Navigating the World of Expanded Access Programs (EAP) in Pharma and Biotech

Why Expanded Access is a Game-Changer in Pharma

In the dynamic world of pharma and biotech, the spotlight is increasingly on EAP. These programs are not just about bringing medicines to market; they are about bringing hope to patients facing serious or life-threatening diseases. With information more accessible than ever, patients and advocates worldwide are keenly seeking out new treatments, whether they are commercialized or still under development.

The 21st Century Cures Act: A Turning Point

The 21st Century Cures Act, enacted in the US in 2016, was a game-changer. It required companies in the late stages of developing a medicine to have a clear, public policy for expanded access. This policy must be comprehensive, covering everything from contact information to the criteria for evaluating requests. It’s not just a legal requirement; it’s a critical step in connecting patients with new, potentially life-saving treatments.

Bridging the Gap: Global Compliance and Perspective

Despite the Cures Act’s clear directive, adherence has been patchy, with a significant number of companies yet to fully implement a compliant policy. This gap underscores a crucial need to not only meet legal requirements but also to embrace the spirit of the Act: improving access to treatments globally.

Action Steps for Pharma and Biotech Companies

Here’s what companies can do:

  • Prioritize Policy Development: For medicines targeting serious diseases, having an expanded access policy is essential.
  • Involve Key Stakeholders: Collaborate with internal teams and patient advocacy groups to create a policy that truly resonates with patient needs.
  • Enhance Accessibility: Ensure that your expanded access policy is easy to find, perhaps even featured on platforms like the Reagan-Udall Foundation’s Expanded Access Navigator.
  • Adopt a Global Mindset: Recognize and address the needs of patients worldwide, not just in the US.

The Bigger Picture: Responsibility and Impact

The responsibility lies with companies of all sizes to manage expectations effectively. It’s about clear communication, whether it’s about the availability of clinical trials or the scope of access to new treatments.

Need Guidance? We’re Here to Help

Navigating the complexities of expanded access can be challenging, especially for companies new to this area or looking to refine their approach. Resources like the Guide for Companies and Sponsors at the Reagan-Udall Foundation for the FDA are invaluable. Remember, developing an expanded access policy is not just a regulatory step; it’s a commitment to patient care and medical progress.

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