PRESCRIPTION DRUGS Imports from Canada concern FDA

The drugs' cost and convenience draw customers to purchase online.
HARTFORD COURANT
WASHINGTON -- Pat and Nicholas Roussos used to drive from their Connecticut home to Canada to buy prescription drugs because of the substantial savings. But about a year ago they switched to the Internet.
"You save time, and the pills are the same," said Pat Roussos, a 77-year-old retiree.
The couple are not alone. An estimated 1 million Americans use the Internet to purchase prescription drugs from Canada, and the number is on the rise. What once was a trickle has become a torrent, said the AARP, which represents Americans 50 and older.
But a recent Food and Drug Administration crackdown on Internet imports has left some worried that the flow will be slowed or stopped. The FDA, which is responsible for the safety of drugs sold in this country, says it is concerned about the "growing potential danger" of imported drugs, even those shipped to Canada from U.S. manufacturing sites.
In warnings to consumers, the FDA said it cannot vouch for the safety of drugs imported into the United States. The National Association of Boards of Pharmacy added another concern.
"In light of threatened terrorist attacks, the risk of tampering [with imported drugs] seems to be one of great significance," the association said.
Not buying it
Some consumer advocates brush aside the FDA's concerns.
"We know of no evidence of any person suffering negative effects or complications from medicine re-imported from Canada," said Robert M. Hayes, president of the Medicare Rights Center in New York City. "But ask any physician in America who treats an elderly population. The damage to our citizens who go without needed medicines is palpable."
An FDA spokeswoman confirmed that the agency does not have examples of U.S. citizens harmed by drugs from Canada, but said there could be cases that have not come to officials' attention. The agency does have examples of injuries and deaths from drugs imported from other countries.
Dr. Alastair J.J. Wood, a Vanderbilt University expert on FDA policies and prescription drugs, said he would have concerns about drugs from some countries, but would use those from licensed Canadian pharmacies.
"If they are truly brand-name drugs, they should be virtually identical [to those sold in the United States]," he said.
Precise figures of Internet pharmaceutical sales are difficult to obtain, but one recent estimate placed the amount at $500 million out of a total of $192 billion in annual U.S. spending on prescription drugs.
Here's the appeal
Two words explain the appeal of prescription drugs purchased online from Canada: convenience and cost.
"I could not believe how simple it was to get prescriptions filled on the Internet," said Pat Roussos, who is happy that she and her husband no longer have to make long drives to Canada.
Typically, the savings average 50 percent, said Dr. Tod Cooperman, who recently established PharmacyChecker.com, an Internet site that evaluates online pharmacies and compares their prices. Unlike the United States, Canada controls prescription drug prices.
Canadian pharmacy sites appeal most to Medicare beneficiaries who do not have prescription drug coverage. Overall, Americans could save about $38 billion a year if they had free access to Canadian drugs, Sen. Byron L. Dorgan, D-N.D., has estimated.
Cooperman cautions, though, that some Canadian sites "are more qualified than others" and said a recent study showed that some online sites do not employ licensed pharmacists. Another problem: Canadian sites do not always have the full range of medicines available at U.S. pharmacies.
Still, Roussos, reflecting the view of many seniors' advocates, scoffs at the FDA's worries about the quality of drugs purchased from Canada.
"They're protecting the big drug companies," she said. "I don't think they're protecting me."
Offering help
The United Health Alliance in Bennington, Vt., and the Minnesota Senior Federation in St. Paul offer help to seniors who are looking for savings in Canada. Peter Wycoff, director of the Minnesota federation, said his program has signed up members from 35 states since it was established in January -- a sign, he believes, of the magnitude of seniors' needs.
For years, the FDA allowed Americans to bring small amounts of prescription drugs into the United States as long as they were for travelers' personal use. Technically, these imports violated U.S. law, but the FDA looked the other way.
But in the last two months, FDA officials have said the "flood of prescription drugs" coming into the United States has given them an increased cause for concern.
As a result, the agency has sent letters to commercial online pharmacies in Arkansas and Louisiana, warning them that they could be held criminally liable if they are convicted of violating import restrictions.
Some experts think the FDA is aiming chiefly at commercial operations, but others said the warnings could chill assistance programs, such as those in Vermont and Minnesota.
"They really did imply they're going after everybody," said Elizabeth A. Wenner, president of the Vermont alliance. But she said she has not heard from the FDA since officials visited her office last summer, and she predicted strong congressional opposition if the agency's crackdown becomes too aggressive. Rep. Dan Burton, R-Ind., already has accused the FDA of needlessly scaring seniors.
Other concerns
Meanwhile, Wenner is concerned about the proliferation of storefront pharmacies in this country that serve mainly as brokers between Canadian pharmacies and consumers. The storefronts typically do not employ health professionals and should be regulated more closely, she said.
Wycoff, head of the Minnesota federation, wants Congress to clarify the law and make it legal for U.S. citizens to import prescription drugs from Canada. A bill allowing such imports easily cleared Congress in 2000, but remains in limbo because the Clinton and Bush administrations have declined to enforce it.
Attempts to pass a new version of the measure began in Congress this year, but face stiff opposition from the politically influential Pharmaceutical Research and Manufacturers of America and from the FDA. In addition, the American Medical Association said it approves of the FDA's crackdown. "Because imported prescription drugs are not regulated or approved by the FDA, the quality is unknown," said AMA President Yank D. Coble Jr.
FDA Commissioner Mark B. McClellan, a Bush administration appointee, recently told the FDA Consumer Magazine that, by law, the safety and effectiveness of drugs are his top concerns.
"The cost of those medical products is not a direct part of that statutory mandate," he said.
The broader issue for the future is the lack of a Medicare prescription drug benefit, said Hayes, the Medicare Rights Center executive. President Bush supports such a benefit, but his priorities this year are pursuing the war on terrorism and enacting a tax cut, and Hayes worries the drug benefit could get lost.