| 1 | 1 | | II |
|---|
| 2 | 2 | | 119THCONGRESS |
|---|
| 3 | 3 | | 1 |
|---|
| 4 | 4 | | STSESSION S. 652 |
|---|
| 5 | 5 | | To provide for the regulation of certain communications regarding prescription |
|---|
| 6 | 6 | | drugs. |
|---|
| 7 | 7 | | IN THE SENATE OF THE UNITED STATES |
|---|
| 8 | 8 | | FEBRUARY20, 2025 |
|---|
| 9 | 9 | | Mr. D |
|---|
| 10 | 10 | | URBIN(for himself and Mr. MARSHALL) introduced the following bill; |
|---|
| 11 | 11 | | which was read twice and referred to the Committee on Health, Edu- |
|---|
| 12 | 12 | | cation, Labor, and Pensions |
|---|
| 13 | 13 | | A BILL |
|---|
| 14 | 14 | | To provide for the regulation of certain communications |
|---|
| 15 | 15 | | regarding prescription drugs. |
|---|
| 16 | 16 | | Be it enacted by the Senate and House of Representa-1 |
|---|
| 17 | 17 | | tives of the United States of America in Congress assembled, 2 |
|---|
| 18 | 18 | | SECTION 1. SHORT TITLE. 3 |
|---|
| 19 | 19 | | This Act may be cited as the ‘‘Protecting Patients 4 |
|---|
| 20 | 20 | | from Deceptive Drug Ads Act’’. 5 |
|---|
| 21 | 21 | | SEC. 2. REGULATION OF CERTAIN COMMUNICATIONS RE-6 |
|---|
| 22 | 22 | | GARDING PRESCRIPTION DRUGS. 7 |
|---|
| 23 | 23 | | (a) R |
|---|
| 24 | 24 | | EGULATION OFCOMMUNICATIONS.— 8 |
|---|
| 25 | 25 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 26 | 26 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
|---|
| 27 | 27 | | •S 652 IS |
|---|
| 28 | 28 | | (1) IN GENERAL.—Section 303 of the Federal 1 |
|---|
| 29 | 29 | | Food, Drug, and Cosmetic Act (21 U.S.C. 333) is 2 |
|---|
| 30 | 30 | | amended by adding at the end the following: 3 |
|---|
| 31 | 31 | | ‘‘(h)(1) In the case of a social media influencer or 4 |
|---|
| 32 | 32 | | health care provider who makes false or misleading com-5 |
|---|
| 33 | 33 | | munications regarding a drug approved under section 505 6 |
|---|
| 34 | 34 | | or licensed under section 351 of the Public Health Service 7 |
|---|
| 35 | 35 | | Act, and subject to section 503(b), or compounded in ac-8 |
|---|
| 36 | 36 | | cordance with section 503A or 503B, shall be liable to the 9 |
|---|
| 37 | 37 | | United States for a civil penalty in an amount described 10 |
|---|
| 38 | 38 | | in paragraph (g)(1), in accordance with a process similar 11 |
|---|
| 39 | 39 | | to the process described in paragraph (g)(2). 12 |
|---|
| 40 | 40 | | ‘‘(2) For purposes of this paragraph— 13 |
|---|
| 41 | 41 | | ‘‘(A) the term ‘false or misleading communica-14 |
|---|
| 42 | 42 | | tions’— 15 |
|---|
| 43 | 43 | | ‘‘(i) means advertisements or promotional 16 |
|---|
| 44 | 44 | | communications on a social media platform 17 |
|---|
| 45 | 45 | | from which there is a financial benefit to the 18 |
|---|
| 46 | 46 | | person engaging in such communications re-19 |
|---|
| 47 | 47 | | garding such drug— 20 |
|---|
| 48 | 48 | | ‘‘(I)(aa) that are made knowingly or 21 |
|---|
| 49 | 49 | | recklessly; and 22 |
|---|
| 50 | 50 | | ‘‘(bb) contain a false or inaccurate 23 |
|---|
| 51 | 51 | | statement or material omission of fact re-24 |
|---|
| 52 | 52 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 53 | 53 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 |
|---|
| 54 | 54 | | •S 652 IS |
|---|
| 55 | 55 | | garding a drug described in subparagraph 1 |
|---|
| 56 | 56 | | (1); or 2 |
|---|
| 57 | 57 | | ‘‘(II) fail to include information in 3 |
|---|
| 58 | 58 | | brief summary relating to side effects, con-4 |
|---|
| 59 | 59 | | traindications, and effectiveness of the 5 |
|---|
| 60 | 60 | | drug in the same manner and to the same 6 |
|---|
| 61 | 61 | | extent as such information is required in 7 |
|---|
| 62 | 62 | | prescription drug advertisements pursuant 8 |
|---|
| 63 | 63 | | to section 502(n); and 9 |
|---|
| 64 | 64 | | ‘‘(ii) does not include— 10 |
|---|
| 65 | 65 | | ‘‘(I) statements that take place in the 11 |
|---|
| 66 | 66 | | course of bona fide patient care or medical 12 |
|---|
| 67 | 67 | | research that are made by professionals 13 |
|---|
| 68 | 68 | | engaged in such patient care or medical re-14 |
|---|
| 69 | 69 | | search; or 15 |
|---|
| 70 | 70 | | ‘‘(II) statements that describe the per-16 |
|---|
| 71 | 71 | | son’s own experience, opinion, or value 17 |
|---|
| 72 | 72 | | judgment; and 18 |
|---|
| 73 | 73 | | ‘‘(B) the term ‘social media influencer’ means a 19 |
|---|
| 74 | 74 | | private individual who has perceived credibility or 20 |
|---|
| 75 | 75 | | popularity and who expresses their opinions, beliefs, 21 |
|---|
| 76 | 76 | | findings, recommendations, or experience on social 22 |
|---|
| 77 | 77 | | media platforms to an audience, including in a man-23 |
|---|
| 78 | 78 | | ner conveying trust or expertise on a topic, for the 24 |
|---|
| 79 | 79 | | purpose to promoting or advertising certain informa-25 |
|---|
| 80 | 80 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 81 | 81 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 4 |
|---|
| 82 | 82 | | •S 652 IS |
|---|
| 83 | 83 | | tion or products or inducing behavior by the audi-1 |
|---|
| 84 | 84 | | ence.’’. 2 |
|---|
| 85 | 85 | | (2) G |
|---|
| 86 | 86 | | UIDANCE.—Not later than 180 days after 3 |
|---|
| 87 | 87 | | the date of enactment of this Act, the Secretary of 4 |
|---|
| 88 | 88 | | Health and Human Services (referred to in this sec-5 |
|---|
| 89 | 89 | | tion as the ‘‘Secretary’’) shall issue guidance on how 6 |
|---|
| 90 | 90 | | the Secretary will administer paragraph (h) of sec-7 |
|---|
| 91 | 91 | | tion 303 of the Federal Food, Drug, and Cosmetic 8 |
|---|
| 92 | 92 | | Act (21 U.S.C. 333), as added by paragraph (1), in-9 |
|---|
| 93 | 93 | | cluding with respect to the factors that will be con-10 |
|---|
| 94 | 94 | | sidered in determining whether a communication is 11 |
|---|
| 95 | 95 | | false or misleading communication, as defined in 12 |
|---|
| 96 | 96 | | such paragraph (h), including— 13 |
|---|
| 97 | 97 | | (A) the various types of statements or 14 |
|---|
| 98 | 98 | | omission of facts regarding a prescription drug 15 |
|---|
| 99 | 99 | | that would constitute false or misleading, such 16 |
|---|
| 100 | 100 | | as statements or omissions related to safety, ef-17 |
|---|
| 101 | 101 | | ficacy, approved or unapproved uses, directions 18 |
|---|
| 102 | 102 | | for use from the label approved by the Food 19 |
|---|
| 103 | 103 | | and Drug Administration, scientific informa-20 |
|---|
| 104 | 104 | | tion, or other similar attributes; 21 |
|---|
| 105 | 105 | | (B) whether the inclusion of the informa-22 |
|---|
| 106 | 106 | | tion in brief summary described in paragraph 23 |
|---|
| 107 | 107 | | (h)(2)(A)(i)(III) of section 303 of the Federal 24 |
|---|
| 108 | 108 | | Food, Drug, and Cosmetic Act (21 U.S.C. 25 |
|---|
| 109 | 109 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 110 | 110 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 5 |
|---|
| 111 | 111 | | •S 652 IS |
|---|
| 112 | 112 | | 333), as added by paragraph (1), alone is suffi-1 |
|---|
| 113 | 113 | | cient in each circumstance to avoid such a de-2 |
|---|
| 114 | 114 | | termination; 3 |
|---|
| 115 | 115 | | (C) actions taken by the social media 4 |
|---|
| 116 | 116 | | influencer, health care provider, or other person 5 |
|---|
| 117 | 117 | | to demonstrate compliance with such paragraph 6 |
|---|
| 118 | 118 | | (h); and 7 |
|---|
| 119 | 119 | | (D) characteristics specific to various so-8 |
|---|
| 120 | 120 | | cial media platforms, and the speed of dissemi-9 |
|---|
| 121 | 121 | | nation of the content on such platform. 10 |
|---|
| 122 | 122 | | (3) A |
|---|
| 123 | 123 | | DDITIONAL REQUIREMENTS FOR TELE -11 |
|---|
| 124 | 124 | | HEALTH PROVIDERS.— 12 |
|---|
| 125 | 125 | | (A) I |
|---|
| 126 | 126 | | N GENERAL.—Section 502(n) of the 13 |
|---|
| 127 | 127 | | Federal Food, Drug, and Cosmetic Act (21 14 |
|---|
| 128 | 128 | | U.S.C. 352(n)) is amended by adding at the 15 |
|---|
| 129 | 129 | | end the following: ‘‘For purposes of this para-16 |
|---|
| 130 | 130 | | graph, ‘manufacturer, packer, or distributor’ in-17 |
|---|
| 131 | 131 | | cludes a person who issues or causes to be 18 |
|---|
| 132 | 132 | | issued an advertisement or other descriptive 19 |
|---|
| 133 | 133 | | printed matter with respect to a specific drug 20 |
|---|
| 134 | 134 | | subject to section 503(b)(1) or compounded in 21 |
|---|
| 135 | 135 | | accordance with section 503A or 503B, and 22 |
|---|
| 136 | 136 | | who directly or indirectly offers to bring to-23 |
|---|
| 137 | 137 | | gether a potential patient and a prescriber or 24 |
|---|
| 138 | 138 | | dispenser through use of electronic information 25 |
|---|
| 139 | 139 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 140 | 140 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 6 |
|---|
| 141 | 141 | | •S 652 IS |
|---|
| 142 | 142 | | and telecommunication technologies to engage 1 |
|---|
| 143 | 143 | | in prescribing or dispensing of any drug subject 2 |
|---|
| 144 | 144 | | to section 503(b)(1). Nothing in this paragraph 3 |
|---|
| 145 | 145 | | shall apply to a private communication between 4 |
|---|
| 146 | 146 | | a practitioner licensed by law to prescribe or 5 |
|---|
| 147 | 147 | | dispense a prescription drug (or an individual 6 |
|---|
| 148 | 148 | | under the direct supervision of such a practi-7 |
|---|
| 149 | 149 | | tioner) and an individual patient or their rep-8 |
|---|
| 150 | 150 | | resentative.’’. 9 |
|---|
| 151 | 151 | | (B) R |
|---|
| 152 | 152 | | EGULATIONS.—Not later than 1 year 10 |
|---|
| 153 | 153 | | after the date of enactment of this Act, the Sec-11 |
|---|
| 154 | 154 | | retary shall update the regulations promulgated 12 |
|---|
| 155 | 155 | | to carry out section 502(n) of the Federal 13 |
|---|
| 156 | 156 | | Food, Drug, and Cosmetic Act (21 U.S.C. 14 |
|---|
| 157 | 157 | | 352(n)) in accordance with the amendments 15 |
|---|
| 158 | 158 | | made by subparagraph (A). 16 |
|---|
| 159 | 159 | | (4) R |
|---|
| 160 | 160 | | ULE OF CONSTRUCTION .—Nothing in this 17 |
|---|
| 161 | 161 | | subsection, including the amendments made by this 18 |
|---|
| 162 | 162 | | subsection, precludes a drug manufacturer from tak-19 |
|---|
| 163 | 163 | | ing any corrective action to mitigate the potential 20 |
|---|
| 164 | 164 | | for patient harm from false or misleading commu-21 |
|---|
| 165 | 165 | | nications described in paragraph (h)(2)(A) of section 22 |
|---|
| 166 | 166 | | 303 of the Federal Food, Drug, and Cosmetic Act 23 |
|---|
| 167 | 167 | | (21 U.S.C. 353), as added by paragraph (1). 24 |
|---|
| 168 | 168 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 169 | 169 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 7 |
|---|
| 170 | 170 | | •S 652 IS |
|---|
| 171 | 171 | | (5) EFFECTIVE DATE.—The amendments made 1 |
|---|
| 172 | 172 | | by paragraphs (1) and (3) shall take effect 180 days 2 |
|---|
| 173 | 173 | | after the date on which the regulations described in 3 |
|---|
| 174 | 174 | | paragraph (3)(B) are finalized. 4 |
|---|
| 175 | 175 | | (b) R |
|---|
| 176 | 176 | | EPORTINGREQUIREMENT.— 5 |
|---|
| 177 | 177 | | (1) I |
|---|
| 178 | 178 | | N GENERAL.—Any payment described in 6 |
|---|
| 179 | 179 | | paragraph (2) with respect to the promotion of, or 7 |
|---|
| 180 | 180 | | communications regarding, a covered drug shall be 8 |
|---|
| 181 | 181 | | treated as a payment from an applicable manufac-9 |
|---|
| 182 | 182 | | turer to a covered recipient for purposes of section 10 |
|---|
| 183 | 183 | | 1128G of the Social Security Act (42 U.S.C. 1320a– 11 |
|---|
| 184 | 184 | | 7h), and shall be reported to the Secretary of Health 12 |
|---|
| 185 | 185 | | and Human Services by the drug manufacturer or 13 |
|---|
| 186 | 186 | | health care provider making the payment and made 14 |
|---|
| 187 | 187 | | publicly available by the Secretary in accordance 15 |
|---|
| 188 | 188 | | with such section 1128G. 16 |
|---|
| 189 | 189 | | (2) P |
|---|
| 190 | 190 | | AYMENTS DESCRIBED .—A payment de-17 |
|---|
| 191 | 191 | | scribed in this paragraph is— 18 |
|---|
| 192 | 192 | | (A) a payment by a drug manufacturer to 19 |
|---|
| 193 | 193 | | a health care provider, including a telehealth 20 |
|---|
| 194 | 194 | | company or other similar entity, or social media 21 |
|---|
| 195 | 195 | | influencer; or 22 |
|---|
| 196 | 196 | | (B) a payment by a health care provider, 23 |
|---|
| 197 | 197 | | including a telehealth provider or other similar 24 |
|---|
| 198 | 198 | | entity, to a social media influencer. 25 |
|---|
| 199 | 199 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 200 | 200 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 8 |
|---|
| 201 | 201 | | •S 652 IS |
|---|
| 202 | 202 | | (3) DEFINITIONS.—In this subsection— 1 |
|---|
| 203 | 203 | | (A) the terms ‘‘applicable manufacturer’’ 2 |
|---|
| 204 | 204 | | and ‘‘covered recipient’’ have the meanings 3 |
|---|
| 205 | 205 | | given such terms in section 1128G(e) of the So-4 |
|---|
| 206 | 206 | | cial Security Act (42 U.S.C. 1320a–7h); and 5 |
|---|
| 207 | 207 | | (B) the term ‘‘covered drug’’ means any 6 |
|---|
| 208 | 208 | | drug, including a biological product (as defined 7 |
|---|
| 209 | 209 | | in section 351(i) of the Public Health Service 8 |
|---|
| 210 | 210 | | Act (42 U.S.C. 262(i))), for which payment is 9 |
|---|
| 211 | 211 | | available under title XVIII of the Social Secu-10 |
|---|
| 212 | 212 | | rity Act (42 U.S.C. 1395 et seq.) or a State 11 |
|---|
| 213 | 213 | | plan under title XIX or XXI of such Act (42 12 |
|---|
| 214 | 214 | | U.S.C. 1396 et seq.; 42 U.S.C. 1397aa et seq.) 13 |
|---|
| 215 | 215 | | (or a waiver of such a plan). 14 |
|---|
| 216 | 216 | | (c) M |
|---|
| 217 | 217 | | ARKETSURVEILLANCE OF PRESCRIPTION 15 |
|---|
| 218 | 218 | | D |
|---|
| 219 | 219 | | RUGADVERTISING ORPROMOTION.— 16 |
|---|
| 220 | 220 | | (1) I |
|---|
| 221 | 221 | | N GENERAL.—The Secretary may conduct 17 |
|---|
| 222 | 222 | | market surveillance activities regarding any pro-18 |
|---|
| 223 | 223 | | motion of prescription drugs on social media plat-19 |
|---|
| 224 | 224 | | forms. The activities under this section may in-20 |
|---|
| 225 | 225 | | clude— 21 |
|---|
| 226 | 226 | | (A) activities, carried out directly or by 22 |
|---|
| 227 | 227 | | contract, relating to— 23 |
|---|
| 228 | 228 | | (i) aggregating and analysis of public 24 |
|---|
| 229 | 229 | | communications (which may involve the 25 |
|---|
| 230 | 230 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 231 | 231 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 9 |
|---|
| 232 | 232 | | •S 652 IS |
|---|
| 233 | 233 | | use of artificial intelligence applications), 1 |
|---|
| 234 | 234 | | including to establish any relationship be-2 |
|---|
| 235 | 235 | | tween a manufacturer of a prescription 3 |
|---|
| 236 | 236 | | drug and individuals engaging in commu-4 |
|---|
| 237 | 237 | | nications about such drug; 5 |
|---|
| 238 | 238 | | (ii) analytical tools to review submis-6 |
|---|
| 239 | 239 | | sions of promotional communications; 7 |
|---|
| 240 | 240 | | (iii) engagement with representatives 8 |
|---|
| 241 | 241 | | of social media platforms on strategies and 9 |
|---|
| 242 | 242 | | opportunities to address false or mis-10 |
|---|
| 243 | 243 | | leading promotion of prescription drugs, 11 |
|---|
| 244 | 244 | | including through methods of technology 12 |
|---|
| 245 | 245 | | or functionality to identify and assess false 13 |
|---|
| 246 | 246 | | or misleading communications; and 14 |
|---|
| 247 | 247 | | (iv) developing and disseminating pub-15 |
|---|
| 248 | 248 | | lic facing communications and educational 16 |
|---|
| 249 | 249 | | materials and programs for prescription 17 |
|---|
| 250 | 250 | | drug manufacturers, social media plat-18 |
|---|
| 251 | 251 | | forms, and the public, which may include 19 |
|---|
| 252 | 252 | | communications and educational materials 20 |
|---|
| 253 | 253 | | and programs regarding the Bad Ad pro-21 |
|---|
| 254 | 254 | | gram of the Food and Drug Administra-22 |
|---|
| 255 | 255 | | tion; 23 |
|---|
| 256 | 256 | | (B) hiring additional staff for the Office of 24 |
|---|
| 257 | 257 | | Prescription Drug Promotion of the Center for 25 |
|---|
| 258 | 258 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 259 | 259 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 10 |
|---|
| 260 | 260 | | •S 652 IS |
|---|
| 261 | 261 | | Drug Evaluation and Research and the Adver-1 |
|---|
| 262 | 262 | | tising and Promotional Labeling Branch of the 2 |
|---|
| 263 | 263 | | Center for Biologics Evaluation and Research 3 |
|---|
| 264 | 264 | | for the review of advertising or promotion of 4 |
|---|
| 265 | 265 | | prescription drugs on digital platforms, such as 5 |
|---|
| 266 | 266 | | social media, and such other purposes as the 6 |
|---|
| 267 | 267 | | Secretary determines appropriate; and 7 |
|---|
| 268 | 268 | | (C) establishing a task force, jointly with 8 |
|---|
| 269 | 269 | | the Federal Trade Commission, to coordinate 9 |
|---|
| 270 | 270 | | and enhance communication between the Fed-10 |
|---|
| 271 | 271 | | eral Trade Commission and the Food and Drug 11 |
|---|
| 272 | 272 | | Administration related to monitoring of, and 12 |
|---|
| 273 | 273 | | compliance activities relating to, prescription 13 |
|---|
| 274 | 274 | | drug advertising or promotion. 14 |
|---|
| 275 | 275 | | (2) R |
|---|
| 276 | 276 | | ULE OF CONSTRUCTION .—Nothing in 15 |
|---|
| 277 | 277 | | paragraph (1) shall be construed to affect the au-16 |
|---|
| 278 | 278 | | thority of the Secretary to carry out activities de-17 |
|---|
| 279 | 279 | | scribed in such paragraph pursuant to other provi-18 |
|---|
| 280 | 280 | | sions of law. 19 |
|---|
| 281 | 281 | | (3) FDA |
|---|
| 282 | 282 | | NOTICE TO MANUFACTURERS .—The 20 |
|---|
| 283 | 283 | | Secretary may establish a process for providing in-21 |
|---|
| 284 | 284 | | formation to the holder of an approved application 22 |
|---|
| 285 | 285 | | of a prescription drug under section 505 of this Act 23 |
|---|
| 286 | 286 | | or section 351 of the Public Health Service Act for 24 |
|---|
| 287 | 287 | | the purpose of notifying such holder of instances of 25 |
|---|
| 288 | 288 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 289 | 289 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 11 |
|---|
| 290 | 290 | | •S 652 IS |
|---|
| 291 | 291 | | communications by health care providers or social 1 |
|---|
| 292 | 292 | | media influencers that fail to include information in 2 |
|---|
| 293 | 293 | | brief summary relating to side effects, contraindica-3 |
|---|
| 294 | 294 | | tions, and effectiveness of the drug in the same 4 |
|---|
| 295 | 295 | | manner and to the same extent as such information 5 |
|---|
| 296 | 296 | | is required in prescription drug advertisements pur-6 |
|---|
| 297 | 297 | | suant to section 502(n) of the Federal Food, Drug, 7 |
|---|
| 298 | 298 | | and Cosmetic Act (21 U.S.C. 352(n)). 8 |
|---|
| 299 | 299 | | (4) R |
|---|
| 300 | 300 | | EPORTING.—The Secretary shall— 9 |
|---|
| 301 | 301 | | (A) not later than 2 years after the date 10 |
|---|
| 302 | 302 | | of enactment of this Act, submit to Congress a 11 |
|---|
| 303 | 303 | | report on the activities carried out under this 12 |
|---|
| 304 | 304 | | subsection; 13 |
|---|
| 305 | 305 | | (B) not later than 4 years after the date 14 |
|---|
| 306 | 306 | | of enactment of this Act, submit to Congress, 15 |
|---|
| 307 | 307 | | and make publicly available, a report on the ac-16 |
|---|
| 308 | 308 | | tivities carried out under this subsection; and 17 |
|---|
| 309 | 309 | | (C) make publicly available on the website 18 |
|---|
| 310 | 310 | | of the Food and Drug Administration notice of 19 |
|---|
| 311 | 311 | | all enforcement actions taken under paragraph 20 |
|---|
| 312 | 312 | | (h) of section 303 of the Federal Food, Drug, 21 |
|---|
| 313 | 313 | | and Cosmetic Act (21 U.S.C. 333), as added by 22 |
|---|
| 314 | 314 | | subsection (a). 23 |
|---|
| 315 | 315 | | (5) A |
|---|
| 316 | 316 | | UTHORIZATION OF APPROPRIATIONS .—To 24 |
|---|
| 317 | 317 | | carry out this subsection, there are authorized to be 25 |
|---|
| 318 | 318 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S652.IS S652 |
|---|
| 319 | 319 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 12 |
|---|
| 320 | 320 | | •S 652 IS |
|---|
| 321 | 321 | | appropriated $15,000,000 for each of fiscal years 1 |
|---|
| 322 | 322 | | 2025 through 2029. 2 |
|---|
| 323 | 323 | | (d) S |
|---|
| 324 | 324 | | OCIALMEDIAINFLUENCER.—In this section, 3 |
|---|
| 325 | 325 | | the term ‘‘social media influencer’’ has the meaning given 4 |
|---|
| 326 | 326 | | such term in paragraph (h) of section 303 of the Federal 5 |
|---|
| 327 | 327 | | Food, Drug, and Cosmetic Act (21 U.S.C. 333), as added 6 |
|---|
| 328 | 328 | | by subsection (a). 7 |
|---|
| 329 | 329 | | (e) S |
|---|
| 330 | 330 | | EVERABILITY.—If any provision of this Act or 8 |
|---|
| 331 | 331 | | of any amendment made by this Act, or the application 9 |
|---|
| 332 | 332 | | of such provision or amendment to any person or cir-10 |
|---|
| 333 | 333 | | cumstance, is held to be invalid, the remainder of the pro-11 |
|---|
| 334 | 334 | | visions of this Act and of the amendments made by this 12 |
|---|
| 335 | 335 | | Act and the remainder of the provisions of the Federal 13 |
|---|
| 336 | 336 | | Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 14 |
|---|
| 337 | 337 | | and the application of any such provision or amendment 15 |
|---|
| 338 | 338 | | to other persons not similarly situated or to other cir-16 |
|---|
| 339 | 339 | | cumstances, shall not be affected. 17 |
|---|
| 340 | 340 | | Æ |
|---|
| 341 | 341 | | VerDate Sep 11 2014 03:32 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6301 E:\BILLS\S652.IS S652 |
|---|
| 342 | 342 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB |
|---|