Medical Legal Regulatory (MLR) Review Process in Pharma

The medical, legal, and regulatory (MLR) review is undoubtedly one of the most important procedures in the pharmaceutical industry. Yet, it is also one of the most complex and time-consuming as well. For many experts, especially in pharma marketing, MLR review often feels a bit drawn-out due to old methods and outdated software. Still, it remains a huge element of any content validation process. Learn all the basics of MLR reviews, their challenges, and their benefits in our guide.

What is MLR Review?

MLR review, or medical, legal, and regulatory affairs review, is an important process in the healthcare industry that helps companies ensure that all their content complies with current standards and laws and can be published without posing any risks to patients and healthcare professionals.

The Role of MLR in the Pharma Industry

Regulatory hurdles in pharma rank among the top three biggest challenges in the industry. Even the smallest misstep can lead to significant problems. This is why medical, legal, and regulatory (MLR) reviews exist: to help companies create digital content that won’t harm their patients’ health or the company’s reputation. Let’s take a look at a few more reasons why MLR is so important in the pharmaceutical and life sciences industries.

1. Ensuring the accuracy and authenticity of all your content

Every pharmaceutical or healthcare organization, company, or even small business that creates and publishes any type of content faces a huge responsibility: providing both healthcare professionals and patients with true information backed by facts, studies, and other evidence. Even the smallest mistake can put someone’s life in danger, which makes an optimized MLR review an important part of any content creation process.

2. Promoting content worldwide

When a pharmaceutical company publishes content, it often considers the norms and laws of the country in which it operates. But what if this company decides to expand worldwide? How can it ensure compliance with the laws it is not familiar with? This is where MLR reviews play a huge role. With the right MLR process, pharmaceutical companies can ensure compliance in medical marketing not only in their country of origin but anywhere in the world as well.

3. Adhering to legal regulations

Distributing inaccurate and misleading information can lead to serious repercussions. The pharmaceutical industry is very strict about complying with the laws; even the smallest mistake could result in huge fines. When an organization is found guilty of fraudulent marketing or misrepresenting its content and offerings, it could face fines amounting to millions of dollars, if not more. For example, Pfizer was fined $2.3 billion for the illegal marketing of four of its off-label drugs, which became one of the biggest fraud settlements in the healthcare industry.

4. Maintaining a good brand reputation

If your marketing content is inappropriate, filled with errors, contains misleading information, and includes made-up facts, it’s likely that sooner or later, it will make the news. This will put not only your patients but also your entire organization at risk. Your reputation will be severely damaged, and restoring it will be a huge challenge. At the very least, it will be a time-consuming and expensive process, potentially taking many years to settle.

Types of MLR Submissions

Many pharma and life sciences companies integrate MLR reviews into their workflows in the wrong way. MLR reviews are often conducted when there is a serious paper about to be published or a huge conference coming up where everyone would be listening to what the organization has to say. The truth is that MLR reviews are needed in 90% of cases, whether it is a website blog post or an important research paper. Here are some of the most common types of MLR submissions:

Promotional content

In many countries, companies might be fined for false advertising. Combined with pharmaceutical industry regulatory standards, it becomes crucial for every organization to ensure compliance in every promotional piece they create, even if it is a small tweet or Instagram post.

Educational content

This type of content might be used by both patients and healthcare professionals. If there is a mistake in it, many people are likely to remember it and might even subconsciously use this incorrect knowledge in the future. MLR review filters out false information, errors, and other types of mistakes from infiltrating educational content and influencing patients’ health.

Scientific publications

Even though research is always published by scientists who are experts in their field, their publications should still be reviewed to catch any potential oversights or errors. This includes verifying the evidence presented, the research results, and even the factual information.

Compliance documentation

Compliance documentation, such as pharma regulatory guidelines for audits and reviews, standard operating procedures, reports, and records, should also be verified by an MLR team. Just a small error could lead to many people adhering to compliance documentation and making the same mistake in their work.

Internal communication

All in-house communication, such as training documents, newsletters, surveys, and learning programs, often requires review if there is a possibility that any information mentioned in these documents might harm someone’s health or safety. All communication within the firm determines the work of people who are just starting to work there, directly impacting their interactions with patients and healthcare professionals.

MLR Review Process Challenges & Their Solutions

Ensuring pharmaceutical regulatory compliance is not an easy task. From creating a thriving environment for your MLR review team to meeting all possible deadlines, there are just too many details too important to forget. So, how can you polish the MLR review process, and what are the challenges behind it? Let’s discuss:

Unfitting technology

MLR reviews heavily depend on the software used to conduct them. If the chosen tools are not up-to-date, don’t consider all current laws and regulations, and simply don’t work well with all formats your organization works with, it’s likely that the final MLR review of your content will be incomplete and even incorrect. Instead of spending money on new tools and an additional workforce for additional reviewing, it’s best to invest in innovative software and tools that are regularly updated, fit your organization’s needs, and are easy to use for everyone who creates and submits content.

High workload

Speaking of the workforce, companies often rely too much on too few experts who can handle reviews of marketing materials. As a result, two possible issues arise. First, when just a small team of people work on the same important task all the time, it’s likely that at some point, most of them will feel overworked and even burned out.

Moreover, when professionals responsible for MLR reviews eventually leave, they will also take all important knowledge with them, such as the location of any documents, specifics, and nuances inherent to an MLR review for a particular company, formatting requirements, the best content approval strategies specific to different types of documents, etc. All of the knowledge accumulated over the years will be gone without a proper management system that allows for not only streamlining MLR processes but also gathering insights from already conducted reviews. Ensure that you create a healthy environment for your employees and integrate proper solutions for MLR efficiency.

Lack of communication among reviewers

When MLR reviewers barely talk to each other, this causes a number of issues, including transparency problems. To better understand why this is a huge deal, let’s picture a situation. One of the reviewers looked at a piece of content submitted by a marketing team and left a few comments. After going through the document, another reviewer decided to message one of the authors regarding a few issues found in the text. The other reviewer is not aware of these issues and proceeds to contact the author to provide the same feedback, forcing a person to go through the identical process twice.

In another scenario, some reviewers might create multiple versions of content without even knowing so, resulting in a lost final version and delayed content delivery. Situations like this happen all the time, and to avoid them, reviewers should treat any task as a collective effort and focus on communicating problems and ideas instead of just doing their jobs separately from others.

The time-consuming content review process

Content creation is a lengthy process itself, often requiring a lot of resources and time to be finished. And when, after all this time, content gets cut or, in the worst-case scenario, doesn’t even get approved, marketers feel like they have wasted all their time for nothing. For both MLR and marketing teams, situations like this cause a lot of stress, which is why some companies have started to adopt a modular approach to creating content. Instead of being a single unit, modular content can be broken down into different pieces or modules that work interchangeably. This way, marketers save time on content production, and MLR experts can focus on reviewing separate blocks of content.

Difficulty coordinating promotional review committee (PRC) meetings

Marketers and promotional review committees might not see eye to eye all the time. There is always a risk of a conflict in schedule, opinions, and priorities. For many companies, PRC meetings are quite rare, and when they do happen, there is a high chance that they will be inefficient. Remember that no matter how different everyone might be, they are still colleagues and share the same goals, so it’s best for everyone to focus on distributing roles and responsibilities within the teams and finding the most fitting solutions to the present challenges. For example, if there is a problem meeting deadlines, it might be a good idea for the marketing team and pharma review committee to discuss what both sides can do to speed up content delivery.

Summing Up

Healthcare marketing has always been challenging. Creating content that offers correct medical information, complies with current regulations, and properly represents the company’s vision is quite a conundrum. However, with the right approach, it’s possible to always stay ahead of the competitors while keeping up with all the trends and staying on the same page with stakeholders.

If you would like to learn more about MLR approval in healthcare and how you can create content that will be 100% approved, contact us now. Our experts will provide you with a personalized consultation on the best solutions for pharmaceutical companies.

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