Getting reorganized

FDA is reorganizing the Office of New Drugs to stay ahead of drug development

FDA is reorganizing the Office of New Drugs in its Center for Drug Evaluation and Research, seeking to make review oversight more consistent while encouraging senior staff to become thought leaders.

The changes at OND are being implemented as CDER ramps up hiring and personnel policies in anticipation of a staffing cliff that will dramatically change the face of the agency over the next few years (see “CDER’s Cliff”).

Details of the OND reorganization will be rolled out this summer.

FDA Commissioner Scott Gottlieb previewed the plan, and the agency’s strategies for recruiting a new management cohort, in a recent conversation with BioCentury.

CDER Director Janet Woodcock, who took on the role of acting OND director when John Jenkins stepped down from the position in January 2017, is leading the reorganization.

She is setting new goals for OND, aiming to expand the ambitions of its staff from ensuring that the trains run on time to improving public health, Gottlieb told BioCentury. “We are at a point where we need to look beyond just meeting PDUFA goals, to trying to achieve public health goals through the new drug review process -- and to make that part of how we measure success.”

“We are at a point where we need to look beyond just meeting PDUFA goals.”

Scott Gottlieb, FDA

This shift does not reflect a downplaying of the importance of meeting PDUFA goals, he said. Rather, FDA has determined that meeting review goals is necessary but not sufficient to achieving OND’s mission.

“A lot of the internal organization around the new drug review process has been focused around PDUFA deadlines, for good reasons,” Gottlieb said. “These are benchmarks the agency was externally assessed on. They are important, but they are process goals, and by and large we meet them.”

The idea now, Gottlieb said, is to change the culture “so if you ask someone at CDER how they measure success, it is not hitting review goals, it is how they improve public health.”

A key to this shift in culture is for senior OND staff to conceive of their jobs as helping to shape and direct medical progress, not simply to respond to applications as they are submitted.

Sidebar: CDER’s cliff

From managers to leaders

Gottlieb said he and Woodcock want OND division directors to think of themselves, and to be perceived by their medical and scientific peers, as leaders in their fields.

The goal is for more FDA staff to attain the stature that Richard Pazdur, director of the FDA’s Oncology Center of Excellence, and members of his team have achieved, Gottlieb said. “The model that Rick has established in oncology is a great model. His folks engage in a lot of thought leadership in their fields.”

Pazdur and oncology therapy reviewers frequently present at medical and scientific meetings, publish in prestigious journals, and engage with medical societies to reshape regulatory science.

One of the ways CDER plans to help division directors expand their horizons is by creating more review divisions, and possibly a new Office of Drug Evaluation (ODE).

There are currently four ODEs, which each have oversight responsibility for 19 review divisions.

The new divisions will reflect advances in science that are differentiating once monolithic medical fields. “The scope of development in some more targeted therapeutic areas is brisk enough to support having more targeted review divisions,” Gottlieb said.

For example, the Division of Gastroenterology and Inborn Errors Products (DGIEP) will likely be broken up. This could result in three separate divisions with responsibility for drugs to treat gastrointestinal, liver and rare diseases.

Another logical change would be to move oversight of pain and addiction medications, which are now grouped with metabolism, endocrinology, pulmonary and rheumatology, into an ODE with a focus on neurology.

The carving out of new divisions creates more opportunities for FDA staff to step up into leadership roles both at the agency and within their disciplines.

Creating new review divisions will also reduce management burdens on division directors. Some review divisions have 80 employees. OND’s goal is to have a maximum of about 40 employees per division.

Smaller divisions with lighter workloads will afford directors more opportunities to focus on policy issues, including “more time to engage in developing the scientific standards and principles we review against,” Gottlieb said.

Policy office

To support the broadening focus of ODE and division heads, Woodcock is creating a new policy office in OND. The office will be charged with helping document and disseminate best practices.

Putting practices and policies in writing ensures that they will persist after the individuals who created them move into other positions or leave FDA. It also helps address one of industry’s most frequent complaints about OND, that reviewers often make different decisions when faced with similar situations.

The policy office will “distill and align regulatory, clinical and scientific reasoning of review divisions to promote policy transparency and consistency,” Gottlieb told a congressional committee in April.

Keith Flanagan, transition lead for policy at OND, is heading up a team that is creating OND’s policy office. He is expected to lead the office after it has been formally created.

“It might sound underwhelming to say that the memo informs the way you function in the review process, but it does.”

Scott Gottlieb, FDA

Prior to joining OND, Flanagan was director of the Office of Generic Drug Policy (OGDP).

Flanagan’s team has already started work on one of its priorities, ramping up the number of OND guidance documents.

Gottlieb has committed OND to produce “hundreds” of disease-specific guidance documents if it receives a funding boost the Trump administration has requested for FY19.

To reach this goal, OND has reimagined guidance documents and re-engineered the process of creating them, Flanagan told BioCentury.

Traditionally, authors of guidance documents have sought to make them as comprehensive as possible. Writing and reviewing them was an arduous process that often took years.

To speed up the process, Flanagan said OND has started a pilot project to “streamline development and clearance of bulleted guidances.”

The idea is to produce guidance documents that use bullet points to highlight critical elements of policy.

Examples include a four-page draft guidance released in January on “Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders,” and a draft guidance released in April on “Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs,” that is less than three pages.

Another draft guidance released in April on developing depot buprenorphine products to treat opioid addiction barely spilled over six pages.

Prior to the bulleted format, CDER guidance documents typically were over 10 pages, and often exceeded 20.

“Clarifying regulatory expectations and frequently issuing up to date disease-specific guidances should expedite drug development and review,” Flanagan said.

He emphasized that OND’s new policy office is not a top-down effort to impose new practices on FDA medical reviewers.

“The ODEs and divisions are our customers and we champion and advocate for them,” Flanagan said. “What is new and different is policy folks embedded with and integrated with the review program to ensure that policy reflects the practices and views of folks actually doing the work.”

OND will focus on creating guidance documents “laying out the pathway for developing drugs targeted to less common and serious conditions where there’s a lack of available therapy and drug development pathways can be more challenging,” Gottlieb told the House Appropriations Committee in April.

Guidance documents under development include criteria for the development of drugs targeted to ulcerative colitis, rare pediatric cancers and pediatric HIV.

To increase consistency, Woodcock is also planning to centralize OND’s project management, Gottlieb said.

Project managers, who are the primary point of contact between sponsors and review staff, are currently assigned to review divisions.

The new arrangement is intended to make project management a more clearly defined discipline, and to eliminate discrepancies in the way project managers interact with sponsors.

A new memo

While many of the changes at OND will not be obvious to the world outside of FDA’s campus, execution of its plan to reconfigure new drug review memos will be.

Currently, sponsors receive a series of memos reflecting the separate reviews conducted by staff specializing in different disciplines such as epidemiology, biostatistics and manufacturing.

Current review memos are often a poorly organized hodgepodge of high-level conclusions and detailed data containing a great deal of duplication.

The disorder in memos reflects the disorder in review process.

Under the system Woodcock is creating, this process will be replaced by “consolidated, collaborative teams,” Gottlieb said. The emphasis on teamwork will be reflected in a common review memo.

“It might sound underwhelming to say that the memo informs the way you function in the review process, but it does,” Gottlieb said. “Changing the review memo will make the process more collaborative.”

FDA is also piloting a project under which sponsors provide more data to FDA electronically. One goal for these electronic submissions is to bring review memos into the cyber age. Rather than cut-and-paste data into PDF versions of review memos, the goal is to embed hyperlinks to the data.

Companies and Institutions Mentioned

Pfizer Inc. (NYSE:PFE), New York, N.Y.

Reagan-Udall Foundation for the FDA, Washington, D.C.

U.S. Food and Drug Administration (FDA), Silver Spring, Md.


U.S. Food and Drug Administration. “Atopic dermatitis: timing of pediatric studies during development of systemic drugs.” Guidance for Industry (2018)

U.S. Food and Drug Administration. “Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders.” Guidance for Industry (2018)

U.S. Food and Drug Administration. “Opioid dependence: developing depot buprenorphine products for treatment guidance for industry.” Guidance for Industry (2018)

User Sign In