,,ii #aaith ,,congress #ast ,session ,s4 #feb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #bj1 #bjbe,mr4 ,durbin 7for himself and ,mr4 ,marshall7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to provide for the regulation of certain communications regarding prescription drugs4 #a4 ,short title ,this ,act may be cited as the ,protecting ,patients from ,deceptive ,drug ,ads ,act4 #b4 ,regulation of certain communications regarding prescription drugs 7a7 ,regulation of communications 7#a7 ,in general ,section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is amended by adding at the end the following3 7h7 7#a7 ,in the case of a social media influencer or health care provider who makes false or misleading communications regarding a drug approved under section #eje or licensed under section #cea of the ,public ,health ,service ,act1 and subject to section #ejc7;b71 or compounded in accordance with section #ejc;,a or #ejc;,b1 shall be liable to the ,united ,states for a civil penalty in an amount described in paragraph 7g77#a71 in accordance with a process similar to the process described in paragraph 7g77#b74 7#b7 ,for purposes of this paragraph-- 7,a7 the term false or misleading communications-- 7i7 means advertisements or promotional communications on a social media platform from which there is a financial benefit to the person engaging in such communications regarding such drug-- 7,i7 7aa7 that are made knowingly or recklessly2 and 7bb7 contain a false or inaccurate statement or material omission of fact regarding a drug described in subparagraph 7#a72 or 7,,ii7 fail to include information in brief summary relating to side effects1 contraindications1 and effectiveness of the drug in the same manner and to the same extent as such information is required in prescription drug advertisements pursuant to section #ejb7n72 and 7ii7 does not include-- 7,i7 statements that take place in the course of bona fide patient care or medical research that are made by professionals engaged in such patient care or medical research2 or 7,,ii7 statements that describe the person's own experience1 opinion1 or value judgment2 and 7,b7 the term social media influencer means a private individual who has perceived credibility or popularity and who expresses their opinions1 beliefs1 findings1 recommendations1 or experience on social media platforms to an audience1 including in a manner conveying trust or expertise on a topic1 for the purpose to promoting or advertising certain information or products or inducing behavior by the audience4 4 7#b7 ,guidance ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall issue guidance on how the ,secretary will administer paragraph 7h7 of section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc71 as added by paragraph 7#a71 including with respect to the factors that will be considered in determining whether a communication is false or misleading communication1 as defined in such paragraph 7h71 including-- 7,a7 the various types of statements or omission of facts regarding a prescription drug that would constitute false or misleading1 such as statements or omissions related to safety1 efficacy1 approved or unapproved uses1 directions for use from the label approved by the ,food and ,drug ,administration1 scientific information1 or other similar attributes2 7,b7 whether the inclusion of the information in brief summary described in paragraph 7h77#b77;,a77i77,,iii7 of section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc71 as added by paragraph 7#a71 alone is sufficient in each circumstance to avoid such a determination2 7,c7 actions taken by the social media influencer1 health care provider1 or other person to demonstrate compliance with such paragraph 7h72 and 7,d7 characteristics specific to various social media platforms1 and the speed of dissemination of the content on such platform4 7#c7 ,additional requirements for telehealth providers 7,a7 ,in general ,section #ejb7n7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7n77 is amended by adding at the end the following3 ,for purposes of this paragraph1 manufacturer1 packer1 or distributor includes a person who issues or causes to be issued an advertisement or other descriptive printed matter with respect to a specific drug subject to section #ejc7;b77#a7 or compounded in accordance with section #ejc;,a or #ejc;,b1 and who directly or indirectly offers to bring together a potential patient and a prescriber or dispenser through use of electronic information and telecommunication technologies to engage in prescribing or dispensing of any drug subject to section #ejc7;b77#a74 ,nothing in this paragraph shall apply to a private communication between a practitioner licensed by law to prescribe or dispense a prescription drug 7or an individual under the direct supervision of such a practitioner7 and an individual patient or their representative44 7,b7 ,regulations ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall update the regulations promulgated to carry out section #ejb7n7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7n77 in accordance with the amendments made by subparagraph 7,a74 7#d7 ,rule of construction ,nothing in this subsection1 including the amendments made by this subsection1 precludes a drug manufacturer from taking any corrective action to mitigate the potential for patient harm from false or misleading communications described in paragraph 7h77#b77;,a7 of section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec71 as added by paragraph 7#a74 7#e7 ,effective date ,the amendments made by paragraphs 7#a7 and 7#c7 shall take effect #ahj days after the date on which the regulations described in paragraph 7#c77;,b7 are finalized4 7b7 ,reporting requirement 7#a7 ,in general ,any payment described in paragraph 7#b7 with respect to the promotion of1 or communications regarding1 a covered drug shall be treated as a payment from an applicable manufacturer to a covered recipient for purposes of section #aabh;,g of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;h71 and shall be reported to the ,secretary of ,health and ,human ,services by the drug manufacturer or health care provider making the payment and made publicly available by the ,secretary in accordance with such section #aabh;,g4 7#b7 ,payments described ,a payment described in this paragraph is-- 7,a7 a payment by a drug manufacturer to a health care provider1 including a telehealth company or other similar entity1 or social media influencer2 or 7,b7 a payment by a health care provider1 including a telehealth provider or other similar entity1 to a social media influencer4 7#c7 ,definitions ,in this subsection-- 7,a7 the terms applicable manufacturer and covered recipient have the meanings given such terms in section #aabh;,g7e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;h72 and 7,b7 the term covered drug means any drug1 including a biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i7771 for which payment is available under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or a ,state plan under title ,,xix or ,,xxi of such ,act 7#db ,u4,s4,c4 #acif et seq42 #db ,u4,s4,c4 #acig;aa et seq47 7or a waiver of such a plan74 7c7 ,market surveillance of prescription drug advertising or promotion 7#a7 ,in general ,the ,secretary may conduct market surveillance activities regarding any promotion of prescription drugs on social media platforms4 ,the activities under this section may include-- 7,a7 activities1 carried out directly or by contract1 relating to-- 7i7 aggregating and analysis of public communications 7which may involve the use of artificial intelligence applications71 including to establish any relationship between a manufacturer of a prescription drug and individuals engaging in communications about such drug2 7ii7 analytical tools to review submissions of promotional communications2 7iii7 engagement with representatives of social media platforms on strategies and opportunities to address false or misleading promotion of prescription drugs1 including through methods of technology or functionality to identify and assess false or misleading communications2 and 7iv7 developing and disseminating public facing communications and educational materials and programs for prescription drug manufacturers1 social media platforms1 and the public1 which may include communications and educational materials and programs regarding the ,bad ,ad program of the ,food and ,drug ,administration2 7,b7 hiring additional staff for the ,office of ,prescription ,drug ,promotion of the ,center for ,drug ,evaluation and ,research and the ,advertising and ,promotional ,labeling ,branch of the ,center for ,biologics ,evaluation and ,research for the review of advertising or promotion of prescription drugs on digital platforms1 such as social media1 and such other purposes as the ,secretary determines appropriate2 and 7,c7 establishing a task force1 jointly with the ,federal ,trade ,commission1 to coordinate and enhance communication between the ,federal ,trade ,commission and the ,food and ,drug ,administration related to monitoring of1 and compliance activities relating to1 prescription drug advertising or promotion4 7#b7 ,rule of construction ,nothing in paragraph 7#a7 shall be construed to affect the authority of the ,secretary to carry out activities described in such paragraph pursuant to other provisions of law4 7#c7 ,,fda notice to manufacturers ,the ,secretary may establish a process for providing information to the holder of an approved application of a prescription drug under section #eje of this ,act or section #cea of the ,public ,health ,service ,act for the purpose of notifying such holder of instances of communications by health care providers or social media influencers that fail to include information in brief summary relating to side effects1 contraindications1 and effectiveness of the drug in the same manner and to the same extent as such information is required in prescription drug advertisements pursuant to section #ejb7n7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7n774 7#d7 ,reporting ,the ,secretary shall-- 7,a7 not later than #b years after the date of enactment of this ,act1 submit to ,congress a report on the activities carried out under this subsection2 7,b7 not later than #d years after the date of enactment of this ,act1 submit to ,congress1 and make publicly available1 a report on the activities carried out under this subsection2 and 7,c7 make publicly available on the website of the ,food and ,drug ,administration notice of all enforcement actions taken under paragraph 7h7 of section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc71 as added by subsection 7a74 7#e7 ,authorization of appropriations ,to carry out this subsection1 there are authorized to be appropriated #ae1jjj1jjj for each of fiscal years #bjbe through #bjbi4 7d7 ,social media influencer ,in this section1 the term social media influencer has the meaning given such term in paragraph 7h7 of section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc71 as added by subsection 7a74 7e7 ,severability ,if any provision of this ,act or of any amendment made by this ,act1 or the application of such provision or amendment to any person or circumstance1 is held to be invalid1 the remainder of the provisions of this ,act and of the amendments made by this ,act and the remainder of the provisions of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 and the application of any such provision or amendment to other persons not similarly situated or to other circumstances1 shall not be affected4