By: Perry  S.B. No. 241
         (In the Senate - Filed November 16, 2022; February 15, 2023,
  read first time and referred to Committee on Health & Human
  Services; March 20, 2023, reported adversely, with favorable
  Committee Substitute by the following vote:  Yeas 9, Nays 0;
  March 20, 2023, sent to printer.)
Click here to see the committee vote
 
  COMMITTEE SUBSTITUTE FOR S.B. No. 241 By:  Hancock
 
 
A BILL TO BE ENTITLED
 
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 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.
 
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