Plus ça Change, Plus c'est la Même Chose

In last week's column, I stated that “the Alliance is proud that over a 10-year period we have helped push FDA’s BA funding from $1.5 billion to $2.7 billion.”Long-time Alliance members will remember the terrible shape the FDA was in a dozen years ago. Others, especially those who have joined in recent years, may not. Here is some history on a vital, downtrodden agency whose resources finally started to grow, but whose mission and responsibilities have grown even faster.In the early 2000s, FDA was a hard-working agency that was overwhelmed by its responsibilities and was given few resources. In FY 2004, FDA received a budget authority (BA) appropriation of $1.4 billion, only $11 million more than it received in the prior year. It took three more increases before FDA finally topped $1.5 billion in FY 2007.The Alliance was founded just in time to add our support for FY 2007 funding, what was then considered a massive, year-over-year increase for the FDA: $77 million. That same year, we started what became an enduring graphic: comparing the $1.85 billion budget of Montgomery County schools (where FDA is located) to FDA’s BA funding of $1.55 billion. In subsequent years, we knew we were making progress because Hill staffers kept asking: has FDA caught up with Montgomery County schools?In late 2007, the FDA Science Board, an independent advisory committee to the FDA Commissioner, issued a 400-page report that concluded the state of science at FDA was highly problematic -- mainly due to lack of resources. The Science Board report provided an important judgment that FDA needed additional funds and was the catalyst for significant attention. Subsequently, then-FDA commissioner, Andrew Von Eshenbach, issued a highly-unusual, “professional judgment budget” that requested substantial new funds for FDA.At last, FDA’s resource woes were finally getting the attention they deserved! There were still critics who wanted to cut the agency, even though much of the agency’s problems were a result of too few dollars and staff. In the face of that, we are particularly grateful to the Members and staff of the House and Senate Ag/FDA appropriations subcommittee who -- then and now -- have worked with us to change the perception of FDA and become advocates for better FDA funding.As BA funding grew, there was hope that resources might catch up to the responsibilities. As an exercise, you can overlay today’s budget on FDA’s 2010 activities and imagine there is a good fit. But when responsibilities keep growing and other factors come into play, it becomes clear that more BA monies are still needed. So many things have changed, even in the last half-dozen years.New FDA laws and initiatives have grown massively: biosimilars, food safety modernization, compounding, drug security, patient-centered drug development, regulatory science, combating opioid abuse, and 21st Century Cures, plus a slew of non-user fee provisions included in 2012’s FDASIA and 2017’s FDARA. FDA’s mission has also broadened to include working with NIH and the private sector to support innovation. Meantime, food and medical product globalization has accelerated and the agency is faced with scientifically complex problems and opportunities that were unknown a decade ago.Hopefully, this helps explain my conclusion in last week’s column:

... our efforts are needed now, more than ever. Help us in the coming year to lead the stakeholder community in preserving and expanding the funding that FDA needs.