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Surveillance Becomes More Active

Congress reauthorizes an act to increase tracking of post-market drugs.

By Catherine Varmazis

July 14, 2008 | Speakers at the recent Post-Approval Summit* left no doubt that we are entering a new era of “active surveillance” of post-market drugs with Congress’ reauthorization last fall of the FDA Amendments Act (AA) being the most recent legislative impetus for these changes.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), said that under the AA, CDER’s role in the safety of marketed drugs will expand both on the analytic side and as it acts more in “an influence mode” in the post-market phase. Woodcock said Title 9 of the AA, which focuses on post-market safety, was Congress’ response to many of the weaknesses they saw in FDA’s authority in the last 10 years as safety problems emerged. The new provisions give FDA the ability to require post-market epidemiologic studies of clinical trials at any time. FDA will be able to require sponsors to make safety label changes and to develop risk evaluation and mitigation strategies (REMS), which “intersect” with RiskMAPs but do not replace them.

The AA also mandates that the FDA build new ways to do active post-market surveillance, said Woodcock. “This is an historic shift from the idea that you do the clinical trial, throw the drug over the wall (from the FDA’s perspective) and then send us your Medwatch reports and let us know what happens.” Woodcock said the oversight required by the AA was not possible sooner because “we had a very small armamentarium—we didn’t have the technological tools for post-approval studies” 20 years ago.

New systems with privacy guards will have to be built to implement these changes, and the FDA will rely on public/private partnerships to build a distributed network for population-based studies and a multidisciplinary approach to the review of drug safety data. Plans are also under way to establish a center for advanced computational analysis of drug safety data, and Woodcock stressed that more scientists and informaticians will be needed to staff the center.

Needed: Data and Transparency
Mark McClellan, former head of the FDA and current chairman of the Reagan-Udall Foundation—a private/public organization chartered by Congress in the AA—also addressed the summit.

Citing legislative changes, public expectations, and technological gains, McClellan said, “It’s going to be a new world,” one in which lots more data will be available, and clinical trials will be more transparent. Active post-market surveillance is critical for the development of personalized medicine, he said, and if done right, will be “an opportunity to move away from current bifurcated, costly and time-consuming pre-market/post-market process” to a more continuous “improvement life cycle approach.”

The current practice of characterizing safety issues in Phase 3 will be replaced by a population-based approach in which drugs are monitored while in active, long-term use, he predicted. To accomplish that, the AA envisions the FDA and its partners having the capacity to do active surveillance on a population of 25 million Americans by 2010 and on 100 million by 2012. “Such an approach is very different from the current system based on ‘spontaneous adverse events report’ to manufacturers and one-off studies,” he said.

Key elements in such a system of post-market active surveillance include:

  • The ability to aggregate data in a HIPAA-compliant way using distributed networks and a consistent method of gathering data and reporting findings
  • Better biostatistical methods to enable adaptive trials, randomized trials, and better signal extraction techniques.
  • Better communication strategies. “We have to find better ways to talk to the public about what we know and why we don’t know more, and what steps are underway to fix problem.”
  • Better governance and a broad-based and transparent approach because most data will come from private sector.
  • Sustainability: “We should be able to learn a lot more without necessarily spending a lot more. It’s a different way of spending money—a redirection—and we have not yet worked out a way to do that,” concluded McClellan.


*May 14-15, 2008, at the Harvard Medical School.


This article appeared in Bio-IT World Magazine.

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