Keynote Address; Deputy Director Kumar Kibble

Deputy Director Kumar Kibble of the U.s. Immigration and Customs Enforcement (ICE), Department of Homeland Security delivered the keynote address.  

Kibble started his remarks by reminding us that he is personally inspired Dr. Francses Kelsey of the FDA who blocked the use of thalidomide in the US for pregnant women in 1960, while over 10,000 children in other countries suffered serious birth defects from a medication that was not tested appropriately before use.  Kelsey was concerned by some data suggesting dangerous side effects in patients who took the drug repeatedly. While she continued to withhold approval, the manufacturers tried everything they could to get around her judgement. 

Said Kibble, HSI is leading a team of experts from 19 federal agencies to share information to conduct national and international counterfeit medication investigations, among other types of international crimes.  HSI prioritizes the prosecution of crimes that impact national security and public safety.

Kibble praised the FDA for it's efforts to take on the "enormous responsibility" to make sure that our food and drugs are not harmful while ICE acts as an enforcer for the FDA.  Counterfeiting is a modern day threat, he said, as a result of globalization and the rise of the itnernet.

Globalization has made safeguarding our goods harder. America imports goods at the highest rate ever. 80% of the active ingredients in prescription drugs come from outside US borders. In order to protect supply chains, ICE extends its overview to overseas.  ICE attempts to stop criminal activity within legitimate supply chains.  Thousands of websites sell prescription drugs without prescription requirements, which is against the law in the U.S.  Drugs purchased over the internet and imported into the US are not FDA approved and there is no guarantee that they are safe.  They can be packaged to look legitimate, but still be fake.

Said Kibble, "If you're not part of the solution, you're part of the problem."  Payment processors, domain name registrars, online advertisers, etc., are all being approached by IPEC to wage a fight against illegal pharmacies through the development of The Center for Safe Internet Pharmacies.

However the public's demand for prescription drugs helps drive the demand for the counterfeits.  Also, counterfeiters put personal profit over health and wellbeing of the public.  There are huge profits to be made in the illicit drug trade.  ICE analyzes links and routes for distribution of counterfeit medications, and involves multilateral investigations including international partners, including INTERPOL.

Kibble higlighted a few recent operations: 

In 2010, a multi-day surge operation called "Operation Mercury" – more than 17,000 mail express parcels contained pharmaceuticals and more than 1,300 were illicit drugs.  

In 2011, 12 enforcement surges called "Operation Apothocary," which evaluated international mail facilities and land borders. There were738 seizures and the examination of 7,000 parcels.  Hundreds of criminals were prosecuted.

For the past four years, Operation Pangea has targeted websites selling counterfeit medications internationally.  ICE and FDA managed the process for the U.S.  

Said Kibble, "All of this reinforces the global threat of counterfeit medication.  A united, coordinated and aggressive stance against counterfeiters shows the results through operations like Mercury, Pangea and Apothecary."

Kibble recounted the story of Manuel Calvelo and Jeffrey Westmoreland, US based criminals who used an international ring of businesses to keep their online counterfeit medicines business below law enforcement agents radar.  However, Calvelo was captured in Costa Rica, extradicted, tried and convicted of counterfeit drug distribution within the U.S. Westmoreland remains fugitive.

Concluded Kibble, reminding us of Dr. Kelsey, "How many people, at the conference today born in the years between 1946 and 1964, would have had a different fate if the FDA had acted differently and allowed thalidomide to be used in the U.S? Think about the power we have if we collectively work together to keep counterfeit medications out of our country."