Life Under the Continuing Resolution

Top-Line: Alliance members and media should sign up to listen to CDER leadership discuss their priorities on a special Alliance webinar (see below and in this week's Analysis and Commentary). FDA is working under the CR. Congress is in and out of town, with the key variable being whether there will be another COVID-19 relief bill. A new survey shows Americans, on a bipartisan basis, continue to support science and science investment.Life Under the Continuing Resolution. Given how busy FDA has been in FY 20, continuing that level of funding and personnel should not create any short-term problems, at least as far as we are aware. The most immediate impact of the Continuing Resolution (which runs through December 11) is that no new activities can be undertaken and long-term planning is made more difficult. At some point, FDA will need additional funding in FY 21 to cover its expanding set of responsibilities. The Alliance has articulated this point on many occasions. In addition, last week’s Analysis and Commentary (here) explores this topic in more detail.Congress: In, Out or In-Between? The House is in recess until November 16. Members have been told that votes may be scheduled before that date, but they will be given at least 24 hours advance notice to return to DC. We do not anticipate Speaker Pelosi triggering this recall to Washington unless there is a deal on COVID-19 funding that requires a House vote.Meantime, the Senate is in recess until October 19, although Supreme Court hearings will occur next week. No actions, other than moving judicial nominations, are anticipated before the election. However, Majority Leader McConnell will need to carefully consider how to position the Senate if COVID-19 relief talks resume. He has 20 incumbent Republican Senators up for re-election next month. Eight of them are on Roll Call’s list of the 10 most-vulnerable Senators.Dr. Cavazzoni and Dr. Stein to Address Alliance Members and Media on October 16. Next Friday morning, the Alliance will be hosting a webinar with Acting CDER Director Patrizia Cavazzoni, MD and Director of the Office of New Drugs Peter Stein, MD. The date and times are: October 16 from 9:30-10:30 a.m. To sign-up to participate, please contact Reed Diskey. The event is limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman. This week’s Analysis and Commentary describes some of the areas that we expect Dr. Cavazzoni and Dr. Stein to address.COVID-19 Negotiations at a Standstill; Minor FDA Provisions Included in House-Passed Bill. When negotiations on COVID-19 funding bogged down, House Speaker Pelosi decided to move forward with a comprehensive relief act, albeit quite a bit smaller than the House’s prior bill. The bill passed the House and now represents a marker should negotiations resume. We were able to find only two FDA-related provisions in the House-passed bill. The first would provide FDA with $1.5 million to hold one or more advisory committee meetings on coronavirus vaccine applications. The other is titled “extended shelf life dates for essential devices.” It provides FDA with the authority to require manufacturers to submit information pertinent to an extension of medical device shelf life dates in cases of shortages or material slowdowns during public health emergencies.​Commitment to Science Remains High Among Americans. Alliance member, Research!America, released a survey this week documenting broad bipartisan support for science among Americans. While the poll tests support for science in broad terms, this is good news for FDA and other public health agencies who depend on public support for science in order to fulfill their missions. Among the survey findings: overwhelming majorities of Americans say science benefits them personally, want America to maintain its global leadership in science, and agree the U.S. is at a critical point for committing to a major new initiative to assure health, security, and prosperity for the nation. One area of concern: adults aged 18-29 appear to see science as less consequential to our nation’s future.