Monday, July 12, 2021

Working remotely helped FDA’s CDER shape a new and improved workforce, director says. What now?


One surprising consequence of the coronavirus pandemic and its work-from-home zeitgeist? Biopharma companies have been compelled to rethink and perhaps even improve how they operate their businesses.

And the same appears to be true at the FDA, according to commentary from the Cowen Washington Research Group.

The United States government’s regulatory body that oversees the industry—namely the FDA’s Center for Drug Evaluation and Research—had a net gain of more than 100 employees in 2020 and is tracking to reach that number again this year. The two banner years of recruiting and retention follow a 2019 when CDER had a net gain of just 20 employees.

The difference, according to CDER director Patrizia Cavazzoni? The pandemic.

“We think that the greater flexibility with working remotely, not having people all have to move to Silver Spring [Maryland], has made a difference not only in our ability to hire talent, but also to retain talent,” Cavazzoni said during an Alliance for a Stronger FDA webinar on Tuesday.

RELATED: Roll call: How Big Pharma is charting a path back to the office in 2021

Cavazzoni said CDER is examining what its “new normal” will look like, with the understanding that employees have “told us loud and clear that they really enjoy the greater flexibility in how they work.”

Similar discussions are underway at companies such as Novartis and Amgen, which are looking for ways to leverage remote work for years to come.

CDER employs roughly 5,600 on a full-time basis. It’s the division of the FDA that handles applications for new drugs, manages pharmaceutical manufacturing regulations, collects and analyzes safety data, monitors drug advertising and determines which medications require a prescription.

Upgrading CDER’s workforce was already underway before the pandemic thanks to the FDA’s 21st Century Cures Act, which Cavazzoni called “a real godsend” and “a game-changer.” It was signed in 2016 and has given CDER more salary flexibility.

Cavazzoni’s move to CDER, in fact, was a product of the legislation. It allowed the FDA to lure her from Pfizer in 2018 and put her second in command at CDER. Cavazzoni said that 20%, or roughly 1,000, of CDER’s employees are covered by Cures authority.

“It’s not a perfect solution,” Cavazzoni said during the webinar. “We are never going to be able to pay talent as much as the private sector does. But we are more competitive and we are also more able to hire faster.”             

RELATED: A ‘springboard’ to the future: Genentech, Sanofi and Alnylam execs sound off on pharma’s evolving back-to-work plans 

Cavazzoni said that she is monitoring the morale of CDER’s busy workforce as the organization plots the future “within the limitations of the government rules.” As CDER considers remote work in the future, a priority will be to ensure that technology is in place to “accommodate hybrid learning.” 



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