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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.

Continue Reading  Post-Election Life Sciences Policy Menu

Consistent with popular predictions and our prior posts, Congress made drug pricing a key item on its investigative agenda in the first year of the 116th Congress.  Several factors contributed to the uptick in congressional drug pricing oversight activity, including the elevation of new Democratic chairs in the House with longstanding interests in drug

  • Drug pricing presents intriguing political dynamics. Whether and what policy prescriptions actually come to fruition in the next two years remain to be seen, but the rhetoric around the imperative to lower drug pricing — and the political pressure to act — will be more intense than we have seen to date.
  • President Trump and

Today, the President will submit the Administration’s Fiscal Year 2019 budget blueprint to Congress.  The document will set in motion an annual process to analyze the substance, business implications and prospects for various proposals.  Draft documents have already begun to circulate that suggest that both the budget and a forthcoming addendum would, if enacted, have

The post-election period — from the lame duck congressional session to the first 100 days and beyond of a new Administration and Congress — is expected to be a time of extraordinary, if not unprecedented, public policy debate on issues that impact pharmaceutical/life sciences companies and interest groups. These issues present both significant threats and