Some Issues Continue to Raise Questions

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.