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Ansis Helmanis is a former FDA official and founder of RegLink Associates.
Jane Henney, MD, Former FDA Commissioner
Is the research-based industry less productive today than 30 years ago? To former Commissioner Jane Henney, the answer is straightforward. "I don't know of a time when industry hasn't been challenged," she says. Henney, the first woman to head the FDA, notes, "What has changed is the trend toward stronger discovery tools and the increasing number of discovery and development alliances with academia and others." Moreover, "the biotech sector today is similar to what Big Pharma—as it is called now—looked like 30 years ago before the consolidation, with more companies pursuing novel therapies but with limited marketing and development resources."
Jane Henney, MD
Her stamp on the agency was that of "being fair, firm, forthright, and, yes, sometimes tenacious." Those character traits served her in good stead when she fended off a push by the administration to place a number of political appointees at the agency. She reorganized the Office of the Commissioner along more traditional lines, by removing an inherited layer of political-appointee Deputy Commissioners and replacing them with senior FDA staff as her direct reports. She notes, "That extra layer of politics just didn't seem necessary to me."
In her opinion, "what makes the agency work are the career people who are responsible for execution and getting the work of the agency done." That recognition stemmed from her previous tenure at the agency when she served as Deputy Commissioner for Operations, a position that gave her a unique insight into the mission of the agency and how it worked, and left her with "an abiding respect for the career FDAers" that work diligently to fulfill that mission. When asked to return to Federal service to become the Commissioner she said the decision was a "no-brainer—I had hired most of the senior management at the agency and I could return to a team I knew and greatly respected."
Indeed, Henney relishes building strong teams and watching them flourish. Providing an environment and forums where the Center Directors could work together was one indication of this. She also noted that her directive to FDA staff was simple: "Look to our legal mandate and the scientific evidence and make your decisions accordingly. FDA always works in a climate that is filled with strong opinions and views so it is critical to stay grounded in the evidence that supports every decision—review or regulatory." In that regard, she followed the advice given to her by a former FDA Commissioner, Charlie Edwards: "You know what you're doing, so keep on doing it."
Henney sees several challenges facing the industry and the FDA, notably around the issue of reputation: the industry and the Agency will need to work in a more transparent manner to maintain public confidence. "What both do is simply a black box to many people, and when people don't understand what's happening or how and why things are done, they often jump to the wrong conclusions."
Another key driver of change for both industry and the agency in the next five years "is the economy and how it will be reshaped." For industry, reimbursement policy will influence how much can be reinvested to sustain ongoing discovery and development efforts. For the agency, the question will be whether the Administration will support—and whether Congress will appropriate—the necessary funding for the Agency to meet its many mandates. – Ansis Helmanis