The post-election Life Sciences policy menu can generally be described as lame duck leftovers and meaty oversight next Congress.
A number of “super riders” and other add-ons were ultimately not included in the 5 year re-authorization of the various FDA user-fee acts (UFAs), “clean” versions of which passed in the current Continuing Resolution (CR).
Since the must-pass UFAs are typically a vehicle for other health policy related reforms, stakeholders were understandably disappointed – but remain hopeful of moving their priorities during the lame duck session.
For what it is worth, there is some level of bipartisan support for attaching each of the super riders in the end of year package — including The VALID Act (Lab Developed Tests), Cosmetics reform, Dietary Supplement Reform, ARPA-H authorizing legislation and the PREVENT Pandemics Act — as well as a mental health package and targeted reforms that address, among other things, insulin pricing, clinical trial diversity and accelerated approval. But there are many competing priorities and time is short.
Next Congress will see attention to the landmark Medicare negotiations and other Rx price controls of the Inflation Reduction Act (IRA), which were unanimously opposed by the GOP. Efforts to repeal writ large are a non-starter — though bills have been introduced to do just that. While some Republicans might recognize the need to make substantive changes, politically that could also be a non-starter because, like with the ACA, there will be resistance to making what in their minds is bad legislation marginally less bad.
That said, Republican leaders have already indicated their intention to use oversight authority to force transparency around implementation by the Administration of the Rx price control provisions of the IRA. So there will likely be opportunities for industry stakeholders and patient advocates to make the case against the new law by substantiating criticisms that it undermines the value of patents and discourages innovation.
At the end of the day, there is some possibility that stakeholder consternation could force a revisiting of targeted IRA drug pricing provisions, including the one that dis-incentivizes investment in second indications for orphan drugs. The key will be to identify modest tweaks of the law that will be politically difficult to oppose on both sides of the aisle.
There remains bipartisan interest in other Rx pricing reforms, including PBM transparency. And drug importation remains a populist issue that brings together unlikely political bedfellows in the Senate, where proponents Rand Paul and Bernie Sanders might be the leaders of the HELP Committee. There should also be bipartisan support for 21st Century Cures II if someone on the GOP side assumes ownership in the absence of retiring champion Fred Upton.
For its part, the Biden Admin might attempt to use administrative levers to advance policies beyond what they could accomplish legislatively — one example being the recent Executive Order directing CMS’ Innovation Center to develop additional drug price reduction proposals. Like with IRA implementation, there will be opportunities for stakeholder input – directly with the Administration and in the oversight context with Congress.
The GOP is expected to press the Administration on its COVID response, including vaccine mandates, and – with the possible exception of telehealth flexibilities — push to roll back residual policies and block additional funding.
One potential vehicle for COVID rollbacks is the Pandemic All Hazards Preparedness Act, which is up for re-authorization. It will be interesting to see whether COVID fatigued Republicans have an appetite to consider pandemic preparedness again – especially in the absence of retiring HELP Ranking Member Richard Burr, who has been the GOP leader in this space.
Also look for Republicans to highlight supply chain issues, including reliance on China and other foreign-sourced pharma and health care products, as well as to address the continued opioid crisis and increased threat from fentanyl.
There was surprisingly little campaign focus on Medicare reform and the ACA; so these thorny political issues do not appear to be on the table in a significant way given the landscape – perhaps other than as possible oversight topics.
In sum, the health-related committees have a greater bi-partisan track record than most; there will be opportunities for cooperation going forward but the political will in the current environment is still TBD – in the lame duck and next Congress.