Us Congress 2025-2026 Regular Session

Us Congress House Bill HB685 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 685
5	5	To amend the Federal Food, Drug, and Cosmetic Act to prohibit the approval
6	6	of new abortion drugs, to prohibit investigational use exemptions for
7	7	abortion drugs, and to impose additional regulatory requirements with
8	8	respect to previously approved abortion drugs, and for other purposes.
9	9	IN THE HOUSE OF REPRESENTATIVES
10	10	JANUARY23, 2025
11	11	Mr. L
12	12	ATTA(for himself, Mr. ROUZER, Mr. BRECHEEN, Mr. STRONG, Mrs.
13	13	M
14	14	ILLERof Illinois, Mr. WEBSTERof Florida, Mr. FINSTAD, Mr. ADER-
15	15	HOLT, Mr. FEENSTRA, Mr. SMITHof New Jersey, Mr. FULCHER, Mr.
16	16	F
17	17	LOOD, Mr. MANN, Mr. HARRISof Maryland, Mr. FONG, Mr. ELLZEY,
18	18	Mr. W
19	19	EBERof Texas, Mr. MCCORMICK, Mr. MOOLENAAR, Mr. OGLES,
20	20	Mr. G
21	21	UEST, Mr. HIGGINSof Louisiana, Mr. PALMER, Mr. MOOREof
22	22	North Carolina, Mr. S
23	23	HREVE, and Mr. LAHOOD) introduced the following
24	24	bill; which was referred to the Committee on Energy and Commerce A BILL
25	25	To amend the Federal Food, Drug, and Cosmetic Act to
26	26	prohibit the approval of new abortion drugs, to prohibit
27	27	investigational use exemptions for abortion drugs, and
28	28	to impose additional regulatory requirements with respect
29	29	to previously approved abortion drugs, and for other
30	30	purposes.
31	31	Be it enacted by the Senate and House of Representa-1
32	32	tives of the United States of America in Congress assembled, 2
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35	35	•HR 685 IH
36	36	SECTION 1. SHORT TITLE. 1
37	37	This Act may be cited as the ‘‘Support And Value 2
38	38	Expectant Moms and Babies Act of 2025’’ or the ‘‘SAVE 3
39	39	Moms and Babies Act of 2025’’. 4
40	40	SEC. 2. ABORTION DRUGS PROHIBITED. 5
41	41	(a) I
42	42	NGENERAL.—Section 505 of the Federal Food, 6
43	43	Drug, and Cosmetic Act (21 U.S.C. 355) (as amended by 7
44	44	Public Law 117–328) is amended by adding at the end 8
45	45	the following: 9
46	46	‘‘(aa) A
47	47	BORTIONDRUGS.— 10
48	48	‘‘(1) P
49	49	ROHIBITIONS.—The Secretary shall not 11
50	50	approve— 12
51	51	‘‘(A) any application submitted under sub-13
52	52	section (b) or (j) for marketing an abortion 14
53	53	drug; or 15
54	54	‘‘(B) grant an investigational use exemp-16
55	55	tion under subsection (i) for— 17
56	56	‘‘(i) an abortion drug; or 18
57	57	‘‘(ii) any investigation in which the 19
58	58	unborn child of a woman known to be 20
59	59	pregnant is knowingly destroyed. 21
60	60	‘‘(2) P
61	61	REVIOUSLY APPROVED ABORTION 22
62	62	DRUGS.—If an approval described in paragraph (1) 23
63	63	is in effect for an abortion drug as of the date of 24
64	64	enactment of the Support And Value Expectant 25
65	65	Moms and Babies Act of 2025, the Secretary shall— 26
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68	68	•HR 685 IH
69	69	‘‘(A) not approve any labeling change— 1
70	70	‘‘(i) to approve the use of such abor-2
71	71	tion drug after 70 days gestation; or 3
72	72	‘‘(ii) to approve the dispensing of such 4
73	73	abortion drug by any means other than in- 5
74	74	person administration by the prescribing 6
75	75	health care practitioner; 7
76	76	‘‘(B) treat such abortion drug as subject to 8
77	77	section 503(b)(1); and 9
78	78	‘‘(C) require such abortion drug to be sub-10
79	79	ject to a risk evaluation and mitigation strategy 11
80	80	under section 505–1 that at a minimum— 12
81	81	‘‘(i) requires health care practitioners 13
82	82	who prescribe such abortion drug— 14
83	83	‘‘(I) to be certified in accordance 15
84	84	with the strategy; and 16
85	85	‘‘(II) to not be acting in their ca-17
86	86	pacity as a pharmacist; 18
87	87	‘‘(ii) as part of the certification proc-19
88	88	ess referred to in clause (i), requires such 20
89	89	practitioners— 21
90	90	‘‘(I) to have the ability to assess 22
91	91	the duration of pregnancy accurately; 23
92	92	‘‘(II) to have the ability to diag-24
93	93	nose ectopic pregnancies; 25
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96	96	•HR 685 IH
97	97	‘‘(III) to have the ability to pro-1
98	98	vide surgical intervention in cases of 2
99	99	incomplete abortion or severe bleed-3
100	100	ing; 4
101	101	‘‘(IV) to have the ability to en-5
102	102	sure patient access to medical facili-6
103	103	ties equipped to provide blood trans-7
104	104	fusions and resuscitation, if necessary; 8
105	105	and 9
106	106	‘‘(V) to report any deaths or 10
107	107	other adverse events associated with 11
108	108	the use of such abortion drug to the 12
109	109	Food and Drug Administration and to 13
110	110	the manufacturer of such abortion 14
111	111	drug, identifying the patient by a non- 15
112	112	identifiable reference and the serial 16
113	113	number from each package of such 17
114	114	abortion drug; 18
115	115	‘‘(iii) limits the dispensing of such 19
116	116	abortion drug to patients— 20
117	117	‘‘(I) in a clinic, medical office, or 21
118	118	hospital by means of in-person admin-22
119	119	istration by the prescribing health 23
120	120	care practitioner; and 24
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123	123	•HR 685 IH
124	124	‘‘(II) not in pharmacies or any 1
125	125	setting other than the health care set-2
126	126	tings described in subclause (I); 3
127	127	‘‘(iv) requires the prescribing health 4
128	128	care practitioner to give to the patient doc-5
129	129	umentation on any risk of serious com-6
130	130	plications associated with use of such abor-7
131	131	tion drug and receive acknowledgment of 8
132	132	such receipt from the patient; 9
133	133	‘‘(v) requires all known adverse events 10
134	134	associated with such abortion drug to be 11
135	135	reported, excluding any individually identi-12
136	136	fiable patient information, to the Food and 13
137	137	Drug Administration by the— 14
138	138	‘‘(I) manufacturers of such abor-15
139	139	tion drug; and 16
140	140	‘‘(II) prescribers of such abortion 17
141	141	drug; and 18
142	142	‘‘(vi) requires reporting of administra-19
143	143	tion of the abortion drug as required by 20
144	144	State law, or in the absence of a State law 21
145	145	regarding such reporting, in the same 22
146	146	manner as a surgical abortion. 23
147	147	‘‘(3) R
148	148	EPORTING ON ADVERSE EVENTS BY 24
149	149	OTHER HEALTH CARE PRACTITIONERS .—The Sec-25
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152	152	•HR 685 IH
153	153	retary shall require all other health care practi-1
154	154	tioners to report to the Food and Drug Administra-2
155	155	tion any adverse events experienced by their patients 3
156	156	that are connected to use of an abortion drug, ex-4
157	157	cluding any individually identifiable patient informa-5
158	158	tion. 6
159	159	‘‘(4) R
160	160	ULE OF CONSTRUCTION .—Nothing in 7
161	161	this section shall be construed to restrict the author-8
162	162	ity of the Federal Government, or of a State, to es-9
163	163	tablish, implement, and enforce requirements and re-10
164	164	strictions with respect to abortion drugs under provi-11
165	165	sions of law other than this section that are in addi-12
166	166	tion to the requirements and restrictions under this 13
167	167	section. 14
168	168	‘‘(5) D
169	169	EFINITIONS.—In this section: 15
170	170	‘‘(A) The term ‘abortion drug’ means any 16
171	171	drug, substance, or combination of drugs or 17
172	172	substances that is intended for use or that is in 18
173	173	fact used (irrespective of how the product is la-19
174	174	beled) to intentionally kill the unborn child of 20
175	175	a woman known to be pregnant, or to inten-21
176	176	tionally terminate the pregnancy of a woman 22
177	177	known to be pregnant, with an intention other 23
178	178	than— 24
179	179	‘‘(i) to produce a live birth; 25
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182	182	•HR 685 IH
183	183	‘‘(ii) to remove a dead unborn child; 1
184	184	or 2
185	185	‘‘(iii) to treat an ectopic pregnancy. 3
186	186	‘‘(B) The term ‘adverse event’ includes 4
187	187	each of the following: 5
188	188	‘‘(i) A fatality. 6
189	189	‘‘(ii) An ectopic pregnancy. 7
190	190	‘‘(iii) A hospitalization. 8
191	191	‘‘(iv) A blood loss requiring a trans-9
192	192	fusion. 10
193	193	‘‘(v) An infection, including endo-11
194	194	metritis, pelvic inflammatory disease, and 12
195	195	pelvic infections with sepsis. 13
196	196	‘‘(vi) A severe infection. 14
197	197	‘‘(C) The term ‘gestation’ means the pe-15
198	198	riod of days beginning on the first day of the 16
199	199	last menstrual period. 17
200	200	‘‘(D) The term ‘health care practitioner’ 18
201	201	means any individual who is licensed, reg-19
202	202	istered, or otherwise permitted, by the United 20
203	203	States or the jurisdiction in which the indi-21
204	204	vidual practices, to prescribe drugs subject to 22
205	205	section 503(b)(1). 23
206	206	‘‘(E) The term ‘unborn child’ means an in-24
207	207	dividual organism of the species homo sapiens, 25
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210	210	•HR 685 IH
211	211	beginning at fertilization, until the point of 1
212	212	being born alive as defined in section 8(b) of 2
213	213	title 1, United States Code.’’. 3
214	214	(b) O
215	215	NGOINGINVESTIGATIONALUSE.—In the case of 4
216	216	any investigational use of a drug pursuant to an investiga-5
217	217	tional use exemption under section 505(i) of the Federal 6
218	218	Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) that 7
219	219	was granted before the date of enactment of this Act, such 8
220	220	exemption is deemed to be rescinded as of the day that 9
221	221	is 3 years after the date of enactment of this Act if the 10
222	222	Secretary would be prohibited by section 505(aa)(1)(B) of 11
223	223	the Federal Food, Drug, and Cosmetic Act, as added by 12
224	224	subsection (a), from granting such exemption as of such 13
225	225	day. 14
226	226	Æ
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