUAL REPORT; DISCLOSURE OF CERTAIN ECONOMIC |
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BENEFITS. (a) Not later than January 1 of each year, a manufacturer |
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or repackager that sells or repackages prescription drugs in this |
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state shall submit to the department the name and address of the |
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individual responsible for the manufacturer's or repackager's |
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compliance with this section. |
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(b) Not later than February 1 of each year, a manufacturer |
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or repackager that sells or repackages prescription drugs in this |
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state shall submit to the department a report that discloses any |
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gift, fee, payment, subsidy, or other economic benefit received by |
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a physician, physician's office, hospital, nursing home, |
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pharmacist, health benefit plan administrator, or other person |
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authorized by law to dispense or prescribe prescription drugs in |
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this state in connection with detailing, promotional, or marketing |
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activities of the manufacturer or repackager, directly or through |
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its pharmaceutical marketers. |
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(c) The report required under Subsection (b) must cover the |
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preceding calendar year and must be submitted on a form, including |
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any electronic form, prescribed by the department. The report must |
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include: |
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(1) the name and address of each recipient of an |
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economic benefit; |
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(2) the value and a description of the economic |
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benefit; and |
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(3) the date of receipt of the economic benefit. |
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(d) The department shall make available to the public on |
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request a report submitted under this section. |
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(e) Not later than March 1 of each year, the department |
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shall make all reports submitted under this section available on |
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the department's Internet website. |
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Sec. 431.453. EXEMPTIONS. The following economic benefits |
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are exempt from disclosure under Section 431.452: |
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(1) a gift, fee, payment, subsidy, or other economic |
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benefit with a fair market value that is less than $75; |
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(2) free samples of prescription drugs intended for |
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distribution to patients; |
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(3) payment of reasonable compensation and |
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reimbursement of expenses in connection with bona fide clinical |
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trials conducted in relation to 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; 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 bona fide educational, |
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scientific, or policy-making conference of an established |
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professional association if the recipient of the scholarship or |
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other support is selected by the association. |
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Sec. 431.454. PENALTIES; INJUNCTION. (a) The commissioner |
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may, in accordance with the procedures applicable to administrative |
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penalties assessed under Subchapter C, assess an administrative |
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penalty against a person who does not file a report required under |
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this subchapter. |
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(b) The attorney general may bring an action: |
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(1) for injunctive relief to compel a person to file a |
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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 a report required under this subchapter. |
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(c) Each failure to file a report required under this |
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subchapter constitutes a separate violation. |
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(d) 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 (b). |
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SECTION 2. (a) Not later than January 1, 2008, the executive |
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commissioner of the Health and Human Services Commission shall |
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adopt the rules and procedures necessary to implement Subchapter O, |
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Chapter 431, Health and Safety Code, as added by this Act, including |
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rules defining bona fide clinical trials and bona fide conferences |
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under Sections 431.453(3) and (4), Health and Safety Code, as added |
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by this Act. |
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(b) Not later than January 1, 2008, the Department of State |
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Health Services shall develop the form required by Section 431.452, |
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Health and Safety Code, as added by this Act. |
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(c) Notwithstanding Section 431.452, Health and Safety |
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Code, as added by this Act, a manufacturer or repackager of |
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prescription drugs is not required to submit the report required by |
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that section before February 1, 2009. |
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SECTION 3. (a) Except as provided by Subsection (b), this |
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Act takes effect September 1, 2007. |
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(b) Section 431.454, Health and Safety Code, as added by |
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this Act, takes effect January 1, 2009. |