Heparin Deaths

I am founder and owner of an FDA consulting practice, FDA Imports.com, Inc., and a practicing attorney representing foreign and domestic food, drug, medical device and cosmetic companies in matters involving the U.S. Food and Drug Administration (FDA). I am a 17-year veteran of the U.S. Food and Drug Administration (FDA). From 1986 to 2003 I held the positions of Regulatory Microbiologist in FDA’s Baltimore Microbiology Laboratory, Consumer Safety Officer and Compliance Officer in FDA’s Baltimore District Office, Special Agent with FDA’s Office of Criminal Investigations in the Miami Field Office, Compliance Officer in FDA’s Miami Resident Post, and Regulatory Counsel to FDA’s Associate Commissioner for Regulatory Affairs (or ACRA) in Headquarters. I resigned my most recent FDA position as Regulatory Counsel to the ACRA in July 2003 — a position I held in FDA for over three years as a Title 42 appointee.

Today we are confronted with serious adverse events involving a widely used drug product that appears to have been made using substituted active ingredients at a foreign facility that was never inspected by FDA – because of some human error in deciding whether an inspection had already been conducted or should be conducted. I believe that we are truly on the brink of a series of these events and that waiting for FDA to take some action that actually mitigates risk or encouraging the agency to act unilaterally will be an exercise in futility. As I said in the press and to your staff, Mr. Chairman, this recent case appears to be the close cousin of the same conduct discovered nearly two decades ago. At that time, it was through intensive and smart facility inspections and by the efforts of forward thinking forensic scientists and investigators the activity was discovered. Moreover, the successfully prosecuted counterfeit bulk drug case was made possible only through the intellectual connections between certain domestic inspections at U.S. facilities by a keen FDA investigator who had previously conducted the foreign inspection of the bulk supplier, coupled with follow up inspections at the foreign supplier, which were themselves targeted with knowledge of where evidence of illegal conduct was likely to be found.

It is no different today – except that we now have available to us significantly improved technological solutions that may prove useful to more precisely and efficiently identify, target, and intercept safety risks prior to their realization in the market place.