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Us Congress Senate Bill SB932

Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB932 Compare Versions

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11 II
22 119THCONGRESS
33 1
44 STSESSION S. 932
55 To amend the Federal Food, Drug, and Cosmetic Act with respect to
66 molecularly targeted pediatric cancer investigations, and for other purposes.
77 IN THE SENATE OF THE UNITED STATES
88 MARCH11 (legislative day, MARCH10), 2025
99 Mr. M
1010 ULLIN(for himself and Mr. BENNET) introduced the following bill;
1111 which was read twice and referred to the Committee on Health, Edu-
1212 cation, Labor, and Pensions
1313 A BILL
1414 To amend the Federal Food, Drug, and Cosmetic Act with
1515 respect to molecularly targeted pediatric cancer investiga-
1616 tions, and for other purposes.
1717 Be it enacted by the Senate and House of Representa-1
1818 tives of the United States of America in Congress assembled, 2
1919 SECTION 1. SHORT TITLE. 3
2020 This Act may be cited as the ‘‘Give Kids a Chance 4
2121 Act of 2025’’. 5
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2525 SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDI-1
2626 TIONAL AUTHORITIES OF FOOD AND DRUG 2
2727 ADMINISTRATION REGARDING MOLECU-3
2828 LARLY TARGETED CANCER DRUGS. 4
2929 (a) I
3030 NGENERAL.— 5
3131 (1) A
3232 DDITIONAL ACTIVE INGREDIENT FOR AP -6
3333 PLICATION DRUG; LIMITATION REGARDING NOVEL - 7
3434 COMBINATION APPLICATION DRUG .—Section 8
3535 505B(a)(3) of the Federal Food, Drug, and Cos-9
3636 metic Act (21 U.S.C. 355c(a)(3)) is amended— 10
3737 (A) by redesignating subparagraphs (B) 11
3838 and (C) as subparagraphs (C) and (D), respec-12
3939 tively; and 13
4040 (B) by striking subparagraph (A) and in-14
4141 serting the following: 15
4242 ‘‘(A) I
4343 N GENERAL.—For purposes of para-16
4444 graph (1)(B), the investigation described in this 17
4545 paragraph is a molecularly targeted pediatric 18
4646 cancer investigation of— 19
4747 ‘‘(i) the drug or biological product for 20
4848 which the application referred to in such 21
4949 paragraph is submitted; or 22
5050 ‘‘(ii) such drug or biological product 23
5151 used in combination with— 24
5252 ‘‘(I) an active ingredient of a 25
5353 drug or biological product— 26
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5757 ‘‘(aa) for which an approved 1
5858 application under section 505(j) 2
5959 under this Act or under section 3
6060 351(k) of the Public Health 4
6161 Service Act is in effect; and 5
6262 ‘‘(bb) that is determined by 6
6363 the Secretary, after consultation 7
6464 with the applicant, to be part of 8
6565 the standard of care for treating 9
6666 a pediatric cancer; or 10
6767 ‘‘(II) an active ingredient of a 11
6868 drug or biological product— 12
6969 ‘‘(aa) for which an approved 13
7070 application under section 505(b) 14
7171 of this Act or section 351(a) of 15
7272 the Public Health Service Act to 16
7373 treat an adult cancer is in effect 17
7474 and is held by the same person 18
7575 submitting the application under 19
7676 paragraph (1)(B); and 20
7777 ‘‘(bb) that is directed at a 21
7878 molecular target that the Sec-22
7979 retary determines to be substan-23
8080 tially relevant to the growth or 24
8181 progression of a pediatric cancer. 25
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8585 ‘‘(B) ADDITIONAL REQUIREMENTS .— 1
8686 ‘‘(i) D
8787 ESIGN OF INVESTIGATION .—A 2
8888 molecularly targeted pediatric cancer inves-3
8989 tigation referred to in subparagraph (A) 4
9090 shall be designed to yield clinically mean-5
9191 ingful pediatric study data that is gathered 6
9292 using appropriate formulations for each 7
9393 age group for which the study is required, 8
9494 regarding dosing, safety, and preliminary 9
9595 efficacy to inform potential pediatric label-10
9696 ing. 11
9797 ‘‘(ii) L
9898 IMITATION.—An investigation 12
9999 described in subparagraph (A)(ii) may be 13
100100 required only if the drug or biological 14
101101 product for which the application referred 15
102102 to in paragraph (1)(B) contains either— 16
103103 ‘‘(I) a single new active ingre-17
104104 dient; or 18
105105 ‘‘(II) more than one active ingre-19
106106 dient, if an application for the com-20
107107 bination of active ingredients has not 21
108108 previously been approved but each ac-22
109109 tive ingredient is in a drug product 23
110110 that has been previously approved to 24
111111 treat an adult cancer. 25
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115115 ‘‘(iii) RESULTS OF ALREADY -COM-1
116116 PLETED PRECLINICAL STUDIES OF APPLI -2
117117 CATION DRUG.—With respect to an inves-3
118118 tigation required pursuant to paragraph 4
119119 (1)(B), the Secretary may require the re-5
120120 sults of any completed preclinical studies 6
121121 relevant to the initial pediatric study plan 7
122122 be submitted to the Secretary at the same 8
123123 time that the initial pediatric study plan 9
124124 required under subsection (e)(1) is sub-10
125125 mitted. 11
126126 ‘‘(iv) R
127127 ULE OF CONSTRUCTION RE -12
128128 GARDING INACTIVE INGREDIENTS .—With 13
129129 respect to a combination of active ingredi-14
130130 ents referred to in subparagraph (A)(ii), 15
131131 such subparagraph shall not be construed 16
132132 as addressing the use of inactive ingredi-17
133133 ents with such combination.’’. 18
134134 (2) D
135135 ETERMINATION OF APPLICABLE REQUIRE -19
136136 MENTS.—Section 505B(e)(1) of the Federal Food, 20
137137 Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 21
138138 amended by adding at the end the following: ‘‘The 22
139139 Secretary shall determine whether subparagraph (A) 23
140140 or (B) of subsection (a)(1) applies with respect to an 24
141141 application before the date on which the applicant is 25
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145145 required to submit the initial pediatric study plan 1
146146 under paragraph (2)(A).’’. 2
147147 (3) C
148148 LARIFYING APPLICABILITY .—Section 3
149149 505B(a)(1) of the Federal Food, Drug, and Cos-4
150150 metic Act (21 U.S.C. 355c(a)(1)) is amended by 5
151151 adding at the end the following: 6
152152 ‘‘(C) R
153153 ULE OF CONSTRUCTION .—No appli-7
154154 cation that is subject to the requirements of 8
155155 subparagraph (B) shall be subject to the re-9
156156 quirements of subparagraph (A), and no appli-10
157157 cation (or supplement to an application) that is 11
158158 subject to the requirements of subparagraph 12
159159 (A) shall be subject to the requirements of sub-13
160160 paragraph (B).’’. 14
161161 (4) C
162162 ONFORMING AMENDMENTS .—Section 15
163163 505B(a) of the Federal Food, Drug, and Cosmetic 16
164164 Act (21 U.S.C. 355c(a)) is amended— 17
165165 (A) in paragraph (3)(C), as redesignated 18
166166 by paragraph (1)(A) of this subsection, by 19
167167 striking ‘‘investigations described in this para-20
168168 graph’’ and inserting ‘‘investigations referred to 21
169169 in subparagraph (A)’’; and 22
170170 (B) in paragraph (3)(D), as redesignated 23
171171 by paragraph (1)(A) of this subsection, by 24
172172 striking ‘‘the assessments under paragraph 25
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176176 (2)(B)’’ and inserting ‘‘the assessments re-1
177177 quired under paragraph (1)(A)’’. 2
178178 (b) G
179179 UIDANCE.—The Secretary of Health and 3
180180 Human Services, acting through the Commissioner of 4
181181 Food and Drugs, shall— 5
182182 (1) not later than 12 months after the date of 6
183183 enactment of this Act, issue draft guidance on the 7
184184 implementation of the amendments made by sub-8
185185 section (a); and 9
186186 (2) not later than 12 months after closing the 10
187187 comment period on such draft guidance, finalize 11
188188 such guidance. 12
189189 (c) A
190190 PPLICABILITY.—The amendments made by this 13
191191 section apply with respect to any application under section 14
192192 505(b) of the Federal Food, Drug, and Cosmetic Act (21 15
193193 U.S.C. 355(b)) and any application under section 351(a) 16
194194 of the Public Health Service Act (42 U.S.C. 262(a)), that 17
195195 is submitted on or after the date that is 3 years after the 18
196196 date of enactment of this Act. 19
197197 (d) R
198198 EPORTS TOCONGRESS.— 20
199199 (1) S
200200 ECRETARY OF HEALTH AND HUMAN SERV -21
201201 ICES.—Not later than 6 years after the date of en-22
202202 actment of this Act, the Secretary of Health and 23
203203 Human Services shall submit to the Committee on 24
204204 Energy and Commerce of the House of Representa-25
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208208 tives and the Committee on Health, Education, 1
209209 Labor, and Pensions of the Senate a report on the 2
210210 Secretary’s efforts, in coordination with industry, to 3
211211 ensure implementation of the amendments made by 4
212212 subsection (a). 5
213213 (2) GAO
214214 STUDY AND REPORT.— 6
215215 (A) S
216216 TUDY.—Not later than 8 years after 7
217217 the date of enactment of this Act, the Comp-8
218218 troller General of the United States shall con-9
219219 duct a study of the effectiveness of requiring 10
220220 assessments and investigations described in sec-11
221221 tion 505B of the Federal Food, Drug, and Cos-12
222222 metic Act (21 U.S.C. 355c), as amended by 13
223223 subsection (a), in the development of drugs and 14
224224 biological products for pediatric cancer indica-15
225225 tions, including consideration of any benefits to, 16
226226 or burdens on, pediatric cancer drug develop-17
227227 ment. 18
228228 (B) F
229229 INDINGS.—Not later than 10 years 19
230230 after the date of enactment of this Act, the 20
231231 Comptroller General shall submit to the Com-21
232232 mittee on Energy and Commerce of the House 22
233233 of Representatives and the Committee on 23
234234 Health, Education, Labor, and Pensions of the 24
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238238 Senate a report containing the findings of the 1
239239 study conducted under subparagraph (A). 2
240240 SEC. 3. EXTENSION OF AUTHORITY TO ISSUE PRIORITY RE-3
241241 VIEW VOUCHERS TO ENCOURAGE TREAT-4
242242 MENTS FOR RARE PEDIATRIC DISEASES. 5
243243 (a) E
244244 XTENSION.—Section 529(b)(5) of the Federal 6
245245 Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)(5)) is 7
246246 amended by striking ‘‘December 20, 2024, unless’’ and all 8
247247 that follows through the period at the end and inserting 9
248248 ‘‘September 30, 2029.’’. 10
249249 (b) U
250250 SERFEEPAYMENT.—Subsection 529(c)(4) of 11
251251 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 12
252252 360ff(c)(4)) is amended by striking subparagraph (A) and 13
253253 inserting the following: 14
254254 ‘‘(A) I
255255 N GENERAL.—The priority review 15
256256 user fee required by this subsection shall be due 16
257257 upon the submission of a human drug applica-17
258258 tion under section 505(b)(1) or section 351(a) 18
259259 of the Public Health Service Act for which the 19
260260 priority review voucher is used. All other user 20
261261 fees associated with the human drug application 21
262262 shall be due as required by the Secretary or 22
263263 under applicable law.’’. 23
264264 (c) GAO R
265265 EPORT ONEFFECTIVENESS OFRAREPE-24
266266 DIATRICDISEASEPRIORITYVOUCHERAWARDS IN 25
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270270 INCENTIVIZINGRAREPEDIATRICDISEASEDRUGDEVEL-1
271271 OPMENT.— 2
272272 (1) GAO
273273 STUDY.— 3
274274 (A) S
275275 TUDY.—The Comptroller General of 4
276276 the United States shall conduct a study of the 5
277277 effectiveness of awarding rare pediatric disease 6
278278 priority vouchers under section 529 of the Fed-7
279279 eral Food, Drug, and Cosmetic Act (21 U.S.C. 8
280280 360ff), as amended by subsection (a), in the de-9
281281 velopment of human drug products that treat or 10
282282 prevent rare pediatric diseases (as defined in 11
283283 such section 529). 12
284284 (B) C
285285 ONTENTS OF STUDY .—In conducting 13
286286 the study under subparagraph (A), the Comp-14
287287 troller General shall examine the following: 15
288288 (i) The indications for each drug or 16
289289 biological product that— 17
290290 (I) is the subject of a rare pedi-18
291291 atric disease product application (as 19
292292 defined in section 529 of the Federal 20
293293 Food, Drug, and Cosmetic Act (21 21
294294 U.S.C. 360ff)) for which a priority re-22
295295 view voucher was awarded; and 23
296296 (II) was approved under section 24
297297 505 of the Federal Food, Drug, and 25
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301301 Cosmetic Act (42 U.S.C. 355) or li-1
302302 censed under section 351 of the Pub-2
303303 lic Health Service Act (42 U.S.C. 3
304304 262). 4
305305 (ii) Whether, and to what extent, an 5
306306 unmet need related to the treatment or 6
307307 prevention of a rare pediatric disease was 7
308308 met through the approval or licensure of 8
309309 such a drug or biological product. 9
310310 (iii) The size of the company to which 10
311311 a priority review voucher was awarded 11
312312 under section 529 of the Federal Food, 12
313313 Drug, and Cosmetic Act (21 U.S.C. 360ff) 13
314314 for such a drug or biological product. 14
315315 (iv) The value of such priority review 15
316316 voucher if transferred. 16
317317 (v) Identification of each drug for 17
318318 which a priority review voucher awarded 18
319319 under such section 529 was used. 19
320320 (vi) The size of the company using 20
321321 each priority review voucher awarded 21
322322 under such section 529. 22
323323 (vii) The length of the period of time 23
324324 between the date on which a priority re-24
325325 view voucher was awarded under such sec-25
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329329 tion 529 and the date on which it was 1
330330 used. 2
331331 (viii) Whether, and to what extent, an 3
332332 unmet need related to the treatment or 4
333333 prevention of a rare pediatric disease was 5
334334 met through the approval under section 6
335335 505 of the Federal Food, Drug, and Cos-7
336336 metic Act (42 U.S.C. 355) or licensure 8
337337 under section 351 of the Public Health 9
338338 Service Act (42 U.S.C. 262) of a drug for 10
339339 which a priority review voucher was used. 11
340340 (ix) Whether, and to what extent, 12
341341 companies were motivated by the avail-13
342342 ability of priority review vouchers under 14
343343 section 529 of the Federal Food, Drug, 15
344344 and Cosmetic Act (21 U.S.C. 360ff) to at-16
345345 tempt to develop a drug for a rare pedi-17
346346 atric disease. 18
347347 (x) Whether, and to what extent, pedi-19
348348 atric review vouchers awarded under such 20
349349 section were successful in stimulating de-21
350350 velopment and expedited patient access to 22
351351 drug products for treatment or prevention 23
352352 of a rare pediatric disease that wouldn’t 24
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356356 otherwise take place without the incentive 1
357357 provided by such vouchers. 2
358358 (xi) The impact of such priority re-3
359359 view vouchers on the workload, review 4
360360 process, and public health prioritization ef-5
361361 forts of the Food and Drug Administra-6
362362 tion. 7
363363 (xii) Any other incentives in Federal 8
364364 law that exist for companies developing 9
365365 drugs or biological products described in 10
366366 clause (i). 11
367367 (2) R
368368 EPORT ON FINDINGS .—Not later than 5 12
369369 years after the date of the enactment of this Act, the 13
370370 Comptroller General of the United States shall sub-14
371371 mit to the Committee on Energy and Commerce of 15
372372 the House of Representatives and the Committee on 16
373373 Health, Education, Labor, and Pensions of the Sen-17
374374 ate a report containing the findings of the study 18
375375 conducted under paragraph (1). 19
376376 Æ
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