S.B. No. 241
AN ACT
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