Pharmaceutical Advertising 2025

Welcome to the 2025 edition of the Chambers Global Practice Guide on Pharmaceutical Advertising. First of all, I would like to express gratitude to colleagues for their expert contributions to this Guide. They have collectively covered the latest developments of a wide range of regulatory compliance issues in their respective jurisdictions. I wish to take the opportunity to make a few opening remarks.

January 2025 marked the beginning of the second Trump administration, overseeing the world’s largest national economy and leading global trader. Given the considerable influence of the United States, unsurprisingly, the consequences of the new US administration are beginning to reverberate around the world. Most importantly, there has been significant leadership change of various federal government departments, which will likely result in potentially seismic policy changes, some of which could have profound global impact.

Relevant to the life sciences and healthcare sector, the new president nominated Robert Kennedy Jr as the Secretary of State for the Department of Health and Human Services (HHS). Kennedy has been viewed by many as a controversial figure given his stance on vaccines. Many medical experts including a former Food and Drug Administration (FDA) Commissioner have expressed serious concerns about his nomination. Kennedy is also highly critical of direct-to-consumer advertising of prescription medicines – unique to the United States – and has questioned the FDA’s reliance on user fees to support its budget. By a narrow margin, the US Senate voted on 13 February 2025 in favour of installing Kennedy at the helm of the HHS. His remit in government is broad, including overseeing approval of pharmaceuticals, medical devices and biological products such as vaccines through the FDA. Following his confirmation, in his address to HHS staff, Kennedy called for a new era of radical transparency and worked towards tightening up the rules on conflicts of interests on HHS advisory committees to re-establish public trust in the system. The nominated FDA Commissioner, Dr Marty Makary, a practising cancer surgeon at Johns HopkinsUniversity, is yet to be confirmed by the US Senate at the time of writing. He is widely reported to be a system disruptor with a commitment to delivering better evidence-based patient care.

Vaccine scepticism and vaccine hesitancy arising from misinformation being disseminated and from misguided views is not a new phenomenon. Vaccine misinformation outpaces efforts to counter it. It has occurred and continues to occur in various geographical regions. Misinformation targets all kinds of vaccines, including childhood vaccines, COVID-19, flu, human papillomavirus and many more. Increasing use of social media has proliferated misinformation internationally that has led to rising levels of vaccine hesitancy.

In an era of an increasingly patient-focused and cost-sensitive healthcare delivery environment, patients and those involved in health policy are demanding up-to-date information be communicated to support equitable, inclusive and evidence-based decisions. It is now widely recognised that patients are active partners in their personal healthcare, and their views are increasingly sought in research and regarding effective allocation of healthcare resources. The European Medicines Agency (EMA) in February 2025 highlighted the need for a patient-centred approach to evidence generation to guide regulatory decision-making.

Therefore, one cannot overestimate the importance of proper external engagement with healthcare professionals and patients to ensure accurate and up-to-date information is disseminated to advance public health and patient care. Moreover, the sharing of knowledge, information and collaboration with external stakeholders is a powerful tool in science and medical research by translating ideas into innovations. Legitimate scientific communications to convey accurate information can build public trust and stimulate debates on contentious scientific and public health issues. Misinformation erodes scientific integrity. Given their public health impact, such externally facing communications and engagements are increasingly subject to regulatory scrutiny.

The laws in many countries distinguish between promotional and non-promotional communications by focusing on the effect of such communications on prescribing behaviours and utilisation. Material or communication that is purely informative, without promotional characteristics, is generally not covered by advertising and promotional rules. However, in certain circumstances, the line between genuine scientific exchange on the one hand and advertising and promotional communications on the other may become blurred. That said, the principles guiding best practice require the communication to be accurate, up to date, verifiable and complete. The communication should also not exaggerate the properties of the product by presenting the information objectively. 

In October 2023, building on the long-established policy position, the FDA released a non-binding draft guidance on essentially the best practice related to communications with healthcare professionals on off-label use, and this has been considered as representing the most significant development in the FDA’s regulation of off-label communications in recent years. In Europe, the heads of agencies representing all national competent authorities in the EU and EEA and the EMA have considered the need for regulatory authorities and industry to embrace an effective communication strategy to present information that is accurate, meaningful and actionable to a varied audience such as patients, the general public and healthcare professionals to build trust in scientific developments and regulatory systems.

The rise of digital advertising and evolving healthcare practices have required companies to adapt to novel regulatory questions that may arise from external engagements. As such, companies need to consider whether internal policies and processes continue to be adequate in the face of emerging compliance risks. The disruptive rise of digital health may lead to certain novel compliance risks. For example, such technologies are often patient-facing software applications which assist patients to treat, prevent or manage illness. Developers should be mindful of the regulatory risks of such applications, given how their products intertwine with the practice of medicine and decision-making with respect to treatment options. The use of social media to promote products has seen a plethora of regulatory actions. It has been widely reported that a growing number of influencers with extensive followings on social media are making claims – regarding a wide array of diseases and conditions – that are not capable of being substantiated.

Compliance with the globally diverse regulatory systems will need to be continually adapted to ensure that good practices are applied in proper management of external communications and engagements in response to the ever-changing socio-economic and technological environment.