Q: Should Congress remove barriers to consumers who want to use online pharmacies? NO: These barriers help several government agencies maintain drug quality and safety

Insight on the News, July 8, 2003 by Merrill Matthews, Jr.

Byline: Merrill Matthews Jr, SPECIAL TO INSIGHT

On a daily basis I get "spam" e-mails from well, I am not sure exactly who they're from promising "wholesale prescription medicines" and informing me that "our licensed doctors will write your prescriptions for free."

The drugs generally are lifestyle drugs for "weight loss, muscle and general pain relief, allergies, men and women's health, impotence, heartburn, migraines and more!" All I need to do is provide the company with a credit card and answer a few short questions so the "doctor" can make a thorough (wink, wink) evaluation of my medical condition and write a prescription. The online pharmacy promptly will fill that prescription and have it to me overnight.

I ask myself, "overnight from where?" So I peruse the Website to see if I can find a return address. Hmmm! No return address, no phone number, no contact information. I can, of course, send the company an e-mail, but I have no idea who runs the company or where it is located. There is no accountability whatsoever.

There are responsible online pharmacies, often run by the national "brick-and-mortar" chain drugstores, which comply fully with state and federal laws and are accredited by the National Association of Boards of Pharmacy. But there are others many of which operate outside this country that are unregulated and may pose real threats to their customers' health. Weakening federal and state regulations that attempt to control these entities and protect the public will lead to an even greater explosion of the questionable online pharmacies than we have seen in the last few years.

Access to less-expensive prescription drugs has become the Holy Grail of Washington as politicians consider expanding prescription-drug coverage to seniors, imposing various types of price controls or helping Americans buy their prescriptions from other countries primarily Canada where government price controls mean lower prices on many popular drugs. Some U.S. consumers cross the Canadian and Mexican borders to buy their drugs. IMS Health, a company that tracks prescription-drug sales, estimates that Americans spend $650 million in cross-border purchases.

But a growing number of Americans are willing to buy their drugs online. As a result, the number of online pharmacies has exploded both here and abroad. There are an estimated 80 online-pharmacy Websites in Canada that sell prescription drugs, many of which are shipped to U.S. customers. While it is impossible to tell how many drugs are purchased from Canadian Websites, U.S. Food and Drug Administration (FDA) Commissioner Mark McClellan estimates it to be about 1 percent to 2 percent of pharmaceutical sales and growing.

Now some doctors, pharmacies, politicians and insurers are encouraging and even helping patients to get their brand-name prescriptions from Canada. Those concerned about online-pharmacy sales especially sales from other countries cite patient safety as the primary issue. GlaxoSmithKline, one of the largest pharmaceutical companies, has decided to stop selling its products to Canadian-based online-drug vendors that are reimporting.

It is important to understand that it is against the law to import (or reimport) drugs into this country. For practical and political reasons the FDA and the U.S. Bureau of Customs and Border Protection (U.S. Customs) allow U.S. citizens traveling internationally to bring back or to purchase online small amounts of prescription drugs for personal use. That doesn't mean the practice is legal; the law just is not rigidly enforced.

Twice Congress has passed legislation that would allow Americans to buy their drugs from Canada, but the legislation came with a caveat: The secretary of health and human services had to determine that U.S. consumers would be safe. The secretaries have been unable to come to that conclusion, and they aren't alone. Ten former FDA commissioners, the U.S. Customs Service and the Drug Enforcement Administration (DEA) have raised serious concerns about the safety of drugs coming from other countries, even those drugs alleged to have been made originally by U.S. manufacturers.

Thus, U.S. politicians who encourage seniors even help them arrange for buses to travel to Canada to buy their prescription drugs from other countries are helping those Americans break the law. Bizarrely, some U.S. politicians are threatening to punish any drug company that chooses not to sell to Canadian online pharmacies that break U.S. law.

Proponents of buying drugs across international borders claim that drugs purchased from Canada are just as safe as those bought in the United States. But are they? See if you can reconcile the following two stories. An April 21 Wall Street Journal story begins, "Canada is boosting security at its seaports following stinging criticism that they are rife with crime and could be used to smuggle weapons of mass destruction into North America." According to the story, this action is the result of a Canadian Senate committee which said that "crime groups including Asian Triads, the Russian mafia and the Hell's Angels motorcycle gang are active at Canada's ports, using them to smuggle illegal drugs, weapons and refugees into North America."