As the forces reshaping the U.S. drug distribution system come to bear on the country's gatekeepers, "discretion" -- a word that Brooks and customs inspectors near San Diego and Laredo, Tex., all used -- has overtaken regulation.
U.S. officials draw a bright line at smuggled medications or obvious counterfeits or drugs that have been rejected for the U.S. market. But a traveler who has a prescription and buys no more than a three-month supply of medication for his own use will most likely be allowed in.
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 Washington. "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 Miami was "a real train wreck," England said.
In May, the FDA released nearly 2,140 mail packages of counterfeit Viagra that had been seized seven months earlier in Miami because they did not appear to be made by Viagra's manufacturer, Pfizer Inc., according to customs and FDA records. Samples from the packages, mailed from Belize, had been sent to the FDA for testing. In January, the lab concluded that some pills were less than full strength and others some were overly strong -- a more serious risk, given Viagra's side effects. Despite that information, the FDA headquarters released the packages to the U.S. customers who had ordered them. Some of the FDA's Miami staff questioned that decision: "Shouldn't we refuse entry particularly on a Rx drug like Viagra?" one wrote in an e-mail. The reply from a supervisor: "We released it because we do not have the resources to deal with mail entries."
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 U.S. land borders. Since 1970, travelers who obtained a prescription narcotic abroad -- presumably for a medical reason -- were allowed to bring it home without a U.S. prescription. In 1998, to stop widespread abuse, the law was amended to limit a traveler crossing from Mexico or Canada to an amount less than "50 dosage units" of any given drug.
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.
Hugo Moreno, all pumped-up chest and wraparound sunglasses, flashes a dazzling smile and tilts his chin: "What are you looking for? We'll have it. C'mon over, look at these prices."
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, Moreno, 23, has undeniable curb appeal, slinging jargon he picked up at college in Arizona, winking to the men as he points out the Viagra prices, bending down to boost an older woman with a cane from the street to the pavement.
"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."
Not that Moreno would have to work hard. Americans flock here.
Even on a slow June morning, license plates from throughout the Southwest, Midwest and West could be seen on cars whose doors opened to let out gaggles of white-haired men and women. Trunks popped to release canes, walkers and at least one portable oxygen tank -- every bit of that equipment summoned to aid an older person in a slow and deliberate walk to Los Algodones's pharmacies.
Painted as purple as Barney, Liqui's is anything but subtle. A sandwich board posts prices for hot brand names -- Lipitor, Fosamax, Premarin, Captopril -- that translate into a list of maladies hitting older Americans: high cholesterol, osteoporosis, menopausal effects, heart failure. Sheets of paper -- 144 in all -- curtain the store's front windows, each one an "especial."
Inside, bottles of drugs sit in glass cases. Many are generics, some made in Mexico, others repackaged in Mexico with their manufacturing site not apparent. Others, with Spanish labels, say they were made in Germany or Panama.
Medications, including bottles labeled as the blood thinner Coumadin -- which requires a prescription in the United States and regular blood testing to monitor dosages -- could be bought off the shelf.
Dick Kujawa, 63, and his daughter, Dee Blake, of Mesa, Ariz., studied the prices. A recently retired warehouse worker, Kujawa lost prescription drug coverage when he shifted onto Medicare. His daughter and her husband run an Internet-based business, "and don't have health insurance because it's so high for self-employed people," she said.
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 United States, he said.
"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 Mesa scanned the list of medications in her hand, some hers, some from friends. Until she turned 65 and had to rely on Medicare, she "didn't think about drug costs. I always had insurance."
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 Tijuana has converted to a veritable medication mall. The painted burros are still there for tourist photos and so are the leather stores. But along a street once thick with strip clubs and bars, farmacias dominate, with "we have English" and signs for "smoothees" jostling signs for menopause medication.
Ignacio Romo, head of the pharmacists association in Tijuana known as Union de Farmacias y Boticas de Tijuana, winces at the explosion of pharmacies along Revolucion Avenue. Romo, who has run one small drugstore in a Tijuana neighborhood since 1951, said "it's become anarchy" along the avenue. Speaking through an interpreter, he said he worries "the professionalism of pharmacists is being degraded" by shops that post clerks in medical coats but offer no real expertise. "Just because you dress like a nun doesn't make you one," Romo said.
Elsewhere in Los Algodones and Tijuana, doctors were offering to write prescriptions for controlled substances in exchange for $20 or $30, no medical exam needed. A pharmacy in Los Algodones had preprinted and signed prescription pads on hand to give to American buyers in case they were challenged at the border. Another pharmacy in Los Algodones sold an American a generic antibiotic that was unapproved in the United States. A clerk in white coat packed it in a baggie and suggested the American hide it in a pocket to get it past customs.
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 U.S. medicine "as a test. It's worth a shot." She bought Xenical, which aids in weight control, because at $90 it was $30 less than what she had paid the previous month at her drugstore -- a bill she carried in her hand as she ducked in and out of the pharmacies lined nearly door-to-door along Revolucion Avenue in Tijuana.