Proactive Pharmacovigilance is the Game Changer Biotech Needs

The most common approach to pharmacovigilance (PV) emphasizes waiting for conclusive summary data before investigating data trends, which can inadvertently leave patients vulnerable and expose companies to certain risks later. Instead, the industry should adopt a forward-thinking mentality – or what I describe as “proactive pharmacovigilance.”

Today, PV operates with a focus on strict adherence to regulatory guidelines. This prioritizes compliance, but often leads to delayed action and missed opportunities for early risk mitigation; in other words, it is a reactive method. For instance, waiting for conclusive evidence before investigating signal detection trends may expose patients to avoidable problems.

Concentrating on meeting minimum health authority requirements for expedited reporting during the clinical phase can attract regulatory scrutiny, and result in audits, clinical holds, and approval delays. Furthermore, a reactive approach can slow the process of accurately defining a drug or device’s safety profile, leading to increased costs because of additional time, trials, and tasks. In some cases, it can even prevent a product from reaching the market.

Reactive PV is not inherently bad; it serves an important role in ensuring that companies meet regulatory requirements. However, its limitations may surface when adverse reactions are not addressed early or thoroughly enough, which can lead to preventable issues.

Let’s consider a biotech company conducting a phase III trial for a promising drug. Early trials seemed successful – efficacy was clear, and no major safety concerns had emerged. The company followed regulatory guidelines to the letter, using the "final rule" regarding US reporting to override investigators' assessments when they believed they better understood the drug's effects. Confident in their compliance, they waited for definitive summary evidence of the data before addressing potential issues regarding safety.

During an FDA audit, the agency flagged the company for ignoring early signs, despite technically complying with the regulations. This resulted in a clinical hold that delayed the trial and inflated costs. The company was forced to conduct another phase III trial with an added control arm, slowing the life cycle of this investigational product, driving up the client’s costs, and the drug ultimately failed to secure marketing authorization. This case shows that while compliance is crucial, focusing solely on it may result in missed opportunities for early intervention and, as seen in this instance, affect the company’s product approval. 

Proactive PV goes beyond meeting basic compliance standards and offers several clear advantages. Firstly, it improves patient safety by enabling early and thorough investigation of safety trends, while also refining safety profiles by monitoring and analyzing signal trends, including and excluding adverse effects. Economically, proactive PV may require a higher initial investment, but it can help prevent costly recalls, legal issues, and reputational damage, ultimately fostering trust among regulators, healthcare providers, and patients. Moreover, there is a regulatory advantage; companies that address potential issues often experience smoother regulatory reviews, fewer delays, and a higher likelihood of approval. 

Merely meeting compliance standards is insufficient in the current regulatory environment. By exceeding the minimum requirements and proactively managing risks, companies can ensure that every drug they bring to market can withstand rigorous scrutiny. In this context, compliance is the foundation, not the end goal.

However, implementing proactive PV requires a shift in mindset. Drug developers should be encouraged to dig deeper, ask tough questions, and address emerging concerns about their products. Of course, this is but one change – having a capable PV team is also essential! Do reactive methods have their place? Yes, but now is the time to be bold and set a new standard that ensures a safer, more reliable future for medicine.