Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am Senior Fellow at the National Center for Health Research. Our research center analyzes scientific and medical data, promotes consumer-oriented health policy and legislation, and focuses on patient-centered research and treatment. We do not accept funding from industry, so I have no conflicts of interest to report.
We thank the FDA and NIDA for convening today’s meeting to elevate patients’ stories. It is critical to know patients’ perspectives on Opioid Use Disorder, and this meeting is a positive step in initiating a productive dialogue.
We know that the FDA has made a commitment to finding ways to reduce opioid abuse and addiction, including approving more treatments for Opioid Use Disorder. We also know that drug companies are eager to get patients who want more treatments to talk with FDA officials. Kaiser Health News recently published their Pre$cription for Power database and reported that in 2015, pharmaceutical companies gave at least $116 million to patient advocacy groups. We want the FDA to hear from patients and are concerned that they are not hearing perspectives that represent the wide range of patients and their loved ones affected by Opioid Use Disorder.
Patients who aren’t involved with these Pharma-funded patient groups may not know how to engage with the FDA. If they know about public meetings like this one, they may not have the means to attend, and many don’t know about opportunities to send written public comments to the FDA docket.
Patients often ask us if it’s worth their time and expense to come to an FDA meeting when they are given only a few minutes to speak and can only register to speak the morning of the meeting. We have heard from patients that they don’t want to come to an FDA meeting at their own expense without a guarantee that they will have a chance to speak and be heard.
Patients who are not involved in Pharma-funded organizations also tell us that it’s difficult to get in-person meetings with FDA officials who will engage in meaningful dialogue. These patients want to share opinions and knowledge with FDA officials who make decisions.
Patients’ perspectives on how this challenging disorder is affecting their health, well-being, and daily lives will help the FDA and drug companies focus on studying outcomes that are most important and clinically relevant for patients. Patients’ lived experiences with using medical treatments and therapies for OUD are urgently needed to further drug development and research. In addition, knowing barriers that patients face in accessing treatments for OUD will help improve access to medically necessary care.
To ensure that the patient perspective is well-represented, the patient engagement process should be inclusive and transparent. We encourage the FDA to reach out and include patients who are not recruited by industry. While all patient voices should be heard, industry-supported perspectives should be augmented by independent patient voices. For example, the USA Patient Network is an independent organization of patient advocates who have been trained through a Patient-Centered Outcomes Research Institute (PCORI) award to understand clinical trial research design and analysis. These patients can serve as independent voices and connect the FDA with other patients who want their voices to be heard.
Thank you to the patients here today who have bravely shared their stories and for the opportunity to express our views.