It goes without saying that the pharmaceutical industry is a competitive one. Companies need and want to get the word out about their new or updated product as soon as possible–delays can significantly impact their bottom line, not to mention patient health.

That’s why company leaders are always looking for ways to speed up the time- and labor-intensive MLR (Medical, Legal, and Regulatory) review process. However, while time is of the essence, cutting corners could lead to big problems down the road. 

What is MLR (Medical, Legal, and Regulatory) review?

MLR review is critical to ensuring the claims being made about a drug or treatment in a pharmaceutical company’s marketing materials—like websites, social media posts, emails, and brochures—comply with regulatory requirements and approved labeling for the treatment. The materials, which are created by a company’s marketing department or agency, need to be reviewed and approved by a cross-functional panel of medical, legal and regulatory experts before they can be released.

The process generally involves multiple rounds of reviews and edits, so it can take weeks for more complex projects to get the green light. 

Why do companies want to speed up MLR review?

In such a competitive market, being able to get accurate, quality materials approved and released in a timely manner is essential for long-term financial success. Specifically, companies that are able to:

• Establish brand recognition: Early and consistent messaging will allow the product to be top of consumers’ minds when it’s time to make a decision.

• Recoup development costs:  Research, development and production are all expensive, so companies need to quickly generate revenue to be on a path to financial stability. 

• Secure a loyal consumer base: The sooner a company enters the market, the longer it will have to communicate with consumers and earn their trust.  

• Differentiate from the competition: Control the narrative between your product and competitors in the same category, quickly responding and fine-tuning messaging. 

• Capitalize on market opportunities: By being able to respond swiftly to emerging trends and crises, companies are able to establish themselves as thought leaders and innovators.

• Enhance marketing efforts: With an efficient MLR process in place, companies can make real-time adjustments to campaigns to maximize performance.

What are the risks of rushing MLR review?

While it’s tempting to want to get to market quickly, speed doesn’t always pay off. In fact, there could be some significant consequences if inaccurate or non-compliant marketing materials are pushed through MLR review. 

Errors could result in:

• An “Untitled Letter”: This is a letter issued by the FDA, which we covered in our last post, notifying a company that it’s not in compliance with FDA regulations. 

• Legal action: A company may be hit with a lawsuit for issues like copyright violations, claims of false advertising or regulatory violations.

• Compromised patient health and safety: A simple mistake could put a patient in harm’s way unnecessarily.

• Loss of scientific credibility: Once a company’s standing within the scientific and medical communities is jeopardized, it can be harder to gain trust and support for future products.

• Increased costs: Resources may need to be diverted from strategic initiatives to invest in training, rework processes and update materials.

Any of these could potentially damage a company’s reputation, reduce stakeholder confidence, invite increased scrutiny, and lead to financial instability.

Increase speed and improve accuracy with Revisto

With Revisto, companies no longer have to choose between speed and accuracy when it comes to MLR review–they can balance both, resulting in significant competitive advantage. Revisto’s AI-driven platform streamlines a company’s entire process, reducing the release time of marketing materials while ensuring their quality and compliance. 

Here are a few ways it does that:

• Pairing content with approved claims and highlighting discrepancies

• Learning team member preferences over time and steering them to the most important annotations 

• Checking content against relevant FDA 21 CFR regulations and guidance documents to automatically indicate any violations

• Providing immediate feedback aligned with brand and regulatory requirements, while eliminating tedious manual updates

• Seamlessly integrating with a company’s existing workflows and CMS software, enhancing collaboration between marketing, medical and legal teams

The faster materials can be released, the faster the product can get into the market. Not only does this save the company valuable time and money, more patients are able to get the care they need, when they need it.

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Find out how Revisto can help speed up your MLR review process without compromising quality and accuracy. Request a demo today.