Woodcock Becomes PCORI Board's First FDA Representative
Executive Summary
Center for Drug Evaluation and Research director accepts six-year term on Board of Governors of the Patient-Centered Outcomes Research Institute, which funds comparative effectiveness studies.
Janet Woodcock has become the first US FDA official named to the Patient-Centered Outcomes Research Institute's Board of Governors and will lend her clinical trial and drug development expertise to its research agenda.
The position is yet another job for the already busy director of the Center for Drug Evaluation and Research, who also is temporarily running its Office of New Drugs until a permanent director is found.
FDA said Woodcock's PCORI service will be part of her duties as CDER director, which will continue unchanged. As a board member, she will "provide her expertise on evidence generation."
"Clinical evidence is an important part of drug regulation, and PCORI is intended to contribute to the body of evidence on clinical interventions," the agency told the Pink Sheet.
A PCORI Board of Governors term, which lasts six years, does not appear to be a substantial time commitment. Jean Slutsky, PCORI chief engagement and dissemination officer, told the Pink Sheet in a written statement that the PCORI board holds monthly conference calls, but two or three times a year substitutes the call for an in-person meeting in Washington, DC.
Throughout her long career at the CDER helm, Woodcock's expertise and experience have been in demand by staff and stakeholders. In a 2016 interview with the Pink Sheet, Woodcock said sometimes she has 16 meetings in a day. She also speaks regularly to stakeholder groups and at conferences, and often is called to Capitol Hill to testify on agency operations. (Also see "Woodcock's Legacy: CDER Organizational Improvements" - Pink Sheet, 10 Aug, 2016.)
Woodcock indicated during a recent appearance at an event hosted by the Alliance for a Stronger FDA that she would like to find a new OND director so she no longer has two jobs. That wish may come true – FDA has made an offer to a candidate and an announcement is expected soon. (Also see "US FDA May Wait Until Late 2019 Before A Cures Hiring Enhancement Is Available" - Pink Sheet, 27 Sep, 2018.)
PCORI Issues Overlap With FDA Priorities
PCORI, an independent non-governmental organization created in 2010, funds comparative effectiveness research to help patients and providers make better decisions. (Also see "Multiple Sclerosis Drug Prices Rising By Double-Digits Despite Rebates" - Pink Sheet, 16 Oct, 2016.)
While a board member, Woodcock likely will review and help distribute funding for many research projects related to issues and FDA and CDER already face.
PCORI announced Aug. 21 that the board approved $5m for a University of Washington "natural experiment study" comparing approaches to reduce unsafe opioid prescribing in the Ohio and Washington workers' compensation systems. It is the largest in PCORI's portfolio of substance abuse and pain management research, which includes 15 opioid-related studies.
FDA like many federal health care agencies is helping fight the opioid epidemic. In legislation expected to be signed by President Trump, FDA was directed to create prescribing guidelines for indication-specific treatment of pain, an area unfamiliar to agency staff. (Also see "Opioid Prescribing Guidelines Put US FDA In Unfamiliar Territory" - Pink Sheet, 3 Oct, 2018.)
The bill also requires the agency to outline how it will consider abuse potential when reviewing opioid drug applications. (Also see "Opioid Approvals: Congress Wants US FDA Guidance On Abuse Potential" - Pink Sheet, 30 Sep, 2018.)
PCORI also announced Sept. 7 that the board approved a new policy expecting researchers it funds to share their data for reanalysis. Certain research teams, including those receiving larger awards, now must place data into a PCORI-designated repository.
Industry Officials Also Join Board
The 21-member PCORI Board of Governors includes a wide variety of health care stakeholders.
PCORI is required to include three members representing patients and health care consumers, seven representing physicians and providers, three representing private payers, three representing pharma, device and diagnostic manufacturers, and one representing quality improvement or independent health service researchers.
The board also must include two representatives of the federal government or states, including at least one from a "federal health program or agency." The directors of NIH and Agency for Healthcare Research and Quality or their designees also sit on the panel, according to the PCORI website.
Joining the board along with Woodcock are Trent Haywood, [Blue Cross Blue Shield] Association senior VP, Office of Clinical Affairs and chief medical officer, Michelle McMurry-Heath, Johnson & Johnson worldwide VP for global regulatory affairs, international clinical evidence and strategic operations for medical device companies and others. (See table below.)
Veteran board members include NIH Director Francis Collins, Ellen Sigal, chair and founder of the Friends of Cancer Research, and Freda Lewis-Hall, Pfizer Inc. executive VP and chief medical officer.
Grayson Norquist, vice-chair of the Emory University Psychiatry and Behavioral Sciences Department, chairs the board.
The US Comptroller General appoints the PCORI board, its chair and vice-chair.