By: Junell H.B. No. 590
73R2288 KLL-D
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to approval by the Texas Department of Health for new
1-3 drugs used in treating progressive, fatal diseases.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Section 431.114(a), Health and Safety Code, is
1-6 amended to read as follows:
1-7 (a) A person shall not sell, deliver, offer for sale, hold
1-8 for sale or give away any new drug unless:
1-9 (1) an application with respect thereto has been
1-10 approved and the approval has not been withdrawn under Section 505
1-11 of the federal Act,<;> and if the product is manufactured in this
1-12 state,
1-13 <(2)> a copy of the letter of approval or
1-14 approvability issued by the Federal Food and Drug Administration is
1-15 on file with the commissioner; or
1-16 (2) the product is manufactured in this state for use
1-17 in treating progressive, fatal diseases, an application with
1-18 respect thereto has been approved by the department, and the
1-19 approval has not been withdrawn <if the product is manufactured in
1-20 this state>.
1-21 SECTION 2. Subchapter E, Chapter 431, Health and Safety
1-22 Code, is amended by adding Sections 431.1141-431.1145 to read as
1-23 follows:
1-24 Sec. 431.1141. NEW DRUG APPLICATION. A person who files a
2-1 new drug application with the department under Section
2-2 431.114(a)(2) shall submit the following information as part of the
2-3 application:
2-4 (1) a full report of all investigations that have been
2-5 made to show whether or not the new drug is safe for use and
2-6 whether the drug is effective in use under the conditions
2-7 prescribed, recommended, or suggested in the labeling or
2-8 advertising of the drug;
2-9 (2) a full list of the components of the new drug;
2-10 (3) a full statement of the composition of the new
2-11 drug;
2-12 (4) a full description of the methods used in, and the
2-13 facilities and controls used for, the manufacture, processing, and
2-14 packing of the new drug;
2-15 (5) samples of the new drug and of the components of
2-16 the drug as the department may require; and
2-17 (6) specimens of the labeling and advertisements
2-18 proposed to be used for the new drug.
2-19 Sec. 431.1142. APPROVAL OF APPLICATION; HEARING. Not later
2-20 than the 180th day after the date a new drug application is filed
2-21 under Section 431.1141, or on a later date agreed to by the
2-22 department and the applicant, the department shall:
2-23 (1) approve the application if no grounds for denying
2-24 approval exist; or
2-25 (2) give the applicant notice of an opportunity for a
2-26 hearing on whether the application is approvable.
2-27 Sec. 431.1143. DENIAL OF APPLICATION. (a) The department
3-1 shall issue an order refusing to approve an application if, after
3-2 written notice to the applicant and an opportunity for a hearing,
3-3 the department finds that:
3-4 (1) the reports of investigation required under
3-5 Section 431.1141 do not include adequate tests by all methods
3-6 reasonably applicable to show whether the new drug is safe for use
3-7 under the conditions prescribed, recommended, or suggested in the
3-8 proposed labeling and advertisement of the drug;
3-9 (2) the results of the tests submitted under Section
3-10 431.1141 to show whether the new drug is safe for use under the
3-11 conditions prescribed, recommended, or suggested in the proposed
3-12 labeling and advertisement of the drug show that the drug is unsafe
3-13 for use under those conditions or do not show that the drug is safe
3-14 for use under the conditions prescribed, recommended, or suggested
3-15 in the proposed labeling and advertisement;
3-16 (3) the methods, facilities, and controls used in the
3-17 manufacture, processing, or packing of the new drug are inadequate
3-18 to preserve its identity, strength, quality, purity, composition,
3-19 or other characteristics;
3-20 (4) on the basis of information submitted as part of
3-21 the application, or on the basis of any other information before it
3-22 with respect to the new drug, the department has insufficient
3-23 information to determine whether the drug is safe for use under the
3-24 conditions prescribed, recommended, or suggested in the proposed
3-25 labeling and advertisement;
3-26 (5) evaluated on the basis of the information
3-27 submitted as part of the application and any other information
4-1 before it with respect to the new drug, there is a lack of
4-2 substantial evidence that the drug will have the effect it purports
4-3 or is represented to have under the conditions of use prescribed,
4-4 recommended, or suggested in the proposed labeling or advertisement
4-5 of the drug; or
4-6 (6) based on an evaluation by the department of all
4-7 material facts, the proposed labeling or advertising of the new
4-8 drug is false or misleading in any particular.
4-9 (b) An order issued under this section shall be revoked by
4-10 the department if the department finds that the facts justify the
4-11 action.
4-12 Sec. 431.1144. RECORDS AND REPORTS. (a) A person who
4-13 obtains approval of a new drug application shall establish and
4-14 maintain records and make reports to the department of data
4-15 relating to clinical experience and other data or information
4-16 received or otherwise obtained by the applicant with respect to the
4-17 drug as the department may prescribe by rule, or by order with
4-18 respect to the application.
4-19 (b) A rule adopted or order issued under this section shall
4-20 have due regard for the professional ethics of the medical
4-21 profession and the interest of patients and shall provide, where
4-22 the department determines that it is reasonably necessary, for the
4-23 examination on request, by the persons to whom the rule or order is
4-24 applicable, of similar information received or otherwise obtained
4-25 by the department.
4-26 (c) A person required to maintain records and a person in
4-27 charge or in custody of the records shall, on request of an
5-1 authorized agent of the department, permit the agent at all
5-2 reasonable times to have access to and copy and verify the records.
5-3 Sec. 431.1145. WITHDRAWAL OR SUSPENSION OF APPROVAL. (a)
5-4 The department shall issue an order withdrawing approval of an
5-5 application concerning any new drug if, after giving written notice
5-6 to the applicant and an opportunity for a hearing, the department
5-7 finds that:
5-8 (1) clinical or other experience, tests, or other
5-9 scientific data show that the new drug is unsafe for use under the
5-10 conditions of use on the basis of which the application was
5-11 approved;
5-12 (2) new evidence of clinical experience, not contained
5-13 in the application or not available to the department until after
5-14 the application was approved, tests by new methods, or tests by
5-15 methods not considered reasonably applicable when the application
5-16 was approved, evaluated together with the evidence available to the
5-17 department when the application was approved, shows that the new
5-18 drug is not shown to be safe for use under the conditions of use on
5-19 the basis of which the application was approved;
5-20 (3) on the basis of new information with respect to
5-21 the new drug, evaluated together with the evidence available to the
5-22 department when the application was approved, there is a lack of
5-23 substantial evidence that the drug will have the effect it purports
5-24 or is represented to have under the conditions of use prescribed,
5-25 recommended, or suggested in the labeling or advertising of the
5-26 drug;
5-27 (4) the application contains any untrue statement of a
6-1 material fact;
6-2 (5) the applicant has failed to establish a system for
6-3 maintaining required records, has repeatedly or deliberately failed
6-4 to maintain those records or to make required reports, or has
6-5 refused to permit access to or copying or verification of those
6-6 records;
6-7 (6) on the basis of new information before the
6-8 department, evaluated together with the evidence before it when the
6-9 application was approved, the methods used in or the facilities and
6-10 controls used for the manufacture, processing, and packing of the
6-11 new drug are inadequate to assure and preserve its identity,
6-12 strength, quality, purity, composition, and characteristics as
6-13 determined by qualified experts selected by the department, and
6-14 were not made adequate within a reasonable time after receipt of
6-15 written notice from the department specifying the matter complained
6-16 of; or
6-17 (7) on the basis of new information before it,
6-18 evaluated together with the evidence before it when the application
6-19 was approved, the labeling or advertisement of the new drug, based
6-20 on an evaluation of all material facts, is false or misleading in
6-21 any particular and is not corrected within a reasonable time after
6-22 receipt of written notice from the department specifying the matter
6-23 complained of.
6-24 (b) The department may immediately suspend the approval of
6-25 an application concerning a new drug if the department finds that
6-26 there is an imminent hazard to the public health.
6-27 SECTION 3. The importance of this legislation and the
7-1 crowded condition of the calendars in both houses create an
7-2 emergency and an imperative public necessity that the
7-3 constitutional rule requiring bills to be read on three several
7-4 days in each house be suspended, and this rule is hereby suspended,
7-5 and that this Act take effect and be in force from and after its
7-6 passage, and it is so enacted.