Bill Text: TX SB241 | 2023-2024 | 88th Legislature | Enrolled
Bill Title: Relating to written notification provided by drug manufacturers regarding the cause of generic or biosimilar insulin prescription drug unavailability.
Spectrum: Bipartisan Bill
Status: (Passed) 2023-05-27 - Effective on . . . . . . . . . . . . . . . September 1, 2024 [SB241 Detail]
Download: Texas-2023-SB241-Enrolled.html
S.B. No. 241 |
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relating to written notification provided by drug manufacturers | ||
regarding the cause of generic or biosimilar insulin prescription | ||
drug unavailability. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. Chapter 439, Health and Safety Code, is amended | ||
by adding Subchapter D to read as follows: | ||
SUBCHAPTER D. INSULIN | ||
Sec. 439.101. DEFINITION. In this subchapter, | ||
"manufacturer" has the meaning assigned by Section 531.070, | ||
Government Code. | ||
Sec. 439.102. WRITTEN VERIFICATION REQUIRED FOR BRAND NAME | ||
INSULIN DRUG MANUFACTURER. (a) The manufacturer of a brand name | ||
insulin prescription drug for which a generic or biosimilar | ||
prescription drug is not available and that is included in the | ||
Medicaid vendor drug program formulary must submit to the Health | ||
and Human Services Commission a written verification stating | ||
whether or not the unavailability of the generic or biosimilar | ||
prescription drug is the result, wholly or partly, of: | ||
(1) a scheme by the manufacturer to pay a generic or | ||
biosimilar prescription drug manufacturer to delay manufacturing | ||
or marketing the generic or biosimilar drug; | ||
(2) a legal or business strategy to extend the life of | ||
a patent on the brand name prescription drug; | ||
(3) the manufacturer directly manipulating a patent on | ||
the brand name prescription drug; or | ||
(4) the manufacturer facilitating an action described | ||
by Subdivisions (1)-(3) on behalf of another entity. | ||
(b) The executive commissioner shall adopt rules | ||
prescribing the form and manner for submission of the written | ||
verification required under Subsection (a). | ||
SECTION 2. This Act takes effect September 1, 2024. | ||
______________________________ | ______________________________ | |
President of the Senate | Speaker of the House | |
I hereby certify that S.B. No. 241 passed the Senate on | ||
March 23, 2023, by the following vote: Yeas 31, Nays 0. | ||
______________________________ | ||
Secretary of the Senate | ||
I hereby certify that S.B. No. 241 passed the House on | ||
May 12, 2023, by the following vote: Yeas 139, Nays 1, two | ||
present not voting. | ||
______________________________ | ||
Chief Clerk of the House | ||
Approved: | ||
______________________________ | ||
Date | ||
______________________________ | ||
Governor |