|
|
A BILL TO BE ENTITLED
|
|
AN ACT
|
|
|
relating to the disclosure of certain economic benefits provided to |
|
health professionals in the marketing of prescription drugs, |
|
medical devices, and medical supplies; 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. REPORTING REQUIREMENTS RELATED TO MARKETING OF |
|
PRESCRIPTION DRUGS, MEDICAL DEVICES, AND MEDICAL SUPPLIES |
|
Sec. 431.451. DEFINITIONS. In this subchapter: |
|
(1) "Bona fide clinical trial" means any study |
|
assessing the safety or efficacy of: |
|
(A) drugs administered alone or in combination |
|
with other drugs or other therapies or assessing the relative |
|
safety or efficacy of drugs in comparison with other drugs or other |
|
therapies; or |
|
(B) a medical device. |
|
(2) "Distributor" means a person who furthers the |
|
marketing of a prescription drug, medical device, or medical supply |
|
from the original place of manufacture to the person who makes final |
|
delivery or sale to the ultimate consumer or user. |
|
(3) "Gift" means a payment, food, entertainment, |
|
travel, honorarium, subscription, advance, service, product |
|
sample, or anything of value, unless consideration of equal or |
|
greater value is received, and includes anything of value provided |
|
for less than market value. |
|
(4) "Health professional" means: |
|
(A) a physician; |
|
(B) a physician medical practice; and |
|
(C) a physician group practice. |
|
(5) "Manufacturer" means a person who manufactures, |
|
fabricates, distributes, or repackages a prescription drug, |
|
medical device, or medical supply. |
|
(6) "Marketer" means a person who, while employed by |
|
or under contract to represent a manufacturer, repackager, or |
|
retailer, engages in detailing, promotional activity, or other |
|
marketing of a prescription drug, medical device, or medical supply |
|
in this state to a physician, hospital, nursing home, pharmacist, |
|
health benefit plan administrator, or other health professional. |
|
(7) "Medical device" or "device" means an instrument, |
|
apparatus, implement, machine, contrivance, implant, in vitro |
|
reagent, or other similar or related article, including any |
|
component, part, or accessory, which is: |
|
(A) recognized in the official National |
|
Formulary or the United States Pharmacopia, or any supplement |
|
thereto; |
|
(B) intended for use in the diagnosis of disease |
|
or other conditions, or in the cure, mitigation, treatment, or |
|
prevention of disease in humans; or |
|
(C) intended to affect the structure or any |
|
function of the human body, and which does not achieve its primary |
|
intended purposes through chemical action within or on the human |
|
body and which is not dependent upon being metabolized for the |
|
achievement of its primary intended purposes. |
|
(8) "Prescription drug" has the meaning assigned by 21 |
|
C.F.R. Section 203.3. |
|
(9) "Repackage" means repackaging or otherwise |
|
changing the container, wrapper, or labeling of a prescription |
|
drug, medical device, or medical supply to further the distribution |
|
of the drug, device, or supply. The term does not include |
|
repackaging by a pharmacist to dispense a drug, device, or supply to |
|
a patient. |
|
(10) "Repackager" means a person who engages in |
|
repackaging. |
|
(11) "Retailer" means a person who is engaged in the |
|
business of buying for resale, selling, or exchanging a medical |
|
device or medical supply or offering a device or supply for sale, |
|
exchange, or lease-purchase to a consumer or user. |
|
Sec. 431.452. APPLICABILITY OF SUBCHAPTER. This subchapter |
|
applies only to a manufacturer, repackager, or retailer that |
|
exceeds $30 million in annual gross revenue and that manufactures, |
|
markets, sells, distributes, produces, prepares, compounds, |
|
converts, or processes a medical device, medical supply, or |
|
prescription drug for which payment is available through the |
|
medical assistance program under Chapter 32, Human Resources Code, |
|
or under Title XVIII, XIX, or XXI of the Social Security Act (42 |
|
U.S.C. Sections 1395 et seq. and 1397aa et seq.). |
|
Sec. 431.453. ANNUAL DISCLOSURE OF CERTAIN ECONOMIC |
|
BENEFITS. (a) Not later than March 31 of each year, a manufacturer |
|
or repackager that sells, repackages, or distributes prescription |
|
drugs, medical devices, or medical supplies in this state, and a |
|
retailer that sells medical devices or medical supplies in this |
|
state, shall submit to the department a report that discloses any |
|
gift, fee, payment, subsidy, or other economic benefit given, paid, |
|
or provided by the manufacturer, repackager, or retailer to a |
|
physician, physician's office, hospital, nursing home, pharmacist, |
|
health benefit plan administrator, or other health professional in |
|
connection with detailing, promotional, or marketing activities of |
|
the manufacturer, repackager, or retailer, directly or through a |
|
marketer. |
|
(b) A report required under Subsection (a) must cover the |
|
preceding calendar year and must be submitted on a form, including |
|
any electronic form, prescribed by the department. In connection |
|
with each gift, fee, payment, subsidy, or other economic benefit |
|
required to be disclosed under this subchapter, the report must |
|
include: |
|
(1) the name and business address of each recipient of |
|
the benefit; |
|
(2) the value of each benefit; |
|
(3) the date of payment or transfer of each benefit; |
|
(4) a categorized description of the form of each |
|
benefit, including: |
|
(A) cash or cash equivalent; |
|
(B) an in-kind item or service; |
|
(C) an ownership interest or other return on |
|
investment, including securities, stock options, dividends, or |
|
profit-sharing arrangement; and |
|
(D) any other category the commissioner deems |
|
appropriate; |
|
(5) a categorized description of the nature of each |
|
benefit, including: |
|
(A) a consulting fee; |
|
(B) compensation for a service other than |
|
consulting; |
|
(C) honoraria; |
|
(D) a gift; |
|
(E) entertainment; |
|
(F) food; |
|
(G) travel; |
|
(H) education; |
|
(I) research; |
|
(J) a charitable contribution; |
|
(K) a royalty or license; |
|
(L) current or prospective ownership of an |
|
investment interest; |
|
(M) compensation for serving as faculty or as a |
|
speaker for a continuing medical education program; |
|
(N) a grant; and |
|
(O) any other category the commissioner |
|
determines appropriate; |
|
(6) if the payment or transfer of the benefit is |
|
related to marketing, education, or research specific to a |
|
particular prescription drug, medical device, or medical supply the |
|
name of the drug, device, or supply; and |
|
(7) any other category of information regarding the |
|
payment or transfer of a benefit the commissioner determines |
|
appropriate. |
|
(c) Not later than May 1 of each year, the department shall |
|
make all reports submitted under this section on or before March 31 |
|
available on the department's Internet website. The department |
|
shall make reports submitted under this section after March 31 |
|
available on the department's Internet website as soon as |
|
practicable. |
|
(d) The reporting requirements described by Subsections (a) |
|
and (b) do not apply in an area of the state designated in an |
|
executive order or a proclamation by the governor under Chapter |
|
418, Government Code, during the 30-day period after the executive |
|
order or proclamation is issued. |
|
Sec. 431.454. EXEMPTIONS. (a) The following economic |
|
benefits are exempt from disclosure under Section 431.453: |
|
(1) a gift, fee, payment, subsidy, or other economic |
|
benefit with a fair market value that is less than $50; |
|
(2) free samples of prescription drugs intended for |
|
distribution to patients; |
|
(3) any prescription drug rebate or discount; |
|
(4) payment of reasonable compensation and |
|
reimbursement of expenses in connection with a bona fide clinical |
|
trial; |
|
(5) 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; |
|
(6) 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; |
|
(7) educational materials that directly benefit |
|
patients or are intended for patient use; |
|
(8) in-kind items used for the provision of charity |
|
care; |
|
(9) any transfer or payment of a benefit to treat a |
|
health condition of an individual described by Section 431.453(a), |
|
where the individual is a patient and is not acting in a |
|
professional capacity; |
|
(10) a dividend or other profit distribution from, or |
|
an ownership or investment interest in, a mutual fund or |
|
publically-traded security; |
|
(11) the loan of a device for a short-term trial |
|
period, not to exceed 90 days, to permit evaluation of the device by |
|
the recipient; and |
|
(12) items or services provided under a contractual |
|
warranty, including the replacement of a device, where the terms |
|
for the warranty are set forth in the purchase or lease agreement |
|
for the covered device. |
|
(b) Notwithstanding Subsection (a)(1), any aggregate |
|
payment or transfer of a benefit to a single recipient during an |
|
annual reporting period that does not exceed $100 is exempt under |
|
this section. Any value associated with free samples or with a |
|
dividend or other profit distribution may be excluded from the |
|
calculation of aggregate value. |
|
Sec. 431.455. 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 fails to 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). |
|
Sec. 431.456. PUBLIC RECORDS. The information required to |
|
be submitted to the department under this subchapter and the data |
|
and reports compiled by the department based on that information |
|
are public records under Chapter 552, Government Code. |
|
Notwithstanding any other provision of law, the identity of any |
|
recipient of a gift, fee, payment, subsidy, or other economic |
|
benefit required to be reported under this subchapter does not |
|
constitute confidential information or a trade secret. |
|
Sec. 431.457. SUSPENSION OF STATE REPORTING REQUIREMENTS. |
|
If a federal law provides for the disclosure of gifts to health |
|
professionals by manufacturers, repackagers, or retailers to whom |
|
this subchapter applies and the commissioner determines that the |
|
federal law substantially meets the purposes of provisions of this |
|
subchapter, the department shall suspend the application of the |
|
state reporting requirements imposed under those provisions. |
|
SECTION 2. (a) Not later than March 31, 2011, 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 programs and conferences |
|
under Subdivisions (5) and (6), Section 431.454, Health and Safety |
|
Code, as added by this Act. |
|
(b) Not later than March 31, 2011, the Department of State |
|
Health Services shall develop the form required by Section 431.453, |
|
Health and Safety Code, as added by this Act. |
|
(c) Notwithstanding Section 431.453, Health and Safety |
|
Code, as added by this Act, a manufacturer, repackager, or retailer |
|
of prescription drugs, medical devices, or medical supplies is not |
|
required to submit the report required by that section before |
|
March 31, 2012. |
|
SECTION 3. This Act takes effect January 1, 2011. |
|
|
|
* * * * * |