Regulatory Resolutions

CDER Director Janet Woodcock takes a look back and a look forward

As is tradition, the FDA’s Center for Drug Evaluation and Research (CDER) sends their publicity staff to corner the director to discuss major events from the year past and goals for the New Year. Dr. Janet Woodcock recently posted her thoughts and aspirations on her Director’s Corner blog. Woodcock opened with a cheery “Happy New Year everyone!” and then offered her take on the agency’s “resolutions” for 2016. But first she took a look back, recounting the agency’s top three 2015 successes. At the top? CDER’s Generic Drug program.

Since its inception, the industry has made it clear there are problematic issues associated with the FDA’s Generic Drug Fee User’s Act (GDUFA) program. Last summer the FDA asked for comments; among those submitting was the Generic Pharmaceutical Association (GPhA) that pointedly critiqued the FDA for how the agency had spent the money it had collected since 2012. “FDA still has $277 million in unused funds from the generic industry that could be applied to site inspections or approvals,” said GPhA. “The high carry-over amount is especially confounding,” given, it said, FDA’s ongoing struggles to speed up regulatory review times. “In 2011 when GDUFA began, median review time to approval was at 30 months,” explained GPhA. “Since then, median review times increased to … an estimated 42 months in FY2014. At the industry’s best estimate, current fiscal year median approval times will be 48 months — the slowest it has ever been.”

Without directly referring to its less-than-stellar performance, Woodcock may have hinted to at least one major cause (besides federal-style bureaucratic mud): “Number one was the successful transformation in the Generic Drug Program and getting into a very high level of productivity,” said Woodcock. That included, she said, “standing up a whole new IT platform, as well as transformation of the whole generic drug process to a modern process.” Woodcock declared it a “huge” accomplishment, one that the entire agency can be proud of. Congratulations are due. Seriously, I can’t think of anything I would like to do less than trying to force-fit a new IT system into a federal government agency.

Woodcock touted the “stand-up” of the Office of Pharmaceutical Quality early in 2015 as accomplishment #2. “We’ve been working on it all during the year,” she said, noting that the industry is “very appreciative that we now have a modern quality organization that looks after all pharmaceutical quality [and] who have the same standards.” At #3 she declared the Office of Pharmaceutical Quality launched successfully, and that’s a good thing for the generic drug review process in 2016.

What’s ahead? According to Woodcock, “What’s going to dominate much of our thinking is … the user fee negotiations.” She said the agency hopes to bring them all to a conclusion in 2016, but says they still need to marshal the staff/resources to carry on these programs. Addiction and other consequences of prescription opioid dependence are on the agency’s radar as well. “Now there are many other parties that have a more leading role,” said Woodcock, “but we have many things that we can do.”

Probably the agency’s biggest resolution is to hire more employees to get the job done. “If I could have 800 people on board this very minute who aren’t here right now, I think we’d all be in a much better position to get all this done in the next year.” I think that will be tougher than sticking to a diet and exercise plan, don’t you?

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