In the past, members of Congress have criticized the FDA for a lack of aggressiveness and swift action when it came to debarment actions. In a Federal Register (FR) notice today (here), the FDA issued a debarment of Armando Santos, a nurse, for failure to accurately maintain records and “falsely signing certifying that Medicare beneficiaries were in need of home health services that were medically unnecessary, and he submitted false weekly visit/time records,” thus, causing the fraudulent billing of medical service to Medicare.
Here is a person not involved at all in the drug review or approval process, nor in the conduct of clinical studies used to support the filing or approval of any drug product, yet the FDA took the time to single this person out for debarment. The FR notice provided FDA’s reasoning as follows: “the Agency found, on the basis of these convictions and other information, that Mr. Santos had demonstrated a pattern of conduct sufficient to find that there is reason to believe he may violate requirements under the FD&C Act relating to drug products…. Having considered the conduct that forms the basis of his conviction and the fact that this conduct occurred in the course of his profession and showed a disregard for the obligations of his profession, FDA finds that Mr. Santos has demonstrated a pattern of conduct sufficient to find that there is reason to believe that, if he were to provide services to a person that has an approved or pending drug application, he may violate requirements under the FD&C Act relating to drug products. Therefore, FDA has reason to believe that, if Mr. Santos were to provide services to a person that has an approved or pending drug application, he may violate requirements under the FD&C Act relating to drug products.” So with all of issues the Agency is facing today (e.g., implementation of GUDFA, mutual recognition of inspections, etc.), FDA took the time to initiate debarment proceedings against an individual that, at the time of his convictions, had no apparent connection what-so-ever to the pharmaceutical industry. Now granted, I am not trying to say that the statute does not permit the debarment of such an individual, I am just saying this is the strangest case of debarment I have ever seen. And if this is the new standard, why have all of the others that have been convicted of Medicare/Medicaid fraud or other healthcare related fraud not been debarred? What do you think? I can be reached at r.pollock@LachmanConsultants.com for comments.