FDA Cites 2 Canadian Pharmacies for Offering Unapproved Drugs to Americans

On May 24, 2012, Thomas Christi, Acting Office Director for the FDA’s Office of Drug Security, Integrity and Recalls sent warning letters to Pharmawest Pharmacy and Best Price Rx, two Canadian pharmacies known by their websites www.bestpricerx.com and www.northwestpharmacy.com.  The warning letters state that the FDA has determined that the companies’ websites “offer an unapproved and misbranded new drug for sale in violation” of US law and requests that the companies cease marketing these products to US consumers.

Both companies are selling alitretinoin, trade name Toctino, claiming it can treat eczema.  Alitretinoin is a retinoid that is not approved for use in the U.S.  Although it is approved for use in Canada, its Canadian labeling requires it be “prescribed only by physicians knowledgeable in the use of systemic retinoids and who understand the risks of teratogenicity in females of childbearing potential.”

Warns the FDA, “Because Toctino is unapproved in the United States, these safety controls are bypassed when alitretinoin is purchased over the Internet by customers in the United States without consultation with and a valid prescription from a physician. This places American patients who use the drug at risk for adverse effects.”

We searched both websites after the announcement, but could not find these products for sale.  It is not known if they are selling them to Americans.

Questions and Answers about the FDA's warning letters to BestPriceRX.com and NorthWestPharmacy.com

Does the FDA regulate Canadian pharmacies that sell to Americans?

Canadian pharmacies are not subject to the FDA's jurisdiction, which means American customers aren't protected by the FDA's safety regulations.  If they were to run afoul of laws that the US Food and Drug Administration enforces, they would be considered criminals operating from overseas.

Building a case against them can be challenging, and bringing a criminal who operates outside US borders who mails contraband to Americans back to the US for prosecution is challenging, but it can be done.

If they choose to sell these unapproved products to Americans, is there anything the FDA could do to prosecute them?

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, unapproved, misbranded, and adulterated drugs are prohibited from importation into the United States.

At mail facilities, Customs officials identify parcels that may violate the FD&C Act for FDA examination. FDA inspectors then determine if these products should or should not be permitted to enter the country. If detained, FDA must issue a notice to the addressee describing the potential Federal violation and provide the individual with an opportunity to respond and provide reasons why the drug parcel should be allowed entry. If the addressee does not respond or provides an inadequate response, FDA will give the parcel back to Customs to have it returned to the exporter¹.

The irony is that even if the products are counterfeits, the Customs officer must send them back to the counterfeiters.  They will probably simply send them in again.

Ultimately the FDA can build a case against a foreign-operating unapproved drug sellers, but actually getting them back to the United States and into court is challenging.

Are these pharmacies regulated by the Canadian government?

Not necessarily.  Some online pharmacies that say they’re from Canada are actually pharmacies regulated by Health Canada, and some aren’t even really in Canada.    Some are just post office boxes that refuse to sell within Canada, and therefore are considered "shipping" companies by the Canadian government, not pharmacies.

Are these pharmacies certified by any other entities? 

The only certifying entity that Americans can trust is the National Association of Boards of Pharmacy Verified Internet Pharmacy Program certification (VIPPS).  Find a safe, online pharmacy here.  There are other organizations that claim to certify pharmacies for safe use, but they do not meet FDA and NABP standards for pharmacy safety.

Do those certifications require that these "Canadian pharmacies" only sell approved drugs to Americans?

No.  Only VIPPS pharmacies can sell medication safely to Americans.  The FDA has noticed a proliferation of websites that offer drugs purportedly from Canada directly to U.S. consumers. A number of these websites claim that drug sales from Canadian pharmacies directly to U.S. consumers are legal. This is false.

Could a regulated American pharmacy be allowed to endanger American patients in this manner and retain its license?

The FDA does not allow unapproved and misbranded drugs for sale in the U.S.  Any pharmacy that attempted to sell a product that had not been through safety review would endanger American patients, and would quickly find their pharmacy license in jeopardy.

Only websites that operate beyond the regulation of the FDA would have the gall to offer American patients drugs that hadn't yet passed safety standards.