POTUS's FY 16 Budget Request ... On Careful Reflection

Last Friday, I described the annual release of the President’s Budget Request as:

the chaos of 300 (or more) pages of text, dozens of charts and countless numbers ... and the imperative to make sense of it, pronto.

This, my follow-up column, is my chance to provide some analysis and context that fall under the category of “upon further reflection.”First, the Alliance is pleased with the overall budget request ($148 million) and feels good about the food safety request ($109.5 million). However, the rather meager amount being added to the medical products side of the ledger is disappointing. It is tallied as $33 million, but this is reduced by nearly $11 million that is intended to cover rent and facility costs. That leaves a net of $21 million for the implementation of the precision medicine initiative, drug compounding oversight, antibiotics development, FDASIA, drug and device security, and revision of the sunscreen monograph. The most charitable thing to say is that the proposed medical products monies are very thin for the level of new activity that will be required.Second, the President’s overall request for FDA is encouraging, but it is premised on Congress spending more money on discretionary programs than the constrained amount permitted by the Ryan-Murray budget caps. Our concerns are directly related to the negligible amount the caps will go up this year and the threat of a sequester. In this context, the President’s request for FDA is heartening, but perhaps not of very much relevance to appropriators looking at “very bad” and “worse” as the only two scenarios available. Sooner or later, Congress will have to resolve the taxes vs. entitlement portion of deficit reduction, loosen the budget caps or continue to chop away at vital infrastructure and services provided by agencies like FDA.Third, the sequestration threat may yet be averted. I was given new hope by an article in an American Enterprise Institute (AEI) publication, entitled “Ryan-Murray 2.0: Contours of a Price-Enzi sequestration ‘fix.’” The author’s goal is to find additional monies for defense spending, but acknowledges that this will probably require an equal amount of cap relief for domestic programs. Altogether, about $165 billion in budget savings will be required to offset the proposed increase in defense and domestic spending. The article then lists areas where agreement might be achieved and provides the budget savings that would be associated with each item. It still will be terribly hard to reach an agreement, but the list makes it at least seem possible.Barring rescue from the sequester and tight budget caps, we have already been told that the Ag/FDA subcommittee is likely to be allocated less money than last year, assuring a tight squeeze on all programs. The exact number is at least a couple of months off, leaving open the possibility that a budget deal could be fashioned before mark-ups start in mid to late May.Despite this fierce macro-budgetary landscape, our job at the Alliance remains, as it always has been, to be sure that Congress has a full appreciation of why FDA needs additional resources. As part of that, we have to show that existing monies are well-spent and that there is a strong rationale for prioritizing FDA over other pressing demands. To achieve this, please plan on joining the Alliance on February 18 for freshman/sophomore briefings on the House side and on March 18 for a broader set of meetings with House and Senate staffers on our annual Hill day.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.