Regulations in the pharmaceutical sector are constantly changing, and it’s up to businesses to have a thorough understanding of how those rules impact their marketing efforts when advertising to the public. The regulations concerning promotional materials are designed to ensure that consumers are given accurate information that leads them to make sound decisions regarding their health and promote a fair marketplace overall.
Read more below…
Basic compliance considerations
Although direct-to-consumer advertising of prescription drugs is only permitted in the USA and New Zealand, requirements that pharma marketers must consider when creating promotional content include:
- Listing drug info and uses that comply with the approved prescribing information
- Balancing benefit claims with associated risks
- Prohibiting the use of misleading or deceptive claims
- Including all necessary material information to ensure effective use
Why should pharma marketers care about compliance?
Pharma marketers have a legal responsibility to ensure compliance with the regulatory requirements established by the FDA in the U.S. and TGA (Therapeutic Goods Administration) in Australia.
As the content gatekeepers, their participation in the creation and review of compliant marketing material could mean the difference between avoiding civil and criminal penalties, incurring losses in customer and brand loyalty or wasting billions of dollars in marketing budgets.
In 2012, GlaxoSmithKline settled the largest healthcare lawsuit to date for unlawfully promoting their prescription drugs.
They paid $3 million to resolve civil liabilities and a criminal penalty.
Pharma marketers’ compliance checklist
In order to effectively address unique industry requirements, pharma marketers have to balance several factors that impact successful compliance.
- Keep a pulse on changing regulations
- Successfully interpret how those rules must be applied
- Create compliant content on an increasing number of channels and platforms
- Ensure seamless collaboration with agency, legal and regulatory partners on direct-to-consumer and healthcare provider marketing material
- Manage large advertising budgets and avoid missteps in compliance that could unravel expensive campaign work
Increasing industry competition has made pharmaceutical companies value the work that marketing and sales professionals add to their bottom line. To ensure their products get in front of the right audience, marketing budgets are even surpassing research and development budgets. In 2020, for example, big pharma spent $6.58 billion on advertising, $2 million more than the year prior (2019).
With financial stakes this high and very little room for legal error, pharma marketers are relying on sophisticated compliance technology to help their teams identify and mitigate risk in any form or type of content.
Ensure pharma marketing compliance
Red Marker’s highly customizable pharma compliance software alleviates pharma marketing challenges by integrating compliance protocols into a content review process to support legal and marketing teams on their regulatory initiatives.
Through innovative artificial intelligence and powerful machine learning capabilities, Red Marker can automatically check for issues including misleading statements, disclaimers, and other-high risk images and text before moving marketing material into the next set of hands. Additionally, each member of a content review team can have direct visibility into the level of risk any piece of promotional content could pose before distributing it to the public or their audience of healthcare professionals.
Want to take a proactive approach to compliance? Schedule a demo with Red Marker and implement a content review process that’s 30X more efficient than manual legal review.