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In 1988 the FDA issued a directive regarding the importation of medications for personal use. This came about as a result of the tremendous pressure the FDA got from senior citizens, aids activists etc. In addition, drug prices were outpacing inflation by some 12%. The FDA decided to allow some experimental drugs to be imported that had not been approved by the FDA. Their guideline was a 90 day supply, for personal use only. It takes the FDA years and endless red tape to approve a new drug. According to their guidelines, this did not include drugs already approved in the USA, nor did it allow the importation of controlled substances. The then current director of the FDA had the foresight to realize to potential corruption of his agency in the future by commercial enterprises, such as US drug manufacturers and retail chains, so this FDA provision was set-up so it could not be modified nor deleted by future FDA administrations. Soon after, millions of people began importing medications of all kinds with the exception of illegal or banned medications. Pharmacies all over the world started websites promoting their products. Because of pressure from congress and to a lesser extent, the public, (who were getting ripped off), the FDA began cracking down on overseas websites that promoted their products. With the cooperation of the Thailand Government, they began shutting down Thailand sites many that were unregulated and associated with organized mobsters. They also began seizing almost every parcel that came out of Thailand. Soon after that, the FDA began to issue warning letters to overseas pharmacies that were commercially promoting their products and put many of these sites on import alert which means the parcels were to be opened and seized. They then sent the recipient a letter, which said, in effect, the medications you ordered were not manufactured in the USA and since the FDA did not approve them, they posed a risk to the citizen’s health. The letter they sent had no teeth to it. Millions of people threw them away and kept right on ordering. The reason was that there was a very small chance a parcel would be opened considering the millions that were coming over the border every day. Today, there is outrage over the high cost of medications and congress is finally listening to their constituents. For the most part, medications manufactured overseas are tested just like they are here. The only difference is that big drug companies do not influence overseas governments the way they do here. As a result, the folks on Capitol Hill are telling the FDA to chill out. If a citizen can get an antibiotic overseas for half the price, they should be allowed to do so. They are telling the FDA to stop stealing people’s medications and to cease and desist the irritating, yet toothless letters sent to USA citizens. To give you an idea of the state of the Washington power structure on this issue, consider that in the closing days of the Clinton administration both houses of Congress unanimously passed legislation removing all doubt about the importation of drugs. (see article below import bulletin) Unfortunately the legislation contained a provision that it could not take effect without the approval of the FDA, and that agency, which is notoriously cozy with the drug companies, refused approval. Consider however that the bureaucrats in the FDA are well aware of the unanimous opinion of Congress and are therefore highly unlikely to “rock the boat” by beginning enforcement of the letter of the law. This has not become law as of yet so caution is still warranted. This is why we are including this commentary, to help you interpret the wide ranging and confusing FDA regulations (see more in FDA Bulletin below) and more importantly to keep you away from the unscrupulous scammers that take advantage of people in pain or other medical conditions. U.S. Food & Drug
Administration Bulletin
Imported Drugs Persons wishing to ship a drug to the United States, and persons in the United States wishing to import the same must bear in mind that the article may be detained and refused admission if it does not comply with the applicable drug provisions of the Federal Food, Drug, and Cosmetic Act. A drug which has been used outside the United States, and which may be regarded as safe and effective by experts in other countries, but which has not been marketed in this country, is likely to be regarded as a new drug under the Federal Food, Drug, and Cosmetic Act. A new drug will be admitted only if the Food and Drug Administration has approved a New Drug Application for it. However, exceptions to this rule include drug importation for personal use only if specific conditions are met. COVERAGE OF PERSONAL IMPORTATIONSGENERAL GUIDANCE The statements in this chapter are intended only to provide operating guidance for FDA personnel and are not intended to create or confer any rights, privileges, or benefits on or for any private person. FDA personnel may use their discretion to allow entry of shipments of violative FDA regulated products when the quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user. Even though all products that appear to be in violation of statutes administered by FDA are subject to refusal, FDA personnel may use their discretion to examine the background, risk, and purpose of the product before making a final decision. Although FDA may use discretion to allow admission of certain violative items, this should not be interpreted as a license to individuals to bring in such shipments. PURPOSE To provide guidance for the coverage of personal-use quantities of FDA-regulated imported products in baggage and mail and to gain the greatest degree of public protection with allocated resources. BACKGROUND Because the amount of merchandise imported into the United States in personal shipments is normally small, both in size and value comprehensive coverage of these imports is normally not justified. This guidance clarifies how FDA may best protect consumers with a reasonable expenditure of resources. Commercial or Promotional Shipments Commercial and promotional shipments are not subject to this guidance. Whether or not a shipment is commercial or promotional may be determined by a number of factors including, for example, the type of product, accompanying literature, size, value, and/or destination of the shipment. FDA personnel may also consider whether an importation of drugs or medical devices is a commercial shipment by evaluating whether the article appears to have been purchased for personal use or whether the quantity suggests commercial distribution (i.e., the supply exceeds what one person might take in approximately three months). Commercial shipments generally include shipments other than those products that are personally carried, shipped by a personal non-commercial representative of a consignee, or shipped from a foreign medical facility where a person has undergone treatment. Drugs, Biologics, and Devices When personal shipments of drugs
and devices that appear violative are brought to FDA's attention by
Customs, FDA personnel will use their discretion to decide on a
case by case basis whether to detain, refuse, or allow entry of the
product. Generally, drugs and devices subject to Import Alerts
are not amenable to this guidance. Devices to be used by practitioners
for treating patients should not be viewed as personal importations
subject to this chapter. Drugs subject to Drug Enforcement Agency (DEA)
jurisdiction should be returned to Customs for handling.
Clinton Administration Stops Congressional BillIn one of it's last
administrative acts, the Clinton Administration refused to support the
Congressional Bills which were unanimously passed by both the House
and Senate this summer. Stating it's case, Clinton representatives
declared that the big pharmaceutical business concerns in the USA
would not be deterred by such a law being passed. The spirit of the
bill was to somehow or other create opportunity for those who can not
afford their prescription medications here in the USA an alternative,
by giving them more facility to purchase foreign equivalents. The bill
however did not address the facility now existing for personal
imports, but rather with the proposition of allowing "pharmacists" the
facility to purchase meds wholesale from abroad and then to sell them
to those with a prescription in the USA, in much the same way they
currently sell generics. In an article released today by the New York
Times News Service (see below). The Administration took special
care to mention that this defeat of the proposed legislation is not
meant to discourage personal import of meds in 90 day supply for
consumers. And essentially announces to all those who may not know as
much, that such facility exists. More importantly this acknowledgement
by Congressional leaders of the need for such alternatives has now
been squarely placed in public view, removing the stigma long
associated with personal import of meds for medical need. BUY NOW |
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