How would I improve the FDA?

People ask me some version of this question all the time, usually focused on the device center, since that is where I served in a senior position. The FDA and industry just negotiated the user fees for the next five years, and Congress will soon make that official, meaning the center's goals and focus will be set for the next 5 years.

In this setting, I decided to pick some key ways to improve the processes, systems etc., and even extended a bit into payment for medical devices. In the current FDLI Food and Drug Policy Forum, my proposal is published (available here).

Table 1 from the article gives an overview of the 4-part proposal.

There are many, many scientist/reviewers who gifted for both their scientific/technical skills as well as their creativity. The more their value is appreciated and celebrated, the better their impact.

And why have the creative people work on the mature, predictable products. Align the nature of the personnel with the expected nature of the work.

Read the article for more details, and share the article link freely. Perhaps Congress would see wisdom in considering at least #3, though that would require them to stand up to the AMA, which now controls the slow, bureaucratic and unnecessarily slow process of generating billing codes for new devices/procedures. Dissemination of important advances will happen faster by tackling this need.

Most of us work in the "pick the winner" world, and know that a failing program does not deserve "good money thrown after bad." Sometimes tough choices need to be made.

How would you improve the landscape of medical device development?

What about drug development?

These processes allow for outsiders to influence the outcomes.