Counterfeit Drugs Affect Even Legitimate Sources: Hospitals and Pharmacies Charlie Cichon, Executive Director National Association of Drug Diversion Investigators
Homeland Security 2014 Each year, more than 11 million maritime containers arrive at our seaports. At land borders, another 10 million arrive by truck and 3 million by rail. An additional quarter billion more cargo, postal, and express consignment packages arrive through air travel 23,140 Number of Seizures by Homeland Security in the US Over 70% of all Seizures came from 1 country? Over 75% of the pharmaceuticals seized came from 1 country? 2
Definition Counterfeit Medicines - products deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make them appear to be a genuine product (generic or branded) Each year it is estimated these criminal products cause the death of between 100,000 and one million people Examples: Less or more active pharmaceutical ingredients (API) Unsanitary, unsafe manufacturing practice Counterfeit packaging to extend expiration date 3
FDA Gets New Authority to Stop Fake Drugs When an importer is caught bringing counterfeit or poor-quality food or medical devices into the United States, the products typically get destroyed But, curiously, that isn't the case with fake or adulterated pharmaceuticals. If customs officials find a shipment of counterfeit drugs, it would be detained and sent back to the country of origin. Experts have said that counterfeiters just repackage the drugs in another shipment to sneak into the U.S. The Food and Drug Administration issued a final rule on September 14, 2015 that allows the agency to destroy any drug valued at $2,500 or less that was refused admission into the United States The agency received the authority to destroy imports in the 2012 Food Drug and Safety Innovation Act 4
Possible Source of Diverted Drugs - Hospital Pharmacies The counterfeit drug trade is directly linked to the diverted drug trade, when the drug diverters have used falsified drugs to meet their supply issues Diverted drugs may be expired, diluted, contaminated, stored under the wrong conditions (excessive heat, exposed to sunlight, extreme cold temperatures), or relabeled with wrong information 5
Definition of Prescription Drug Diversion Prescription drug diversion is the unlawful removal of an approved pharmaceutical product from the legal distribution system and subsequent distribution to an illicit market place Any criminal act involving a prescription drug (NADDI) Diversion can occur anywhere in the legal chain of distribution from pharmaceutical manufacturer, drug packager, transporter, wholesaler, to the retail pharmacies, clinics and hospitals, or the patient Diverted pharmaceuticals can be distributed to the legal and illegal markets 6
Puerto Rico Indicts Suspects in $650M Drug Scheme A group of wholesalers and 23 people have been accused of generating $650 million dollars in sales from 2007 to 2011 in selling diverted prescription drugs NOT approved by FDA to chain and retail pharmacies in Detroit, Miami, New York, Los Angeles and Washington, DC The press release stated, There was evidence that the drugs were expired and had counterfeit labels, many with incorrect dosages Some of the drugs listed in the indicted were Advair, Celebrex, Nasonex, Valtrex and drugs to treat HIV, cancer and depression The indictment also stated The pedigrees also stated the drugs were obtained from authorized distributors when they actually originated from a network of unlicensed suppliers, mainly in New York and California 7
Counterfeit Drugs Affect Patients Nationwide In the U.S., counterfeits have been found in every therapeutic area Antibiotics cancer drugs insulin and other diabetic supplies cardiovascular dedications Treatments for other chronic conditions HIV and Alzheimer s disease Pain medicines and weight loss medications 8
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Who are the victims? Children who need antibiotics, receiving counterfeits purchased by their parents at local markets Diabetics using fake test strips and incorrect readings (like printing $1 bills) Cancer patients who receive saline solution instead of therapeutic treatment Women with counterfeit IUDs made in unsanitary conditions Chronic disease patients, e.g. high blood pressure, asthma, who get gradually worse when their medication doesn t control their disease 11
The FDA Finds Fake Cancer Drugs In 2011, the FDA seized a counterfeit version of the life-saving cancer drug Avastin and found that it contained NO ACTIVE INGREDIENT February 13, 2012 Los Angeles, CA Roche located foreign-supplied counterfeit Avastin with no active ingredient April 12, 2012 La Jolla, CA FDA seized 120 vials of fake Avastin shipped through the U.K. from Turkey February 5, 2013 Great Neck, NY FDA found counterfeit Altuzan distributed through an unauthorized wholesaler 12
Counterfeit Drugs in the United States December 2012 FDA warns doctors and hospitals about fake Botox warning letters were sent to 350 medical offices counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe September 2012 Black market osteoporosis medicine from an unlicensed foreign company FDA issued warning letters to 23 U.S. medical practices Adderall May 2012 the FDA warned consumers and healthcare professionals about a counterfeit version of Adderall sold on the internet Flu Treatments In February 2013, the FDA warned consumers about fraudulent flu treatments sold over-the-counter and through fake on-line pharmacies that do not prevent or treat flu symptoms 13
Fake Medicines on the Shelves Ventura and LA County 14
Authentic Cialis Carton Counterfeit Cialis Carton (expanded) Authentic Cialis Blister Foil (Red Color-shift) Authentic Cialis Blister Foil (Gold colorshift) Counterfeit Cialis Blister Foil (No color-shift) 15
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Patient Impact The drugs were found to come from Mexico, Pakistan, and other foreign countries where quality control is lacking or non-existent. A preliminary analysis of the medications showed that a large portion of these drugs were counterfeit or adulterated. Some of the drugs were made with shredded plastic Investigators learned through the investigation that a recipient of medication purchased from one of these stores suffered a near fatal infection 17
Counterfeit Drugs in Clinics and Medical Offices Another threat to American patients is black market drugs sold directly to doctors offices and clinics. Counterfeiters are now directly targeting health care professionals with advertisements for non-fda approved drugs from unknown sources 18
Wholesalers Selling Illegally to Physicians Gallant Pharma case: Distributed more than 17,000 units of non-fda approved cancer and cosmetic drugs to doctors across the United States Smuggled into the US and sold more than $12.4 million in non-fda approved chemotherapy drugs and injectable cosmetic drugs and devices, generating profits of $3.4 million Gallant Pharma sold illegally imported and misbranded drugs to doctors, hospitals, and medical offices across the country 19
Patient Impact Many of these drugs were subject to strict temperature controls to protect drug potency Gallant Pharma shipped and received such drugs with ice packs, not dry ice as used by legitimate distributors. On at least one occasion, a shipment containing such drugs took more than two weeks to arrive in Virginia from overseas during a July 2012 heat wave Many drugs sold by Gallant Pharma were also required to carry a FDA black box warning, which indicates that a drug carries a significant risk of serious or lifethreatening adverse effects. The versions sold by Gallant Pharma did not meet this or other FDA labeling requirements Non FDA approve drugs used on patients without the patients knowledge or consent 20
Criminal Penalties Doctors, Importers, Office Managers On Dec. 2, 2013, Gallant Pharma pleaded guilty to two counts of illegal importation, five counts of introducing misbranded drugs and five counts of unlicensed prescription drug wholesaling Syed Farhan Huda, 39, co-founder and co-owner of Gallant Pharma, was sentenced to 36 months in prison, followed by two years of supervised release plus $3.4 million in forfeiture and restitution to victims. Huda pleaded guilty to illegal importation, introducing misbranded drugs, unlicensed medical wholesaling and wire fraud Deeba Mallick, 37, was sentenced to nine months in prison, one year of supervised release and a $75,000 fine. Mallick pleaded guilty to misprision of a felony 21
Criminal Penalties Doctors, Importers, Office Managers Anoushirvan Sarraf, 48, and Eva Montejo Pritchard, 48, were convicted by a federal jury for their involvement in the scheme. Sarraf, a licensed doctor and the owner of Aphrodite Skin Care & Esthetic Clinic in McLean, Virginia, and Pritchard, Aphrodite s office manager, received hundreds of shipments addressed to Aphrodite, containing illegal importations intended for Gallant Pharma, in exchange for a deeply discounted price on non-fda approved drugs and devices To date, twelve defendants associated with Gallant Pharma have been convicted. Two additional defendants named in the indictment, Robert Wachna and Munajj Rochelle, remain fugitives and are believed to be in Canada Agencies involved: DEA s Group 33 Diversion Task Force, FDA-OCI, ICE-HSI, U.S. Postal Inspection Service, INTERPOL and Arlington County PD 22
Counterfeit Drugs Affects Even Legitimate Sources Learn more: Resources at www.safemedicines.org 23
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