Wednesday, January 3, 2024

Scott Gottlieb Op Ed: How FDA Should Regulate Disruptive Innovations

Header:  Scott Gottlieb publishes JAMA op ed on how FDA should approach innovation.


In the fall of 2023, I had the chance to hear two hour-long talks by Scott Gottlieb, who headed the FDA 2017-2019.   In October, he keynoted at the Value Based Cancer Care (VBCC) conference in New York City; in November, he gave a lead talk at the Personalized Medicine Coalition (PMC) conference in Laguna Beach.   I provided a detailed (and AI-assisted) report on his October talk at this blog, here.   At YouTube, you can see the video of his November talk at PMC, an interview with Tempus's Lauren Silvis, here

Now, see a new open access essay that captures much of his current thinking on FDA and regulation, at JAMA Health Forum - here.


Overall, Gottlieb advocates for a world where regulatory policies are as innovative as the technologies they govern.  But, he sees a pathway by using past experiences and established benchmarks to navigate the complexities of emerging medical technologies.   His three key points and case studies are:

  1. Begin with Established Processes: 
    1. Gottlieb emphasizes using familiar regulatory pathways for new technologies. This approach, exemplified by the FDA’s handling of the Apple Watch as a medical device, allows quicker market entry and gradual regulatory adaptation based on real-world use. It also includes a shift from product-based to a firm-based approach, where the manufacturer’s overall validation efforts are considered.
  2. Take a Risk-Based Approach to Regulation: 
    1. The essay highlights the importance of distinguishing between low-risk and high-risk activities in new regulatory fields. This was evident in the FDA's approach to regulating autologous stem cell therapies, which some parties argued were local procedures (and autologous), outside FDA purview.  FDA led by applying stricter oversight to higher-risk activities.
  3. Use Existing Authoritative Benchmarks: 
    1. The essay suggests leveraging established benchmarks and standards for evaluating new technologies, as seen in the FDA's policy for regulating next-generation sequencing.  FDA designated certain databases like ClinVar as valid, allowing test developers to validate their NGS product against FDA-recognized public databases
Gottlieb is writing a book on the history and promise of stem-cell-based therapies. 


Gottlieb opens his essay by talking about FDA & AI; though that is not the focus of his essay.   For a new STAT article on regulation and AI, outlook 2024, here.

FDA with Apple Watch (Dalle 3)