Doubt Cast on ‘Safety Argument’ Regarding Canadian Drugs

Doubt Cast on ‘Safety Argument’ Regarding Canadian Drugs

The tide seems to be turning on the battle of whether or not to permit U.S. residents to order prescription drugs from Canada. In early October, the Department of Homeland Security, which operates the Customs and Border Protection agency, disclosed that it would halt confiscation of Canadian drugs and instead conduct random sampling to identify counterfeit and unsafe drugs. This differs from the trend in recent months where the U.S. government was confiscating as much as 20 percent of the shipments. Indeed, as of July 2006, over 37,000 prescription drug orders had been confiscated.

This large number of seizures had not always been the case. While the purchase of medications from abroad has been illegal, customs and Federal Drug Administration (FDA) officials have generally allowed the practice. With Canadian drug prices on average 25 to 50 percent below the U.S. market, more than 200 million Americans purchased over $800 million of prescription drugs from Canada in 2004. This number was a 33 percent increase from the year before. In the past year, however, the FDA said it began seizing more packages because a large portion of drugs sent from Canada are counterfeit and might be unsafe for consumers. Yet, as seen in the resulting halt on drug confiscation, an increasing number of citizens and advocates are demanding access to Canada’s cheaper drugs, and U.S. lawmakers from both parties are casting doubt on this safety argument.

Last year’s increase in seizures started after a policy change on November 17, 2005, two days after the enrollment in the Medicare prescription drug program began. In part because of this ‘coincidence’ in timing, several advocates and Canadian pharmacy officials believed that the increased seizures were related to the launch of the new Medicare prescription drug benefit, and claimed it was being used as a way to encourage beneficiaries to enroll in Part D. While both the U.S. customs and FDA denied this relationship, many lawmakers and advocates still alleged that the policy change was more about protecting U.S. drug makers’ sales at high domestic prices than consumer safety.

An article from Consumer Reports, Prescription Drugs: the Facts About Canada, summarizes some strong evidence against the ‘consumer safety’ argument. First, in terms of public opinion, 70 percent of the 1,400 people surveyed by the Henry J. Kaiser Family Foundation and the Harvard School of Public Health in November 2004 said that allowing citizens to order drugs from Canada would make medicines more affordable without sacrificing safety or quality. Second, the FDA states that Canadian drugs are of unknown quality and may be counterfeit. Yet according to an October 2003 study by the state of Illinois’ Office of Special Advocate for Prescription Drugs, Canada’s manufacturing and regulatory system is comparable to that of the U.S. Canada’s pricing and distribution system is also actually less likely than the U.S. to foster the drug counterfeiting that concerns the FDA. Drugs in the U.S. typically move through multiple vendors (manufacturers, wholesalers, repackagers, retailers, second repackagers, etc.) before reaching the patient. In Canada, however, medications are dispensed mainly in typical dosages and shipped in sealed packages directly from manufacturer to pharmacy. This more direct process leaves less opportunity for counterfeiting to occur. In addition, in a June 2004 report, the U.S. Government Accountability Office said that all of the prescription drugs it ordered from Canadian Internet pharmacies contained the proper chemical compositions, were shipped in accordance with special handling requirements, and arrived undamaged.

Another concern of the FDA is that news of product recalls issued in Canada may not reach U.S. consumers. Yet, as argued by Andy Troszok, president of the Canadian International Pharmacy Association (CIPA), this ‘concern’ falls short in recognition of a global recall policy that has been in place in industrialized countries for decades. If a recall is issued for a drug sold in Canada, Canadian pharmacies are required to alert all consumers who purchased the affected lot, regardless of where they live.

In addition, representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA) who are against allowing the purchase of Canadian drugs, argue that consumers may be risking their health. Some Canadian Internet pharmacies “have been known to sell fake and potentially unsafe medicines to unknowing American consumers – and may be run by shady dealers in countries such as India, China, and North Korea,” said Ken Johnson, senior vice president of PhRMA. Yet, this concern can be easily avoided by ordering only from pharmacies that have been thoroughly scrutinized by CIPA. To display a CIPA seal on its web site, an online pharmacy must have a valid Canadian license, submit to a quarterly on-site inspection, and keep personal information confidential in compliance with the Personal Information Protection and Electronic Document Act (PIPEDA), the Canadian privacy act similar to The Health Insurance Portability and Accountability Act, or HIPAA, in the U.S.

The online pharmacy must also require people to submit a valid prescription and medical history and to check for possible drug interactions. And CIPA members must let customers know in advance if they are supplying them with a medication from another country so that they have the right to refuse. To verify a web site’s CIPA seal, visit the CIPA site and type in that pharmacy’s information.

With the growing evidence against industry’s and FDA’s consumer safety argument, more legislators are working towards easing restrictions on purchasing Canadian drugs. In July 2006, the Senate voted 68-32 to approve an amendment that would prohibit seizures by Customs of prescription drugs purchased from Canadian pharmacies by U.S. residents. In the end of September, both the House and the Senate unanimously approved the fiscal year 2007 Homeland Security appropriations bill, which includes a provision that would allow U.S. residents to personally transport as much as a 90-day supply of FDA-approved prescription drugs from Canada. The legislation would exclude controlled substances and some biological products. While the outcome of these pieces of legislation is unclear at the time of this article’s publication, all this action suggests a potential turn in the tide. In addition, several states and cities, including Kansas, Illinois, Minnesota, Missouri, New Hampshire, Wisconsin, Boston, Massachusetts and Portland, Maine, have already set up programs to help residents and employees import Canadian drugs.

California has lagged behind in such efforts as Governor Schwarzenegger vetoed four bills two years ago that would have made it easier for Californians to buy cheaper drugs from Canada. Advocates as well as the media were quick to notice that soon after these vetoes, PhRMA became and continues to be one of the governor’s key supporters.

With the still rising cost of prescription drugs, in spite of the beginning of Medicare Part D, having an alternative, safe, and cheaper source of medications is of growing importance. In an effort for a permanent change in policy, people can write to their state and national Congress people and ask them to take action on this urgent issue.

Information for this article was contributed in part from: Prescription Drugs: Seized Medications from Canada Being Released to Customers, Kaiser Network Daily Reports, March 1, 2006; Policy Leads to Seizures of Drugs from Canada, California Healthline, July 26, 2006; Amendment Would Prevent Medication Seizures, California Healthline, July 12, 2006; Drug Companies’ PAC Gives Big After Schwarzenegger’s Vetoes, San Francisco Chronicle, March 11, 2005; Prescription Drugs: the Facts About Canada, Consumer Reports, October 2005.

Karen Fletcher
Our blogger Karen J. Fletcher is CHA's publications consultant. She provides technical expertise, writing and research on Medicare, health disparities and other health care issues. With a Masters in Public Health from UC Berkeley, she serves in health advocacy as a trainer and consultant. See her current articles.