On October 20, 2022, the Rare Disease Legislative Advocates (RDLA) hosted their monthly webinar. These webinar help provide updates to the rare disease community on legislation and other policy initiatives that are relevant to the treatment and management of rare diseases under the law. In this program, the speakers were addressed in a panel format to discuss the impacts of the upcoming mid-term elections and future prospects for bills that the rare community has been pushing for.
Panel speakers for this program included:
- Jennifer Bernstein, Horizon Government Affairs
- Cheryl Jager, Williams & Jensen, PLLC
- Daron Watts, The Watts Group
- Eric Gascho, National Health Council
As the year begins to wind down, the window of opportunity for new legislation to pass begins to narrow. Jennifer noted that the Prescription Drug User Fee (PDUFA) agreement that passed this year was ‘clean’ meaning that it wasn’t changed over the last version. Unfortunately, this means that many of the new provisions that the rare community was pushing for were not included. However, there may yet be other ways that these can move forward.
Thankfully, the political parties are as a general rule not strongly divided on most of the initiatives that the community is seeking. New bills like the Accelerated Approval Integrity Act could still be tagged onto a bigger bill at the end of the year.
Cheryl notes that for legislation that hasn’t yet received attention this year, the chances of it seeing any movement before the new Congress begins is relatively low. While the outcome of the mid-term election has yet to be decided, it’s likely that the Rare Disease Caucus will see some changes as some members are likely to get voted out. However, there is of course an opportunity in having new members join, and if you wind up getting a new member of Congress, making contact about the caucus is valuable.
Eric points out that the appropriations bills is the final big piece of legislation that must pass by December 16, 2022, and if anything is going to get tagged on last minute, it will likely be to this bill. The new Congress is likely to have new leadership for the relevant committees. Eric is optimistic about legislation related to clinical trial diversity and believes this has a good chance of passing in the next Congress regardless of what happens.
Daron notes that while there are differences between some Democrats and Republicans on how to address the needs of rare patients, there is a higher degree of interest in finding solutions when compared to more contentious political subjects. He notes that as new treatments such as gene therapies become more widespread, the systems in place will need to be changed in order to account for the impacts they can have.
Learn about this and more by watching the full recording of the panel, which can be found here.