By: Nathalie Bere, MSc
I recently returned from a two-week fellowship at the FDA Headquarters in Silver Spring, Md. My mission was to learn about the FDA’s engagement with patients. And, at the same time, to share information on how we involve patients in our work here at the European Medicines Agency (EMA).
The EMA is responsible for the scientific evaluation primarily of innovative and high technology medicines developed by pharmaceutical companies for use in the 28 current EU member states as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. Experts participate in the work of the EMA as members of its scientific committees, working parties, scientific advisory groups, or as members of assessment teams evaluating medicines. They are chosen on the basis of their scientific expertise. The patients and health care professionals’ voices are also fully integrated within the work at the EMA.
At the beginning of December, as I stood outside the buildings at the FDA’s White Oak Campus, I wondered if this somewhat challenging task was going to be feasible within such a short timeframe. I felt that it was very important for me to not only capture the essence of the work at the FDA but to really learn about the different challenges and issues they have faced and how they have been handled. Overall, I wanted to be able to identify areas which could ultimately benefit from an exchange of EMA/FDA experience.
I had no need to worry. I was received openly and positively within the FDA offices by all the staff who took time from their busy schedules to meet me and share their respective work practices. An extensive schedule had been set up to give me the opportunity to learn about the relevant offices and divisions, as well as attend two Advisory Committee Meetings and participate in a Patient Representative Training Webinar. I also had several opportunities to share information with FDA colleagues on how EMA involves patients throughout the development, evaluation, and surveillance of medicines.
It was enlightening to learn that, overall, many of the challenges and benefits of working with patients are remarkably similar for the two agencies.
Engaging with patients is a vital part of any regulator’s work, and this is recognized as a high priority by both the EMA and FDA. Of course, there are differences in the way each agency achieves this, due in part to their different review processes. However, there are definitely areas where I believe each agency can benefit from the other’s experience.
For example, the EMA can benefit from the FDA’s experience in organizing and conducting public events such as advisory committee meetings and patient-focused drug development meetings where FDA experts reach out and gather data from the audience.
Other promising concepts for the EMA include the FDA’s “patient representative program,” comprising a pool of interested, screened and trained patients who bring the patient voice to the FDA discussions about new and already approved drugs and devices and policy questions. Still more interesting patient-specific communication tools used by FDA are webinars, interactive live-chats and a dedicated newsletter used for training and raising awareness.
In turn, the FDA could benefit from EMA’s experience of engaging with patients earlier during its discussions on specific product assessments. In the EMA’s system patient input can be regularly solicited throughout the medicine’s lifecycle, e.g. in all expert meetings, through written patient consultations, and by patients as voting members within committees.
Other areas that could benefit the FDA include: patient review of all package leaflets and safety communications, and the establishment of a permanent group of patient/consumer organizations that provide a platform for exchange of information on general issues within the EU system.
Now that I am back at the EMA’s London headquarters after quite a hectic, but enriching experience, I hope there will be an opportunity at EMA to reciprocate with my new FDA colleagues, who invited me so warmly into their workplace.
This fellowship has provided an opportunity for both the EMA and the FDA to gain an understanding of each other’s respective programs of engaging with patients, and a rich source of valuable information has been shared.
We look forward to further collaboration and regular sharing of information on patient engagement.
I would like to thank Sabine Haubenreisser, EMA Liaison Official to the FDA, based at White Oak; Heidi Marchand, Assistant Commissioner of the Office of Health and Constituent Affairs; and Health Programs Coordinator Andrea Furia-Helms, who facilitated this fellowship.
Nathalie Bere, MSc, works in patient relations in the Stakeholder and Communication Division of the European Medicines Agency in London.
Through the EMA/FDA confidentiality arrangements our organizations have established procedures to enable our organizations to share information that is not public. These arrangements also facilitate the exchange of staff, including secondments and fellowships, to work together on defined topics and foster increased dialogue and cooperation.