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Gains and Gaps in Knowledge about Shutdown Processes

April 19, 2019

In early January, the Alliance put out an “FDA shutdown toolkit” that was well received. We were working on a revised version when the shutdown (thankfully) ended. … READ MORE …

Advocacy at a Glance

April 19, 2019

Budget and Appropriations: Progress But No Clear Path Forward. The budget and appropriations situation was extensively briefed in last week’s Friday Update (here and more here) and Congress has been in recess since then. … READ MORE …

FY 20: The “Ask”; the Possible; and the Realities

April 12, 2019

Q:  We know that the late arrival of the President’s budget made it difficult to put together the Alliance’s FY 20 “ask.” Where did the Alliance finally come out?

A: The top-line; the Alliance is requesting $418 million in additional FDA programming for FY 20. Of that amount: $316 million is for medical products activities (the same amount as the President’s request) and $102 million is for food safety activities ($60 million above the President’s request). Our “ask” is built around a total number of dollars FDA needs and some general priorities for justifying that amount. We encourage Alliance members to support the Alliance “ask” and the general priorities we lay out. For Alliance members who are advocates for funding specific programs and initiatives within FDA, please utilize the Alliance position and supplement it with your own advocacy positions. The text of the Alliance “ask” is here. It is also described in slightly greater detail in the testimony that the Alliance submitted to the House and Senate Ag/FDA Appropriations Subcommittee. House testimony is here and Senate testimony is here.

Q:  Since January, every Alliance Q&A on the FY 20 appropriations process has said how difficult it is going to be. Are things getting any better?

A:  Maybe. One of the purposes of having Congress pass a joint budget resolution is that it provides top-line spending numbers (section 302(a)). Working within that amount, the appropriations committees then allocate a certain amount to each subcommittee (the often-cited 302(b) numbers). Sometimes House and Senate allocate different amounts to subcommittees, which can create a stumbling block to reaching agreement on specific appropriations bills. That pales in comparison to times when — in the absence of a budget resolution — the House and Senate adopt different 302(a) spending ceilings.

That’s where the FY 20 process (the current one) was heading and still may go. It is a very hopeful sign that Speaker Pelosi and Majority Leader McConnell are talking about a budget deal that might fix several impediments to a smooth FY 20 appropriations process. Presumably, they are looking for an agreement that would prevent the massive spending cuts that would be required by the spending limits in the Budget Control Act of 2011.  Also, it has been reported that House Appropriation Chair Nita Lowey has said that her committee staff are already working on setting 302(b)’s numbers so that subcommittees in the House can at least can get started.

Beyond that, we would hope they would agree on a common 302(a) spending number, so both House and Senate start allocating dollars to subcommittees using the same bottom line. A deal might also resolve how much defense spending will be placed under the Overseas Contingency Operations (OCO), which is designed to support the cost of military operations, i.e. wars, and does not count against spending ceilings. For purposes of agencies like FDA — that are part of the non-defense discretionary portion of the budget — there is a risk that routine DOD expenditures will get passed through the OCO and weaken efforts to keep non-defense growing by the same amount as defense.

Of course, there is no guarantee that a deal will be reached. Democrats and Republicans have different ideas on how to resolve their differences. But there will also be great pressure to find common ground and avoid further government disruption.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.

Advocacy at a Glance

April 12, 2019

Hearings on FDA’s Budget are Completed. What Next?  Both the House and the Senate have talked about accelerating schedules for FY 20 appropriations. The House leadership would like to have all 12 bills completed by July 1. Senate Appropriations Committee leadership has set as its goal getting all 12 bills out of committee by July 1. With the President’s request submitted to Congress and the Commissioner having testified before each of the subcommittees, the next step is subcommittee mark-up. The House usually goes first, but nothing prevents the Senate from marking up if they are ready to do so.

Congress is on recess for the next 2 weeks, so mark-ups won’t start before May. Historically, Military Construction/VA. Legislative Branch, and Defense are moved first, so the Ag/FDA mark-up is more likely to be mid-to-late May or early June. Also, there is strong sentiment to move Labor-HHS in tandem with Defense appropriations and eventually make them one bill. This was a successful tactic in the FY 19 cycle.

But Can Appropriations Move Forward Without a Budget Bill? The answer is yes, but the path is not an easy one. The most pressing issue is that the Budget Control Act would force more than $70 billion in defense cuts and more than $50 billion in non-defense cuts, relative to the final FY 19 levels. That isn’t going to happen and, reportedly, House Speaker Nancy Pelosi and Senate Majority Leader Mitch McConnell have agreed to begin talks on a 2-year budget bill that would re-set the caps to a level that Congress can accept. More about the current state of the budget process and implications for FDA are in this week’s Analysis and Commentary.

Thanks to All Who Attended the Last Two Alliance Events. This week, Anna Abram, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs, spoke to a large group of Alliance members. Her remarks covered a large number of FDA initiatives — and, as always, the number and breadth of FDA responsibilities is remarkable. In her speech, as well as in the question and answer session, she emphasized continuity. While Dr. Gottlieb will be missed, acting commissioner Sharpless has the same goals and Secretary Azar has also spoken about his commitment to policy and program continuity at FDA. At the end of March, the Alliance also had the honor of hosting one of Commissioner Gottlieb’s last public appearance as Commissioner. More than 100 Alliance members and media attended.

Dr. Sharpless Now Acting FDA Commissioner.  With Dr. Gottlieb’s departure on April 5, Dr. Ned Sharpless, NCI Director, has become Acting FDA Commissioner. He will serve until a new commissioner is nominated and confirmed. NCI is known to work more closely with FDA than many of the other NIH institutes, so he arrives with considerable knowledge about the agency and its responsibilities. At the time of his appointment as acting commissioner, the Alliance commented here.

Alliance Submits Testimony to Senate Ag/FDA Subcommittee. This week, the Alliance submitted its testimony for the record to the Senate Ag/FDA appropriations subcommittee. The testimony is here. More about the Alliance “ask” is contained in this week’s Alliance and Commentary.

What Chairman Hoeven Said, and Why

March 29, 2019

In his opening statement at this week’s subcommittee hearing, Chairman Hoeven noted that: … READ MORE …

Advocacy at a Glance

March 29, 2019

Commissioner Gottlieb Testifies Before the Senate Ag/FDA Appropriations Subcommittee. The Senate Ag/FDA Appropriations Subcommittee held a hearing on Thursday, March 28, to review the FY 20 budget request for the Food and Drug Administration. Members were complimentary of Commissioner Gottlieb and clearly positive about the FDA’s vital work and the need for the agency to be well-funded. The video of the hearing (about an hour) can be found here. Chairman Hoeven’s opening statement can be found here. While Commissioner Gottlieb’s opening statement — as presented — focused on opioids, his prepared remarks described FDA’s actual budget request and can be found here. Questions were primarily on opioids, dairy standards of identity, Farm Bill provisions related to hemp and the regulation of CBDs, the USDA-FDA agreement regarding the regulation of cell-based meat, and prescription drug pricing. This week’s Analysis and Commentary looks at the evolution of Congressional attitudes toward FDA.

Commissioner Gottlieb to Testify Before the House Ag/FDA Appropriations Subcommittee on April 3. The hearing will be at 9:00 a.m. on Wednesday, April 3. It will be held in Rayburn 2362-A, where the subcommittee has held past hearings.

House Appropriations Committee Sets April 5 Deadline for Public Witness Testimony for the Record; Senate Sets April 12. Every year, there is an opportunity for public (non-governmental) organizations to submit testimony for the Appropriations Committee record. This year, the House Ag/FDA subcommittee has set Friday, April 5, as the final day to submit testimony. The key documents are Instructions for Public Witness Testimony and Public Witness Truth in Testimony Form. We encourage Alliance member organizations to submit Statements for the Record. Information for Senate submissions (by April 12) is here. If you need additional information or assistance in preparing testimony for either the House or Senate, contact Roger Szemraj.

FDA Reorganization to Start March 31. Just in time for Acting FDA Commissioner Ned Sharpless to take over, Dr. Gottlieb has gotten approval for his reorganization plans. The key change is that the center directors will formally report directly to the Commissioner rather than through deputy commissioners. There were a number of other changes, many important, as reported here.

Alliance to Host FDA Deputy Commissioner for Policy on April 10. Alliance members and media are invited to our upcoming meeting with Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis at FDA. The event is on Wednesday, April 10 from 2:00 to 3:00 p.m. and will be at a convenient downtown DC location. Her remarks should provide valuable insight into FDA’s priorities for the rest of FY 19 and for FY 20. To RSVP, click here.

Senate Also on Accelerated Schedule to Pass Appropriations Bills.  As reported by Research!America (a long-time Alliance member), a key Senate staffer has told them the goal is for the Senate to complete mark-ups on all Appropriations bills before July 4. Previously, we had reported the House’s goal to pass all Appropriations bills by the end of June, an even faster pace. While it’s hard to imagine either body fully meeting those goals, it strongly suggests that bills are going to be formulated and moved earlier and faster than in recent years. The Senate staffer also confirmed that the Senate is considering pairing bills together (e.g., DOD and L-HHS), as was done successfully in FY 19. The House also is thinking along these lines (see here).

Gottlieb and McClellan: A “Fireside Chat”

March 22, 2019

Please join us on March 29 at 08:30 to 09:30 a.m., when the Alliance for a Stronger FDA will be hosting a conversation between current FDA Commissioner Scott Gottlieb and former FDA Commissioner Mark McClellan.

The conversation will focus on major accomplishments at the FDA over the past 2 years, and how those accomplishments will have a long-term impact on the FDA.

The location of the event will be at the offices of the Pew Charitable Trusts at 901 E St NW, Washington, DC

This event is open exclusively to Alliance Members and to members of the media in the order RSVPs are received.

To RSVP, please click here

For more information about the Alliance, its activities, or membership, contact Steven Grossman.

For more information on this event, contact Samantha Beard.