Bill Text: TX HB1033 | 2021-2022 | 87th Legislature | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Relating to prescription drug price disclosure; authorizing a fee; providing an administrative penalty.

Spectrum: Slight Partisan Bill (Republican 6-2)

Status: (Passed) 2021-05-18 - Effective on 9/1/21 [HB1033 Detail]

Download: Texas-2021-HB1033-Introduced.html

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87R268 SCL-F
By: Oliverson H.B. No. 1033

A BILL TO BE ENTITLED
AN ACT
relating to prescription drug price disclosure; authorizing a fee;
providing an administrative penalty.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter A, Chapter 441, Health and Safety
Code, is amended by adding Section 441.0003 to read as follows:
Sec. 441.0003. RULES. The executive commissioner may adopt
rules to implement this chapter.
SECTION 2. Chapter 441, Health and Safety Code, is amended
by adding Subchapter B, and a heading is added to that subchapter to
read as follows:
SUBCHAPTER B. PRESCRIPTION DRUG PRICE DISCLOSURE
SECTION 3. Section 441.0002, Health and Safety Code, is
transferred to Subchapter B, Chapter 441, Health and Safety Code,
as added by this Act, redesignated as Sections 441.0051, 441.0052,
441.0053, and 441.0054, Health and Safety Code, and amended to read
as follows:
Sec. 441.0051 [441.0002]. ANNUAL REPORT [DISCLOSURE OF
DRUG PRICING INFORMATION]. [(a)] Not later than the 15th day of
each calendar year, a pharmaceutical drug manufacturer shall submit
a report to the department [executive commissioner] stating the
current wholesale acquisition cost information for the United
States Food and Drug Administration-approved prescription drugs
sold in or into this state by that manufacturer.
Sec. 441.0052. PRESCRIPTION DRUG PRICE INFORMATION
INTERNET WEBSITE. [(b)] The department [executive commissioner]
shall develop an Internet website to provide to the general public
prescription drug price information submitted under Section
441.0051 [Subsection (a)]. The Internet website shall be made
available on the department's [Health and Human Services
Commission's] Internet website with a dedicated link that is
prominently displayed on the home page or by a separate easily
identifiable Internet address.
Sec. 441.0053. PRESCRIPTION DRUG COST INCREASE
INFORMATION. (a) If during a calendar year [(c) This subsection
applies only to] a prescription drug with a wholesale acquisition
cost of at least $100 for a 30-day supply increases in price by
[before the effective date of an increase described by this
subsection. Not later than the 30th day after the effective date of
an increase of] 40 percent or more over the preceding three calendar
years or 15 percent or more in the preceding calendar year in the
wholesale acquisition cost of the prescription [a] drug, the [to
which this subsection applies, a] pharmaceutical drug manufacturer
must include in the annual [shall submit a report to the executive
commissioner. The] report submitted under Section 441.0051 [must
include] the following information:
(1) the name of the prescription drug;
(2) whether the prescription drug is a brand name or
generic;
(3) the effective date of the change in wholesale
acquisition cost;
(4) aggregate, company-level research and development
costs for the most recent year for which final audit data is
available;
(5) the name of each of the manufacturer's
prescription drugs approved by the United States Food and Drug
Administration in the previous three calendar years;
(6) the name of each of the manufacturer's
prescription drugs that lost patent exclusivity in the United
States in the previous three calendar years; and
(7) a statement regarding the factor or factors that
caused the increase in the wholesale acquisition cost and an
explanation of the role of each factor's impact on the cost.
(b) [(d)] The quality and types of information and data that
a pharmaceutical drug manufacturer submits to the department
[executive commissioner] under Subsection (a) [(c)] must be
consistent with the quality and types of information and data that
the manufacturer includes in the manufacturer's annual
consolidated report on Securities and Exchange Commission Form 10-K
or any other public disclosure.
Sec. 441.0054. PUBLICATION OF COST INCREASE INFORMATION.
[(e)] Not later than the 60th day after receipt of the report
submitted under Section 441.0051 [Subsection (c)], the department
[executive commissioner] shall publish the cost increase
information required by Section 441.0053 [report] on the
department's prescription drug price information [Health and Human
Services Commission's] Internet website [described by Subsection
(b)].
[(f) The executive commissioner may adopt rules to
implement this section.]
SECTION 4. Subchapter B, Chapter 441, Health and Safety
Code, as added by this Act, is amended by adding Section 441.0055 to
read as follows:
Sec. 441.0055. FEE. (a) A pharmaceutical drug
manufacturer shall submit a fee in the amount provided by
department rule with each report submitted under this subchapter.
(b) The executive commissioner by rule shall set the fee in
the amount necessary for the department to administer this chapter.
SECTION 5. Chapter 441, Health and Safety Code, is amended
by adding Subchapter C to read as follows:
SUBCHAPTER C. ENFORCEMENT
Sec. 441.0101. RIGHT TO CORRECT. (a) If the department
determines that a pharmaceutical drug manufacturer failed to submit
a report or fee required under Subchapter B and the rules adopted
under this chapter, the department shall provide written notice of
the failure to the manufacturer.
(b) On receipt of notice described by Subsection (a), a
pharmaceutical drug manufacturer shall submit, as applicable:
(1) a report that:
(A) complies with Subchapter B and rules adopted
under this chapter; and
(B) addresses the issues raised in the notice; or
(2) the fee required by Section 441.0055.
(c) The department may not assess an administrative penalty
under Section 441.0102 against a pharmaceutical drug manufacturer
that submits to the department the required report or fee, as
applicable, on or before the 45th day after the date the
manufacturer receives notice under Subsection (a).
Sec. 441.0102. ADMINISTRATIVE PENALTY. (a) The department
may assess an administrative penalty against a person who violates
this chapter or a rule adopted under this chapter.
(b) In determining the amount of the penalty, the department
shall consider:
(1) the person's previous violations;
(2) the seriousness of the violation;
(3) the person's demonstrated good faith; and
(4) any other matters as justice may require.
(c) The penalty may not exceed $1,000 a day for each
violation.
(d) Each day a violation continues may be considered a
separate violation.
(e) The enforcement of the penalty may be stayed during the
time the order is under judicial review if the person pays the
penalty to the clerk of the court or files a supersedeas bond with
the court in the amount of the penalty. A person who cannot afford
to pay the penalty or file the bond may stay the enforcement by
filing an affidavit in the manner required by the Texas Rules of
Civil Procedure for a party who cannot afford to file security for
costs, subject to the right of the board to contest the affidavit as
provided by those rules.
(f) The attorney general may sue to collect the penalty.
Money collected under this section shall be deposited in the state
treasury and may be appropriated only to the department for the
purposes of administrating this chapter.
Sec. 441.0103. ADMINISTRATIVE PROCEDURE. A proceeding to
impose an administrative penalty under Section 441.0102 is
considered to be a contested case under Chapter 2001, Government
Code.
SECTION 6. Subchapter C, Chapter 441, Health and Safety
Code, as added by this Act, applies only to a violation occurring on
or after the effective date of this Act.
SECTION 7. This Act takes effect September 1, 2021.