The 2010 annual Drug Information Association meeting began with a new dual-element musical interlude. The first composition amounted to elevator music, by an anonymous band inspired by the hard rock of Van Halen. The purpose of that aural interlude? To inspire and energize.
The second musical offering at DIA, a live string quartet (performers on stage with two violins, a viola and cello) was intended as an antidote to the first. It was about as different from the Van Halen as it is possible to be. Elegant and graceful, the classical ensemble seemed to have been hand-picked by the DIA leaders to introduce a note of serenity and calm into what is almost always a frenetic conference.
Game for anything, keynote speaker and FDA commissioner Margaret Hamburg tried to straddle both musical genres.
This might be challenging for some speakers. But Hamburg is not your average federal official. She spoke clearly, emphatically and with considerable charisma, much like her ultimate commanding officer, the current occupant of the Oval Office. That was the rock music. Hamburg was dynamic, energetic and, frankly, inspiring. She appears to be cut from different cloth than the long-slumbering U.S. regulators claiming to oversee the economy’s banking and energy sectors. Her Hamburg spirited intelligence left no doubts about competence.
Rock & Bach
But there was a classical aspect to Hamburg’s talk. A certain vague, anodyne, bromide-filled quality to her remarks seemed intended to relax a professional audience. Hamburg didn’t say, “relax, we appreciate how many regulations your companies are grappling with” but she may have been broadcasting that sentiment telepathically.
The main message of Hamburg’s talk concerned—stop the presses!—support for the importance of science. Not just any science, regulatory science. What does this phrase encompass? All of the assays and tests and principles that regulators themselves use to assess what industry does.
In a sense, regulatory science is to science what metadata is to data. The best way to understand regulatory science is to hearken back to the Critical Path agenda at the FDA. Hamburg didn’t utter that phrase, but she certainly seems to have been briefed on it and could be trying to rebrand it.
Noting that Abraham Lincoln had established a predecessor to the FDA in the 1860s, and that it had been located in a Washington, D.C. basement, Hamburg said she still feels the agency needs more money: “Today, we’re doing considerably better, though I too complain about the lack of adequate resources. We still do need more.”
Looking for Partners
One problem with mentioning money is that some of the sensible, mundane details of regulatory science could be beyond the education, background or intellectual depth of U.S. politicians who will need to splurge on it. Hamburg cited stem cells, an artificial pancreas and combination therapies as examples of priorities in regulatory science, and it was hard to imagine an American politician getting any of it, even with a briefing book from a staff member.
Hamburg also reviewed a range of newsworthy FDA priorities, including the inspection of massive quantities of imported food products and active ingredients in pharmaceutical products. In passing, she cited a huge upsurge in clinical trials overseas. But she did not delineate any big new initiatives or priorities in augmenting the agency’s staff or inspection activities outside the U.S. She offered only hints at what she might request. “We must bring our oversight in line with the reality of the global economy,” she said, keeping her comments on a noncontroversial plane.
In tone, her keynote address was harmonized to the same key as Barack Obama’s own silvery rhetoric. Hamburg was conciliatory and friendly, in regard to both the DIA and the industry in general. She opened the door for partnerships with DIA and industry—and left the audience with a warm sense of her as a person. “Regulatory science is a dynamic and import part of our scientific enterprise. It’s a field that I believe must be fully embraced by academia, industry and government,” Hamburg said. “We need new approaches. The truth is, this is not a task we can approach on our own.”d9A2t49mkex