Canadian pharmacies generally accept prescriptions from the United States, even though the physician writing the prescription does not have a Canadian license. Under the Federal Food, Drug, and Cosmetic Act, people who order and receive prescription drugs from Canada, or other countries, break the law. The U.S. Food and Drug Administration's primary concern is that it cannot measure and control the quality of drugs from other countries. The FDA regulates the pharmaceutical industry, in part, by inspecting drug manufacturing facilities and pharmacies in the United States. Furthermore, demand from the United States for Canadian pharmaceuticals compromises the Canadian supply for some medicines. Canadians frequently speak out on the issue. Their lawmakers are currently drafting legislation to shore up Canadian pharmaceutical supplies.
A Possible Loophole? There is one exception that the FDA exercises as a matter of policy, not law. The 2002 publication, FDA Consumer, outlines this policy.
Although importing unapproved prescription drugs is illegal, the FDA's guidance on importing prescription drugs for personal use recognizes that there may be circumstances in which the FDA can exercise discretion to not take action against the illegal importation.
The guidance allows individuals with serious conditions, such as a rare form of cancer, to get treatments that are legally available in foreign countries but are not approved in the United States.
The importation of certain unapproved prescription medication for personal use may be allowed in some circumstances if all of these factors apply:
- If the intended use is for a serious condition for which effective treatment may not be available domestically.
- If the product is not considered to represent an unreasonable risk.
- If the individual seeking to import the drug affirms in writing that it is for the patient's own use and provides the name and address of the U.S.-licensed doctor responsible for his or her treatment with the drug or provides evidence that the drug is for continuation of a treatment begun in a foreign country.
- If the product is for personal use and is a three-month supply or less and not for resale. Larger amounts would lend themselves to commercialization.
- If there is no known commercialization or promotion to U.S. residents by those involved in distribution of the product.
So, this begs the question: Does rasagiline (marketed in Canada as Azilect) qualify under the above guideline? Few would claim PD is not serious. However, we can all imagine people who claim there is an effective treatment for Parkinson's. Levodopa was and is pretty miraculous. On the issue of risk, there is speculation that rasagiline remains unapproved precisely because of risk questions.
While the FDA may never rule on rasagiline, noticeably absent is any provision that allows one to import drugs to save money. Nevertheless, it is true that towns, cities, and states continue to plot to import pharmaceuticals from Canada to take advantage of lower prices.
For people with Parkinson's, the toughest challenge may be persuading a physician to write a prescription for an unapproved drug and pay malpractice insurance premiums. Physicians may be concerned about safety with any new drug. If it is not yet approved in the United States, it may heighten their concern.
Physicians may also worry about the potential for malpractice. The difference between reasonable practices and malpractice is defined by standards within the medical community. If physicians write a prescription for an unconventional medicine they may be stepping out of their professional standards. It makes it hard for physicians to be progressive in some instances.
But people don't take a Parkinson's drug based on legal arguments. People take them to maintain as much health as possible. Please email us and tell us about your experiences importing drugs from Canada. Have you tried ordering Rasagiline? How much did it cost? Let Matt know at mnilsen@myparkinsonsinfo.com.
This Consumer Reports article about Canadian drug importation is insightful.
