of Americans Look Outside
Mary Pat Flaherty and Gilbert M. Gau, The
William Brooks has a good job and good prescription drug benefits. He also has rosacea, a skin ailment he treats with an ointment. His employer's health plan picks up most of the cost, leaving him to pay only $14 when he fills his prescription.
Brooks said he can buy the ointment for $6 -- and does -- "over
there," jutting his thumb toward the narrow road into
Brooks, 48, is one of millions of Americans who have turned to
What makes him different is this: He is the director at the Andrade port of entry for the U.S. Bureau of Customs and Border Protection, in charge of stopping prescription drugs from illegally entering the country.
The port director embodies a national contradiction: Although U.S. law bans nearly all imports of foreign medications, Americans are bringing in those drugs in record numbers.
In the process, the nation's drug distribution chain is being breached, exposing consumers to risk and swamping regulators, according to state and federal records and interviews with dozens of federal agency officials, state investigators, academics and security specialists for the pharmaceutical industry.
Customs estimates 10 million
At peak season at Andrade, when snowbirds flock to the desert crossing
The Food and Drug Administration said that nearly all of the medications brought in from foreign sources by individuals are illegal and possibly unsafe. But agency officials have said they do not want to be the ones seizing medications from seniors. Customs and border inspectors who are the frontline enforcers of federal law allow in most pharmaceuticals, because "we are not in the business of taking away medication from people who need it," as Brooks said.
The debate over allowing Americans to take advantage of cheaper drugs
from overseas has been a recurring battle in Congress for the past three
years. Proposals have ranged from allowing imports from about 30 countries
to allowing them only from
As those congressional debates continue, however, many Americans have reached their own decisions, buying foreign medication pill by pill and package by package.
Top FDA officials say sheer volume makes inspecting every package at the border or in the mail impossible. Customs inspectors set aside packages that appear to be medications so an FDA inspector can decide whether they can be released to the buyer. But the agency does not have inspectors on site every day, even at large border crossings and mail facilities.
In 2001, the FDA proposed that all medication mailed into the United States be returned to its sender, except for a fraction that doctors could import for gravely ill patients. The proposal went in a memo to Health and Human Services Secretary Tommy G. Thompson. Two years later, the memo remains unanswered.
The FDA is trying to develop strategies to assess risks and identify prime targets for enforcement. "We can't win this playing man to man," FDA Commissioner Mark B. McClellan said.
If the FDA decides to hold packages, citizens can appeal, a process that can take months and creates huge backlogs of stored medications. It also lands the agency at the center of an emotional debate on how to make medication more affordable.
"We get beat up," said William K. Hubbard, the FDA's senior associate commissioner. "It's more phone calls from the Hill. The politics of seniors drives the political issue and will for a while until we give people a way to get their drugs here."
Laura M. Nagel, deputy administrator of the Drug Enforcement Administration, is concerned about prescription narcotics and other controlled substances coming across the borders and by mail. She said she has "nothing but sympathy for these poor, lower-pay-grade customs inspectors who are becoming pharmacists as they work against the tide."
But after years of promises that the FDA would take action, Nagel's
sympathy is at its end: "I want my law enforced." As the forces
Even that allowance strays from the original 1954 regulation, revised in 1988, for travelers who bring in foreign medication. Known as the personal-use exemption, the 1988 revision came when AIDS was surging and domestic treatments were scarce. The FDA responded by saying that patients with life-threatening illnesses under a doctor's care could import a few months' worth of medications, even if the drugs were not approved in the United States.
But that exemption opened the floodgates. It rapidly became abused and misquoted by everyone from Congress members to Internet pharmacy owners who say anyone is entitled to bring in a three-month supply of any medication. In the absence of enforcement, foreign imports poured in. Today, the result is confusion.
The FDA's "lax" response to abuses of the personal
importation exemptions coupled with the rise of the Internet has led to
"a massive problem," said Benjamin England, a former regulatory
counsel at FDA headquarters and 17-year veteran of the agency now in
private practice in
"It didn't take long for someone to fill the opening that created, and now you've generated a whole market," he said. "By the time FDA recognized the problem, the economic engine was running wide open and it was out of their hands. They let it become a political issue because they didn't address it when they should have, and that's where they're stuck."
An incident this summer in
In May, the FDA released nearly 2,140 mail packages of counterfeit
Viagra that had been seized seven months earlier in
The FDA headquarters has since said it made "a mistake" and sent letters to customers warning them that the agency could not vouch for the safety of the foreign shipment. But the FDA did not share with consumers what the lab tests had found, a copy of the letter shows. An FDA spokesman later said that the agency had sent a standard letter.
Since 2000, customs officials have asked the FDA for written guidelines on what ought to be held for FDA inspection. If the FDA will not ban virtually everything -- as current law demands -- what should customs stop?
Three times since 2000, FDA officials have testified they are preparing the answers. But written guidance has yet to come, Elizabeth Durant, director of trade programs for customs, told a congressional committee this past summer "If FDA told us to just ship it back, we could ship it back," she said.
In addition to the personal-use exemption, regulators struggle with another loophole.
The DEA is moving to close an opening through which painkillers and
other controlled substances cross
Some travelers just shifted to carrying in their drugs in increments of 49 doses apiece.
"An exemption for legitimate travelers has got bastardized," said Elizabeth A. Willis, chief of drug operations for the DEA. The DEA now is proposing a limit of 50 doses total per trip -- a change that would cut but not eliminate the traffic, Willis acknowledged.
He works the sidewalk in front of the "Purple Pharmacy," as the big shop directly across the border in Los Algodones has come to be called by American customers who cannot manage its proper name, "Pharmacia Liqui's."
With his running patter,
"In there," he says nodding toward the clerks, "you need to know a little something about medicines. Out here," he says with a grand sweep of his arms, "it's all personality."
Even on a slow June morning, license plates from throughout the
Inside, bottles of drugs sit in glass cases. Many are generics, some
Medications, including bottles labeled as the blood thinner Coumadin --
which requires a prescription in the
Dick Kujawa, 63, and his daughter, Dee Blake, of
She was shopping for an antibiotic. Her father takes medications for
high cholesterol, high blood pressure and heart failure. His drug bills
run about $700 every three months, he said. A sign offering Zocor, a
cholesterol medicine, caught their attention. At about $28 for 30 pills,
each 80 milligrams, that cost would be half what he pays in the
"That's worth the trip, even if it is the generic," he said. Guessing whether a drug is the same might not be the best system, he said, but "it should be embarrassing to our country that we have to come down here for medicine, period."
Inside the Purple Pharmacy, Virginia Plowman, 65, of
The price for Zetia, another cholesterol-lowering drug, disappointed her. At $31 for 20 pills of 10 milligrams, it cost more than the $50 she paid at home for 90 pills. But she had already seen savings on Prilosec and Celebrex that she was considering but was determined to shop around "since that's what I'm here for."
While Los Algodones retains a rustic air, the main street of
Ignacio Romo, head of the pharmacists association in
Elsewhere in Los Algodones and
In both towns were American shoppers who insisted they were saving at least half on drugs they need for chronic illnesses. Joyce Ernst, 65, of Las Vegas looked over the pills offered for sale and scanned the Physicians' Desk Reference, confident she could tell by sight if they matched the drugs she bought back home.
She decided against a full complement of Pariet, a treatment for
stomach ulcers, because the pills looked slightly different. She bought
just seven tablets to alternate those with her