Hours after President Biden was inaugurated on Tuesday 19th January 2021, Dr Janet Woodcock was named as acting commissioner for the Food and Drugs Administration (FDA). “The FDA’s public health work is more critical than ever as we continue to fight this global pandemic… The American people can be certain that science – above all – will continue to guide the FDA’s regulatory actions now and into the future,” she said in a statement.
The Biden administration has not yet nominated a permanent commissioner, but Dr Woodcock is one of the candidates under consideration, according to several media reports. She has worked at the agency since 1984, serving in a variety of roles, most recently as the head of the FDA’s Center for Drug Evaluation and Review.
PharmaBoardroom spoke to Woodcock last year in an exclusive interview that could serve as a blueprint for her tenure. She touched on a host of current hot-button issues, from the challenges of the approval process to the high prices of therapeutics in the US and how new technology is transforming the healthcare industry and system.
From the get-go Dr Woodcock defined her role as one of public service above all. “My focus has been on ensuring that we do the very best for the public… We need to keep up with the pace of change – both scientific and social – and continuously improve and evolve,” she told us.
The high, and still rising, cost of medications in the US was one of her primary concerns: “on the social side, one of the really big issues is drug prices in the USA. That is affecting us in many ways… Obviously, there is a lot of interest in us improving competition in the USA… There is tremendous pressure. We do not set drug prices, but we are approving these drugs, and some of them end up with outrageous prices.”
When asked for solutions, she pointed to their generics and biosimilars programs and the proposal to import drugs from Canada. But Dr Woodcock cautioned that the price of medications is only one part of the equation, explaining that it is the whole treatment process in which fees for service end up making patients go through a higher amount of testing.
I believe that data and AI may be game changers, but not in the immediate future
Dr Janet Woodcock
Since last year around 41 percent of the FDA’s approvals were novel approvals for rare disease, the new Acting Commissioner revealed that part of the reason is that Congress gave them some appropriations to help move them along. “That is a big change from two decades ago when most development was in common diseases, antimicrobials, cardiovascular diseases and so forth.”
Dr Woodcock clarified her stance on the role that big data will play in the future of healthcare. “I believe that data and AI may be game changers, but not in the immediate future. We have made a huge amount of effort in this space with the Sentinel initiative, which covers several hundred million lives, in claims data, and we have been told to use real-world evidence (RWE). However, the old maxim about data – garbage in, garbage out – still holds. Honestly, the European healthcare systems are in better shape. There is more standardization. US electronic healthcare records are not interoperable. Even within electronic health records, a lot of the terms are not standardized. There is a huge problem of noise in the system,” she added.
But data, particularly real-world evidence, seems to be, at least for her, part of the key: “Conducting clinical trials is becoming impossibly expensive. It is the most expensive part of drug development. There is a hope that by using real-world data or evidence, that they can make their trials smaller or substitute data for trials. There is a lot of hope that data can provide a solution to this.”
“We are working with companies and we have certainly done approvals based on registry data as a comparator for rare diseases for example. We are funding experiments where you do observational studies in parallel with one of these confirmatory trials, and then, we can see the performance characteristics… we may learn some things from that, but we are not at a stage where we can make a lot of decisions based on these kinds of data,” she said.
A graduate of Bucknell University and Northwestern University Medical School, Dr Woodcock is a specialist in internal medicine and rheumatology, which has served her well in her career. “The agency hired me in 1986 because I had expertise in monoclonal antibodies. And so, a few monoclonals were approved over the next couple decades. But monoclonals have only really hit their stride in the last decade. So, what happens is that it takes technology time to settle down once they get into humans – it is not as easy as it seems… Things have really changed from way back then when it was all laboratory mumbo jumbo and people didn’t actually know how to do things reliably,” she said.
Finally, reflecting back on her long tenure at the FDA, the new Acting Commissioner explained that “the most dramatic change has been the genomic revolution, it has really taken over drug development so to speak. We get a lot of genetically targeted therapies now, we can diagnose disease better because of genomics and so forth. The cancer drug revolution is driven by understanding the somatic mutations that underlie cancer and maybe targeting those.”
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