FDA plans to increase the number of criminal prosecutions by the agency along with other measures to curb criminal violations of the Food, Drug, and Cosmetic Act. These aren’t intended for your every day criminal. instead, FDA wants to go after top officials in regulated industry. In my previous post I discuss FDA proposing new regulations for reporting the falsification of research data in the first significat rule change regarding clinical trials by the new FDA leadership. It seems that FDA’s leadership is focused onexpanding its use of the criminal jurisdiction FDA has had for decades. According to Alicia Mundy in the Wall Street Journal:
“The Food and Drug Administration plans to increase prosecutions of pharmaceutical and food industry executives as part of an effort to refocus its criminal division, which has been under attack in Congress and is criticized in a new government report.”
The Office of Criminal Investigations
The Office of Criminal Investigations (OCI) is technically part of the FDA’s field organization, the Office of Regulatory Affairs. However, there is little contact between the field employees that conduct Bioresearch Monitoring and other regulatory inspections and the criminal investigators of OCI. During the 13 years that I worked in ORA after the criminal group was formed I met an OCI official only once. She was a former Secret Service officer and a very smart professional. However, she did not have extensive knowledge about clinical trials, which is why we met. FDA seems to want to improve the relationship between OCI and the rest of the Agency. The Government Accountability Office (GAO) issued a critical report regarding OCI to Congress last Thursday, March 4th. Responding in a letter to Congress FDA stated it wanted to:improve procedures for information-sharing between OCI and other Agency components with the goal of enhanced allignment of criminal/regulatory priorities and activities.”
The FDA letter also mentions increasing the “appropriate use of misdemeanor prosecutions” the item that has gotten most of the attention. This seems like a good idea and I’m all for prosecuting people who submit false data and commit other crimes. People who commit crimes are called criminals and white collar criminals have been neglected all too often. The letter also discusses the debarment of clinical investigators. The last item mentioned by the letter hasn’t received very much press attention when it states:
“Finally, the committee recommended that FDA improve the coordination of its response to cargo theft of FDA-regulated products, such as pharmaceuticals and infant formula. Potential threats include counterfeiting, diversion, tampering, adulteration, misbranding, theft, and terrorist acts.”
That sounds like serious stuff. I’m not sure that I consider FDA the right federal agency to take on all of that, but I’m a regulatory consultant, not a criminal one. FDA has limited resources, even with theproposed increase in funding (see previous post). On one hand these developments seem that they are addressing critical needs.
On the other hand, FDA is a Public Health and regulatory agency and the regulation of critical industries, such as banking, insurance, food, transportation, and pharmaceuticals, has suffered in the past decade. Increasing criminal prosecutions may be a very good thing. But will it come at the expense of modernizing FDA’s other regulatory responsibilities? All too often public health has suffered due to an increase in funding for criminal prosecutions. I believe the primary focus of FDA should be a public health focus on the regulation of food, drugs, vaccines, and medical devices. FDA should look into updating regulations for clinical trials and other issues such as a recall authority for adulterated foods.
FDA leadership has said, “In some cases, the agency may need to modernize existing standards in order to address ambiguities.” I would suggest that there are existing ambiguities in FDAs clinical trial regulations. There hasn’t been a substantive rewrite of the Investigational New Drug (IND) regulations since March 1987. This is an item that I consider to be of importance. There have been revisions of certain parts of the IND regulations, but we are basically working with regulations that are over 20 years old.Most clinical trial professionals I know are not criminals. They are dedicated, highly motivated, hard-working professionals who would like to do the right thing, if FDA would tell them. The IND regulations have overly vague specifications on what an “adequate and accurate case history” is and I can’t count the times people have asked me the requirements for source documents. Definitions for common industry and regulatory terms such as “trial master file” and “adverse event” cannot be found in FDA’s regulations.
In addition, the business of running a clinical trial has changed dramatically in the past 23 years. There has been an explosion of clinical trial vendors and outsourcing. The industry is qualitatively different than it was in the 1980s. It would be good if there was a concrete regulation telling a sponsor on how to provide oversight of a clinical laboratory or an eCRF vendor. I certainly am glad to see that FDA is taking on white collar criminals with increased criminal prosecutions. I think it is the right thing to do. I’m also in favor of federal law enforcement agencies, including FDA, taking on the problem of the theft of pharmaceuticals and infant formula. However, we also need to update the regulations for law-abiding researchers. I hope that Congress and FDA gives this some attention as well.
You can read the Alicia Mundy article here:
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