One method of assessing postmarket drug  safety is through the collection and analysis of reports of adverse events  associated with drug use. We also found in 2006 that FDA faced constraints in its access to data that  allow it to monitor the safety of marketed drugs. Changes to FDA’s Postmarket Drug Safety Authority and Funding

The Food and Drug Administration Amendments Act of 2007 (FDAAA)  provided the agency with additional responsibilities intended to improve  its oversight of postmarket drug safety. However, as part of the MOA, FDA has transferred authority for one  regulatory responsibility related to premarket drug safety from OND to  OSE and plans to transfer authority for two postmarket responsibilities,  but has not set a time frame for doing so. Agency officials added  that coordinating some elements of the remaining responsibilities will be  more complex and OSE still needs to increase its staff to assume these  additional responsibilities. OSE and OND employees in our small group interviews generally  identified positive outcomes from FDA’s initiatives, although most OSE  employees indicated that OND still has more authority in the postmarket  decision-making process. With regard to  OSE’s influence in the postmarket decision-making process, 75 percent (39  of 52) of OND and OSE employees who completed our DCI indicated that  OSE’s influence has increased since 2006. An employee also said that  turnover among the safety project manager positions has made it difficult  for the individuals holding those positions to gain experience. FDA Is Revising Its Program for Resolving Scientific Disputes but the Changes Have Not Sufficiently Addressed the Independence of the Process

FDA is revising CDER’s program for resolving scientific disputes raised by  individual employees, but the changes do not sufficiently address our prior  recommendation for improving the independence of the process. FDA Plans to Implement New Adverse Event Systems and Is Increasing Access to External Sources of Drug Safety Data

FDA plans to improve its identification of drug safety issues by developing  new adverse event systems to collect and store adverse event reports and  by increasing access to external sources of data. FDA Increased Funding for External Data Acquisition and Is Beginning to Access Data from Federal Sources

FDA increased funding for acquiring the external data that it uses to  examine drug safety issues from about $5 million in fiscal year 2007, to  about $28 million in fiscal year 2008. FDA Is in the Early Stages of Developing a Network of External Data Providers Intended to Enhance Its Drug Safety Surveillance

FDA is also taking steps to improve identification of safety issues by  creating a network of external drug safety data providers, but the agency  is in the early stages of developing it. FDA Reports That New Postmarket Drug Safety Responsibilities Have Increased Its Workload and That It Is Challenged by Competing Priorities

FDA reports that new postmarket drug safety responsibilities and other  factors have led to an increased workload for which FDA has identified a  need for increased staff. OND medical reviewers described challenges meeting their premarket and  postmarket responsibilities. FDA indicated that  since the start of fiscal year 2008, OND increased its staff from 736 to 928  and OSE increased its staff from 114 to 193. Given the estimated workload increases identified in  the FDA contractor’s December 2008 review, OSE may be challenged to  hire staff quickly enough to meet its increasing workload. FDA Faces Technological and Staffing Challenges That Limit Its Capacity to Conduct a Growing Number of Postmarket Safety Studies

FDA officials said that they lack adequate computational capacity and  enough staff to make full use of external sources of data for drug safety  studies, and FDA expects the number of such studies to grow. An official  said the agency is reviewing approximately 43 candidates for potential  conflicts of interest, with the goal of filling the DSaRM vacancies as soon  as possible. As one of its efforts to enhance postmarket decision making, the agency  plans to transfer additional authorities from OND to OSE. Transferring  these authorities could help FDA better align decision-making  responsibilities with the division of expertise between the two offices. Specifically, we  recommended that FDA:  1.  revise and implement its draft policy on major postmarket drug safety  2.  clarify the Office of Surveillance and Epidemiology’s (OSE) role in  FDA’s scientific advisory committee meetings involving postmarket  drug safety issues, 3. improve the Center for Drug Evaluation and Research’s (CDER)  dispute resolution process by revising the pilot program for resolving  differing professional opinions (DPO) to increase its independence,  and 4.  establish a mechanism for systematically tracking OSE’s  recommendations and subsequent safety actions. This manual does not specifically address the role of  presentations by OSE staff in those advisory committee meetings.
Why GAO Did This Study

There have been long-standing concerns regarding the Food and Drug Administration's (FDA) oversight of postmarket drug safety. In 2006, GAO reported that FDA had not clearly defined the roles of two offices involved in making decisions about postmarket safety--the Office of New Drugs (OND) and the Office of Surveillance and Epidemiology (OSE). GAO and others reported additional concerns such as limitations in the data FDA relies on to identify postmarket drug safety issues and the systems it uses to track such issues. At that time, GAO made recommendations, including that FDA improve the independence of its program for resolving scientific disputes related to postmarket drug safety. In 2007, legislation further expanded FDA's postmarket responsibilities. This report examines the steps that FDA is taking to (1) enhance its processes for making decisions about the safety of marketed drugs, (2) improve access to data that help the agency identify drug safety issues, and (3) build its capacity to fulfill its postmarket drug safety workload. GAO reviewed FDA policies and planning documents, and interviewed FDA officials.

What GAO Found

FDA is beginning to address previously identified weaknesses in its oversight of postmarket drug safety issues, but challenges remain. The agency is changing its postmarket decision-making process as part of its Safety First Initiative, which includes formalizing interactions between OND and OSE and providing OSE with added responsibilities. The one authority FDA transferred from OND to OSE is a premarket review responsibility. FDA officials said the agency plans to transfer authority for two postmarket responsibilities for reviewing certain types of drug safety studies, but the agency does not have a time frame for their transfer. Officials said that OSE must still gain experience leading the one transferred responsibility and expand its staff before it can assume these additional responsibilities. While most of the OSE and OND employees GAO interviewed indicated that OSE's role in managing safety issues has increased since 2006, most OSE employees GAO interviewed said that OND's perspective still carries more weight in decision making. OND recently created safety management positions in each of its 17 divisions; OSE expanded its similar positions from 9 to 25, although an employee said turnover has made it difficult for the OSE managers to gain experience. FDA is also revising its program for resolving scientific disputes, but these changes have not increased its independence, as GAO recommended. FDA plans to implement new data systems and is increasing access to external data to assist with drug safety decisions. FDA plans to implement new systems in 2010 to improve the timeliness, quality, and analysis of reports of adverse events associated with human drug use. FDA has also increased funding for contracts with private companies and is in the early stages of forming partnerships with federal data holders to access external data. As mandated in the 2007 legislation, FDA is developing the Sentinel System, a network of external data providers intended to enhance drug safety surveillance, but the agency is in the early stages of developing it. FDA faces challenges meeting an expanding workload. The agency indicated that expanded responsibilities resulting from the 2007 legislation increased its workload, and both OND and OSE employees described difficulties meeting their responsibilities. FDA indicated that since fiscal year 2008, OND staff increased from 736 to 928 and OSE staff increased from 114 to 193. However, an agency review suggests that OSE may still need to more than double its staff of 193 by fiscal year 2011 to meet its new responsibilities. Although OSE has increased its staff, officials cited hiring challenges, such as competition from the private sector, that may make it difficult to hire staff quickly enough to meet the increasing workload. FDA also expects to complete a growing number of drug safety studies, but technological and staffing challenges limit its capacity to conduct these studies. To assist its decision making, FDA has increasingly sought advice from members of its external drug safety advisory committee. However, the agency has encountered difficulty filling several committee vacancies. An official said FDA is reviewing candidates with the goal of filling these vacancies as soon as possible.