March 28, 2017

How Might the FDA's Proposed Patient Affairs Office Impact Patient Advocacy Efforts?

Earlier this month, the Food and Drug Administration (FDA) solicited public comments on the agency’s proposal to create a new Office of Patient Affairs. The agency said in its Federal Register notice that the concept was developed through earlier feedback solicited as part of the agency’s overarching patient-focused drug development (PFDD) work.

In response to a question about the proposed office from Rep. Mike Bilirakis, R-FL, during a recent House Energy & Commerce Committee hearing on the Prescription Drug User Fee Act (PDUFA), Center for Drug Evaluation and Research Director Dr. Janet Woodcock said the office will serve as the FDA’s front door to field inquiries from patient stakeholders. Dr. Woodcock also said it would help patients who aren’t as familiar with the workings and structure of the FDA find answers to questions and receive appropriate navigation and guidance. In addition, the proposed office would manage related dockets and meetings to facilitate communications between the agencies and patient groups and to resolve any challenges that may arise.

The proposal builds on several years of activities aimed at strengthening the role and voice of the patient in the product development and review process. Foundational elements include provisions in PDUFA V (FDA Safety and Innovation Act) dating back to 2012, the agency’s ensuing PFDD meetings and, more recently, its externally-led PFDD meeting pathway. Several recently enacted provisions within the 21st Century Cures Act also focus on patient engagement.

On the surface, an office intended to bring more clarity and transparency to a complex yet vitally important government agency like the FDA sounds useful. As stakeholders consider weighing in with support or opposition, a few points are worth considering.

First and foremost, what impact might this office have on existing or potential engagement opportunities involving patient groups and the agency, particularly interactions involving the critically important review divisions? Groups already involved in working with existing components of the agency would want to ensure that any new office or agency function does not interrupt or complicate these relationships. Many of the FDA’s current patient engagement efforts are managed by the Office of Health and Constituent Affairs, and it remains unclear whether those activities might be transferred if a new office is established.

Additionally, stakeholders who are new to the agency would want to know that the proposed office does not create another administrative level between patient groups and key agency personnel. An office developed to help field and navigate inquiries to expedite the necessary contact or response across the agency would be most appropriate.

Finally, stakeholders should consider urging the agency to produce details on the complete mission of the office, including working relationship between the office leaders and other agency officials. Clarity here will help patients better understand what to expect and not expect. This also provides the FDA with an opportunity to remind external stakeholders of other existing ways in which they can engage with the agency.

Stakeholders have until June 12, 2017 to file a comment.

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