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