Had a delightful dinner last night with Greg Simon, Global Head of Policy at Pfizer. Some meaningful thoughts he had. I’m summarizing, and mostly quoting a snippet that had meaning for me.

Greg: I was on the (Obama’s) FDA transition team, we interviewed people who have worked with FDA since 80s, we were in a windowless room, for 2 days in a row, talking to FDA. More than 1 person burst into tears. People have been there 10, 20, 30 years, no one has ever asked their opinion.  They are overwhelmed, underfunded, constantly criticised. They now have dynamic leadership, with the smartest people out there. The thing that I see that is challenging is now they (FDA leadership) aren’t asking the industry to do anything. I think it behooves the FDA to constantly ask the people from industry “What are you doing to make this better”. The budget at FDA is going up, but it has a lot farther to go. Currently 60% of the FDA budget is paid by the industry. This has to change, and PhARMA is trying to play a huge role in getting it there.

We are trying to put some game changers on the table with FDA, not about deadlines, but about attitude: attitude about safety, attitude about risk taking, attitude about what it means to introduce a drug into society. You can’t have a war against cancer without some casualties and patients are willing to take those chances, but FDA won’t let them. How do we convince people that it’s a game we all share, it’s not a game you play against somebody. Patients, doctors, drug companies, everybody have to be involved in sharing the risk, sharing the data, total transparency so they understand what works and what doesn’t.

We must put patients first in everything we do. We have to bring it up all the time. Patients are partners in everything we do, whether you’re a VC, pharma company, regulatory.  Urge us all to think, “how would it look if you’re in a hospital bed”. We have a lot more to do, a lot more to say. I urge you to do it with patients in mind. Don’t be shy with getting patients involved in this. If we delegate this to trade associations and government lobbyist, we all lose.

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