Albion Monitor /News

FDA Intercepts Legal Drugs From Overseas

by David Sjostedt

Drugs seized include standard prescriptions that cost 50 percent less overseas

Melinda Vadas ordered the drugs to treat her bone disease and chronic fatigue syndrome from Europe. LIving on $442 per month Social Security Disability Insurance, she couldn't afford to buy the exact same drugs at her local pharmacy; the mail-order versions were often half the price. Then the FDA seized the next package of foreign drugs mailed to her.

The Food and Drug Administration routinely seizes shipments of drugs imported from other countries by U.S. citizens. The seized items range from prescription drugs available at local pharmacies, "smart" and "longevity" drugs not sold in this country, to dietary supplements that can be bought at most health food stores. These seizures violate the FDA's own policy that allows Americans to import a 3-month supply of drugs for their own use. This does not include "scheduled substances" (like opiates, amphetamines, or psychedelics) which are illegal to possess in this country.

A drug may confiscated simply because it was from a company on a "import alert list"

Originally implemented to permit AIDS patients to buy drugs used overseas to fight the HIV virus or the opportunistic diseases associated with a weakened immune system, the policy quickly drew the attention of others.

Low-income people discovered that they could save money by importing their own drugs.Those using drugs reputed to increase intelligence, improve memory, or prolong the human lifespan could only get them from from foreign sources since the FDA has not approved them, and likely never will.

Due to the enormous volume of mail, most of these foreign shipments get through, but the FDA does detain many. And, says consumer lobbyist John Hammell, "No two district offices interpret FDA regulations in the same way."

When it does detain drugs, the FDA sends a note inviting the buyer to go to the district office and "present evidence as to the manner in which the article can be brought into compliance with the Act." Frequently, nothing the buyer can say can induce the FDA to release his purchase.

Sometimes the FDA confiscates a drug simply because it was purchased from a company on its "import alert list." George Zutaut of Chicago found his shipment of Lucidril detained, although he can buy it over the counter in Mexico and drive it back over the border with impunity. But purchase it from A. Werner & Company in Prague and the FDA will intercept your mail and detain it.

Engaging in a long legal process to get one's drugs released often results in only a pyrrhic victory. After having his $175 shipment of drugs detained, Jim Gebhard of Sitka, Alaska was angry enough to run up a $300 phone bill, send seven notarized letters to the FDA and to his U.S. Senators, and retain legal counsel. His long battle finally won, he received a letter from the FDA indicating that his shipment would be released to him. But the letter ended: "This notice does not constitute assurance that the merchandise involved complies with all provisions of the FD&C [Food, Drug, and Cosmetic Act] and other related acts and in no way precludes further action should it be determined that the merchandise is violative."

Some suspect that the FDA is more interested in protecting the U.S. pharmaceutical industry, the former -- and often future -- employer of some FDA staffers, than in protecting the health of Americans.

The FDA said that exactly the same drugs were a health hazard when bought cheaply oversas

North Carolinian Melinda Vadas ordered Premarin and Calcitrol, drugs approved for treatment of Osteomalacia in this country, from an overseas supplier. The FDA seized them.

After many letters and phone calls, and with the help of her congressman, Vadas eventually did receive her drugs along with a letter from the FDA's Diane Thompson stating that Vadas could not continue buying low-cost medications from foreign sources because such purchases were a "hazard to her health."

Vadas wondered how the seized Calcitrol could be a health hazard since it was made by Roche Laboratories in Switzerland, the supplier of Calcitrol to U.S. buyers. The drug sells for a much higher price in this country than abroad.

The FDA targets foreign drug companies much the way it does some U.S. manufacturers of vitamins, herbs, and other food supplements. It declares that the companies make unfounded health claims for their products. (The FDA raided one U.S. supplier of coenzyme Q10 simply because he mailed, at customer request, reprints of newspaper or magazine articles detailing medical research on his product.) It then may confiscate any product shipped by that company.

The U.S. Congress defeated a bill last year that would have expanded the FDA's control over the sale of vitamins, herbs and other dietary supplements in this country. Additionally, the House Subcommittee on Oversight and Investigation has begun hearings to provide Congress with information on the need for reform of the FDA.

Albion Monitor October 9, 1995 (

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