Key Take-Aways from Hill Day (Part One)

Our House meetings this week served as a reminder that -- despite the long hours and often low pay -- the Hill is still a place that attracts smart and inquisitive staff. Here are some of the questions we were asked, along with the answers.Q: Is ensuring a well-resourced FDA a bipartisan cause?A: Yes, a strong FDA is important to both Republicans and Democrats. Not only is FDA important to the public health, it promotes scientific and technological innovation and is a major part of sustaining and building our economy.Q: Is the Alliance requesting an increase in funding for FDA just because of the COVID-19 pandemic?A: No. Wholly apart from COVID-19, FDA’s responsibilities increased in 2020 and will again in 2021 and 2022. This is a combination of new areas where FDA is being called upon to act and existing workloads that continue to expand and become more complex.Q: Why doesn’t the $500 million increase in FDA funding (through the COVID relief bill) satisfy the agency’s need for additional resources?A: Acting Commissioner Woodcock addressed this question when she spoke to the Alliance on April 14 (transcript here). The bulk of the monies will be used for surveillance of COVID vaccines and therapies -- pre-market, during the EUA stage, and post-market. FDA is also going to invest in supply chains, advanced manufacturing, and recovery plans that address areas (such as inspections) that have been thrown off by the pandemic.Q: It has been a hard year for FDA. How is morale?A: A government-wide employee viewpoint survey was conducted in November and FDA employees had extremely high morale. As Acting Commissioner Woodcock told the Alliance: FDA staff “are very proud of what they have been able to accomplish ... and I am very proud of that.”Q: How do investments in data modernization improve FDA’s work and benefit the American people?A:The FDA needs substantial investment to modernize its data and technological systems. Among the limitations of current systems is the collection of information into data silos with no interoperability. In the food area, FDA’s lead initiative, the New Era of Smarter Food Safety, is dependent on new and better data collection systems to enable food tracing. In the medical products area, key safety databases need upgrades to assure that regulators and companies can make informed decisions.Q: Does greater government investment in the biomedical sciences and medical technology have an impact on FDA’s resource needs?A: Yes. For almost all medical products, the pathway “from bench to bedside” runs through the FDA. The agency is not just involved in product decisions at the end. FDA staff spends tens of thousands of hours working with patients, academic medicine, and industry to assure that non-clinical and clinical investigations produce data that meets statutory and agency standards. If public and private research funding increases, then the demands on FDA will also increase.Q: Why can’t the agency’s activities be paid for from user fees?A: Budget Authority appropriations pay for all of the public health activities of the agency as well as a substantial part of product reviews. User fees pay for specific program enhancements. The agency needs both. In a larger sense, the primary beneficiary of  FDA’s activities, as well as the agency’s largest concerns, is the American public. Americans need to maintain and expand their say in the agency’s mission.Q: Why did the Alliance not mention tobacco?A: The Alliance does not advocate on tobacco funding, nor does it have any members who are tobacco companies. The Alliance’s mission is to advocate for the appropriated resources available to the agency; whereas tobacco programs at FDA are completely paid for by industry user fees.Q: What is the worst-case scenario for FDA in the FY 22 appropriations cycle?A: For an agency with growing responsibilities and an expanding mission, an FY 22 Continuing Resolution at the FY 21 funding level would be devastating for FDA. The odds of that happening are impossible to calculate, but Congress is expected to struggle setting total discretionary funding levels (the so-called “302(a) number”). An impasse over total spending could result in Congress adopting a CR to prevent a government shutdown.Alliance members should be comforted by the fact that staffer after staffer acknowledged the importance and value of FDA action. But we cannot and should not take anything for granted. They want more information and the Alliance is committed to providing it to these offices.Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.