The pharmaceutical industry is a key player in advancing patient care. Through their development of novel diagnostics and therapeutics, physicians and other medical professionals are able to detect and treat health disorders and diseases more effectively. However, like any industry, pharma is not free from legal and ethical standards that must be adhered to. And in the context of pharma marketing and sales, compliance is of vital importance.
Why? Because compliance helps ensure that patient care remains a top priority, above all else. Not to mention, compliant organizations face fewer liabilities. Non-compliance in pharma marketing and sales efforts can result in serious consequences ranging from regulatory fines and lawsuits to reputational harm. There are even criminal considerations.
In March 2023, the Department of Justice (DOJ) updated its Evaluation of Corporate Compliance Programs (ECCP). This document1 is meant to serve as a guidance document for prosecutors when evaluating corporate compliance programs. Among other updates, the ECCP Guidance now includes a new directive for assessing how companies govern employees’ use of personal devices, communication platforms and messaging applications.
It’s a lot to take in, and we feel your pain! So, to help executives cut through the compliance clutter, we’re doing a deep dive into why it plays such a crucial role in pharma’s sales and marketing efforts. We’ll look at what compliance means, discuss the risks involved with non-compliance, and outline a framework for achieving compliance in pharma marketing and sales.
What Does Complaint in Pharma Marketing Mean?
Being compliant in pharma marketing means adhering to the regulatory guidelines and ethical standards set forth by relevant authorities. It involves conducting marketing and promotional activities in a manner that is transparent, accurate and prioritizes patient safety and care. When it comes to pharmaceutical marketing, there are a lot of rules and regulations that companies must follow. But what exactly does compliance look like in practice?
At its most basic level, compliance in pharma marketing refers to following all of the laws and regulations related to drug promotion and advertising. These laws are in place to protect the public from false or misleading information and ensure that drugs are promoted in a safe and effective manner. Some of the key guidelines that companies must follow include:
- Disclosing all known risks and side effects of a drug.
- Only promoting a drug for its approved use(s).
- Not making false or misleading claims about a product’s effectiveness or safety.
- Including all necessary warnings and precautions in promotional materials.
And while compliance is critical, it can also be challenging to navigate. Some of the common issues that companies face when it comes to staying compliant include:
- Balancing the need to promote products with the need to disclose risks and potential side effects.
- Staying up to date on changing laws and regulations across multiple jurisdictions.
- Managing the complexity of global marketing campaigns that must abide by different rules in different countries.
- Ensuring that all employees, from marketing teams to sales reps, are on the same page when it comes to compliance.
By prioritizing these aspects, pharmaceutical companies can ensure that their pharma marketing and sales activities align with legal requirements, ethical considerations, and patient-centered care, ultimately benefiting both the industry and the individuals who rely on their products.