Bottom-Line: FDA cops operate with little accountability to the FDA…let alone the American people.
Evil doers beware. The cops at the FDA are getting better organized and more cash to chase executives who seek to do harm to the public’s health. Cops at the FDA you ask? Why yes there are cops at the FDA. Within the FDA the Office of Criminal Investigations (OCI) investigates alleged criminal activity related to FDA-regulated products. This criminal activity could run from the sale of bogus drugs to the exclusion of important safety data by corporate executives and scientists.
The Government Accountability Office (GAO) issued its final report(PDF) on the OCI this week and it is clear that accountability is the magic word. Specifically, the Office of Criminal Investigations lacks accountability to the FDA itself!
I Know Nuthin’ About Nuthin’
Up until now senior FDA officials never heard about OCI investigations unless the director of the department decides to share it. Can you imagine telling your boss “none of your business” if she asks about the specifics of a project you are working on? You would be undoubtedly be fired. Yet this is what the Office of Criminal Investigations can say to the FDA. According to the report, the FDA doesn’t have any requirements that the OCI report any specific information about their current investigations.
On top of that, the FDA has an internal investigations unit called the Office of Internal Affairs (OIA). The OIA is an office within the OCI that investigates FDA employee misconduct. The OIA is not required to report specific information to OCI or any other FDA senior-level office. In addition, there is no process in place to ensure compliance with policies that guide investigations.
The FDA responded to the report in a letter(PDF) to Senator Grassley (R-Iowa). The FDA’s letter highlighted reforms to deal with the shortcomings pointed out in the GAO report. The FDA highlights successful prosecutions since the start of the Office of Criminal Investigations in 1992. Well, its great to throw counterfeit drug makers and people who send contaminated products out into the market but what about the corporate officials responsible for hiding key safety data? The FDA plans to increase the use of misdemeanor* prosecutions to punish those officials.
FDA To Develop Procedures To Disqualify Investigators
Of greater importance is the FDA’s commitment to develop procedures to disqualify certain clinical trial investigators from participating in the drug approval process. This is something that will be addressed in a post sometime in the near future but its important to mention that the FDA does not conduct its own studies.
The FDA relies mostly on clinical trial data from the drug company to prove that the company’s drug is safe and effective. Disqualifying certain clinical trial investigators from submitting data is, in my opinion, one of the most important reforms that the FDA can make.
*misdemeanors are those crimes generally punished with fines.