Advocacy at a Glance

Top-Line: The House will not return to DC until September 8 (for committee work) and until September 14 for floor votes. While the Senate is scheduled to return on September 8, as well, no specific floor or committee schedules have yet been announced. It is all but certain that FDA and the rest of the government will be funded under a Continuing Resolution. Party Platforms are reviewed, although they are probably not important. This week’s Analysis and Commentary describes the policy and political environment for FY 21 funding between now and the end of the calendar year.Reminder to Media: Friday Update is on-the-record. Further, we are always available to both our members and media to answer additional questions.FRIDAY UPDATE WILL NOT APPEAR ON AUGUST 21 AND 28. OUR NEXT EDITION WILL BE ON SEPTEMBER 4.Congress Out of Session Until September. Congress is out-of-session until September 8, with no House floor votes until the following week. Barring some unexpected breakthrough, negotiations on the fourth pandemic relief bill will not resume until September and may not ever pass. In light of that, it is unlikely there is either time or sufficient agreement to do FY 21 funding bills in September. That would mean Congress would need to pass a Continuing Resolution (CR) to fund the government from October 1, 2020, through some time after the election. This week’s Analysis and Commentary looks at the difficult path for FY 21 funding from now until the end of the year.Party Platforms Don’t Matter, Probably. Every four years, as part of the presidential election cycle, each party puts together a platform, a compendium of the positions that the party, and (supposedly) its presidential candidate, intend to follow if they win. Platform fights were often very contentious and very visible, but less so in more recent years. There is an argument that they are relics. So, it is hard to know how concerned to be about this year’s platforms.The 2020 Republican Platform (here) is verbatim repeat of the 2016 Platform. Thus, it repeats strong words about regulatory reform (page 28) and the mission of FDA (page 38). I think there is a good argument that after four years in office, the attitude of the Republican party towards FDA is different than it was in 2016.The 2020 Democratic Platform (here) does not, based on the table of contents, take positions on either FDA or regulatory reform. There are some references to the pharmaceutical industry in the context of affordability of healthcare (pages 26 and 27). From a policy standpoint, there does not appear to be anything there that is not already well-known.FDA, Vaccines and Public Scrutiny. There continues to be dialogue in the national media about the process that FDA will use to assure that any COVID-19 vaccine is safe and effective before being given to the American public. This week, Laurie McGinley of the Washington Post profiled CBER Director Dr. Peter Marks (here) and RAPS News had an extensive review of Dr. Hahn’s comments at the Reagan-Udall Foundation meeting (here). Last week’s Advocacy at a Glance also covered Dr. Hahn’s op-ed in the Washington Post on the same topic (here).Next Issue of Friday Update Will Be September 4. The Alliance wishes everyone a safe and healthy conclusion to Summer 2020.

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"Somehow the CR Will Pass", But When?

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CDER Priorities: During the Pandemic and for 2021