Eliminate Counterfeit Drugs, Don’t Curb Access to Safe and Affordable Medication

Eleven years ago, an eighteen year old American named Ryan Haight tragically died from
an overdose of Vicodin, purchased online without a prescription. The Vicodin was real, not fake. In Niger, a much larger tragedy occurred – 2,500 people died out of 50,000 who were inoculated with bogus medication. The worst tragedy in recent U.S. history was the death of 238 Americans after ingesting fake Heparin found in the legal U.S. drug supply in 2007 and 2008. The Institute of Medicine reports that 100,000 Americans die each year due to prescription drug errors here in the USA.

What do all of these disparate and depressing statistics have in common? They have nothing to do with personal drug importation from properly credentialed online pharmacies. And yet opponents of safe importation insist that it is not safe, an assertion that runs contrary to the evidence.

A recent study published by the National Bureau of Economic Research, called “Unveiling
the Mystery of Online Pharmacies: an Audit Study,” shows that Americans who purchase
medicine from properly credentialed non-US online pharmacies receive genuine (not fake)
medication at much lower prices than U.S. pharmacies. In this study mystery purchases of
popular brand name drugs were tested for authenticity. All tested medications that were ordered from U.S. and non-U.S. websites approved by PharmacyChecker.com, National Association of Boards of Pharmacy, LegitScript.com, and the Canadian International Pharmacy Association were found to be authentic. Some non-credentialed website purchases failed testing.

A few weeks back Senator John McCain introduced an amendment to the Prescription Drug User Fee Act (PDUFA) to facilitate personal drug importation from credentialed Canadian online pharmacies. Unfortunately, while the larger bill passed, McCain’s amendment failed 54-43. Even worse, though removed from the Senate version by unanimous consent, the House version of PDUFA, which passed with overwhelming support, contains a section – 805 – that authorizes the Department of Homeland Security (DHS) to seize and destroy safely imported genuine medication valued at $2,000 or less. Since imported medication valued under $2,000 is for “personal use” the language was clearly aimed at destroying medication ordered internationally, often online, by individual Americans.

The putative goal of Section 805 is to protect Americans from counterfeit and dangerous drugs. In reality it will only hurt patients by blocking their ability to obtain affordable medication. Other parts of PDUFA contain forward thinking measures to protect us from counterfeit and substandard drugs, such as increasing penalties against drug counterfeiters, strengthening registration requirements on, and improving inspections of, foreign drug manufacturers. It also has provisions that could help bring needed pediatric medicines to market faster. But seizing and destroying safe personal imports will not help solve the counterfeit drug problem. Moreover, tens of millions of Americans don’t fill prescriptions each year due to the high cost of medication – 48 million in 2010 according to the Commonwealth Fund. Aggravating this public health crisis by destroying people’s prescription drug orders will result in more sickness, hospitalizations and death.

About a million Americans rely on safe non-US online pharmacies. If Section 805 is not
removed from PDUFA then DHS will seize and destroy safe prescription drug orders en
route to patients. That is medically unethical and a threat to public health. Section 805 must be removed from the final bill to avoid even more Americans going without needed medication.

Gabriel Levitt
Vice President
PharmacyChecker.com