Four Key Points for Hill Day 2016

For those who are participating in Capitol Hill Day — and those still considering it -- here are four key points (in bold) that represent our “ask” of Congress: The Alliance has characterized the President’s FY 17 budget request of +$15 million for FDA as “disappointing” and “alarming.” Spread over a $2.7 billion base, this request is basically level-funding. It is “disappointing” that the Administration has chosen to ignore the many ways in which FDA’s job will be larger and harder in FY 17 compared to the current year. It’s alarming because ... If FDA doesn’t receive more than the President’s request, the agency will have to choose among competing public health priorities. The consequences will be felt by patients and the American people, as well as the regulated industries.After reviewing the President’s proposed budget, the Alliance has recommended that FDA’s BA appropriation grow by $120 million. This would take the agency from the FY 16 funding level of $2.73 billion to a proposed $2.85 billion for FY 17. FDA’s need for a larger budget emanates from new legislative requirements, increased complexity of science, globalization, and homeland security activities. Specifically, the Alliance’s proposed funding increases will be used to: (1) carry out a number of medical product initiatives, such as biosimilars, drug compounding, and regulatory science (e.g., validating biomarkers, post-market surveillance) and (2) incrementally fund implementation of food safety activities.No unfunded mandates. Over the last decade, Congress has added significant new responsibilities to the FDA. Even this year, Congress has a number of bills under consideration for new initiatives, new programming and new missions at FDA. While the Alliance does not take a position on whether the bills should pass and become law, it is important that resources be added to match any additional workload given to the agency.These four messages need to be received by: appropriators, authorizers, and House and Senate leadership. They are the target of the Alliance’s Hill Day.To make Hill Day easier, here are a couple of FAQ’s (in bold) to help:Will I have to make these points one-on-one with Congressional staff? No. Each meeting is undertaken by a team of three or four Alliance members. Each team is led by a long-time Alliance member, who will direct the flow of the meeting. Ideally, each team’s members will be from different FDA stakeholder communities.Will I get to talk about the needs and concerns of my group? Yes. We want every Hill staffer to appreciate that FDA’s broad mission involves many diverse stakeholders. The Hill meetings will be run so that every Alliance member has the opportunity to provide their perspective on FDA. You can speak to how important FDA is to your group and also how adequate funding plays a role in bettering the agency’s dealings with your community.Do I have to commit to a whole day of lobbying? No. We can accommodate Alliance members who can only be available for morning or afternoon meetings.Please sign up by e-mailing Lynnette Bechtel. We look forward to your joining us.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.