The recent Post-Approval Summit at Harvard, sponsored by technology firm Outcome, had several senior FDA speakers.

Paul Seligman, associate director of safety policy and communication at the Center for Drug Evaluation and Research at FDA, addressed the thorny topic of drug safety and post-approval trials. He spent some time reviewing material that was probably familiar to many in the audience. Fun fact: CDER has 1,500 employees, two thirds of them with advanced degrees.

But then Seligman launched into a much deeper and more forward-looking discussion, with hints about where the agency would like to go, should funding and legislation permit it.

As other FDA speakers often remind their audiences, he noted that the FDA itself had requested the recent Institute of Medicine report on drug safety, and that Congress is actively considering ways to implement some of it in legislation.

Safety Manifesto

Seligman reviewed a minor reshuffling at the agency designed to give safety a higher profile, and discussed long-promised updates to the existing systems to manage drug safety issues in clinical trials. “We are in the process of updating our adverse event reporting system. We are in the process of migrating to a web-based system.”

Seligman also mentioned the new Sentinel network, a proposed system for gathering spontaneous safety reports. There are transcripts of FDA hearings (and public comments) on that network at the bottom of this page. It’s clear that a variety of people from outside the industry are going to participate in the discussion about what Sentinel will be.

But in general, the agency’s reactive mandate and approach seem to have lost their luster. “We need to figure out a way to start applying these tools and analyses prospectively,” Seligman said.

IT Push

He’s relatively candid about the need for new informatics, and cited partners in the HMO and academic worlds that are already helping to design and build new databases.

Seligman seemed to suggest that FDA would improve access to its safety data, now available quarterly from the FDA using Freedom of Information Act (FOIA) requests, to be more easily accessible to those outside the industry. “It requires some sophistication to actually use our data,” Seligman said.

Communication Challenges

To be sure, he did not discuss any specific plans to change safety data publication policies. It’s not clear to us that Congress would permit that, or that industry would want it. But Seligman did allow that the agency is looking for general assistance in sharpening how it communicates. “We have enlisted some external communication consultants,” he said.

As part of that effort, Seligman said the FDA is planning to re-launch its own post-marketing newsletter (halted in 1999). There is no definite name for the publication yet, he said, but it will capture highlights of some of the 600 post-approval reviews completed by the agency every year. ”We’re not going to publish all of these,” Seligman said. “We hope it will be a valuable and informative piece of communication.”

Are Labels Enough?

Seligman acknowledged that the drug safety priority in years past was to transfer some of the knowledge acquired in a clinical trial to a drug’s label. Reading between the lines, however, it would appear the FDA no longer thinks approving (or modifying) a drug’s label should be its final, official public action on drug safety.

Said Seligman: “Historically, our communication was [to] make sure the label is right. I think the time has long since passed where we can simply rely totally on the label.”

Last year, Seligman noted, there were 960 label changes for 480 different drugs. There were 66 black box warnings in 2006. Within the agency, he said, one emerging issue is how all of that communication is filtering through to ordinary clinical care. “We have no sense to the extent to which that information is valuable and influencing practice,” Seligman said. “We are going to take a careful look at risk communication tools.”

More Dialogue

Indeed, he says the classical communication in the industry (between the sponsor and the agency) could stand to be expanded. It was far from clear how routine or substantive such communications might be. Or when they would begin. Or, for that matter, whether such communications are intended as ceremonial efforts to placate industry and agency critics, or as substantive scientific discussions. All that remains to be seen.

But Seligman seemed sincere in telegraphing the agency’s desire for input from non-sponsor stakeholders. “We have had very little formal feedback from health care practitioners, from patients or payers,” he said. “We really want to engage in a much broader, more open discussion.”

Seligman also lamented a shortage of peer-reviewed research on drug safety. “There is an acute need for research to improve safety,” he said. “FDA generally has not been able to fund such studies. We need partners, we need collaborators, we need consortia.”

Paper Demons

There is no question Seligman was hoping to address both internal and external critics who have savaged the agency’s good name since Merck’s 2004 withdrawal of Vioxx. What’s less apparent, for now, is the degree to which many of the FDA’s new initiatives will come to pass, or are best seen as gestures to deflect more radical changes to drug safety policy that are being contemplated by politicians.

Though Seligman did not issue a formal declaration about paper- or fax-based drug safety data, the subtext of his remarks was clear. The FDA’s reputation may depend on its handling of the next drug safety crisis. Mountains of paper (and the attendant inefficiencies) will be less than helpful in such circumstances. By the same token, it’s also possible to imagine a more rapid, technologically-supported response from the FDA as a rehabilitative tonic to its reputation.