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Pink Sheet – US FDA's Patient Affairs Office Is An Office … In Spirit

Pink Sheet – US FDA's Patient Affairs Office Is An Office … In Spirit

Executive Summary

Rachel Sherman says agency is creating patient affairs staff, but will not undergo reorganization to create an official office.

The US FDA’s new patient affairs office will not be an actual “Office” in the official sense of the word, but will remain a group working to help patients and advocates find their way around the agency.


In part because of the bureaucratic moves that would be necessary to make such a change, the agency is instead creating a patient affairs group, said Principal Deputy Commissioner Rachel Sherman. The clarification comes after agency officials in documents and public appearances have called it a patient affairs office.


“It’s not an office because that requires a reorg,” Sherman said Nov. 14 during the Biopharma Congress, sponsored by Prevision Policy and the Friends of Cancer Research. “But we are standing up a patient engagement staff in what is currently the Office of Medical Products and Tobacco.”


That likely means that there will not be another bubble added to the Office of Medical Products and Tobacco’s organizational chart designating a patient affairs group. OMPT now includes the Offices of Special Medical Programs and Oncology Center of Excellence, as well as the centers for drugs, biologics, devices, and tobacco products.


Indeed, the requirements for adding another office to the FDA organization chart are substantial and time-consuming. It can require massive paperwork, and also in some cases congressional approval.


It took FDA more than two years to create the Office of Pharmaceutical Quality, which moved all chemistry, manufacturing and related staff into one super office within CDER. CDER Director Janet Woodcock announced the office’s creation in September 2012 (Also see “CDER’s Office Of Pharmaceutical Quality Remains A Wild Card” – Pink Sheet, 18 Mar, 2013.), but it did not launch until January 2015. (Also see “FDA Pharmaceutical Quality Office Launches With Team-based Reviews” – Pink Sheet, 12 Jan, 2015.)


The function of the patient affairs group likely will be no different absent an official organizational grouping. It is intended to be a central point of contact for patients, advocates and other stakeholders looking to interact with FDA and are unsure where to go. Sherman reiterated during the conference that those who already have developed relationships within FDA will not lose them when the new group is up and running.


“We wanted a very visible single point of entry to help guide them,” she said.


Commissioner Scott Gottlieb also said the group will help set agency-wide policy. (Also see “US FDA’s Centralized Patient Affairs Office Aims For No Disruption” – Pink Sheet, 13 Sep, 2017.) [Editor’s note: Gottlieb and Woodcock, along with CMS Administrator Seema Verma, will be speaking at the FDA/CMS Summit on Dec. 5-6 in Washington, DC. To register, please visit the conference homepage.]


FDA floated the idea in March and it initially gained support from patient groups. (Also see “US FDA Patient Affairs Office Could Accelerate Involvement With ‘Central Entry Point'” – Pink Sheet, 14 Mar, 2017.) Several met with Sherman and other FDA officials in August to make sure the patient affairs office idea remained a priority. (Also see “Patient Advocates Continue To Push US FDA For Central Office” – Pink Sheet, 5 Sep, 2017.)

Symbolism Not An Issue

Some stakeholders were not overly concerned about the lack of “office” status affecting the patient affairs group.


Nancy Goodman, executive director of the group Kids v Cancer, told the Pink Sheet that she was thrilled the agency was creating the staff. “As long as the reporting of a patient affairs staff goes to senior leadership and that leadership is committed, then we are in great shape and there will be a tremendous opportunity for change,” she said in an email.


FDA has made symbolic statements about some issues based on the positioning of its offices. Establishing OPQ within CDER showed FDA’s focus on manufacturing quality.


The agency also elevated the Office of Generic Drugs to super office status within CDER in 2013 as part of the implementation of the generic drug user fee program, but also to show the importance of generics to public health. (Also see “FDA Generics Office Drinks Super Serum, Then Shrinks” – Pink Sheet, 16 Dec, 2013.)

New Staff Latest Of Several Patient Initiatives

FDA has worked for many years to make patients a more integral part of the drug development and review process. Creating a free-standing patient affairs office seemed to be the inevitable next step.


Wilson Bryan, director of the CBER Office of Tissues and Advanced Therapies, said his center is actively recruiting someone to interact with stakeholder organizations. “I can’t say how soon we’ll hire someone,” Bryan said during the conference. “We are interviewing now.”


FDA currently has a patient liaison team within the Office of Health and Constituent Affairs within the Office of the Commissioner that works on patient inquiries. The agency also announced earlier this year that it was creating a Patient Engagement Collaborative to have regular meetings with patients about enhancing engagement at FDA. (Also see “US FDA Planning Another Patient Group To Boost Involvement” – Pink Sheet, 15 May, 2017.)


As part of PDUFA V, FDA conducted more than 20 disease-focused meetings with patients as part of its patient-focused drug development initiative to gather views about unmet needs and existing treatments. The current iteration of the user fee program has more internally-focused goals, but the agency has said it will send staff to similar meetings organized by patient groups when possible. (Also see “FDA Ends Regularly Scheduled Patient-Focused Drug Development Meetings” – Pink Sheet, 28 Sep, 2017.)…