January 5, 2017
Dear Senators and Representatives,
In December of 2015 we released the attached letter warning Congress of the dangers to American patients from counterfeit drugs brought into America through “importation” proposals. As you consider the budget this year, we wanted to bring to your attention several recent tragic events that show the negative consequences of such policies:
Counterfeit opioids: We’re all familiar with the tragedy of the opioid epidemic, but it’s made worse by counterfeit opioids containing fentanyl. Since late 2015, counterfeit opioids have killed people in 29 different states. They are disguised as well known drugs such as Xanax, Norco, and Percocet, but they contain a powerful banned chemical, fentanyl. The pills are produced in China and Mexico and sold through the web to American patients or smuggled here.1
Counterfeit cancer drugs: In 2015, law enforcement officials busted a $78 million dollar ring of cancer drug smugglers who sold illegally imported medication, including several counterfeit versions of the chemotherapy drug Avastin. Several American oncologists, including one in south Florida, switched to other foreign sources and continued endangering American patients. Counterfeit cancer drugs have been found to contain water and mold, diluted versions of their original active pharmaceutical ingredients, and in some cases, no therapeutic medication at all. All of these are a death sentence to a cancer patient.2
Counterfeit birth control: We’ve been tracking counterfeit IUDs (intrauterine devices) purchased on the black market and inserted into patients since 2009. Just this year, a doctor in Southern California was sentenced to prison and jail time after buying counterfeit IUDs off the Internet and implanting them into patients. Several of his patients experienced negative health effects from these.3
Counterfeit cosmetic injectable: America is currently awash in counterfeit cosmetic injectables. Just in March of 2016 the FDA uncovered the customer list of one smuggler who sold counterfeit injectables to more than 1,300 American medical practices. That’s just one smuggler. Many are still in operation. In many cases they are selling to unlicensed individuals who are masquerading as licensed medical professionals and administering these therapeutically serious drugs without sufficient training, resulting in permanent disfiguration and death.4
Drug importation advocates believe that drugs purchased from countries such as Canada and the United Kingdom are safe, but they, too, have suffered from the counterfeit drug trade. United Kingdom citizen Peter Gillespie was convicted in 2011 of selling over 2 million doses of counterfeit cancer, heart, and mental health medicines he had imported from Asia. 900,000 doses of those drugs reached pharmacies and patients. 2 years later, British law enforcement raided a London flat and found $750,000 in misbranded and unlicensed prescription drugs from India being repackaged for sale online. Opening up importation in the United States would expose us to this dangerous international trade.
We urge you to reject proposals that break the supply chain by encouraging American patients or doctors to purchase from wholesalers or retailers who are not licensed within the United States. Every year we see more and more deaths from Americans harmed by breaking the closed, secure, drug supply chain. Don’t scale this tragedy up to national policy.
Board Member, Partnership for Safe Medicines
Professor Emeritus, College of Pharmacy
University of Texas
Austin, TX 78712
Board Member, Partnership for Safe Medicines
Assistant Director, FDA Office of Criminal Investigations (retired)
- Counterfeit Prescription Pills Containing Fentanyl: A Global Threat, DEA Intelligence Brief, July 2016: http://www.safemedicines.org/wp-content/uploads/Counterfeit-Prescription-Pills.pdf.
- “Palm Harbor Oncologist Convicted of Buying Unapproved Cancer Medications from Foreign Sources and Defrauding Medicare,” United States Department of Justice, November 18, 2016: https://www.justice.gov/usao-mdfl/pr/palm-harbor-oncologist-convicted-buying-unapproved-cancer-medications-foreign-sources.
- “Tehachapi doctor gets to 6 months for defrauding patients, insurers by implanting unapproved IUDS,” 23 ABC News Bakersfield, March 7, 2016: http://www.turnto23.com/news/local-news/tehachapi-doctor-gets-to-6-months-for-defrauding-patients-insurers-by-implanting-unapproved-iuds.
- “FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs,” United States Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm439169.htm.