FDA's Current Initiatives May Or May Not Address Past Shortcomings -- Too Early To Tell, Still
(Posted by Tom Lamb at DrugInjuryWatch.com)
In March 2007 Marcia Crosse, a representative of the U.S. Government Accountability Office (GAO), gave testimony to Congress (the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives) about the current status of the FDA's ability to monitor and manage safety issues for prescription drugs that have been approved by agency and that are being used daily by patients.
According to a March 22, 2007 GAO publication entitled "DRUG SAFETY: FDA Needs to Further Address Shortcomings in Its Postmarket Decision-making Process", as Director of Health Care at GAO, Marcia Crosse was asked to testify on the effectiveness of the FDA’s ability to manage drug safety issues which emerged after the agency had approved a drug, also known as postmarket drug safety. The GAO publication provides this background:
This testimony is based on Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process, GAO-06-402 (March 31, 2006). The report focused on the complex interaction between two offices within FDA that are involved in postmarket drug safety activities: the Office of New Drugs (OND), and the Office of Drug Safety (ODS). OND’s primary responsibility is to review new drug applications, but it is also involved in monitoring the safety of marketed drugs. ODS is focused primarily on postmarket drug safety issues. ODS is now called the Office of Surveillance and Epidemiology....
In its March 2006 report, GAO found that FDA lacked clear and effective processes for making decisions about, and providing management oversight of, postmarket drug safety issues. There was a lack of clarity about how decisions were made and about organizational roles, insufficient oversight by management, and data constraints. GAO observed that there was a lack of criteria for determining what safety actions to take and when to take them. Certain parts of ODS’s role in the process were unclear, including ODS’s participation in the meetings of scientific advisory committees organized by OND to discuss safety issues for specific drugs. In the case of Arava, for example, ODS staff were not allowed to present their analysis of postmarket safety at an advisory committee meeting held to review Arava’s safety risks and benefits. (emphasis added)
As preparation for this testimony by Marcia Crosse, the GAO interviewed FDA officials and reviewed FDA documents in February and March 2007 in order to gather information on FDA’s initiatives since March 2006. Based on that work by the GAO, Ms. Crosse testified that the FDA has introduced some initiatives that, if implemented, could address some of the GAO's March 2007 recommendations that could improve the FDA's oversight of postmarket drug safety. She pointed out in her testimony, however, that none of these FDA initiatives was fully implemented as of March 2007, so it was too early to evaluate their effectiveness.
It seems, therefore, that the inability of our FDA to manage postmarket drug safety issues -- which has been in the spotlight since the Vioxx recall back in September 2004 -- is still a problem we need to be concerned with today.