Gottlieb calls for FDA reform, investment to counter Chinese medical innovation

Former US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said the agency needs to undergo significant reform to address challenges to the medical innovation ecosystem from countries like China. He also cautioned against trying to stifle the flow of intellectual property (IP), which could limit Americans’ access to innovative foreign treatments.

Gottlieb spoke during a meeting hosted by the University of Southern California’s Shaeffer Center for Health Policy on 19 September to discuss the center's recent white paper recommending FDA reforms.

“I think long term, if I was to focus on what I think the biggest challenge is, it's really the secular threat from the ecosystem growing up in China,” said Gottlieb. He noted that traditionally, US drugmakers used to outsource the pharmacology of their drugs to companies in China, which would synthesize them based on specifications, and then send them back to the US for use in clinical trials.

Gottlieb noted that Chinese labs could synthesize the drugs faster and cheaper, and the division of labor was a win-win for everyone. However, over time, Chinese firms have become very good at designing their own novel drugs, which poses a significant challenge to US medical innovation.

"Instead of executing western blueprints, they've started to get into drug development itself, and the result is that you have an ecosystem in China right now where more than twice as many CAR-T trials are currently underway in China than in the US,” said Gottlieb. “The reality is that you're seeing a lot of global innovation shift to China, and as drug development migrates to China, American investments are migrating there too.”

Gottlieb said the actions recommended by USC researchers in a recent white paper on reforming the FDA are important to address the challenges China poses to the US medical innovation position on the global stage.

The researchers recommended six broad areas of FDA reform, including modernizing evidence generation, advancing innovation for rare diseases, enhancing supply chain oversight, strengthening the agency's accelerated approval pathway, investing in its oversight of artificial intelligence and advanced computing technologies, and advancing drug competition.

“There are some reforms we can make to how we design and execute clinical trials that I think can make it far more competitive here in the US,” said Gottlieb. “Our best lever for countering them is really going to be to think about how to modernize our regulatory framework, where we can streamline particularly early phases of development and give American developers the same edge in testing compounds that the Chinese now enjoy.”

Gottlieb noted that China has fewer requirements to protect patients and clinical trial participants, which gives it a competitive edge over the US in preclinical and early-stage clinical trials. While he said there is good reason why the US has more regulations and policies, he also noted there may be ways to maintain the same level of patient safety while making it easier for manufacturers to move from the preclinical to clinical stage of their product development.

Gottlieb also warned against putting up barriers to stifle the flow of intellectual property and prevent products from being developed in China.

“Beyond just creating an international arms race, if you will, an international fight over IP, we'll suddenly be tariffing the flow of intellectual property,” said Gottlieb. “The competition from other countries and the ability to license promising molecules and develop them here is important.

“They provide a lot of public health value,” he added. “There's no question that some of the molecules coming out of China are really important for public health here in the United States.”

Janet Woodcock, former acting FDA Commissioner, also spoke at the meeting. While she agreed with the white paper recommendations, she noted that the recent mass firings at the FDA make it challenging to implement the reforms. She added that stakeholders may have to find ways to move the needle by working together from the outside and taking steps such as creating their own standards.

"Because the agency's been so flattened and their policy staff demolished... what I've been telling people is, come together and lead from the outside," said Woodcock. "I think that people are very used to agency leading, but there's no statutory construct that says FDA has to come up with all these ideas and people can develop guidance externally.

"This is a time when we're not going to see a lot of technical output from the agency other than the actual review mechanics and the different centers."

USC white paper

Gottlieb calls for FDA reform, investment to counter Chinese medical innovation

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