The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock on Monday laid out her proposal to modernize the Office of New Drugs (OND) in an effort to make drug reviews more efficient.
The proposal centers around instituting process changes to make administrative processes more consistent and less time consuming and to reorganize OND’s review divisions to be more focused on specific therapeutic areas.
In a post to FDA’s blog, Woodcock writes that the proposed changes “are intended to free up resources so that our scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly.”
In a separate statement, FDA Commissioner Scott Gottlieb said he is “fully committed” to implementing the proposed changes.
In terms of process improvements, Woodcock said her goal is to develop a common review template that will be used by all OND review divisions and enhance the office’s IT capabilities to make it easier for staff to access information generated during reviews.
“We want to make it easy for staff to find and use scientific and regulatory data, information and precedents,” Woodcock writes.
Other aspects of the modernization plan include a focus on hiring and retention as called for under the 21st Century Cures Act
and the development of a “unified postmarket safety surveillance framework” to better track benefits and risks of drugs throughout the total product lifecycle.
According to Gottlieb, the proposed changes will improve the efficiency of new drug reviews by 20% and free up OND staff to develop hundreds of new clinical and product specific guidances and to be more engaged with external stakeholders such as drugmakers, international regulators and patient groups.
The other component of the modernization effort is to sharply increase the number of offices within OND from five to nine and to increase the number of review divisions within those office from 19 to 30.
“The goal is to make sure that the drug review divisions are therapeutically focused to promote efficient review and provide greater scientific leadership to academic, industry and patient groups,” Gottlieb said.
In the past, Gottlieb said, OND divisions were organized to balance its workload across its offices and divisions, rather than strictly based on therapeutic area.
Woodcock also said that OND and its staff of more than 1,000 will be reorganized to better enable integration between review teams and staff from other CDER offices, such as the Office of Translational Sciences, Office of Surveillance and Epidemiology and Office of Pharmaceutical Quality.
However, it is unclear how soon the proposed reorganization will take place.
FDA spokesperson Jeremy Kahn told Focus
that the agency is “still compiling the proposal” and will need approval from the Department of Health and Human Services, the Office of Management and Budget and Congress.
, Gottlieb Statement