Name: Kristen O’Neill; Hometown: Dallas, Texas; Position: Health policy adviser, Rep. Gene Green, D-Texas; Age: 26; Alma Mater: Wake Forest University
Washington Examiner: Legislation improving the discovery, development and delivery of medical cures that the House passed this summer is one of the biggest bipartisan bills in a while. How did you get to help out with it?
O’Neill: I started in a staff assistant role and since then kind of worked on a number of issues, but really started to go over the healthcare portfolio two years ago. Since doing so, [Green] became ranking member of the [Energy and Commerce] health subcommittee. My boss has always been a really committed legislator — I think that was his background at the state level — and really likes to advance policies and write bills and champion them. And so when the cures bill initially was announced, he was very enthusiastic.
Examiner: Did your boss contribute any specific components?
O’Neill: There were two pieces of legislation he worked on. The Software Act updates and provides some regulatory clarity to the FDA and health IT developers. There was a lot of gray area around whether or not certain information-based products were medical devices, like a calorie counter of an app … and so where do the regulatory lines fall. The Adapt Act follows up on [legislation] to give the FDA authority to approve a drug for a limited population of patients that have few or no treatment options. Both of those were natural fits in the goals of cures and both were included in the final package in a somewhat different form.
Examiner: How much time did you spend working on the cures bill?
O’Neill: During the height of when we were really writing the bill and gearing up to go toward a legislative hearing, we had blocked off four hours a day, every day, for weeks on end. I think there were about 10 members on [Chairman Fred] Upton’s staff, [Ranking Member Frank] Pallone had about seven, and then it was myself and Congresswoman [Diane] DeGette’s staff. And we obviously brought in the administration and stakeholders depending on what the subject was.
Examiner: Did anything get cut from the final bill you wish had stayed in?
O’Neill: There were some things I knew there was bipartisan interest in advancing, but it might not have fit under the umbrella of cures. I mean, when you talk about advancing the discovery, development and delivery of healthcare, you could argue that almost anything falls under that umbrella, so we had to keep it focused to a certain degree so it didn’t fall under its own weight.
Examiner: It’s rare these days for lawmakers to cooperate across the aisle. What was it like working with Republican staffers?
O’Neill: I think that is one of the things I took away from the cures process and appreciated so much. In this line of work, it’s really easy to get jaded or frustrated with the nature of the job, but it was a great reminder that while both sides have lines they’re unwilling to cross, there is a great amount of space between those two lines. The ability to work together and advance a truly meaningful, comprehensive piece of legislation was a great reminder of what we can do when we work together.
Examiner: How do you respond to concerns that the cures bill could unintentionally harm patients by allowing drug approvals without enough oversight?
O’Neill: While a full-scale, double-blind, hugely populated clinical trial is the gold standard, and we would like that to be the reality in all cases, it just isn’t feasible. We don’t want people to be exposed to undue risk, but we need some flexibility to trust the FDA to make the judgment call that’s best for patients. If you have no other options, you’re just willing to accept additional risk if you’re appropriately informed of that risk and able to make the decision for yourself.
Examiner: Did any personal stories of real patients motivate you?
O’Neill: There is this one young patient in our district who was born with her heart outside of her chest and is now a thriving and energetic 3-year-old. She has been up here twice, once when I first took over health and she was this tiny baby. And she visited a few months ago and is this energetic toddler running around challenging members of Congress to footraces. Congressman Green gave me this picture of her to put up on my desk for the long days.
