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USA Patient Network Supports Establishing Office of Patient Affairs at FDA

Docket No. FDA-2017-N-0455 for “Enhancing Patient Engagement Efforts Across the FDA; Establishment Of a Public Docket; Request for Comments”

The USA Patient Network supports the FDA in establishing an Office of Patient Affairs (OPA). We are a network of individuals seeking medical treatments that are as effective, safe and affordable as possible. Since we do not accept money or resources from companies that sell medical products, we are able to bring the independent patient voice to this discussion.

In accomplishing the goal of developing a nuanced understanding of the patient experience by disease, it is critical that any future Office of Patient Affairs at the FDA (OPA-FDA) be conscious of the broad range of diseases and patient experiences, and deliberate in drawing out and responding to the full spectrum of the patient experience and voice in terms of what is clinically meaningful and attitudes toward benefit-risk tolerance. The importance of clinically meaningful evidence was exemplified last year when a well-organized group of caregivers and patients from a particular rare disease population were able to influence the FDA and Congress enough to have a drug approved for use in the disease population which the people represented, even though the drug was not properly tested and failed to show any clear evidence of improved quality of life or disease mitigation. Yet patient advocates managed to get the drug approved only to see the drug company charge an extremely high price and several insurance companies refuse to cover a treatment that was not proven to work. As a result, the approved drug was no longer accessible to many patients.

The above example points toward another area in which the OPA-FDA must use deliberate care to listen to a wide range of patients, and not just those associated (directly or through nonprofit organizations) with drug or device companies. If there is to be a finely nuanced understanding of the patient voice and perspective, then the OPA-FDA will want to be sure that they are listening to patients from all demographics, diseases, and organizations; especially the independent patient voice which represents a broad spectrum of the population who remain unbiased as to industry influence or personal investment in a particular treatment. To have a complete understanding means that the OPA-FDA needs to listen to more than one segment to provide the agency with a balanced perspective. All patients must be heard, and especially the independent voices, whether they are patients with a chronic illness, those currently healthy, or those who were previously harmed.

Another area of focus to secure the success of the OPA-FDA rests in many previous patient experiences with the agency. Many patients who have been harmed by medical devices or pharmaceuticals feel that their concerns have not been treated with the same weight as other groups, leaving them feeling ignored and dismissed by the FDA. Staff at the FDA has voiced questions over how to use the stories of patients who were harmed; discounting their stories as anecdotal rather than as an essential way to understand the risks. A harmed patient is going to be emotional, but that does not disqualify the story as a data point. Patients and their stories are not just anecdotes. A finely nuanced understanding of the patient voice will be able to accept, validate, and include the reported adverse events with the same weight as that of those wishing to advance a treatment.

As for creating one portal for patient entrance into the FDA, along with helping patients understand life inside the agency, we ask the staff of the OPA to also connect with patients and advocates when they bring observations of ways in which the FDA regulatory processes are ineffective or not working well. There is good reason to trust the observations of patients as being accurate even if the patient does not have the specific medical terminology with which to explain the situation. A recent paper published in JAMA Pediatrics showed “in a study of 4 US hospitals, solicited family reporting yielded 5-fold more errors and 3-fold more adverse events than the voluntary hospital incident reports that most hospitals use as their primary patient safety surveillance tool. In addition, whereas hospital reports only captured 5% of errors and 10% of adverse events patient family reporting had a much higher yield - detecting 22% of errors and 29% of adverse events.”[1]

In conclusion, the USA Patient Network supports the establishment of an Office of Patient Affairs within the FDA, but urges that independent voices be recruited and included. When patients are seen and treated as equal partners in health care decisions and treatment delivery, harm will be bridled, costs can be lowered, and outcomes will improve.

The USA Patient Network can be contacted through Linda Radach at

[1] Families as Partners in Hospital Error and Adverse Event Surveillance, by a Children's Hospital, Boston User on 02/27/2017)

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