FDA Funding and 21st Century Cures

On Wednesday, April 29, the House Energy and Commerce Committee released the latest 200-page draft of its 21st Century Cures initiative. Media and a number of commentators were immediately abuzz with the news that the latest draft provides billions of extra dollars for NIH research and, despite all the new responsibilities, no new funding for the FDA.This made for good news stories, but isn’t a complete picture of the situation.NIH: Most federal agencies, including NIH, require an authorization of appropriations to be funded. By setting the NIH authorization ceiling several billion dollars above current spending, the 21st Century Cures draft sends a strong and clear message to appropriators that they would like NIH to receive more money. This is to be applauded and is consistent with a growing number of voices within the Republican Party calling for more biomedical research funding. However, like FDA, final funding for NIH will be determined by the appropriations committee, not the authorizing committee.Above and beyond this — and what is new and unique about the committee’s approach -- is that the Cures draft would also create a new NIH Innovation Fund ($2 billion per year for 5 years). This is intended as a mandatory program, not subject to the appropriations process. Further, there is a maintenance of effort provision so that the appropriations committee cannot lower NIH’s appropriation on the basis that the shortfall would be replaced by funding from the mandatory program.To create the Innovation Fund, the committee will need to find offsets from other mandatory or entitlement programs under its jurisdiction. Later, they would need to negotiate with either Senate HELP or Senate Finance, depending on Senate jurisdiction over the offset.FDA: The committee is definitely aware and accepts that FDA will have additional costs if Cures were to become law. This is a point that we have made in numerous meetings with E&C staff, as well as both times we had E&C speakers at Alliance quarterly member meetings. The committee is in discussion with the agency about the amounts that will be needed.Historically, FDA has not had (or needed) a separate authorization number (this is different from NIH). So, after ascertaining how much additional money is needed, the committee may not create a parallel provision to NIH’s authorization, but may find other ways to express its support for more funding (e.g., report language, letter to appropriators, etc.).The Alliance will be working to make sure FDA’s funding needs are well understood.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.