Focus Needed on Operations
What is to be done? Unfortunately, the CHI-BCG report offers no recommendations on a key question it raises: “How the FDA prioritizes drug reviews and when it chooses to use the tools at its disposal for accelerated approvals, does that align well or perfectly or not at all with public health needs? That’s a discussion we’d like to see and engage in,” CHI president and CEO David L. Gollaher, Ph.D., told GEN.
The CHI-BCG report is more valuable, however, in highlighting two FDA issues that it correctly concludes need attention: Its data collection and analysis as well as its review clock, which Dr. Gollaher likened to the stop-and-start clocks of basketball games.
“We think that a general look at the time from submission to approval in real time would be useful. But more, we want to encourage the agency to engage in a sophisticated discussion about what tools are out there, what algorithms and solutions are the most advanced as aids to decision-making,” Dr. Gollaher said.
That discussion should not result in much new legislation: “A lot of what we’re talking about is well within current statutory authority and is more a matter of managerial focus,” Dr. Gollaher noted. “The opportunity is for the agency to do what any great corporation does, which is to look to its best performance, and try to learn from that, and clone those procedures, activities, and techniques onto areas performing not as well.” He did, however, acknowledge that FDA lacks the flexibility that businesses have to hire, reassign, and fire staff.
One example might be improving the agency’s performance-tracking system, FDA-TRACK, to make it better live up to its acronym for “Transparency, Results, Accountability, Credibility, Knowledge-sharing.” And while FDA now requires electronic submissions, the resulting data deluge often doesn’t help the agency answer the key questions it must address in making drug decisions.