The FDA Patient Focused Drug Development meeting held Monday, March 19, 2018 was a game changer for me – and the life sciences industry. The FDA, specifically, the Center for Drug Evaluation and Research (CDER) Office of Strategic Initiatives is responsible for the implementation of the 21st Century Cures Act. This meeting was the second in a series of workshops to implement a four-stage plan to support the Cures Act. At this workshop, the lead, Theresa Mullins, PhD, Associate Director for Strategic Initiatives, made it clear that the goal of the plan is to ensure the patient has input to the full breadth of drug development – from pre-IND through commercial. This is music to my ears! It stunned me that the FDA has evolved to this degree – and it is going to push the industry.
The main goal of the workshop was to get input from patient stakeholders (patients, caregivers, patient advocates, etc) for the eventual guidance that will be delivered to industry in September 2018. The FDA understands that industry has been slow to incorporate patients into drug development efforts. Many times, if initiatives are executed in pharma, there is not enough of a culture to sustain the effort once the initiative leadership has moved on…so the initiative dies and the institutional learning disappears. To encourage learning, for all stakeholders, the FDA has developed a website for submission of all kinds of data that supports patient engagement – advisory board meeting notes, case studies of patient engagement initiatives, white papers – anything. The submission will be vetted for appropriateness and, if approved will be published to a public site so everyone can continue to learn.
So, next steps to prepare for the FDA guidance coming in September 2018:
- Get to know the Cures Act…well
- Submit comments regarding this stage of the implementation by May 18, 2018
- Prepare for the guidance on the Cures Act implementation
- Assess your company culture – is your organization really ready to entertain patient input to study design? Is your organization really ready to base it’s marketing planning on patient input?
- No organization is perfectly ready – support your organization with training and an internal awareness campaign on value and bottom line benefit of patient input
- Assess if your organization has the competencies to implement the coming guidance – and if not, hire people experienced in patient engagement – not simply consumer marketing
- Even in organizations that consider themselves patient-focused this guidance can still be hard to implement as it really demands a change in thinking. Check back here to continually learn how to incorporate patient engagement into your culture.
Are you ready? Be honest….
We, at Inspired Health Strategies, can’t wait to help you get ready for this sea change,
Patient Engagement Strategist
Inspired Health Strategies, LLC