After a drug is on the market, OND staff receive information about safety  issues in several ways. FDA Lacked a Clear and Effective Decision-making Process for Postmarket Drug Safety

In our March 2006 report, we found that FDA’s postmarket drug safety  decision-making process was limited by a lack of clarity, insufficient  oversight by management, and data constraints. Decision-making Process on Drug Safety Lacked Clarity about Criteria for Action and the Role of ODS

While acknowledging the complexity of the postmarket drug safety  decision-making process, we found through our interviews with OND and  ODS staff and in our case studies that the process lacked clarity about  how drug safety decisions were made and about the role of ODS. In those reviews FDA indicated  that an absence of established criteria for determining what safety actions  to take, and when to take them, posed a challenge for making postmarket  drug safety decisions. A Lack of Communication and Limited Oversight Hindered the Decision- making Process

A lack of communication between ODS and OND’s review divisions and  limited oversight of postmarket drug safety issues by ODS management  also hindered the decision-making process. Another problem was the lack of systematic information on  drug safety issues. According to the ODS Director, ODS maintained a  database of consults that provided some information about the consults  that ODS staff conducted, but it did not include information about whether  ODS staff made recommendations for safety actions and how the safety  issues were handled and resolved, such as whether recommended safety  actions were implemented by OND. Data Constraints Have Contributed to Difficulty in Making Postmarket Safety Decisions

Data constraints—such as weaknesses in data sources and FDA’s limited  ability to require certain studies and obtain additional data—have  contributed to FDA’s difficulty in making postmarket drug safety  decisions. The availability  of these data sources has been constrained, however, because of FDA’s  limited authority to require drug sponsors to conduct postmarket studies  and its resources. FDA’s Initiatives to Improve Postmarket Drug Safety Decision Making

Prior to the completion of our March 2006 report, FDA began several  initiatives to improve its postmarket drug safety decision-making process. Most prominently, FDA commissioned the IOM to convene a committee of  experts to assess the current system for evaluating postmarket drug  safety, including FDA’s oversight of postmarket safety and its processes. IOM issued its report in September 2006. FDA also had underway several  organizational changes that we discussed in our 2006 report. FDA has also begun several initiatives since our March 2006 report that we  believe could address three of our four recommendations. To make the postmarket safety decision-making process clearer and more  effective, we recommended that FDA revise and implement its draft policy  on major postmarket drug safety decisions. To make the postmarket safety decision-making process clearer, we  recommended that FDA clarify ODS’s role in FDA’s scientific advisory  committee meetings involving postmarket drug safety issues. We also suggested in our report that Congress consider expanding FDA’s  authority to require drug sponsors to conduct postmarket studies in order  to ensure that the agency has the necessary information, such as clinical  trial and observational data, to make postmarket decisions. Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct- to-Consumer Advertising.
Why GAO Did This Study

In 2004, several high-profile drug safety cases raised concerns about the Food and Drug Administration's (FDA) ability to manage postmarket drug safety issues. In some cases there were disagreements within FDA about how to address these issues. GAO was asked to testify on FDA's oversight of drug safety. This testimony is based on Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process, GAO-06-402 (Mar. 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. For its report, GAO reviewed FDA policies, interviewed FDA staff, and conducted case studies of four drugs with safety issues: Arava, Baycol, Bextra, and Propulsid. To gather information on FDA's initiatives since March 2006 to improve its decision-making process for this testimony, GAO interviewed FDA officials in February and March 2007, and received updated information from FDA in May 2007.

What GAO Found

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. Insufficient communication between ODS and OND hindered the decision-making process. ODS management did not systematically track information about ongoing postmarket safety issues, including the recommendations that ODS staff made for safety actions. GAO also found that FDA faced data constraints that contributed to the difficulty in making postmarket safety decisions. GAO found that FDA's access to data was constrained by both its limited authority to require drug sponsors to conduct postmarket studies and its limited resources for acquiring data from other external sources. During the course of GAO's work for its March 2006 report, FDA began a variety of initiatives to improve its postmarket drug safety decision-making process, including the establishment of the Drug Safety Oversight Board. FDA also commissioned the Institute of Medicine to examine the drug safety system, including FDA's oversight of postmarket drug safety. GAO recommended in its March 2006 report that FDA take four steps to improve its decision-making process for postmarket safety. GAO recommended that FDA revise and implement its draft policy on the decision-making process for major postmarket safety actions, improve its process to resolve disagreements over safety decisions, clarify ODS's role in scientific advisory committees, and systematically track postmarket drug safety issues. FDA has initiatives underway and under consideration and that, if implemented, could address three of GAO's four recommendations. In the 2006 report GAO also suggested that Congress consider expanding FDA's authority to require drug sponsors to conduct postmarket studies, as needed, to collect additional data on drug safety concerns.