- Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research, announced in-depth changes to the structure of the office this week in a note to staff. The changes will affect the Office of New Drugs, Office of Compliance, Office of Executive Programs, and Office of Communications.
- The aim of the changes, which are pending approval from the Department of Health and Human Services, and submission to Congress for concurrence, are "aimed at modernizing and strengthening the way FDA fulfills its public health and regulatory role," according to Woodcock.
- The director of professional affairs and stakeholder engagement (PASE), John Whyte, is also moving on to become the Chief Medical Officer at medical website WebMD.
The Food and Drug Administration has been going through a period of change and improvement under Commissioner Scott Gottlieb, who has been in role since May 2017. These latest reorganizations will, in the words of Woodcock, "enable us to respond to new priorities more efficiently with a stronger organizational framework and better resources."
"It is important to note that the changes the Commissioner is announcing today are not part of the separate effort related to New Drugs Regulatory Program Modernization, a long-term effort that will include a broader proposed reorganization of [Office of New Drugs]," said Woodcock, adding that she would share updates on that proposed reorganization when available.
The reorganization within the Office of New Drugs (OND) will create an Office of Therapeutic Biologics and Biosimilars (OTBB), with some staff members moving across from one to the other. This will create a stronger infrastructure for biosimilar and interchangeable product review under the Biologics Price Competition and Innovation Act. The announcement comes just days after Gottlieb put out a biosimilar action plan that has been part of the agency's ongoing effort to increase the availability of these copycat medicines and lower drug prices.
"This new structure will ensure that all aspects of the process are managed in a more efficient manner, and will help us achieve the performance goals agreed to by the agency in the reauthorized Biosimilar User Fee Act (BsUFA II)," Woodcock said.
The changes in the Office of Compliance will make the section more robust, helping the team to better address needs through compliance strategies and programs, and through compounding policies and operations. The Division of Compounded Drugs will take on the roles of the Compounding and Pharmacy Practice Branch, and work alongside the Division of Unapproved New Drugs and the Office of Manufacturing Quality. The Office of Manufacturing Quality will establish a third drug quality division with two branches for global compliance. The new branches will allow the FDA to "more efficiently fulfill the increased workload associated with oversight of the manufacturing of compounded drugs" — something that has been an increasing problem in recent years.
"With this, we can further safeguard patients by assuring industry’s compliance with the new drug and misbranding requirements," Woodcock said.
The Office of Executive Programs will oversee CDER's executive programs, including user fee program support and implementation, coordination of executive and legislative activities, and advisory committee meeting management and planning.
Finally, in another move toward greater transparency, the Office of Communications, which works both internally and externally, will expand its work informing FDA stakeholders and the public. This will include broadening the social media presence and using new tools.
Woodcock also announced in another letter to staff that Director of Professional Affairs and Stakeholder Engagement John Whyte will leave CDER at the end of August. Whyte was the driver behind the launch of the External Stakeholder Meeting Request, which aimed to make it easier for stakeholders outside of the industry to request drug development and drug safety meetings with CDER. He also created the Drug Trial Snapshots global report, providing patients with clear and easy-to-understand information about who participated in clinical trials that supported FDA approvals.