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Some Issues Continue to Raise Questions

February 15, 2019

Q: In reviewing the conference agreement, the numbers don’t seem to add. Is the increase really $269 million?

A:  To be precise, the number is $268.6 million, which the committee appropriately rounded up to $269 million. Any seeming discrepancies can be accounted as follows: new monies are $271.4 million minus $2.8 million in proposed savings. That gives the net used in the bill summary and the Explanatory Statement.

Q: Which FDA programs received increases in the FY 19 conference final bill?

A:  For the medical products increases, appropriators specified: $47 million to combat the Opioid Epidemic, $38.5 million to Promote Domestic Manufacturing; $12 million for a New Domestic Drug Industry; $6 million for MedTech Manufacturing; $50.7 million for New Medical Data Enterprise; $25 million for the Growth and Transformation of Digital Health; $43.3 million for New Platform for Drug Development, including a $5 million increase to fully fund FDA’s Oncology Center for Excellence; $25.1 million for Modernizing Generic Drug Development and Review; and $10 million for Investment and Innovation for Rare Diseases. A brief description of each of the Administration’s initiatives — all of which received some money — is here, along with the initial House and Senate positions.

For the increases in food safety activities, appropriators specified: $2 million for FSMA Cooperative Agreements, $2.8 million for Food Import safety, $5 million to address Food Safety Outbreaks; $500,000 to test Antibiotic Resistance in Imported Seafood, $2 million for Standard of Identity and Product labeling; and $1.5 million increase for consumer education and outreach regarding biotechnology.

Q: What did we miss while concentrating on the shutdown and the Continuing Resolution?

A: The best story that didn’t get told: FDA had a significant amount of success in 2018. A lot was accomplished, and a number of year-end goals achieved (e.g., FDA approved 59 novel, first-in-class medicines, a record). Also, the Administration proposed a $400 million increase in agency funding, the most (by far) in many years. In turn, this received a positive response from Congress and has resulted in a $269 million increase in FY 19. FDA can be proud that policymakers across the political spectrum support the agency’s vital mission.

Q: Now that we are past the shutdown and the agency is funded for the FY 19 cycle, what are the prospects for a smooth FY 20?

A: Despite our year-round efforts to support FDA and the increasing bipartisan Congressional support for the agency, the fate of FDA is often affected by unrelated budget and appropriations issue. The recent shutdown is the obvious example. So far, we know of two possible controversies this year. First, the Budget Control Act of 2011 — intended to constrain discretionary federal spending into the 2020s — has been temporarily adjusted several times. Notably, FY 18 and FY 19 had higher ceiling caps than in law, but  FY 20 and FY 21 are not covered by any such arrangement. Based on FY 19 spending levels, meeting the FY 20 caps would require Congress to spend $71 billion less on defense programs and $54 billion less on non-defense programs, a situation that Congress will not be able to accept. Secondly, on March 2, the debt limit will be reinstated from its temporary suspension. As in the past, we would expect the Secretary of the Treasury to implement “extraordinary measures” to avoid defaulting on the federal government’s obligations. That would kick the fight out until mid-summer or early Fall, when it could upset negotiations over FY 20 funding.

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

February 15, 2019

Long Wait Is Over. FY 19 FDA Funding Will Be Set When the President Signs the Appropriations Bill. After the 35-day shutdown and weeks of negotiating both before and after, the entire federal government will be funded for FY 19 when the President signs the Appropriations bill. The top-line is exciting: a $269 million increase for FDA in FY 19, bringing appropriated funding to $3.068 billion. In addition to this total (not included in it), appropriators provided for the entire $70 million to be added to the FDA Innovation Fund, which was created by the 21st Century Cures Act.

The Alliance is extremely pleased with the FY 19 FDA funding increase, noting that it is almost a 9% increase. Further, $269 million is $35 million higher than the mid-point between the House and Senate numbers, reflecting strong Congressional support for the agency. We expressed gratitude to appropriators for their support. We also expressed appreciation for Dr. Gottlieb’s leadership in proposing large increases for FDA, which set the tone for the year.

Many of the details of the FY 19 appropriations bill were covered in yesterday’s announcement from the Alliance. Please find the FDA portion of the Explanatory Statement of the conferees here and the FDA portion of the bill text here. This week’s Analysis and Commentary looks at some details of the FY 19 FDA funding and some related questions about the year ahead.

House Ag/FDA Appropriations Subcommittee Postpones Hearing with Commissioner Gottlieb. The hearing was to be on “FDA — Status of Operations,” a topic on which there is a lot of interest both on and off Capitol Hill. The subcommittee has not yet announced a new date.

Annual Alliance Lobby Day — Mark Your Calendars — March 19. On Tuesday, March 19, 2019, the Alliance will be on Capitol Hill for our Annual Lobby Day. Unlike the more focused meetings we just completed, on Lobby Day we strive for the largest number of participants and meetings, so we can help educate Congress about the mission of FDA and the importance of it being well-funded. Please RSVP here.

New Date Announced: Alliance to Host FDA Deputy Commissioner for Policy. 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 Tuesday, April 10, from 2:00 p.m. 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. Please RSVP here.

Alliance Has Successful February 13 Meetings with Appropriators. Even while we were awaiting final resolution of FY 19 funding, the Alliance had 20 meetings on February 13 with the personal staff of members on the House and Senate Ag/FDA Appropriations subcommittees. Their interest and support for FDA was refreshing, reflecting the increasing awareness of the breadth of FDA’s responsibilities and the need for additional funding to carry out the agency’s mission. Next week’s Friday Update will have more details about what we heard. Meantime, our thanks to the many Alliance members who participated.

House-Senate Conferees Release Proposed Final Appropriations Bill

February 14, 2019

Late last night, the House-Senate conferees released the proposed final appropriations bill, applying to about a quarter of the government, including FDA. … READ MORE …

The Questions — and the Answers — Continue!

February 8, 2019

Q: If House and Senate conferees get a deal in place, what happens next?

A: Virtually all Members of Congress detest shutdowns, including, notably, Senate Majority Leader Mitch McConnell.  No matter how a shutdown comes to be, they believe that the American people perceive an institutional failure on Congress’ part. So, there is a lot of leadership and “rank and file” pressure on appropriators to find a compromise and avert another shutdown. The conferees gave themselves a February 8 deadline, leaving a week to get a bill drafted, pass both Houses and get a bill to the President. If he vetoes it, they will want to know if will he sign another short-term Continuing Resolution to avert a shutdown. Politico reported on Thursday night that a deal was more likely late in the weekend or on Monday, rather than on the target deadline of this Friday. Also, Politico said that House Speaker Nancy Pelosi will enforce the new House rule that bills — once finished — need to be available for 3 days for review before they can be voted on. So, the timing could be tight for a deal to become law by the deadline, next Friday, February 15.

Q: If House and Senate conferees don’t get a deal in place by early next week, does that mean there will definitely be a shutdown?

A:  No. There are a number of scenarios under which there would be no shutdown, primarily because no one benefits from a shutdown. Also, no one gains from a year-long CR — no wall, no expanded funding of homeland security, and no disaster relief, among other things. Congress really has little choice but to continue negotiating. Arguably, the real deadline is not midnight on February 15, but rather early morning on Tuesday, February 19. The federal workforce is greatly diminished on Saturday and Sunday. Monday, February 18 is President’s Day, which is a federal holiday. This scenario has occurred before and while such brinksmanship is undesirable, the long-term impact is small. Another possibility would be to pass another short-term CR to allow Congress more time to break the impasse. Finally, if a deal is in place, but the process (e.g., the 3-day rule) is not completed, the President has the ability to delay the start of the shutdown until the bill reaches his desk. This may have only occurred once. I am sure I have not enumerated all the possibilities for avoiding a shutdown. It still could happen and the lack of an agreement would be ominous, but Congress may use any of these tactics to give themselves more time.

Q: Is it unusual that the FY 20 process has started before the FY 19 appropriations are finished?

A: Actually, such overlap has become common over the last decade. If Congress were able to achieve “regular order” appropriations, then all  bills would be completed and signed into law by September 30. No overlap. Sometime in December or very early January, it becomes too late for the President’s budget request (in this case for FY 20) to include numbers or programs that were in the appropriations bill (in this case, FY 19). Finally, as is the case this year, if appropriations bills linger into February or March, Congress will have  already started hearings on the upcoming year.

Advocacy at a Glance

February 8, 2019

CR/Shutdown Countdown: One Week to Go. Not much has changed from last week. House-Senate conferees are hoping to have a deal in place by Monday, February 11, or sooner. What happens next is the topic of the FAQs in this week’s Analysis and Commentary, along with a question about the overlap of two funding cycles (FY 19 and FY 20).

Commissioner Gottlieb to Testify in Front of House Ag/FDA Appropriations Subcommittee. Dr. Gottlieb will be the sole witness at the hearing, which is scheduled for 10:00 a.m. on February 12 in 2358-A Rayburn. The topic is “FDA — Status of Operations.” The hearing will be livestreamed here.

Feb. 13 Meetings with Appropriators to Talk About FY 20. As we previously announced, on February 13, the Alliance will be meeting with personal staff of members on the House and Senate Ag/FDA Appropriations subcommittees. We already have a good group of people signed up, but can use a few more. If you are available to help for a half day, RSVP to Samantha Beard and tell her whether you are available in the morning or the afternoon.

Annual Alliance Lobby Day — Mark Your Calendars — March 19. On Tuesday, March 19, 2019, the Alliance will storm the Hill for our Annual Lobby Day. Hold the date and we will be asking for RSVPs in a couple of weeks. Unlike the more focused lobbying on February 13, on Lobby Day we strive for the largest number of participants who can help educate Congress about the mission of FDA and the importance of it being well-funded.

Things You Didn’t Know About FDA.  In response to a question about drug inspections, Dr. Gottlieb  tweeted that the number is going up. The chart appended to his tweet shows how the numbers have changed and the increases from FY 13 to FY 17 .

Members’ Questions Are Still Flowing In

February 1, 2019

Q: Apart from the border wall negotiations, what other steps is Congress taking to avoid or reduce the impact of the next shutdown?

A: Almost universally, Members of Congress did not want the shutdown to occur. There was even a deal, ready to go, that would have extended the CR into the new year in order to avoid the shutdown on December 22. By the time the new Congress was sworn in on January 3, 2019, the shutdown had become a source of embarrassment for most Members. The New York Times article on the topic, here, even bore the headline: “With Pain Still Fresh, Lawmakers Make Push to Outlaw Shutdowns.” The text that the House-Senate conferees are negotiating now also reflects the mood. One of its provisions would permanently end government employee furloughs and agency shutdowns.

Q: What could help FDA to better weather the next shutdown?

A: FDA, legislators, and stakeholders are likely to grapple with this question over the next few months. Thus far, there just hasn’t been enough time to have perspective on what’s needed. There is, also, a chance that Congress will enact legislation to permanently end government furloughs (see the prior question). That would reduce the need to look for FDA-specific changes. Even so, it seems likely that FDA’s shutdown experience will be examined to see how the agency could do better in other situations where only part of the staff  is available.

Q: I see that there are lobbying meetings on the Hill on February 13 and the Alliance’s big lobby day is on March 19. I’d like to participate, but don’t know what I should be saying to help the FDA receive better funding.

A: The Alliance schedules prep calls with participants before Hill meetings, so that everyone can hear the goals for the day and the message we need to deliver. More general, but always quite effective, is to be able to tell a Member of Congress or their staff: “My organization supports a well-funded FDA because ….” We can help you with that, as well.

Important to repeat from last week:

Q: Once we are past the shutdown and the FY 19 cycle, what are the prospects for a smooth FY 20?

A: Congress passed the Budget Control Act of 2011 to constrain discretionary federal spending over the following decade. Later negotiations have altered or bypassed, caps in a number of years. Notably, FY 18 and FY 19 had higher ceiling caps than in law. FY 20 and FY 21 are not covered by any such arrangement. Based on FY 19 spending levels, meeting the FY 20 caps would require Congress to spend $71 billion less on defense programs and $54 billion less on non-defense programs. So, there is every reason to the think the FY 20 process for raising these budget caps will be contentious. If so, appropriators may not be able to move bills because they won’t know how much money is available to spend.​

Advocacy at a Glance

February 1, 2019

February 15 Is the New Deadline; Negotiations Begin. After a Continuing Resolution was passed by Congress and signed by the President, FDA employees (and several hundred thousand other federal workers) were told to report back to work. Congress has given itself until February 15 to work out a funding bill that the President will sign. House-Senate conferees began negotiations this week, but it is hard to see how they can reach an agreement that the President will sign. Right now, the only common thread among the conferees is that “no one in Congress wants another shutdown.” If there is no agreement and no extension of the Continuing Resolution (or a CR is vetoed), then the shutdown would resume.

If Border Wall Impasse Is Resolved, Final Bill Should Contain $268 Million Boost for FDA. About 10 days ago, the Appropriations Committees released the House-Senate conference agreement for the bills covered by the Continuing Resolutions in place since the first day of the fiscal year. As a result, the FDA will receive a $268 million increase in FY 19 if (and only if) the FY 19 appropriation bill becomes law (not a continuing resolution). At this time, the House-Senate negotiators on the border wall impasse appear to be working from the conference numbers, which makes us optimistic. The worst-case scenario for FDA would be if Congress passed a Continuing Resolution through September. In that case, FDA would be funded at FY 18 levels and would receive no increase.

This Week’s Analysis and Commentary Contains New FAQ. This week’s questions cover: efforts to prevent or ameliorate the impact of a shutdown, generally and on FDA; preparation for participating in Alliance Hill meetings; and prospects for a smoother pathway for FY 20 appropriations.

Republican Members of the House Ag/FDA Appropriations Subcommittee. Jeff Fortenberry (R-NE) will be the new ranking  minority member on the House Ag/FDA Appropriations Subcommittee. Also on the subcommittee will be Rep. Robert Aderholt (R-AL), Rep. Andy Harris (R-MD), Rep. John Moolenaar (R-MI).

Feb. 13 Meetings with Appropriators to Talk About FY 20. As we previously announced, on February 13, the Alliance will be meeting with personal staff of members on the House and Senate Ag/FDA Appropriations subcommittees. We already have a good group of people signed up, but can use a few more. We particularly encourage food safety advocates to sign-up. If you are available to help for a half day — either morning or afternoon — e-mail Samantha Beard to RSVP.

Annual Alliance Lobby Day — Mark Your Calendars — March 19. On Tuesday, March 19, 2019, the Alliance will storm the Hill for our Annual Lobby Day. Hold the date and we will be asking for RSVPs in a couple of weeks. Unlike the more focused lobbying on February 13, on Lobby Day we strive for the largest number of participants who can help educate Congress about the mission of FDA and the importance of it being well-funded.