Alex Reinthal

The FDA’s Accelerated Approval Program was created to fast-track life-saving drugs for serious diseases, allowing life science companies to bring new treatments to market faster while completing follow-up studies.

However, recent government reviews have raised concerns about the program’s management and prompted new regulatory guidance. For life science companies, these evolving regulations introduce greater complexity, increasing the need for structured, transparent compliance processes.

Let's explore how shifting FDA requirements are raising compliance challenges — and how automation can help companies improve documentation, streamline regulatory reviews, and stay ahead of evolving expectations.

Regulatory uncertainty heightens compliance hurdles

Recent developments highlight a growing regulatory emphasis on compliance transparency and structured approval processes, making it more critical than ever for companies to ensure rigorous tracking and documentation.

The FDA recently issued new guidance clarifying that confirmatory trials must be “underway” before accelerated approvals are granted, but what qualifies as “underway” remains unclear. This lack of clarity creates uncertainty for life sciences companies, which now risk approval delays or even rejections if they fail to meet undefined criteria.

Meanwhile, the Office of Inspector General (OIG) identified serious gaps in regulatory documentation, revealing that some drugs were approved despite concerns from FDA reviewers and without complete records of key regulatory meetings. This lack of proper tracking makes it difficult for companies to demonstrate compliance, increasing regulatory risk.

Together, these developments highlight a common challenge: companies must improve their ability to track, document, and manage compliance at every stage of the regulatory process — from initial approvals to post-market commitments. 

Without the right systems in place, companies risk approval delays, regulatory scrutiny, and potential product withdrawals. The stakes are high, and traditional, manual methods are no longer enough to keep up. To stay ahead, companies must move toward structured, automated solutions that improve compliance tracking, document management, and approval workflows.

The role of automation in reviews and approvals

A structured, automated solution is essential to keeping up with evolving FDA requirements, but what does that actually look like in practice?

The following four automation capabilities — available in solutions like PubPro and Approvia — help regulatory teams streamline compliance, improve documentation, and ensure timely approvals.

1. Pre-approval compliance tracking

Under the FDA’s new guidance, regulatory teams must now prove that confirmatory trials are “underway” before receiving accelerated approval. However, because the agency has not defined what qualifies as ‘underway,’ companies risk approval delays or rejections due to insufficient documentation or unclear trial status. 

Automating pre-approval compliance tracking helps eliminate these risks by:

• Capturing real-time trial progress to provide documented proof that a trial meets the FDA’s “underway” criteria.
• Maintaining an auditable trail of trial milestones and regulatory submissions for compliance verification.
• Triggering automated alerts for submission deadlines, preventing missed timelines and regulatory setbacks.

2. Centralized document management

The OIG’s investigation revealed that some drug approvals lacked proper documentation—including missing records of key FDA meetings. Without accurate, complete regulatory documentation, companies may struggle to demonstrate compliance if approvals are questioned.

By centralizing and automating document management with a solution like Approvia, companies eliminate the risk of lost or incomplete records that could jeopardize approvals.

Centralized document management helps by:

• Maintaining a single source of truth for all regulatory documents, ensuring no critical records go missing.
• Providing version control & automated audit trails, tracking every document change for complete transparency.
• Allowing instant access to historical regulatory discussions to ensure teams can quickly provide documentation when requested by the FDA.

3. Automated approval workflows

Disorganized approval workflows can lead to submission delays and compliance risks. Without automation, bottlenecks form, approvals stall, and deadlines for confirmatory trials and regulatory reviews are missed.

Automating approval workflows ensures efficiency by:

• Ensuring all required reviewers sign off before submission with pre-configured workflow templates.
• Automating routing and task assignments to eliminate delays caused by manual approval processes.
• Enforcing built-in compliance checks to prevent incomplete or incorrect submissions from reaching regulators.

4. Post-approval compliance monitoring

Under the Accelerated Approval Program, companies must conduct post-marketing confirmatory trials to retain FDA approval. However, with stricter oversight, companies that fail to meet commitments face increased regulatory enforcement, fines, or drug withdrawals.

Automating post-approval compliance monitoring ensures ongoing regulatory adherence by:

• Sending automated deadline reminders to reduce the risk of missing post-marketing commitments.
• Providing real-time dashboards to track study progress and regulatory milestones.
• Deploying automatic escalation alerts when compliance risks arise, allowing proactive course correction.

A shifting regulatory landscape demands a smarter compliance approach

As regulatory scrutiny increases, life science companies must evolve their compliance strategies to maintain efficiency, streamline approvals, and minimize risks. Companies that fail to adapt to changing FDA requirements risk delays, compliance failures, and even drug withdrawals.

By embracing automation, organizations can proactively manage compliance rather than reacting to last-minute regulatory concerns. The benefits include:

• Avoiding regulatory penalties by ensuring compliance with evolving FDA requirements.
• Reducing manual errors with automated documentation and workflow management.
• Accelerating approvals by keeping submissions on track and minimizing regulatory bottlenecks.
• Protecting drug investments by avoiding pitfalls that could lead to delayed approvals or product withdrawals.

Automation is no longer optional. It’s essential.

By leveraging AI-driven document management, workflow automation, and structured approval tracking, companies can proactively manage compliance risks and ensure regulatory success.

Learn how PubPro and Approvia can help your team automate regulatory processes and stay ahead of compliance changes. Contact us to request a demo today.

Medical affairs leaders are ready to cut through the buzz and finally get a clear answer to “what can AI actually do for us?”

I’m Alex Reinthal, and as Vice President of Product at BP Logix, I have a unique vantage point on how AI and machine learning technologies will develop in life sciences software.

In this article, I will share my insights into the future of generative AI and machine learning. I’ll also delve into practical examples of these technologies through demonstrations of an upcoming prototype that is currently in the works for our publication management solution, PubPro.

What I'm hearing from life science leaders 

Medical affairs leaders are eager to “be the change” in their organization alongside the R&D and commercial pillars of their organizations. Part of that means being ready to embrace new technologies that can take their work to the next level. 

That's why, with the recent flurry of excitement surrounding the potential of AI to transform the life sciences industry, it’s not surprising to see many medical affairs leaders keeping their ear to the ground to determine their next steps.

"I want AI to do the work so my team can focus on strategy."
- Life sciences leader at MAPS 2024 

Discussions about how best to harness this technology, however, tend to lean theoretical. With so many buzzwords and vague aspirations floating around, conceptualizing practical applications of AI and quantifying their impact is proving to be a real challenge for medical affairs leaders. 

There is clearly enthusiasm for adopting AI-powered solutions, but medical affairs leaders need more to go on than just buzzy jargon. They need a clear answer from software vendors on how artificial intelligence will: 

1. Make their day-to-day lives easier

2. Accelerate processes and time-to-market

Practical applications of machine learning and generative AI 

At BP Logix, we view investing in AI/ML as the logical next step for workflow automation technology. As we plan out the product roadmap for PubPro, we're making sure that medical affairs teams can fully leverage AI/ML capabilities.

And what exactly do these capabilities entail? I will lay out exactly what we’re working on and explain how it’s going to simplify and speed up your publication management processes.

Machine learning

First up, let’s talk machine learning. Machine learning is a subset of AI that enables systems to learn and improve from experience without being explicitly programmed. With its ability to analyze patterns and predict outcomes, machine learning is an incredibly powerful component of process automation that helps you continuously improve efficiency and accuracy in your day-to-day work.

Advanced machine learning already exists in PubPro — it’s an integral component and administrative feature of Process Director for Life Sciences, the scientific communication platform that PubPro is built on. To build upon the product’s AI/ML features already available to administrators, we’re in the process of making these analytic tools and insights more accessible and usable to everyday users of PubPro.

Through our planned enhancements, users will be able to look at how their processes are performing at a high level, easily identify bottlenecks, and optimize their workflows based on analytics.

Generative AI

Generative AI, distinct from machine learning, refers to AI that can generate new content, from text to images, based on the data it has been trained on.

At BP Logix, we want to use generative AI to help PubPro users find the information they need more easily — and with fewer clicks.

We’re starting with Pathfinder, a LLM-powered AI assistant designed to help users with all things PubPro. Here are three examples of Pathfinder capabilities that will make life easier for PubPro users and speed up publication processes.

1. Analytical capabilities

With Pathfinder, PubPro users will be able to perform conversational searches to quickly generate summaries or detailed analyses of specific publications.

If a user requests an executive summary for a publication, Pathfinder will provide concise, relevant insights instantly that aid the user in strategic decision-making.

Video description: On the PubPro dashboard, the user opens up the Pathfinder chatbot and types in a request for an executive summary of a specific publication (via Pub ID number). Pathfinder conducts a literature analysis and generates an executive summary of this publication. Pathfinder asks the user if they would like to copy the executive summary to their clipboard, and the user says yes. This demonstrates Pathfinder’s ability to perform conversational searches, conduct literature analyses, and generate executive summaries of publications with a LLM integration.

2. Competitive research capabilities 

Pathfinder will enhance competitive research in PubPro by enabling users to efficiently query and gather specific market intelligence.

For example, if a user asks for a list of drugs in phase 3 trials for a particular condition, Pathfinder will deliver up-to-date, comprehensive data via an integration with clinicaltrials.gov.

This functionality will not only save time — it will provide a strategic advantage for medical affairs teams that want to maintain their understanding of the competitive landscape.

Video description: On the PubPro dashboard, the user opens up the Pathfinder chatbot and types in the request to aid them in competitive research. Specifically, the user asks Pathfinder to list all drugs treating ulcerative colitis currently in phase 3 trials with their study and study completion date. Pathfinder responds with four drugs that meet the user’s criteria, along with the study info and completion date. This demonstrates Pathfinder’s ability to source data about publications and journals/congresses.

3. System documentation capabilities

With Pathfinder’s ability to reference software documentation, users can ask questions about how to accomplish certain tasks within PubPro and get immediate answers.

To make this feature even more useful, our product roadmap includes plans to eventually equip Pathfinder with the power to navigate users, at their request, to key screens related to their query.

For example, if a PubPro user asks how to adjust due dates for expedited reviews, Pathfinder could not only explain how to make these changes — it could seamlessly redirect the user to the appropriate configuration menu screen to begin carrying out that task.

Video description: On the PubPro dashboard, the user opens up the Pathfinder chatbot and asks how to change due dates for expedited reviews within PubPro. Pathfinder references PubPro system documentation and responds that the setting for expedited review due dates can be found in PubPro’s System Configuration menu page. Pathfinder then asks if the user would like to navigate directly to this page. The user says yes, and then Pathfinder navigates the user to that page.

Looking to the future: Our long-term plans for generative AI

While we already have some exciting AI tools in the works for PubPro, we’re also thinking ahead to what’s next.

One use of generative AI that we’re envisioning for later down the road involves PubPro’s collaborative document editor. We want Pathfinder to help users catch errors and make suggestions for improvement. And we’re not just talking about spell check here. Eventually we could have Pathfinder checking for accuracy on a content substance level. Essentially, AI will provide you with an additional layer of review beyond manual reviewers.

For example, users could have Pathfinder review studies that they're pulling into PubPro and provide feedback. For example, Pathfinder might provide feedback like “When you look at what publications get cited the most, they have ABC characteristics in common. So, you should consider doing XYZ to your publication to make it more effective.”

Over time, this functionality will only get better and better at making sure that your publications are accurate and align with your study information.

Learn more about PubPro

Ready to see our powerful publication management software in action? Contact our team to request a free trial of PubPro.

An efficient publication management process is critical for medical affairs teams tasked with bringing a drug to market. Yet, many companies continue to rely on decentralized tools like Excel and Outlook to manage key aspects of this process. While these familiar tools might seem low-risk and affordable, they come with practical challenges that can hinder growth and compliance risks that could result in delays or penalties.

Explore the strategic dangers and day-to-day hurdles of manual publication management and learn why automation is the key to unlocking growth, innovation, and compliance in the life sciences industry.

Strategic risks of manual publication management tools

Clinging to outdated manual tools for publication management in the fast-paced life sciences industry isn't just a matter of convenience – it carries several profound strategic risks:

1. Cost escalation

Inefficiencies and errors caused by manual processes can lead to higher operational costs due to increased labor hours and rework, not to mention potential fines stemming from compliance violations. The company may also need to invest in additional resources to manage the growing complexity of the publication process.

2. Missed opportunities

Inaccurate or delayed publication submissions can lead to missed opportunities to present research at conferences, submit articles to prestigious journals, or engage with key stakeholders. These missed opportunities can impact the company's visibility, influence, and ability to drive innovation.

3. Delayed time-to-market

Inefficiencies in the publication management process can lead to delays in getting research findings published. These delays can slow the dissemination of critical information to the medical community, regulatory bodies, and other stakeholders, potentially slowing down the development and adoption of new drugs or treatments.

A study by the University of Texas at Austin found that drug approval delays can cost life science companies an average of $1 million in revenue for each day a drug remains in limbo.

4. Reputation damage

Inaccurate or delayed publications, compliance issues, and inefficiencies can tarnish the company's reputation within the industry and among peers, potential partners, investors, and patients. A damaged reputation can undermine the scientific credibility and impact of the company's work, as well as impact the company's ability to secure future funding, partnerships, and collaborations.

Tactical obstacles of manual publication management tools

These strategic risks don't exist in a vacuum; they stem from the tangible issues faced during the daily grind. Let's explore how the practical, day-to-day obstacles inherent in manual publication management tools create and amplify these strategic risks.

1. Manual data entry 

The life sciences industry thrives on precision, accuracy, and timely dissemination of critical information. However, when manual data entry becomes the linchpin of your publication management process, you introduce an element of uncertainty and inefficiency that can have far-reaching consequences.

Why is manual data entry bad news for publication management? There are two key reasons:

• Increases risk of error: Manual data entry and copying and pasting between tools increase the risk of errors. Even small mistakes in data entry can have serious consequences when it comes to the accuracy of publications.
• Poor use of resources: Manual processes and tools are resource-intensive and consume valuable time and labor. Rather than research professionals spending excessive time on time-consuming administrative tasks (such as entering data into Excel spreadsheets or manually consolidating review feedback from multiple reviewers), this time could be better spent focusing on higher-value research tasks such as analyzing data, strategizing, and contributing to the content itself.

LimFlow, an early-stage life sciences company specializing in treatments of critical limb-threatening ischemia (CLTI), was grappling with just this very challenge.

"If we had ten reviewers providing feedback on a single publication, that meant there were ten versions of the publication that needed to be reconciled," LimFlow's Director of Medical Affairs explains. "Manually combing through each version and reconciling all the feedback into one cohesive document requires a lot of time and effort on our part."

To solve this problem, LimFlow implemented PubPro, a publication management system that enabled multiple reviewers to work on the same document simultaneously.

2. Lackluster process visibility

Process visibility is vital at all levels of the medical affairs department — from the tactical day-to-day level of managing the back-and-forth of publication review to the bird's eye 10,000-foot view that provides leaders with insights and data to make informed strategic decisions.

Let's dive into the hallmarks and risks of a publication management process that lacks visibility:

• No automated workflow routing: Reviewing and approving publications often involve multiple rounds of feedback and revisions. Manual tools lack automated workflows for routing documents to the right stakeholders, resulting in delays and potential oversights in the review process.
• Rudimentary or non-existent version control: Managing versions of documents becomes challenging without a centralized system to track changes and maintain version history.
• Creates data silos: Manual tools are often isolated from other systems used within the organization, leading to data silos and duplication of efforts. Information can be scattered across different files, folders, and email threads. These data silos make it difficult to keep track of important details such as publication status, deadlines, and author contributions.
• Limited process insights: Managers and stakeholders need visibility into the publication pipeline to make informed decisions and allocate resources effectively. Manual tools offer limited reporting and analytics capabilities, making it difficult to assess the progress of different publications.
• Limited scalability: As a life sciences company grows and handles more publications, the limitations of manual tools become more pronounced. Managing a larger volume of publications with manual tools becomes increasingly challenging and inefficient. 

3. No auditing features

Compliance is king in highly regulated industries like life sciences. Publication management processes that lack auditing capabilities pose serious risks:

• Compliance violations: Regulatory bodies such as the FDA have strict guidelines for publication and data reporting. Non-compliance with regulatory requirements, industry standards, and internal processes can result in serious legal and financial consequences. Excel and Outlook do not provide the necessary security measures and audit trails to ensure compliance with industry regulations.
• Data security risks: Decentralized tools lack the security measures of dedicated software solutions, increasing the risk of data breaches and loss of sensitive research data.

Why automated publication management solutions matter

While Excel and Outlook have their uses, relying on them for complex publication management in the life sciences industry is a recipe for setbacks and missed opportunities. The practical challenges of version control, auditing, data entry, process visibility, and workflow routing all have tangible impacts that can result in cost escalations, missed opportunities, delayed time-to-market, and reputation damage.

To overcome these challenges and reduce business risks, life sciences companies should ditch the use of manual, decentralized tools and invest in a dedicated publication management software solution such as PubPro.

PubPro is an automated publication management system equipped with outstanding version control, robust auditing features, automated workflows, and analytic tools that offer several key benefits:

• Enhanced efficiency: Streamlined workflows and reduced data entry tasks free up time for high-value activities, accelerating publication timelines.
• Error reduction: Automated data entry and version control mitigate human error, ensuring accurate and reliable publications.
• Seamless collaboration: Dedicated software fosters smooth collaboration, allowing stakeholders to access, review, and contribute to publications in a centralized environment.
• Risk mitigation: Compliance features and alerts ensure adherence to industry regulations, minimizing the risk of fines and reputational damage.
• Resource optimization: By automating manual tasks, companies can reallocate resources to research, development, and innovation.

From Excel to excellence

By embracing the power of specialized software solutions like PubPro, life sciences organizations can not only streamline their publication management processes but also advance scientific knowledge and improve patient outcomes.

Request a demo of PubPro today. 

The world of drug development is evolving rapidly, and nowhere is this more apparent than in the realm of accelerated approvals.

Established in 1992 in response to the HIV/AIDS crisis, the FDA's Accelerated Approval pathway has been a critical tool for getting life-saving drugs to patients faster than ever before. However, recent controversies, such as the approval of the Alzheimer's medication Aduhelm in June 2021, have highlighted the need for stricter regulations around accelerated approvals.

To address this issue, the FDA is proposing new requirements for drug companies to conduct confirmatory studies and provide greater transparency around the results.

Let’s explore the implications of these new requirements and how publication management software solutions like PubPro can help with potential challenges.

FDA drug approval woes: How we got here

The FDA's Accelerated Approval pathway has come under fire in recent years due to concerns about the quality of evidence used to support accelerated approvals as well as the lack of timely follow-through on confirmatory studies afterwards.

Let's talk about one of the most recent controversies.

Imagine a new drug comes onto the market that promises to change the game for Alzheimer's patients. Sounds great, right? But what if the evidence supporting this drug's approval was shaky at best, and the price tag was exorbitant? That's exactly what happened with Aduhelm, which received accelerated approval from the FDA in 2021. This drug removes sticky amyloid plaque from the brain, but because there was no proof that the ability to remove this plaque slows the deterioration of patients' mental faculties, insurers refused to cover its $56,000-per-year price tag.

The controversy surrounding Aduhelm brought the Accelerated Approval pathway into the spotlight and sparked a national conversation about the need for stricter regulations.

A recent report by NPR found that a staggering 42% of confirmatory drug studies required after accelerated FDA approval were either delayed for more than a year or hadn't even started yet.

This highlights the crucial importance of the FDA's new requirements for drugmakers to ensure timely and effective completion of these studies, as well as improved reporting to increase transparency around the pathway.

The role of technology in meeting new FDA requirements

While the FDA's new regulations for accelerated drug approvals are necessary, they pose a challenge for life science companies that must comply with them. These companies are now required to ensure timely and effective completion of confirmatory studies, as well as improved reporting to increase transparency around the pathway. These new requirements can be time-consuming and laborious, but luckily technology can alleviate some of these challenges.

Enter PubPro, a publication management solution that can help life science companies comply with the FDA's new requirements for accelerated drug approvals in two key ways:

Benefit #1: Ensure timely and effective completion of confirmatory studies

The FDA now has more leverage to hold drug companies accountable for their promises about conducting confirmatory studies as a condition of accelerated approval. Drugmakers must ensure they are completing their studies in a timely and effective manner or face potential consequences such as fines or even loss of approval.

PubPro can help drugmakers manage and automate this process, allowing them to easily track confirmatory studies and ensure they meet their regulatory obligations. Here are some of PubPro's key publication management features that can help:

• Automated reviewer assignments ensure that the right people are assigned to review and provide feedback on the necessary documents.

• With its collaborative document editor, PubPro provides a centralized platform for reviewers and authors to communicate and make revisions in real-time, reducing the time it takes to consolidate and implement revisions.

• PubPro's automated reminders and notifications ensure that confirmatory studies are conducted and completed on time, preventing delays and noncompliance.

With these tools, drugmakers can streamline their confirmatory study process and stay on top of their regulatory obligations, ensuring that they comply with the FDA's new requirements and avoid potential consequences.

Benefit #2: Prove compliance and simplify reporting for confirmatory studies

The FDA's new transparency requirements mandate that drugmakers promptly report their confirmatory studies' results, which poses a challenge because drug companies must ensure they can meet these reporting requirements while also ensuring compliance with the FDA's regulations.

PubPro helps alleviate this challenge by providing companies with the tools they need to easily track and manage these reports in a timely and compliant manner. Here's how:

• PubPro's audit tracking abilities allows drugmakers to provide evidence of compliance with FDA requirements, demonstrating that they follow the necessary procedures and processes.

• With PubPro's configurable reporting, drugmakers can generate comprehensive reports for proving compliance, making it easy and quick to ensure all requirements are met.

With these features, PubPro simplifies the reporting process, allowing drug companies to ensure compliance with the FDA's transparency requirements while reducing the time and effort needed to do so.

Streamline publication management with PubPro

PubPro is the ultimate solution for life science companies struggling to comply with the FDA's new requirements for accelerated drug approvals.

By automating key tasks and streamlining the publication management process, PubPro ensures life science companies can stay on top of their regulatory obligations and maintain positive relationships with the FDA.

Stay on top of new FDA regulations

Get in touch today to learn more about how PubPro can help your life science company comply with the new FDA requirements and ease the burden of compliance efforts.

One-size-fits-all solutions don't work when it comes to publication management software.

That's why PubPro from BP Logix offers organizations unparalleled configurability. Built on our low-code Process Director for Life Sciences platform, 80% of the solution already built and the remaining 20% configured within days to your company's specific requirements.

Here are four recent improvements we’ve rolled out on PubPro that make it easier than ever to configure and use the solution according to your organization's SOPs.

1. Automated reviewer assignments

PubPro's automated reviewer assignments feature makes it easy to ensure that the right people review your publications.

When authors submit new publications, PubPro automatically assigns the appropriate reviewer based on criteria such as subject matter expertise or workload.

These automated reviewer assignments help streamline the review process and ensure that publications are always in the right hands.

2. Updated user interface

PubPro's new look is sleek and user-friendly. Our updated interface is more intuitive and straightforward to use than ever, ensuring your team can easily navigate the system and complete tasks efficiently.

3. Role-specific dashboards

PubPro's role-specific dashboards allow users to quickly see the tasks and activities most relevant to their role.

Whether the user is an author, reviewer, or administrator, PubPro's dashboard is tailored to their specific function. For example, here's a peek at a reviewer's dashboard and workflow:

4. Variable user deadline settings

With PubPro, you can configure different turnaround times for reviewers based on your publication's unique requirements. This ensures that everyone works according to the same deadlines and that your publication stays on track.

Don't settle for "one size fits all"

Configurability is vital when it comes to choosing publication management software.

PubPro allows your organization to easily tailor processes to meet specific needs, from automated reviewer assignments to variable user deadline settings.

Contact us today to learn how PubPro can level up your publications team.

With all the hard work that goes into the complex and delicate process of medical innovation, the last thing pharmaceutical and biotech companies want is to see publications delayed by an incomplete or unnecessarily lengthy debarment check process.

The good news is that new technologies can now automate and introduce new efficiencies into checking for debarments. 

Let’s dive into a comprehensive refresh about what debarment checks are, how they work, and how to work them into your pharmaceutical publication processes so that you can more readily identify the advantages of refreshing your company's approach to this regulatory responsibility.

What is an FDA debarment?

In regulatory terms, a debarment is when an individual, organization, or any affiliates are excluded from conducting business with a federal agency.

In the case of the Food and Drug Administration (FDA), there are two types of debarments that apply to the development, approval, or regulation of food and pharmaceutical products:

• Mandatory debarments are the result of a felony conviction for the individual in question. These debarments are typically permanent.
• Permissive debarments usually result from an individual's misdemeanor conviction or a conviction of accessory or conspiracy charges. Corporations can also be debarred for a period of time for direct or indirect violations of FDA law. Permissive debarments can last up to several years.

The FDA maintains a list of individuals who have been convicted of felonies (permanent debarment) and misdemeanors (permissive debarment) related to the development, approval, or regulation of a pharmaceutical product.

What are the business risks of collaborating with debarred individuals?

Working with debarred individuals or entities could have serious ramifications on the development of pharmaceutical products. For example, if a debarred individual is found to have contributed on the planning or development of a new pharmaceutical drug or device, the company and team associated with the project could face fines, delays, and potentially even the temporary debarment of organizations that have neglected to terminate debarred individuals in their employ.

Failure to identify the engagement of debarred individuals or entities can have serious repercussions on the publication and on the company at large. Fines can reach levels of $250K per debarred individual or $1M per organization.

Consider how the failure to screen for or terminate a debarred person would impact your competitive edge in the market. Years of hard work and investment could be jeopardized by a few bad faith collaborators.

With so much at stake, how do medical affairs teams in the pharmaceutical industry ensure they are working above board? By performing thorough debarment checks.

The importance of debarment checks

A debarment check ensures that you have not hired debarred individuals or contracted with debarred entities at any point in the process of bringing a drug to market. When applying to the FDA for approval of a drug, medical affairs professionals at pharma and biotech companies are required to certify that they have not and will not engage in such a hire.

Regular debarment checks are necessary to avoid regulatory penalties, not to mention the bad press or approval delays that could also result for your business if you fail to catch a debarment issue.

When it comes to publication management, the debarment check protects your company against liabilities financial, reputational, and even social. Thorough and regular checks help medical affairs professionals avoid costly fines, protect against damage to company credibility, and prevent go-to-market delays. They also protect consumers and help to maintain the integrity of the FDA as it works to protect consumers as well. When debarment checks work as advertised, it benefits everybody.

Ensuring ongoing compliance with the FDA debarment list

Of course, with the FDA debarment list being continuously updated, ensuring compliance requires ongoing debarment checks. This does not mean that the process has to remain laborious, or turn into a cost that you “just have to eat.”

This is where automation comes in. With the power of low-code automation, medical affairs professionals can build a solution designed with their complex SOPs and compliance requirements in mind — all without having to spend an unreasonable amount of time and money on manual or outsourced debarment checks. 

Automated debarment checks in publication management

The benefits of automation in the publication management process, including debarment checks, are numerous.

First, consider the sheer number of administrative tasks that medical affairs teams need to complete to support the development and approval of a new drug, in compliance with regulations both domestic and international. 

Extending to debarment checks and beyond, smart automations that fit to your existing processes and workflows are sure to introduce new efficiencies that save time and money, resulting in better margins on R&D as well as greater speed-to-market.

PubPro by BP Logix was created with these specific goals in mind. With PubPro, medical affairs directors and managers can:

• Manage publication process timelines, including via metrical data for identifying efficiencies and bottlenecks
• Intelligently route and approve tasks
• Collaborate across document authoring, to conduct quality checks and manage feedback
• Customize reviewer assignments
• Resolve high-stakes compliance gaps, including debarment checks and training verifications
• And more!

This robust automation system produces many efficiencies, including ensuring compliance more quickly, so that you and your team can focus less on administrative work and more on the remainder of the publication management process. PubPro can conduct automated debarment checks for not only the FDA database, but also the OIG (Office of Inspector General) and SAM (System for Awards Management) databases.

Improve compliance and speed up your publication process with PubPro.

Contact us today to learn more about our solution built for medical affairs teams.