Additional Work and Additional Resources Must Go Hand-in-Hand

After a year of hard work, House Energy and Commerce Committee chair Fred Upton (R, MI) and Representatives Diane DeGette (D, CO), Joe Pitts (R, PA), Frank Pallone (D, NJ) and Gene Green (D, TX)< have pulled together a broad and encompassing direction for NIH, FDA, and CMS through the patient-centric “21st Century Cures.” This week’s health subcommittee mark-up was the first step, with full committee mark-up planned for May 21. Without question, the bill and the underlying process has been a primary focus for virtually every health group in Washington.Although the Alliance’s mission is increased resources for FDA through appropriations, the “Cures” bill also has our attention. We have no position on the substance -- our members represent too many diverse viewpoints -- but we are united in our concern that unfunded mandates not be imposed on FDA.As noted in last week’s commentary, FDA has been in this position before. Less than a decade ago, in 2007, the advisors on the agency’s Science Board issued a report that concluded that FDA’s problems were caused, in large part, by inadequate funding. This might be described as too much responsibility chasing too little money and too little manpower. Something (actually many things) had to give. The result was not pretty then ... and would not be now.We have seen this play out recently with the implementation of the Food Safety Modernization Act (FSMA). FSMA gave broad new responsibilities to the agency, but resource limitations have severely impacted the ability to implement this law. Will this same problem play itself out on the medical product side of the agency’s work for the Cures legislation?As passed by the subcommittee, there are 157 pages in the FDA section of the bill. The list of subtitles shows just how broad the bill is:

A. Patient-Focused Drug DevelopmentB. Qualification and Use of Drug Development ToolsC. FDA Advancement of Precision MedicineD. Modern Trial Design and Evidence DevelopmentE. Expediting Patient AccessF. Facilitating Responsible Manufacturer CommunicationsG. Antibiotic Drug DevelopmentH. Vaccine Access, Certainty and InnovationI. Orphan Product Extensions Now; Incentives for Certain Products for Limited PopulationsJ. Domestic Manufacturing and Export EfficienciesK. Enhancing Combination Products ReviewL. Priority Review for Breakthrough DevicesM. Medical Device Regulatory Process ImprovementsN. Sensible Oversight for Technology Which Advances Regulatory EfficiencyO. Streamlining Clinical TrialsP. Improving Scientific Expertise and Outreach at FDA

We have no doubt that the House E&C Members “get it.” You can’t load up this much responsibility on an agency and imagine it can be done within existing budgets.We greatly appreciate Representative DeGette’s steadfast focus on this issue. But we are looking for the committee leadership to publicly state this self-evident fact on a bipartisan basis. For all that FDA does -- and will be expected to do in the future == it deserves an authorizing Committee that recognizes that additional work and additional resources go hand-in-hand. We would be less concerned if statements had already been made and commitments acknowledged. We will be watching next week’s full committee mark-up closely, looking for a signal.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.