{"id":121500,"date":"2025-12-09T12:40:28","date_gmt":"2025-12-09T12:40:28","guid":{"rendered":"https:\/\/my.legal500.com\/guides\/?post_type=comparative_guide&#038;p=121500"},"modified":"2025-12-09T12:40:28","modified_gmt":"2025-12-09T12:40:28","slug":"united-states-pharmaceutical-advertising","status":"publish","type":"comparative_guide","link":"https:\/\/my.legal500.com\/guides\/chapter\/united-states-pharmaceutical-advertising\/","title":{"rendered":"United States: Pharmaceutical Advertising"},"content":{"rendered":"","protected":false},"template":"","class_list":["post-121500","comparative_guide","type-comparative_guide","status-publish","hentry","guides-pharmaceutical-advertising","jurisdictions-united-states"],"acf":[],"appp":{"post_list":{"below_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">King &amp; Spalding LLP<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/my.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2021\/11\/Logo_standard_RGB_Brown.jpg\"\/><\/span><\/div>"},"post_detail":{"above_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">King &amp; Spalding LLP<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/my.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2021\/11\/Logo_standard_RGB_Brown.jpg\"\/><\/span><\/div>","below_title":"<span class=\"guide-intro\">This country specific Q&amp;A provides an overview of Pharmaceutical Advertising laws and regulations applicable in United States<\/span><div class=\"guide-content\"><div class=\"filter\">\r\n\r\n\t\t\t\t<input type=\"text\" placeholder=\"Search questions and answers...\" class=\"filter-container__search-field\">\r\n\t\t\t<\/div>\r\n\r\n\t\t\t\r\n\r\n\r\n\t\t\t<ol class=\"custom-counter\">\r\n\r\n\t\t\t\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What laws are used to regulate advertising on medicines in your jurisdiction?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>In the United States, pharmaceutical advertising is regulated under federal and state laws. The primary federal laws are the Food, Drug, and Cosmetic Act (FDCA) and the Federal Trade Commission Act (FTCA). The FDCA grants the U.S. Food &amp; Drug Administration (FDA) broad authority over the advertising and promotion of prescription drugs. The FTCA prohibits \u201cunfair or deceptive acts or practices in or affecting commerce,\u201d including the dissemination of false advertising for drugs. Through mutual agreements, FDA maintains primary jurisdiction over the labelling of all drugs and the advertising of prescription drugs, while FTC holds primary authority over the advertising of non-prescription, over-the-counter (OTC) drugs. State consumer protection laws also prohibit false or misleading advertising.<\/p>\n<p>Pharmaceutical advertising and promotion may also implicate other federal laws, including the Anti-Kickback Statute (AKS), Civil Money Penalties Statute (CMPS), the civil False Claims Act (FCA), and similar state laws.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Voluntary guidelines issued by trade associations and medical professional associations may apply to pharmaceutical advertising and promotion. In addition, the National Advertising Division (NAD), a non-judicial, industry self-regulatory body, adjudicates advertising disputes brought by consumers, competitors, or on its own initiative.<\/p>\n<p><strong>a. If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?<\/strong><\/p>\n<p>Codes applicable to companies and healthcare professionals (HCPs) include the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (PhRMA Code); PhRMA\u2019s Direct to Consumer Advertising Principles; PhRMA\u2019s Principles on Responsible Sharing of Truthful and Non-Misleading Information; the Accreditation Council for Continuing Medical Education Guidelines; and the American Medical Association policies. These guidelines address a range of activities, including industry funding for continuing medical education, engaging HCPs as speakers or consultants, and providing gifts or items of value to HCPs.<\/p>\n<p><strong>b. What is the legal status of the self-regulatory codes?<\/strong><\/p>\n<p>These self-regulatory codes and professional guidelines are voluntary and hold no legal authority alone. However, some states have made the PhRMA Code mandatory for pharmaceutical companies operating within their borders.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is there a statutory or generally accepted definition of \u201cadvertising\u201d? a) What does the definition cover? \u2013 does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Under the FDCA, there is no statutory definition of \u201cadvertising\u201d; however, a generally accepted definition is established through examples in FDA regulations.<\/p>\n<p><strong>a. What does the definition cover?<\/strong> \u2013 does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?<\/p>\n<p>The definition of advertising includes \u201cadvertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems.\u201d Under FDA policy, \u201cnon-promotional\u201d communications such as disease awareness communications are not considered \u201cadvertising.\u201d<\/p>\n<p>Most types of promotional materials, such as brochures, leaflets, catalogues, literature reprints, mailers, printed or digital sales aids, emails, slide decks, videos, websites, and social media posts, are regarded as labeling. Labeling is defined as \u201call labels and other written, printed or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.\u201d \u201cAccompanying\u201d has been broadly interpreted to encompass a wide range of materials as promotional labeling.<\/p>\n<p><strong>b. Does the definition apply equally to all target audiences?<\/strong><\/p>\n<p>The definitions of advertising and labelling apply equally to all target audiences; however, there are separate rules and policies for advertising and promotion depending on the intended audience (e.g., consumers, HCPs, and payors).<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Press releases discussing approved and investigational drugs are permitted. Press releases discussing an approved drug must comply with FDA requirements for promotional labeling, including being truthful and non-misleading, discussing uses that are consistent with the product label, and maintaining fair balance between risks and benefits, including disclosure of relevant contraindications, warnings, precautions and adverse reactions.<\/p>\n<p>Press releases about investigational drugs, as well as investigational uses of approved drugs, should clearly disclose the investigational status of the drug or use, accurately describe study data, avoid promotional claims or conclusory statements regarding safety or efficacy, and present all material information in a truthful and non-misleading manner.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>FDA regulations for current Good Manufacturing Practices (cGMPs) require controls for product packaging and labeling. For promotional labeling and advertising, it is considered a best practice for companies to adopt internal policies and standard operating procedures to manage the review, approval, and use of such materials. Typically, this process is managed by a cross-functional committee comprised of representatives from the company\u2019s legal, regulatory, medical, and compliance departments.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Do companies have to have material approved by regulatory bodies prior to release?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>FDA does not approve pharmaceutical advertising and promotional materials before dissemination, except under the following circumstances:<\/p>\n<ul>\n<li>required pre-clearance of ads following previous violations of FDA or FTC advertising requirements;<\/li>\n<li>\u201cpre-submission\u201d requirements for prescription drugs approved under FDA\u2019s accelerated approval process; or<\/li>\n<li>pre-dissemination review for certain categories of direct-to-consumer television ads.<\/li>\n<\/ul>\n<p>Companies can always voluntarily submit proposed promotional advertising or promotional labeling to FDA for advisory review and comment.<\/p>\n<p>While FDA approval is not required for most drug advertising and labeling, FDA regulations require pharmaceutical companies to submit prescription drug labeling and advertising materials under Form FDA 2253 to FDA\u2019s Office of Prescription Drug Promotion (OPDP) at the time of first use.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is comparative advertising for medicines allowed and if so, what restrictions apply?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Comparative claims regarding a drug\u2019s efficacy or safety are generally permitted if they are based on the approved indication of a drug to the same approved indication of another drug and are supported by scientifically appropriate and statistically sound data (e.g., head-to-head study, clinically relevant to patients, not false or misleading). Comparative claims should not suggest superior efficacy or safety based solely on the differences in product labeling or on the results of two different studies.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The FDCA and FDA regulations prohibit the promotion of unauthorized medicines (i.e., investigational drugs) and unauthorized uses of approved drugs (i.e., off-label uses) as safe or effective.<\/p>\n<p>Despite this broad prohibition, FDA permits certain non-promotional communications about unauthorized drugs and uses that are considered \u201cscientific exchange,\u201d including support for independent medical education; scientific presentations and publications during scientific conferences; responding to unsolicited requests for information; distributing scientific publications to HCPs; providing firm-generated presentations based on appropriate source publications (e.g., published, peer-reviewed reprints, clinical practice guidelines (CPGs), scientific or medical reference texts, or digital clinical practice resources); publishing information on clinicaltrials.gov; and pre-approval communications with payors.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, and include the information that must or must not be included.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>\u201cDirect-to-consumer\u201d (DTC) advertising of prescription drugs is permitted provided the communication complies with the following requirements.<\/p>\n<ul>\n<li>On-label or consistent with label \u2013 Consistent with the FDA-approved use of the drug, as established by the drug\u2019s FDA-approved labeling (i.e., Prescribing Information).<\/li>\n<li>Fair balance \u2013 Presenting a \u201cfair balance\u201d between presentation of information on product benefits and risks.<\/li>\n<li>Adequately substantiated (i.e., by substantial evidence, substantial clinical experience, or scientifically appropriate and statistically sound evidence).<\/li>\n<li>Otherwise truthful and non-misleading.<\/li>\n<li>Includes other required information (i.e., proprietary and established names; quantitative composition of each ingredient; \u201cbrief summary\u201d in print ads or \u201cmajor statement\u201d in broadcast ads for risk information; MedWatch statement).<\/li>\n<\/ul>\n<p>DTC advertising for OTC drugs must be:<\/p>\n<ul>\n<li>Consistent with the product\u2019s approved labeling (or monograph, as applicable);<\/li>\n<li>Substantiated by competent and reliable scientific evidence; and<\/li>\n<li>Truthful and not misleading.<\/li>\n<\/ul>\n<p>Additionally, FDA strongly recommends that companies use consumer-friendly language in DTC advertising and promotion.<\/p>\n<p>\u201cReminder\u201d advertising and labeling is exempt from the above requirements. To qualify as a \u201creminder\u201d ad, the communication must be limited to the drug\u2019s proprietary and established names (with other optional information), but must not include any reference to indications, dosage, or other promotional claims. Reminder ads are not permitted for drugs with a boxed warning in their FDA-approved Prescribing Information.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Company interactions with patients, patient organizations, and industry are generally permitted, if they:<\/p>\n<ul>\n<li>Comply with fundamental advertising and promotion standards (i.e., on-label \/ consistent with label, fair balanced, adequately substantiated, and otherwise truthful and non-misleading);<\/li>\n<li>Do not violate the AKS by inducing patients or patient organizations to recommend or use the marketed product;<\/li>\n<li>Abide by applicable federal and state privacy and security laws; and<\/li>\n<li>Avoid providing advice for the diagnosis, treatment, care, or prognosis of an individual, which could be regarded as unlawfully engaging in the practice of medicine.<\/li>\n<\/ul>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example, can companies provide information about clinical trials, or reprints of scientific journal articles?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The requirements for advertising directed at HCPs are generally the same as those for DTC. If the advertising and promotion to HCPs involves a prescription drug, it must also include adequate directions for use (i.e., Prescribing Information).<\/p>\n<p>However, HCP advertising requirements differ from DTC advertising in slight ways. The \u201cbrief summary\u201d for HCP-directed print advertisements should provide the complete risk-related sections of the PI, and there is no requirement to include the MedWatch statement.<\/p>\n<p>In addition, under the FDCA, advertising directed to payors may include healthcare economic information (HCEI) related to a product\u2019s indication, provided that it is supported by competent and reliable scientific evidence and is otherwise consistent with FDA guidance regarding communications with payors.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The AKS and similar state laws generally prohibit companies from providing gifts of any value with the intent of inducing referrals or other business; however, the PhRMA Code provides some limited protections.<\/p>\n<p>The PhRMA Code allows manufacturers to offer educational items and reimbursements for meals and travel to HCPs in limited situations. Manufactures may provide items that \u201cadvance disease or treatment education,\u201d but not items intended for the personal benefit of HCPs, including items of de minimis value (e.g., pens, pads, mugs). Manufacturers may also provide modest meals in conjunction with an informational presentation to HCPs. The PhRMA Code recommends that costs are modest and reasonable, but does not set monetary limits; however, some states establish monetary limits on, or prohibit, these activities.<\/p>\n<p>Importantly, the PhRMA Code is neither law nor regulation, but is generally recognized as an important industry guideline. Thus, its condoned activities likely pose a lower risk of prosecution under the AKS and similar state laws, while its prohibited activities carry significant risk.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies allowed to provide samples to healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The Prescription Drug Marketing Act (PDMA) permits a manufacturer to provide samples to licensed HCPs or institutions who request samples, sign for or formally acknowledge receipt, agree to legally prescribe and dispense, and do not resell the samples or bill patients or insurance for them. Samples used as gifts or improper inducements for HCPs to prescribe a particular product could implicate the AKS.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies permitted to sponsor scientific meetings or congresses and\/or attendance by healthcare professionals to these events?  If so, which restrictions apply?  Do additional restrictions apply to events taking place abroad?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>A company may provide financial support to third parties hosting independent scientific or educational conferences or meetings, including those for continuing medical education (CME). The PhRMA Code specifically notes that the company should develop a policy to ensure that CME grants are bona fide and not an improper inducement.<\/p>\n<p>Companies paying for HCP attendance, travel, or hospitality for such events may violate the PhRMA Code and\/or the AKS, unless such payment falls within an established AKS safe harbor.<\/p>\n<p>For events overseas and virtual events, which reach across broader geographies, companies should additionally consider clear disclosures in materials and presentations regarding the intended audience and geographic limitations, particularly if the product\u2019s approval status or indication differs outside of the United States.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Sponsoring, financing, or otherwise facilitating participation in cultural, sports, or other non-scientific events by HCPs risks violating the AKS and is also expressly prohibited by the PhRMA Code.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The personal services and management contracts safe harbor under the AKS protects payments for services provided by HCPs provided that:<\/p>\n<ul>\n<li>There is a written agreement that expressly defines the services to be provided for a term of at least one year;<\/li>\n<li>The contracted services are commercially reasonable in the absence of other business or referrals generated between the parties;<\/li>\n<li>The total compensation over the term of the agreement is fixed in advance and consistent with fair market value; and<\/li>\n<li>The services do not involve any other violation of law.<\/li>\n<\/ul>\n<p>Services arrangements with HCPs sometimes fail at least one of these requirements. The PhRMA Code provides additional guidance to help protect arrangements that cannot meet the safe harbor protection.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Manufacturers may make grants or donations to HCPs or institutions, but should be aware of the AKS. Such grants or donations, whether monetary or in-kind, generally fall within the AKS\u2019s broad definition of \u201cremuneration,\u201d and can have consequences if their purpose is related to generating business from the recipient or individuals involved with the recipient, including influencing clinical or purchasing decision-making. To help avoid this, manufacturers often impose guardrails on provision of grants, such as: limit recipients to charitable or non-profit organizations only; fund grants and donations from non-sales and marketing budgets, establish a Grants Committee made up of non-commercial personnel, document each grant and donation (including its intended purpose), and ensure there is no \u201creturn on investment\u201d analysis with respect to grants or donations.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and\/or companies that do not yet have products on the market?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The federal Physician Payments Sunshine Act (Sunshine Act) and its implementing regulations require some pharmaceutical manufacturers (including foreign drug manufacturers that operate in the U.S.) to annually report to the Centers for Medicare and Medicaid Services (CMS) payments or transfers of value provided to HCPs and teaching hospitals during the previous calendar year and ownership or investment interests held in the manufacturer by physicians and their immediate family members. It does not apply to entities that do not have marketed products in the U.S. Several states also require manufacturers to track and annually report certain information about payments or transfers of value provided to certain HCPs and healthcare organizations within their borders. Specific transparency requirements vary from state-to-state.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any restrictions (whether by law or Codes of Practice) on advertising for medicines on social media directed to healthcare professionals or directed to the general public?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Advertising and promotion of pharmaceuticals on social media is permitted in the U.S. and is subject to the same FDA regulatory requirements as other forms of promotional labeling. FDA has also issued guidance documents relevant to use of social media for prescription pharmaceutical promotion that:<\/p>\n<ul>\n<li>Describe when firms will be held responsible for social media content, including user generated comments (UGC), and how to submit interactive social media to OPDP via FDA Form 2253.<\/li>\n<li>Explain how FDA\u2019s rules regarding disclosure of risk information apply in character-limited communications (e.g., X, sponsored links).<\/li>\n<li>Explain how companies can address misinformation posted about their products on social media or the Internet by third parties unaffiliated with the company.<\/li>\n<\/ul>\n<p>Per FTC guidelines, social media influencers must disclose company\/brand affiliations and limit endorsements to those that reflect the influencer\u2019s honest opinions, beliefs, or experiences. Endorsements may not include false or unsubstantiated statements.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is advertising on the internet for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Advertising and promotion of pharmaceuticals on the internet is also subject to the same FDA regulatory requirements as other forms of promotional labeling and advertising. The FTC has also issued guides regarding disclosures on the Internet and social media.<\/p>\n<p>Neither agency requires companies to include access restrictions on pharmaceutical-related websites intended for HCPs; however, for HCP-targeted websites, it is common industry practice to include an interstitial page (e.g., pop-up webpage) to confirm the viewer is a U.S. HCP.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any anti-bribery rules that apply to communications between pharmaceutical companies and healthcare professionals or healthcare organisations?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The AKS and CMPS are federal anti-bribery laws applicable to interactions between pharmaceutical companies and HCPs. Many states have similar anti-bribery laws. The Foreign Corrupt Practices Act prohibits bribes or kickbacks in the form of certain payments to foreign (non-U.S.) officials, which in some countries may include government employed HCPs.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The AKS is a criminal law prohibiting individuals and entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration to induce the provision of a good or service that is reimbursable under a federal health care program. \u201cRemuneration\u201d includes anything of value (e.g., gifts, payments, discounts or rebates, free or below cost products and services), including items of de minimis value. The scope of the AKS is broad and applies to any individual or entity that provides or receives remuneration\u2014even where the sole or primary purpose is not to provide value for the referral of covered goods or services.<\/p>\n<p>The OIG has promulgated \u201csafe harbor\u201d regulations specifying certain exceptions and several types of arrangements that will not be considered to contravene the AKS (e.g., discounts or rebates, warranties, and employment and services arrangements). If an arrangement satisfies all the criteria of a safe harbor, it will be immune from criminal prosecution and civil exclusion under the AKS. Arrangements falling outside a safe harbor present legal risk that carry both criminal and civil penalties.<\/p>\n<p>Similar to the AKS, the CMPS is a civil law prohibiting the offering or provision of inducements to federal and state healthcare program (Medicare and Medicaid) beneficiaries and impose monetary penalties on entities that offer or transfer remuneration to such a beneficiary when they know or should know it is likely to influence the beneficiary\u2019s selection of a particular provider, practitioner, or supplier of covered items or services.<\/p>\n<p>A violation of the AKS or CMPS could also result in a violation of FCA, which prohibits knowingly making a false statement or filing a false claim regarding payment by any federal health care program. The FCA includes a whistleblower provision that allows private citizens to file complaints on behalf of the U.S. Government, which may be based on violations of the AKS, CMPS or FCA.<\/p>\n<p>Some states have enacted their own anti-kickback statutes that apply to inducements related to healthcare items and services (including drugs) reimbursed by private insurance, not just those reimbursed by a federal or state healthcare program.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>FDA and FTC regulate the advertising and promotion of pharmaceutical products through the FDCA, FTCA, and their implementing regulations. Repeat or egregious violations may prompt FDA and FTC to initiate enforcement proceedings in federal court (brought by the U.S. Department of Justice (DOJ)) to enjoin the behavior and seek penalties.<\/p>\n<p>The DOJ and the Department of Health and Human Services Office of Inspector General (OIG) have authority to enforce the AKS, CMPS and FCA. DOJ has authority over both criminal and civil enforcement actions; OIG has authority over civil actions.<\/p>\n<p>State Attorneys General may take enforcement actions under similar state laws, both civil and criminal.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Competitors do not have a right of action under the FDCA or FTCA to challenge unlawful pharmaceutical advertising, but they may submit trade complaints to FDA and FTC to prompt agency enforcement. In addition, companies may directly challenge competitors\u2019 \u201cfalse and misleading\u201d advertising in court under the Lanham Act and similar state laws. Competitors may also bring challenges before the NAD, a non-judicial, industry self-regulatory body. Companies and their employees can also be whistleblowers under the FCA.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Penalties for unlawful pharmaceutical advertising and promotion vary depending on the statute used to challenge the activity.<\/p>\n<ul>\n<li>For violations of the FDCA, FDA may seize products; for violations regarding DTC advertising, FDA may seek civil monetary penalties.<\/li>\n<li>For violations of the FDCA or FTCA, the government commonly seeks injunctions and may bring criminal charges for more extreme cases.<\/li>\n<li>For violations of the AKS or FCA, the government may pursue civil penalties (i.e., fines and monetary damages) or criminal sanctions (i.e., monetary penalties or imprisonment).<\/li>\n<li>For violations of the Lanham Act, the competitor may seek injunctive and\/or monetary remedies. More rarely, the competitor may seek a preliminary injunction, disgorgement of profits, treble damages, and\/or an award of attorney fees.<\/li>\n<\/ul>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts\/government competent authorities?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Federal government authorities such as FDA and FTC may pursue enforcement against violative advertising and promotion in federal court. Enforcement by state government authorities occurs in state courts. In contrast, enforcement by non-governmental, self-regulatory bodies such as the NAD are not binding in court; however, the NAD may refer certain cases to FTC for potential enforcement.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>In 2025, FDA announced via press release \u201csweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements,\u201d while simultaneously sending notice to thousands of pharmaceutical companies demanding promotional compliance and issuing over 100 enforcement letters to companies for deceptive advertising related to specific products.<\/p>\n<p>The notice (i.e., \u201cDear Pharmaceutical Company\u201d letter) and press release highlighted FDA\u2019s concerns regarding lack of fair balance between drug benefits and risks in drug advertising. FDA also expressed particular concern regarding pharmaceutical advertising on digital and social media channels, including undisclosed paid influencer promotion.<\/p>\n<p>The surge in FDA enforcement letters included letters to pharmaceutical manufacturers as well as letters to clinics, telehealth providers, and compounding pharmacies of GLP-1 agonists and erectile dysfunction drugs. Of the letters issued to pharmaceutical manufacturers, the majority targeted direct-to-consumer television ads, while others focused on sales aids, websites, exhibit booth panels, print ads, sponsored links, and online videos. In addition to targeting fair balance violations and presentation of risk information, most letters also challenged unsubstantiated efficacy claims. Although the majority of FDA\u2019s recent enforcement letters focused on DTC advertising, some letters also challenged promotion to HCPs.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\r\n<div class=\"word-count-hidden\" style=\"display:none;\">Estimated word count: <span class=\"word-count\">4234<\/span><\/div>\r\n\r\n\t\t\t<\/ol>\r\n\r\n<script type=\"text\/javascript\" src=\"\/wp-content\/themes\/twentyseventeen\/src\/jquery\/components\/filter-guides.js\" async><\/script><\/div>"}},"_links":{"self":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide\/121500","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide"}],"about":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/types\/comparative_guide"}],"wp:attachment":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/media?parent=121500"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}