Like the industry it regulates, the FDA finds itself in a slowly closing vise—squeezed between a mission that never seems to get much narrower and a budget that never gets much bigger. So we were interested to hear the comments of Douglas Throckmorton, deputy director in the FDA’s office of the director at the Center for Drug Evaluation and Research (CDER). The meeting was held last month in Boston.

Throckmorton began by reviewing a host of challenges and predicaments that the industry faces. He suggested that the FDA is energized to respond to both the wariness of the public and the weariness of an industry that often feels stigmatized.

“We really are fundamentally in a different kind of year,” Throckmorton said of the FDA. “We are in a transformative place. We are asked to do things fundamentally differently than we have in the past. We also have patients and clinicians who are telling us they want more information earlier to better understand safely how to use those marketed products. We have had increasing public and Congressional scrutiny. We also have accelerating new science.”

More Bodies

In the midst of a much larger agency-wide hiring binge, CDER itself is on track to add 600 people. Said Throckmorton: “The challenge is to integrate those people into the culture so they don’t just make it slower.  We don’t want to build a bigger guild. It’s an opportunity we need to guide.”

In a refrain the agency has expressed before, its technology was pegged as a key area that is destined for an upgrade. “Our IT infrastructure, our bioinformatics, is not going to suffice. Our server farms are old. We have science that is going to demand a much stronger bioinformatics platform. We just simply have to fix the IT or we are not going to be able to fix the other things we need to do.”

Computing Power

Some of that incoming computer power, he said, will be directed toward drug safety and epidemiology. One issue is the speed with which the agency can respond to a question from the scientific community or the anti-scientific community—the political world.  Said Throckmorton: “We need to be able to access those databases in a timely fashion to answer requests from Congress.”

The 2007 FDAAA legislation, he said, is the driver behind that, with a mandate to be able to analyze 100 million patients by 2012. “It is perhaps the most significant legislative change since 1962,” he said of FDAAA. “Congress and the public are paying attention to what happens. It is a complex set of legislation. There are things about it we’re still learning. CDER has to change to meet those challenges successfully. We have to transform our personnel and our processes.”

In all, he said, the agency recognizes that the new mandates and public scrutiny make it more dependent on its partners. “We will not be able to succeed alone,” he said. “We are going to need partnerships with many groups.”