Office of Criminal Investigations Director John Roth to Speak at Interchange
The new Director of the Food and Drug Administration’s (FDA) Office of Criminal Investigations, John Roth, will be the luncheon speaker at the Partnership for Safe Medicines 2012 Interchange on September 28. Roth joins the esteemed panel of Interchange speakers that includes keynote speaker Dr. Margaret Hamburg, Commissioner of the FDA, and panelists Gerald Heddell, Director of Inspection, Enforcement and Standards of the UK's MHRA, and James Dinkins, Executive Associate Director, ICE's Homeland Security Investigations.
Roth will be talking on the FDA's criminal priority areas, its recent experiences combating drug counterfeiters, and how criminal enforcement fits into the FDA regulatory strategy.
PSM asked Roth about his upcoming talk and his experience with counterfeit drug crime. Roth told PSM that the medicine counterfeiters are motiviated to make money with disregard for the welfare of others.
Said Roth, "Willie Sutton was once asked why he robbed banks, and famously replied, 'Because that’s where the money is.' I think that the motivation for drug counterfeiters is similar to many other types of criminals, particularly those involved in illicit commerce – they do it for the money. Because some medicines are more expensive, ounce for ounce, than gold, criminals see opportunity. The level of illicit profit we have seen in many of our cases is enormous, and part of our effort at the FDA is to ensure that we can take the profit out of crime."
PSM asked Roth, "Counterfeit drugs have been in the news a great deal lately. Do you think counterfeit drug incidents are on the rise in the United States?"
Roth replied that while the US is considered to have the safest medicine supply in the world, constant vigilance is what keeps it safe.
"This is a difficult problem to quantify," said Roth. "Certainly, some of the cases we have seen would lead me to believe that the nature of the problem requires serious consideration. The increasing internationalization of the supply chain certainly gives more opportunity for mischief, and those vulnerabilities are likely to increase in the future. The US system seems to represent the global 'gold standard' for safe medicines, but we need to ensure that we have an effective and credible response along the entire spectrum – education, regulation, and enforcement."
PSM asked, "Seeing how drug counterfeiters operate, what can the average person do to protect themselves from counterfeit drugs?"
Roth reminded consumers that doing research to make sure your medicine source is safe is important.
"A general awareness that there is a risk – however unquantified -- of counterfeit drugs, combined with some skepticism, is a healthy thing. There are a number of resources available for consumers to educate themselves – including very helpful material contained within the FDA’s website and those of organizations like PSM, which explain the possible dangers involved with buying drugs from outside the United States or over the internet, and what you can do to protect yourself."
Hear the New Director of the FDA's Office of Criminal Investigations talk about counterfeit drugs, criminal cases, and regulatory strategy at the 2012 Partnership for Safe Medicines Interchange on September 28, in Washington, DC. Tickets are available today.
John Roth was appointed the Director of the Food and Drug Administration’s (FDA) Office of Criminal Investigations in July 2012. Previously, Mr. Roth had been a career criminal prosecutor with the Justice Department, serving in positions ranging from an Assistant United States Attorney in Detroit, Miami and the District of Columbia to some of the most high-level policy and leadership posts in the Justice Department.
Mr. Roth’s extensive experience with the Justice Department includes serving as: Chief of Staff to the Deputy Attorney General; Associate Deputy Attorney General; Acting Deputy Assistant Attorney General overseeing money laundering and narcotics prosecutions for the Criminal Division; Chief of both the Criminal Division’s Narcotics Section and its Asset Forfeiture and Money Laundering Section; Chief of the Narcotics Section in the United States Attorney’s Office in Miami; and Chief of the Fraud and Public Corruption Section in the United States Attorney’s Office for the District of Columbia.
Mr. Roth has also served as Senior Counselor to the National Commission on Terrorist Attacks on the United States (also known as the 9-11 Commission) and was the leader of its team on terrorist financing. Most recently, Mr. Roth was based in Paris, where he acted as the Justice Department’s representative to the Financial Action Task Force, a multilateral group of G-20 countries engaged in the fight against international money laundering.
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