Law Feature -- February 2004
By Walt Borges
"How can I help my patients get those cheaper Canadian drugs?" That was one of the most common questions phoned into the Texas Medical Association legal department right after Congress passed the Medicare prescription drug bill late last year.
The basic response from TMA's lawyers: "Don't do it."
The new Medicare law allows reimportation of American-manufactured drugs from Canada, but Congress said the U.S. Food and Drug Administration (FDA) first must certify that the reimported drugs are medically safe. FDA officials already have said they won't do such certifications.
For the foreseeable future, reimportation remains illegal under federal law, TMA lawyers say, and physicians who help patients secure them might also be liable under Texas law.
The Texas State Board of Pharmacy (TSBP) oversees pharmacists and issues licenses for businesses and individuals who dispense drugs. Unlicensed businesses and individuals who "facilitate" the illegal distribution of prescription drugs can be held liable, as well, says Kerstin Arnold, JD, the board's general counsel.
Ms. Arnold says physicians may find it hard to resist requests for help from patients -- especially the elderly -- who are eager for relief from high drug bills, but they "need to think twice" before doing so.
She says physicians are not obligated to report patients who want to request a Canadian connection for prescription drugs, but they should not participate in processing prescriptions or play a role in the delivery of the drugs. Most Canadian prescriptions are mailed directly to the patient, she noted.
Texas State Board of Medical Examiners (TSBME) spokesperson Jill Wiggins said TSBME Executive Director Donald Patrick, MD, had no comment on physician involvement with drug reimportation from Canada. "That is an issue that the board has not addressed," she said.
Last year, TSBP identified about 20 businesses that were accepting prescriptions and processing drug orders from Canada, actions that are subject to TSBP regulation, Ms. Arnold says. Each business and its owners were sent a cease-and-desist letter, but only a handful responded.
One retail business that was associated with a licensed pharmacist who could be directly sanctioned by the pharmacy board quickly closed. But most of the others did not, Ms. Arnold says.
"The vast majority told us they were following the law as it was written, and if we wanted to stop them, we could come and get them," Ms. Arnold said.
The Houston Chronicle reported that a Houston retail store that helped patients buy prescription drugs from pharmacies in Manitoba Province also decided to close. Many of its 300 customers were retirees who were not computer savvy, the owner told the Chronicle .
Also last year, the FDA obtained an injunction that shut down Rx Depot, an Oklahoma-based national retail operation. FDA regulators said the chain sent prescriptions, credit card information, a patient profile, and legal releases to Canada, where a physician issued a prescription that was filled and sent directly to U.S. patients. Such actions violate the federal Food, Drug and Cosmetic Act, the FDA said.
The FDA letter accused the retail store of misrepresenting the imported drugs and transactions as meeting FDA approval, which they did not.
Why Consumers Want Canadian Drugs
With drug prices continuing to soar, it's not surprising that patients, the employers that insure them, health plans, and state and local governments are looking at alternatives to paying full U.S. prices for prescription drugs.
At least one insurer, UnitedHealthcare, allowed some of its members to be reimbursed for Canadian drugs, dropping a requirement that reimbursements would be issued only for prescriptions filled in the United States.
Consumer interest in the Canadian drugs surfaced in the recent Medicare debate, as Congress instituted an optional drug benefit for senior citizens that begins in 2006. While it is clear that many seniors, especially those on fixed and limited incomes, will benefit from the program, critics of the bill said the benefit was not extensive enough. They charged that the bill did not give federal officials the authority to bargain lower drug prices through negotiations with pharmaceutical manufacturers.
American citizens pay higher prices than do Canadians. U.S. prices can be attributed in part to the cost of preapproval testing and the need for pharmaceutical companies to make sufficient profits to fund the development of other drugs for the physician's arsenal.Canadian drugs are cheaper because the Canadian government has enacted price-control policies that have checked the costs of drugs.
How much cheaper? A savings calculator unveiled in November 2003 by the liberal Civil Society Institute (CSI) estimates that an American consumer who takes one Vioxx a day could save $524 per year by purchasing the drug at Canadian prices. CSI estimates that Lipitor costs $339 less per year in Canada, and Prevacid is $641 cheaper across the border.
In December, five Canadian drug companies told a meeting of state governments interested in Canadian purchases that their companies can offer many drugs for as much as 40 to 60 percent less than they cost in the United States.
New Hampshire already has announced its intention to purchase drugs from Canada. Illinois is engaged in a public dispute with American drug manufacturers trying to head off the foreign purchases. Massachusetts, Oklahoma, West Virginia, Alabama, North Carolina, Vermont, Ohio, Delaware, and Louisiana also are interested in purchasing drugs for their employees and those who are on Medicaid and other public assistance programs.
In July 2003, the American Medical Association opposed a proposed bill to legaliz the reimportation of Canadian drugs. In letters to House members and senators, AMA said it was opposed because the safety of reimported drugs could not be guaranteed.
What About Texas?
While it has warned the states against violating the federal laws governing importation, the FDA has not prosecuted individuals who bring small quantities of prescribed drugs into the country.
In Texas, it is not uncommon for state residents to cross into Mexico to purchase prescription drugs for individual use at cheaper prices. The importation is usually allowed by U.S. Customs officials if the individual has a prescription. U.S. officials also have not blocked the mail order delivery of prescription drugs intended for individuals from Canada.
While allowing reimportation from Canada in the new Medicare bill, albeit under conditions that the FDA will not meet, Congress did not lift the ban on reimportation from Mexico or any other country.
Safety Not Guaranteed
The FDA, however, said during both the Clinton and Bush administrations that it lacks the resources to guarantee the safety of imported drugs. Ms. Arnold of the Texas pharmacy board says safety is a prime concern for both federal and state regulators.
She says federal agents conducted random spot checks in Miami and along the Canadian border in 2003 and found that a large percentage of the drugs brought into the United States were not what was claimed. Some were counterfeit, and others were less potent than prescribed, she says.
"Physicians and patients should think about this: What if patients buy Lipitor from a Canadian online pharmacy and they get sugar pills instead?" Ms. Arnold said. "If they die, they die of a disease that physicians know they had, so little attention is paid to what was actually in the prescription. But they died because they failed to have the medication that was prescribed."
Sometimes, Ms. Arnold added, the "Canadian" pharmacies may be located where ice and snow are unknown.
"One of the problems with ordering from a Canadian pharmacy is that the 'Canadian' pharmacy may be in Cambodia or another location, and they are sending Texans drugs that aren't from American manufacturers at all," Ms. Arnold said.
An Option for Physicians
While the law prevents physicians from rendering direct assistance to patients seeking cheaper drugs from Canada, it does not keep doctors from using assistance programs set up by American pharmaceutical companies to help indigent patients to obtain expensive drugs, says Frank Santos, a Texas lobbyist for the drug manufacturers.
"There are a couple of ways for indigent patients to obtain drugs," Mr. Santos said. "The first is to use the patient assistance programs set up by most pharmaceutical companies."
To use the program, a patient must certify indigence to his or her physician and qualify by not being on other assistance programs, including Medicaid and Medicare. If the patient can do so, doctors call a toll-free number for each manufacturer to arrange for free drugs.
The trade association for drug manufacturers, the Pharmaceutical Research and Manufacturers of America (PhRMA), says 48 of its member companies aided 5.5 million Americans with free drugs in 2002. PhRMA data also indicate that 763,252 Texans received medicine through the patient assistance program in 2002.
PhRMA has an interactive Web site that can help patients and their physicians determine their eligibility and which drugs can be provided. The Web address is www.helpingpatients.org.
Mr. Santos says the second assistance program, called Together Rx, is for seniors. Its qualifications are similar to those in the manufacturers' programs. Its Web address is www.togetherrx.com.
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