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.

• House Appropriations Bill Provides FDA with a $300+ Million Increase. The Agriculture/FDA appropriations subcommittee met this week to mark-up FY 19 funding. Under the subcommittee legislation, FDA’s BA funding would increase from $2.8 billion to $3.1 billion. The bill also provides $70 million for 21st Century Cures funding, which should be separate and additional because the funds come from the agency’s innovation fund and are not discretionary taxpayer (BA) funding. The Alliance’s press release expresses our deep appreciation for the committee’s leadership, notably Chairman Aderholt and Ranking Member Bishop. Their proposals would fund multiple initiatives “to enhance FDA’s role as a protector of the public health, while becoming a more thorough and efficient regulator.”

A summary provided by the subcommittee mentions: a $5 million increase in funding for the Oncology Center of Excellence, $38.5 million to advance modern drug and biological product manufacturing in the U.S., and $27 million for the modernization of generic drug development and review. There is also a reference to $30 million to fight opioid abuse, but it is unclear whether that is a total or an addition to FY 18 funding.

Just before the full committee mark-up, which has been scheduled for Wednesday, May 16, we would expect to see the committee report, which will have more details. We are told that the mark-up might be as early as the week of May 14. This week’s Analysis and Commentary looks at what we know and don’t know ... while we await the full committee mark-up and the committee report.

• Congress Advances User Fee Bills. This week, the House Energy and Commerce Committee adopted both H.R. 5554 (the Animal Drug and Animal Generic Drug User Fee Amendments of 2018) and  H.R. 5333 (the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. The first would reauthorize existing user fee programs relating to new animal drugs and generic new animal drugs. The second would create a new user fee program to modernize regulation of over-the-counter drug and consumer health products. Earlier, the Senate HELP Committee advanced bills intended to achieve the same purposes: S. 2434 (animal user fees) and  S. 2315 (OTC modernization). To the best of our knowledge, none of the bills are yet scheduled for floor consideration.