Posted 05 December 2017
By Michael Mezher
Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system.
Woodcock made the comment at the FDA/CMS Summit in Washington, DC on Tuesday, noting that the rest of CDER's priorities for 2018 will be similar to priorities in 2017.
Among those are implementing the 21st Century Cures Act; working toward the goals of the recently reauthorized user fee agreements; responding to the ongoing opioid epidemic; addressing the agency's hiring and retention issues; and reforming the stagnant over-the-counter monograph process.
"We are, number one, going to continue—until we get it done—a CDER-wide informatics implementation so that we can get out of non-automated processes, that we can capture our workflow automatically [and] connect our databases," she said, adding that much of the work will be down in the weeds and will take a "tremendous" amount of resources to accomplish.
According to Woodcock, having a fully operational informatics platform for generic drugs was key to the agency meeting its goals under the first Generic Drug User Fee Amendments (GDUFA).
"Once you get it up and running and working for you it is extremely helpful; however, we have been working to get it fit for purpose for the new drug review program for some time and we're still not there yet," she said.
As for working toward the goals laid out in the user fee programs, Woodcock said she doesn't think the goals for prescription drugs of biosimilars have changed dramatically from the previous agreements.
"The GDUFA goals in contrast … ratcheted up the program, made it more difficult to get things done and the application rates of generic drugs are skyrocketing … so this program continues to face major challenges," Woodcock said, adding that she expects to meet or exceed all the goals nonetheless.
Woodcock also said the agency will continue its effort to make pre- and postmarket facility assessments more efficient under the recently announced concept of operations (ConOps).
"This just started a month ago, more or less, so it's going to take a while before all inspections that we have are covered under this program," she said.
But Woodcock said that FDA still needs to provide more clarity about current good manufacturing practice (cGMP) and what is expected during inspections, adding that the agency's new inspection protocol project (NIPP) could help in that regard.
"Implementation has been slow … but we would like to get a very standardized inspection protocol that then we can harmonize internationally," she said, adding that an internationally harmonized protocol would benefit ongoing mutual reliance efforts with the EU and through the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
"We're well on our way to mutual reliance with the EU countries on facility inspections … but we can't read things in Turkish. We're going to need some standardized templates eventually that we can use so that we can exchange real information with our regulatory counterparts," Woodcock said.
Other things to look out for in 2018: new guidance documents on identifying subpopulations for targeted therapies, advertising and promotion and resolving drug shortages.