FDA Drug Safety Reform Must Come From Outside Agency – Sen. Grassley
This article was originally published in The Pink Sheet Daily
Executive Summary
Oversight of the agency's drug safety functions is "going to have to be outside the FDA," Senate Finance Committee Chairman Grassley tells HHS Secretary Leavitt. Grassley still wants drug safety reviewers to have guaranteed independence from the Office of New Drugs, despite plans for a new Drug Safety Oversight Board.
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Internal FDA initiatives will not resolve concerns about the agency's drug safety oversight, Senate Finance Committee Chairman Charles Grassley (R-Iowa) said Feb. 16. "FDA oversight: if that is going to work, it seems to me that you're going to have to take ownership of it," Grassley said to HHS Secretary Michael Leavitt during a hearing on the department's fiscal year 2006 budget request. "It's going to have to be outside the FDA and not within the FDA," he declared. Grassley renewed his call to ensure the agency's drug safety reviewers are independent from the Office of New Drugs, noting that he is preparing legislation to that effect (1 (Also see "Sen. Grassley Wants "Independent" Drug Safety Function In FDA" - Pink Sheet, 18 Nov, 2004.)). "There needs to be some changes in existing law to make sure that if we're going to have an Office of Drug Safety, it's not under the thumb of the Office of New Drugs," he said. Grassley did not look for Leavitt's opinion on the matter during the hearing, stating "I'd just as soon have you not respond." Leavitt previously told Grassley that structural changes at FDA should await the completion of a wide-ranging review of drug safety practices by the Institute of Medicine (2 (Also see "FDA Drug Safety Review Will Consider Pros And Cons Of Separate Safety Agency" - Pink Sheet, 5 Nov, 2004.)). In the meantime, HHS unveiled plans to create an inter-agency panel primarily tasked with overseeing a new drug safety website; the so-called Drug Safety Oversight Board would make recommendations about management of the site (3 (Also see "FDA Drug Safety Oversight Board Will Include VA, Other Agencies" - Pink Sheet, 15 Feb, 2005.)). However, Grassley signaled that creation of the panel would not forestall his campaign for wider changes at FDA. "You could say the oversight board is going to make sure there is that independence, but I think there has to be some change to the machinery within FDA," he said. Grassley nevertheless expressed some support for the initiative, declaring that "it's always better to have more watchdogs and more checks on government agencies, and even more so when public health and safety are at stake." "A new drug safety board may contribute to oversight of the FDA," he said. Sen. Christopher Dodd (D-Conn.) also characterized plans for a Drug Safety Oversight Board as a positive but incomplete measure. "This is a step in the right direction, but it doesn't go nearly far enough," Dodd said Feb. 15, noting that he is concerned the board "won't have the independence or the authority to deal decisively with problematic drugs." "I'm also concerned that the agency won't have the resources to adequately oversee drug safety," he added. Dodd is sponsoring legislation that would create a separate Office of Patient Protection within FDA and provide it with a $100 mil. annual budget (4 (Also see "FDA Drug Safety Office Would Have $100 Mil. Budget Under Dodd Bill" - Pink Sheet, 21 Jan, 2005.)). Senate Health Committee Ranking Member Edward Kennedy (D-Mass.), who introduced his own proposal to augment the agency's resources for drug safety reviews, said the oversight board initiative "doesn't go nearly far enough." "It is critical that FDA's resources to monitor drugs be dramatically increased, and the FDA must be given the authority to require drug companies to initiate and complete appropriate safety studies," Kennedy said. - Andrew Dove |