By Susan Wood
The recent study in the NEJM clearly points out that our drug safety system is in need of repair. We shouldn’t need these constant reminders, from Vioxx to Ketek and now to Avandia. Indeed FDA reform legislation is moving through Congress as we speak. But does it do what we need it to do?
The DrugWonks blog has accused those of us who are advocating for a more safety-focused FDA that is less dependent on restricted user fees of “bullying” the agency, but I only wish we were as powerful as they seem to think we are. The Senate bill, now known as S. 1082, the FDA Revitalization Act (new acronym: FDARA), unfortunately got weaker as it went through the process.
I’ll start with the good news. Some advances were made, largely due to the efforts of Senators Mikulski, Dodd and Grassley, along with other supportive Senators. These improvements include some proposals to strengthen the science: establishing an Office of Chief Scientist, requiring all new molecular entities to be brought before an advisory committee, expanding roles of the Drug Safety and Risk Management Advisory Committee, and establishing clear and timely policies for FDA scientists to be able to publish their scientific work. Other improvements increase transparency by having all review documents and a summary document on the basis of approval published promptly on the web (currently it can be many months before this information is made public), and establishing an Advisory Committee on Risk Communication as recommended by the Institute of Medicine report. Although there were minor improvements on increasing the role of the Office of Surveillance and Epidemiology (formerly the Office of Drug Safety), and FDA must now develop reports on how it is implementing the IOM report, much was left undone.
And much was undone during the process, which moved the bill backward. In the earlier version of the bill, all products would need a Risk Evaluation and Management Plan, even if it was a minimal one. The current version requires plans only if done voluntarily by the manufacturer or “if the Secretary determines that, based on a signal of a serious risk with the drug, a risk evaluation and mitigation strategy is necessary to assess such signal or mitigate such serious risk.” Sounds like most drugs won’t fit that category, since if FDA already had such a signal, some form of action would already be underway. Drugs like Avandia or Vioxx didn’t show such signals before approval. That’s part of the point of post market studies, that the signals won’t show up until more widespread use of a product occurs.
And access to study results is key. The fact that Dr. Nissen was able to use Google to track down some publicly available data led to his recent study. But the fact that he (and others in the research community and the public) can’t get access to all of it means that his analysis is not as complete as everyone would like.
The Senate bill also moved backward on this point, ensuring that we won’t have better access to this data either. The current bill only requires that data from “clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved is approved” should be linked to the clinical trials registry. Clinical trials are defined as “controlled clinical investigations, other than a Phase I clinical investigation.” The FDA is then given 30 months to develop regulations on how to require and release clinical trial data. This clearly leaves a lot of studies and analyses out of the database.
The chance at improving the drug safety system at FDA is tightly tied to the reauthorization of the Prescription Drug User Fee program. (See this white paper for background.) I along with distinguished colleagues have called for a return to direct appropriations as the funding source for FDA or for a stopgap reauthorization to give FDA and Congress time to move in that direction. The New York Times has called for a two-year reauthorization, and I hope that Congress will seriously look at that option.
The reality is that this is extremely difficult to accomplish. The forces arrayed in favor of the status quo are legion, and at this point advocates for a strong, independent FDA are not winning.
Susan Wood is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP).