FDA Drug Safety Upgrades Coming; Medicare Bill Could Help Win Funding
This article was originally published in The Tan Sheet
Executive Summary
The Medicare prescription drug coverage legislation should help FDA make the case for additional funding for post-marketing surveillance, according to Center for Drug Evaluation & Research Acting Director Steven Galson, MD
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The Medicare prescription drug coverage legislation should help FDA make the case for additional funding for post-marketing surveillance, according to Center for Drug Evaluation & Research Acting Director Steven Galson, MD. "We think there is a case to be made if the federal government is going to get more involved in the funding of prescription drugs that a portion of that funding should go to investigating new methods of assuring safety of products," Galson said. "We're working closely in the Administration to get support for this idea. We have a lot of support for it," he said. "We've got a lot of exciting projects going on, and we hope that this will catch the imagination of Congress and even the private sector so that we can get more support over the next few years." The Medicare bill includes a request for an Institute of Medicine drug safety study, but its focus will be medication errors rather than adverse events. Galson met with the editors of "The Tan Sheet," for an interview Nov. 18. Director Janet Woodcock, MD, is on a detail to the commissioner's office, though her role could expand into a longer term posting (1 (Also see "CDER Deputy Galson Will Run Drug Center For At Least Six Months" - Pink Sheet, 13 Oct, 2003.), p. 7). FDA expects to announce a new initiative to upgrade the AERS adverse event reporting system this winter. "We've been doing this strategic look at AERS and where we're going," Galson said. "We hope to be able to talk about this real soon." "We have to move into 21st century information technology," Galson said. "We spend a lot of money on AERS, more than $5 mil. a year, and a lot of the money is spent taking paper reports that come in from drug companies and having people sitting down at computer terminals...and translating those paper reports into a format that can go into a database." "We have to figure out how to get them automatically into our database without someone sitting there keying in the data," Galson said. Instead of spending money on inputting reports, "we've got to focus those resources...on new ways of detecting adverse events early, weeding out the ones that are important from the ones that are routine and then acting on them earlier in the system than we do now." "When you think about the fact that electronic medical records are coming across the country, that information about adverse events may be in electronic systems within hours of when an adverse event is actually reported to a physician." "We really should be striving for a system that captures those adverse events, flags them to us as being important and lets us follow up much more quickly than we are doing now." Galson joined the agency in 2001 from the Environmental Protection Agency, where his background in risk assessment provided a good fit at a time when FDA was focusing on drug safety. Since then, the agency has secured additional resources for post-marketing surveillance under the third version of the Prescription Drug User Fee Act. "I think that really represents a sea change in the thinking in the industry and in society as a whole about this being a priority," Galson said. However, under current budgetary constraints, the agency will not have much funding available to pursue new projects in drug safety, Galson noted. During the recent Regulatory Affairs Professional Society annual meeting, Woodcock described the agency's lack of budget flexibility in stark terms, saying her goals for the center in 2004 included "making payroll"(2 , p. 12). One area that could be impacted is FDA's pilot programs working with other government agencies and managed care companies on active surveillance. However, FDA hopes to keep some of those projects alive. "There are a variety of really exciting things going on in this area, partially fueled by [Commissioner] McClellan's enthusiasm for information technology uses and applications in drug safety," Galson noted. "This is, as you know, a challenging budget year for us...so it is going to be difficult for us to fund a lot of new contractual projects." |