Advocacy at a Glance

Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

• President’s FY 17 Budget Request for FDA: Disappointing and Alarming. Despite continued growth in FDA responsibilities, including multiple new initiatives, the President proposed only a $15 million increase in FDA’s budget authority appropriation. Spread over a $2.72 billion base, this comes to about half of a 1 percent increase. Food received a $26 million increase, offset by flat or lower spending on other centers and a decrease in appropriations support for rent payments. In response, the Alliance released a media release that terms the President’s request as “disappointing” and “alarming.” For a further discussion of the proposed FDA budget and the difference between FDA’s stated needs and proposed expenditures, see this week’s Analysis and Commentary.

• FDA Resources Don’t Match Biosimilars Demand. In House testimony, CDER Director Janet Woodcock has said that she lacks the manpower to address the coming wave of biosimilars applications. The biosimilars program is working on 59 proposed biosimilars for 18 reference products and advancing that many applications will strain the agency’s capacity.

• Califf Will Receive Senate Vote on February 22. Senate Majority Leader has filed a cloture motion so that a vote can be scheduled on confirming Dr. Califf as FDA Commissioner. Senator Murkowski has dropped her hold because she has been assured that FDA will take her concerns (about genetically engineered salmon) seriously. Also, the FDA’s updated plan for opioid drugs and addiction satisfied Senator McConnell, whose home state of Kentucky is heavily affected. Democratic holds on the nomination are expected to be overridden via the cloture process.

• House Republicans Clash over Budget Strategy. In a closed-door meeting, Republican leadership offered its members an opportunity to vote down the President’s budget request in a symbolic display of opposition. But the offer was made contingent on a subsequent vote to advance a budget framework to guide appropriators as they write spending bills this year. House GOP conservatives continue to balk at the budget framework negotiated last year by former Speaker John Boehner and Democrats, and are threatening to vote against the budget resolution unless it cuts $30 billion from agreed-upon spending levels. This resistance has prompted some Republicans to suggest that the House skip the budget framework altogether and jump directly to writing annual spending bills based on last year’s budget agreement. When asked this week, House Appropriations Committee Chairman Hal Rogers (R, KY) said he would support this plan. As Republicans negotiate on the budget, a Budget Committee vote is being planned for the last week in February, with the aim of bringing a bill to the House floor for a vote in early March.

• Problems with the Administration’s Request for NIH. Up until now, it has been primarily FDA that has had to deal with lofty statements in the Administration budget that are unmatched by the actual dollars proposed. For example, this year the Administration claimed an 8% increase at FDA; however, all but $15 million was either new proposed user fees or inflation-adjustments to existing user fees. Every year, we have to convince media and Congress that the headline (+8%) is different from the reality (+$15 million). This year, NIH has been hit with a similar problem. The President has claimed that the agency will get a substantial increase, but new monies would come from mandatory funding (unauthorized, subject to “paygo” requirements, etc.). Note that FDA’s proposed $75 million for participation in the cancer “moonshot” initiative is tied into the new monies from mandatory funding. Further, a billion dollars of NIH’s FY 16 base would be converted from BA appropriations to mandatory funding, putting NIH’s base at risk if the mandatory funding is not adopted.

• Fighting Zika Virus a Global Priority; Likely Source of Added FDA Funding. The White House requested $1.8 billion to fight the Zika virus (see attached fact sheet). The request includes $828 million for the Centers for Disease Control and Prevention (CDC), $250 million for the Centers for Medicare and Medicaid Services (CMS), $200 million for vaccine research and diagnostic development and procurement, $210 million for other response activities at the Department of Health and Human Services (HHS), $335 million for the U.S. Agency for International Development (USAID), and $41 million for the Department of State. The Administration intends some of the vaccine/diagnostics monies to go to FDA.