The Unregulated Regulator
We all depend on the US Food and Drug Administration to enforce standards that keep our drugs safe. We expect the agency to set clear guidelines for consumers and manufacturers to follow. We also assume that the agency has standards for its own activities and ways of ensuring that agents comply with those standards. Unfortunately, a recent report from the US Government Accountability Office (GAO) shows that FDA has not entirely lived up to our expectations.
FDA’s Office of Criminal Investigations (OCI) conducts criminal investigations into activities such as the manufacture of counterfeit drugs and illegal drug marketing. FDA managers created a plan to evaluate the investigative and administrative procedures at each of OCI’s six field offices at least every three years. GAO found, however, that only about 30% of the required investigations have been performed to date, none of them during the required three-year time period.
The Office of Internal Affairs (OIA), another office within FDA, investigates allegations of misconduct and criminal activity by FDA employees. Like OCI, OIA has policies in place to guide its investigations. Unfortunately, GAO observed that FDA has no formal arrangements to oversee OIA investigations or to monitor OIA’s adherence to its investigative policies. OIA is not even required to inform FDA about its activities.
I think these lapses are alarming. If OCI violates its policies for conducting investigations, it risks compromising evidence and enabling counterfeiters to escape conviction. And without monitoring, how can we be assured that OIA will investigate FDA employees’ alleged criminal acts properly, or at all? This lack of oversight within FDA clearly jeopardizes public health.
The story offers a ray of hope, though. In a letter to Senator Grassley (R-IA), FDA agreed with GAO’s findings and described the ways that it would adopt the Office’s recommendations for establishing regular oversight. I applaud FDA for taking the report seriously and taking steps to correct the problems it cited.
Once again, I’m thankful for GAO, which seems to be a vigilant and nonpartisan body with the public interest in mind. When it comes to our well being, we should expect no less from public officials.