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FDA meeting to kick off patient-focused development debate

Clinical News | October 02, 2012


Peter Mansell

FDA meeting to kick off patient-focused development debate

A public meeting to be held by the US Food and Drug Administration later this month will set in motion a five-year programme of soliciting views on patient-focused drug development in 20 different disease areas.

The meeting at the FDA’s White Oak Campus in Maryland on 25 October is the agency’s first formal step towards fulfilling obligations under the Food and Drug Administration Safety and Innovation Act (FDAISIA) of 2012, which was signed into law on 9 July.

Title I of FDASIA authorises for the fifth time the Prescription Drug User Fee Act (PDUFA).

In doing so, it sets out various performance goals for the FDA during fiscal years 2013 to 2017, which include a more systematic approach to obtaining patient perspectives on disease severity and currently available treatments in certain disease areas.

The idea is to help improve benefit-risk assessments in the FDA’s regulatory decision-making by establishing the context in which particular decisions are made.

Direct stake

“Patients who live with a disease have a direct stake in the outcome of the review process and are in a unique position to contribute to weighing benefit-risk considerations that can occur throughout the medical product development process,” the agency notes in a Federal Register notice announcing the public meeting.

Although several programmes already exist to facilitate patient representation in this process, “there are currently few venues in which the patient perspective is

discussed outside of a specific product’s marketing application review”, the FDA adds.

Disease list

The agency has published, as part of its Federal Register notice, a preliminary list of disease areas for consideration during the PDUFA V period, as well as the criteria used to nominate these areas.

Each disease area will be the focus of one of 20 public meetings to be held during fiscal years 2013 to 2017. The FDA will convene additional consultation meetings with patient stakeholders to discuss key process questions relating to patient-focused drug development.

Interested parties are invited to comment on the preliminary list of diseases through a public docket and at the forthcoming public meeting, where the FDA will provide an overview of the patient-focused drug development initiative.

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