88R458 KKR-D
By: Perry S.B. No. 241
A BILL TO BE ENTITLED
AN ACT
relating to written notification provided by drug manufacturers
regarding the cause of generic 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 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 prescription drug is the result,
wholly or partly, of:
(1) a scheme by the manufacturer to pay a generic
prescription drug manufacturer to delay marketing the generic 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.