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The measure will let individuals order prescriptions from abroad without a prescription
Feature: Seniors lineup for online RX
Online Drugs: Do you get what you pay for?
U.S. House members slam FDA for drug import block
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Feature: Seniors lineup for online RX
By T.K. Maloy
UPI Deputy Business Editor
WASHINGTON, May 15 (UPI) -- While seniors in search of low-cost medication have been traveling on buses to Canada for several years, they have also started traveling in cyberspace with foreign online drug orders that the FDA had been turning a blind eye toward.
However, the Food and Drug Administration along with state authorities, is beginning to take a less-tolerant view, with warning letters recently sent to a variety of U.S. commercial operators who help import prescription medications.
"Everything coming into this country (via mail) is in violation," said a senior FDA official, asking to remain anonymous, about the importation of medications from abroad.
But in the meanwhile, the FDA has no intention of busting the seniors using the service, the official told United Press International.t
"Safety is the main issue," the FDA official said. "Consumers put themselves at risk."
However, for seniors trying to stretch a few dollars the choice can be obvious.
"It cost a lot less, and all my friends are doing it," said one energetic 78-year-old who asked to remain anonymous.
A classic "snowbird" who spends four months a year in Florida during the winter, she first heard about it from friends who had begun using one of the various "Discount Drugs of Canada" stores that have begun to spring up around the Sunshine State.
The DDC stores serve largely as storefronts, where clerks assist seniors in e-mailing or faxing prescriptions written by U.S. doctors to Canadian pharmacies, along with credit card payment. The northern pharmacies usually have Canadian doctors review the prescriptions, along with a short medical history the seniors have filled out and then write a Canadian prescription, which the pharmacies fill, mailing the medication straight to the front door of the person named no the prescription.
The DDC and other similar operations take a commission from the senior for their services.
With more than 50 walk-in centers throughout the United States, and a possible 200 more in the planning, the company may celebrate its first anniversary with sales topping $100 million, according to a recent press release.
But all is not rosy for Discount Drugs of Canada or similar operations.
"They (FDA officials) are trying to put us out of business, but we haven't been told to shut down yet," said Earle Turow, company founder.
According to Turow, however, he has not received a warning letter yet from the FDA.
Not so lucky is Rx Depot, which received warning letters from the FDA and state authorities in mid-March.
The FDA, acting in conjunction with action by the Arkansas State Board of Pharmacy in mid-March, issued a warning letter to Rx Depot, a storefront operation. The letter put the firm on notice that FDA considers the operation to be a risk to public health. The Arkansas State Board of Pharmacy issued its own letter to the firm instructing them to cease violating state law immediately.
In addition, FDA said in a late March release, that the agency supports the joint actions of the state of Oklahoma State Board of Pharmacy and the Oklahoma Attorney General's Office petition for injunction seeking to stop the Rx Deport storefront operation from violating state laws in Oklahoma.
The state authorities there filed a petition in Oklahoma state court, alleging that Rx Depot is illegally operating an unlicensed pharmacy.
Similar to the storefront operations such RX Depot and Discount Drugs of Canada are Web site-only commercial ventures such as "Polarmeds.com" or "LePharmacy.com" which also allow seniors to fax their U.S. prescriptions.
Neither of these sites offer any so-called "lifestyle" drugs such as Viagra, or anything mood-altering, such as narcotics, but do offer antidepressants.
As an example of prices, a comparative price list at LePharmancy offers 90 40-mg pills of the broadly used anti-cholesterol drug Lipitor for $188.51 compared to $296.16 in the United States.
The FDA estimates that approximately 2 million parcels containing what would usually be FDA-regulated products for personal use -- mostly prescriptions -- enter the United States annually through international mail facilities.
For the agency, the key issue is safety of the medications being shipped, which do not undergo the same scrutiny as medications distributed through U.S. pharmacies.
The Association for the Advancement of Retired Persons said through spokesman Steve Hahn that the group has "not taken a position" on foreign ordering for seniors yet.
At question said the AARP spokesman is the larger health issue.
"We've been working on a drug benefit to Medicare that would help 39 million beneficiaries, Hahn said.
He added, though, that those seniors ordering from Canadian companies exemplify "the (economic) challenges people are facing on this side of the boarder."
The National Association of Boards of Pharmacy noted in a recent white paper on seniors importing drugs from abroad, that "fueling this mass exodus from U.S. pharmacies to foreign outlets, particularly Canadian pharmacies, are high U.S. prescription drug prices."
The NABP also noted that the "newest twist" to Canadian drug importation involves prescription "facilitators," services that take prescription drug orders from patients then transmit them to Canadian pharmacies for dispensing.
"Although these operations, which range from Internet sites to store fronts, do not stock or dispense drugs, it is the position of NABP that they are conducting the practice of pharmacy and must be appropriately licensed by the state board of pharmacy," said the association in its recent paper on the subject.
Grace-Marie Turner, who heads the Galen Institute, a not-for-profit health and tax policy research organization, notes that Canadian pharmacies have found that exploiting price controls can be lucrative. At least 80 Internet enterprises are operating in Canada, employing about 2,500 people and grossing $500 million a year.
"The U.S. FDA does not have jurisdiction in Canada and doesn't begin to have the personnel necessary to monitor every package of pills coming into the United States," she wrote in a recent article for the Heartland Institute.
Echoing FDA comments, Turner told UPI that while cheaper the dark side of ordering from abroad is safety, with seniors possibly not always getting what they ordered.
Like the FDA, she noted that imported drugs raise serious safety concerns since they could be counterfeited, contaminated, expired or mislabeled.
She also said "I don't think a lot of seniors know" that the mail-order importation of medications from Canada and elsewhere is illegal.
A related issue is the potential economic cost to the U.S. pharmaceutical industry, which according to one recent study --- "Foreign Online Pharmacies: Sizing the U.S. Market for Imported Prescription Drugs," by Jupiter Research --- is minimal at the moment.
The Jupiter report added, however, that ordering from abroad will grow as seniors get increased access to online and other ordering methods for cheaper foreign prescription medications.
According to Monique Levy, an analyst at Jupiter Research, "Although the current market size for cheap prescription drug imports is less than 0.4 percent of the overall market, the biggest worry to U.S. pharmaceutical manufacturers and retail pharmacies is the potential of the (Internet) kiosk and Internet cafe-facilitated channel because of lax enforcement by the FDA."
Jupiter noted in its report that given the political sensitivity of drug benefits for seniors it is likely that FDA enforcement will be minimal, despite the strong influence of the pharmaceutical lobby.
The report said that the most effective lever that U.S. pharmaceutical manufacturers have for limiting foreign trade is to continue to restrict supply for example to Canadian wholesalers.
"Defining the potential growth of this (online) market will be unclear until conflicting political, commercial, legal and consumer interests are resolved," stated Levy.
Copyright © 2001-2003 United Press International
May 5, 2003
Online Drugs: Do you get what you pay for?
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Junkies used to get their drugs solely from the streets illegally. Now you can order them legally from pharmacies that break the law sending them to you.
Dangerous chemicals like Valium for stress or Phentermine for weight control can be bought without a prescription. KATU went online and within days, received both drugs without a prescription.
But can you trust what you get?
KATU put its online drug order to the test and found a little pill can become a danger when you buy drugs online without a prescription.
Addiction specialist Dr. Brad Anderson says about half of his patients that used to get opiates like heroin from the street, now get legal opiates online.
"More and more," said Dr. Anderson, "Yes, we see patients who report to us the medicine they're not getting from a doctor they're getting over the Internet."
While it's legal to buy and sell the drugs online it's not legal to import them into the US. The Valium KATU purchased is from Mexico, and was marked as documents. The Phentermine came illegally from Florida.
Phentermine is a very, very close cousin to methamphetamine.
Forensic scientist Dr. Ray Grimsbo says if a pharmacy is willing to break the law to sell drugs, how can you trust them to send you what you thought you bought.
KATU had him test the Phentermine.
Ground into a powder, the Phentermine is put into a testtube. Liquid is added and then it's run through a series of tests against a control.
While tests run, Dr. Grimsbo expresses why he thinks buying medication without a prescription online is so dangerous.
"I can just go online and go to one [website], get a dose," explained Dr. Grimsbo. "Go to another, get a dose, and no one knows because they don't check."
No one checks because it's nearly impossible on the Internet. Without checks, drug purchases can lead to addiction and a visit to Dr. Anderson.
"People's lives fall apart when they get these medications," said Dr. Anderson. "They're not treating themselves, they're not using the medicine to treat an illness. It's a substance which is causing a disease which we call addiction."
Tests on the drug purchased by KATU identified that it was most likely the phentermine that we paid for.
But doctors say taking drugs without a prescription is a real problem.
"Potentially, the wrong medication getting to the wrong patient without the right care and that's a real problem," said Dr. Scott Field who is an O.H.S.U. Family Physician. A problem that can potentially get worse as more and more pharmacies go on line.
The food and drug administration is the agency in charge of keeping drugs like we got from arriving without a legal prescription.
The FDA declined to comment on our story.
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U.S. House members slam FDA for drug import block
Last Updated: 2003-04-04 10:00:05 -0400 (Reuters Health)
WASHINGTON (Reuters Health) - Republicans and Democrats at a U.S. House subcommittee hearing Thursday accused the Food and Drug Administration of protecting the drug industry rather than U.S. consumers when blocking the importation of cut-price drugs from Canada. Noting that the drug industry has given members of Congress and other candidates more than $20 million in the last two election cycles and that they have more than 600 lobbyists on Capitol Hill, "many of us in the Congress believe they do have undue influence," said Rep. Dan Burton, R-Ind., chairman of the House Government Reform subcommittee that held the hearing. Subcommittee member Bernie Sanders, I-Vt., was blunter still. "This is payback time. The industry wants to force Americans to pay outrageously high prices in this country," he said. "Tragically, the FDA and this Administration have chosen to represent the interest of the industry and not the American people." But FDA Associate Commissioner for Policy, Planning and Legislation William K. Hubbard told the subcommittee that the FDA's primary concern is safety. "We are not a price agency," he said. Hubbard defended the agency's recent crackdown on Internet pharmacies that purport to be selling drugs from Canada. One, he said, turned out to be actually located in Thailand and another in Israel. Hubbard also brought packets of imported drugs confiscated from a customs facility in Virginia, including pills that were unlabeled, and a shipment of Accutane, an anti-acne medication that can cause serious birth defects if taken by pregnant women, which failed to include legally-required warnings. Buying drugs online can provide savings and convenience, Hubbard said, "but also unknown risks." And he defended the agency's opposition to allowing U.S. consumers to import drugs themselves. "If you open up the world to these sorts of drugs, it's very easy for the bad guys to get in," he said. Lawmakers at the hearing, however, were unconvinced. Arguments about safety "are grossly overstated," said Rep. Gil Gutknecht, R-Minn., who pointed out that the FDA allows imports of food, including some that turns out to be contaminated. "We should not permit our FDA to stand between American consumers and lower-priced pharmaceuticals," he said. They also accused FDA of failing to implement a law passed in 2000 that would have relaxed the ban on importing prescription drugs from other countries, although that law expired in 2001. "The FDA claims they cannot implement this law because they cannot assure the safety of the products being shipped into the U.S.," said Burton. "I believe the FDA needs to do some innovative, 'out of the pillbox' thinking." Burton also warned Hubbard that he may well be called back to testify again. "This is not over," he said. "I'm going to be chairman of this committee hopefully for six years and you're going to be here a lot." |
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