USA

Advertising includes descriptive texts issued by a manufacturer, packer or distributor and are required to be truthful and not misleading.


Prescription drug advertising in the U.S. is primarily governed by the Federal Food, Drug and Cosmetic Act (FDCA) and the U.S. Food and Drug Administration (FDA).The FDCA sets out requirements for prescription drug promotion and authorises the FDA to promulgate related regulations. The FDA adds details to the framework including direct-to-consumer broadcast advertisements to appropriate risk communication in advertising and social media.


However, the Federal Trade Commission (FTC), on the other hand, regulates non-prescription drugs. They lay out regulations for the structure of  advertisements,  regardless of the media.


Manufacturers are expected to have an internal review process to ensure that advertising materials comply with U.S. law and industry Codes of Practice.


Once disseminated, all advertisements must be submitted to the FDA Center of Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP). They will provide  comments on advertisements prior to publication. The OPDP also act against advertisements which violate  the law, educating the industry about the specifics of the law and encouraging better communication of promotional information. Their mission is to protect  public health by ensuring  prescription drug information is truthful, balanced and accurately communicated, which is accomplished through a comprehensive surveillance, enforcement and education program, fostering better communication of labelling and promotional information to both healthcare professionals and consumers.


The U.S. and New Zealand are the only countries that allow direct-to-consumer (DTC) advertising of prescription medications. On the other hand,  over-the-counter medicines are allowed to be advertised in other countries as well.

 

⇢Checklist: Regulations and regulatory bodies to look out for

  • Federal Food, Drug and Cosmetic Act (FDCA) 
  • U.S. Food and Drug Administration (FDA) 
  • Federal Trade Commission (FTC) 
  • FDA Center of Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP)

Europe

Advertising of non-prescription medicines to the public is permitted in the UK, however direct to consumer advertising (DTCA) of prescription-only medicines is prohibited as per the Advertising Regulations, implemented by the EU Directive. DTCA provides a favourable environment for shared decision-making wherein the patient is aware of the risks and benefits of new drugs.


The law on advertising in the field of healthcare governs pharma advertising by banning the promotion of product brands where the disease has only one treatment option available on  the market. It has also become mandatory for advertisements to advise the public to consult a doctor or pharmacist.


In European countries, apart from Germany, regulations also allow advertising of non-prescription medicines with certain limitations. For example, disease awareness campaigns are considered legal only if such campaigns do not refer directly or indirectly to the product or therapeutic class.

The Trade Descriptions Act 1968 and the Consumer Protection from Unfair Trading Regulations 2008 regulate consumer advertising generally, including the advertising of medicines.


Additionally, the Association of the British Pharmaceutical Industry (ABPI) represent a wide variety of companies in the UK. They established  a Code of Practice for the pharmaceutical industry, which ensures that  advertising of medicines is carried out within a robust framework supporting high quality patient care. It states that prescription-only medicines must not be promoted to the public and that the information available to the public must be factual, balanced, not misleading and must not encourage prescription of a specific prescription-only medicine.


The Medicines and Healthcare products Regulatory Agency (MHRA)  is another Government agency in the UK, which is responsible for ensuring that medicines and medical reviews work and are acceptably safe. The MHRA ensures that advertising is fully compliant with UK and European medicine law, and therefore works closely with other statutory regulators and ensures that self-regulation is not compromised in any way.


The Business Protection from Misleading Marketing Regulations 2008 perform a similar function for advertising to businesses. This legislation is administered by the Office of Fair Trading and the Advertising Standards Authority on behalf of the Department for Business Innovation & Skills. The aforementioned regulations  implement relevant aspects of the EU Directives on misleading and comparative advertising


Regarding  over-the-counter medicines, The Committee of Advertising Practice is responsible for regulating UK advertising codes. They write and enforce the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (the CAP Code), which applies to non-broadcast advertising.

⇢Checklist: Regulations and regulatory bodies to look out for

  • Trade Descriptions Act 1968
  • Consumer Protection from Unfair Trading Regulations 2008 
  • Association of the British Pharmaceutical Industry Code of Practice 
  • Medicines and Healthcare products Regulatory Agency 
  • The Business Protection from Misleading Marketing Regulations 2008 
  • UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing (the CAP Code)

According to  research provided by Bain & Company,  companies carrying out  successful drug launches always do  three things right:

  • differentiate their drug through messaging, post-launch data and services
  • create broad customer advocacy via a superior customer experience
  • organize their launch as a micro-battle and ensure continuous frontline feedback

All the companies in their survey pointed out the importance of market research for a successful advertising campaign, no matter what kind of drug they were launching. Market research tools, including patient pathways, physician segmentation and focus groups are commonly used strategies. Transforming market data into actionable insights is important in order to make the product stand out. Such messages are based on clinical data and built on efficacy and safety. However, it is important to take into consideration some cognitive shortcuts doctors deploy when they learn about new treatments”.


Equally important are post-launch studies enabling closure of any  remaining gaps in data and which ensure superior data quality over competing products and new entrants. According to their research, before the launch, companies create a post-launch evidence-generation plan lasting 18 months. It generates a steady stream of data after the launch which can help  advertising efficacy. Additionally, the effectiveness of the campaign can be increased by including a competitive service offer to address patient and physician pain points. It has been shown that physician services, such as diagnostics, patient identification, onboarding, reimbursement support and compliance, can play a significant role in a successful advertising campaign.


The average television viewer in the United States  watches as many as nine drug advertisements per day and in total about 16 hours of such advertisements per year, far exceeding the time an average individual spends with their  primary care physician. Therefore, building a successful advertising campaign is crucial for the success of a  drug launch.

Sources:

https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/usa

https://www.fda.gov/drugs/prescription-drug-advertising/background-drug-advertising

https://www.fdli.org/2017/08/prescription-drug-advertising-promotion-regulations-enforcement-select-global-markets/

https://www.abpi.org.uk/media/6655/abpi-code-of-practice-2019.pdf

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/376398/Blue_Guide.pdf

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/376398/Blue_Guide.pdf

http://www.cek.ef.uni-lj.si/u_diplome/basic4488.pdfhttps://www.pagb.co.uk/codes-guidance/4-1-control-counter-medicines-advertising-uk-professional/

https://www.bain.com/insights/how-to-make-your-drug-launch-a-success/