Internet Pharmacies and Prescription Drug Importation I

PART ONE
by Mark A. Krohn, Esq., Partner
Jacobowitz & Gubits, LLP

Current Law. The Federal Food, Drug, and Cosmetic (FD&C) Act limits the types of drugs that may be imported into the United States. Currently, the only types of legally imported drugs are: 1) those that are manufactured in foreign FDA-inspected facilities and the subject of an FDA-approved drug application, or 2) those that are U.S.-approved and manufactured in the U.S., sent abroad, then re-imported to the U.S. by the manufacturer under proper controls and in compliance with FD&C Act requirements.

Are greedy drug companies gouging seniors, only to sell drugs cheaply abroad? Given current FDA standards, its takes an average of 12 to 15 years and $800 million before a company can bring a new drug to market. Before any profit can be made, research and development costs have to be recovered. Socialized medical systems in other countries impose price controls. Thus, drug companies charge market prices here, in America, and “take what they are offered” in other countries. This makes foreigners beneficiaries as Americans pay most of the R&D costs.

How easy is it for a senior to buy drugs from another country? As easy as a few clicks away on your computer. However, the FDA warns that some web sites are not U.S. state-licensed pharmacies or are not pharmacies at all. Further, the FDA warns that medication sold over the internet may be fake, too strong or too weak, contain dangerous ingredients, are out-of-date, are not FDA-approved, are not safe to use with other medicine that you may take, or are not labeled, stored, or shipped correctly.

Is it illegal for me to buy drugs on-line? Not with a valid prescription. However back in 1987 Congress, at the urging of drug companies, passed a law to ban the re-importation of drugs from a foreign country back into the United States. Thus, although it may not be illegal for an individual to purchase from a foreign pharmacy a validly prescribed drug, it is illegal for the foreign pharmacy to re-import into the U.S. such drugs unless it complies with current law as described above. On March 9, 2006 the US District Court for the Southern District of New York permanently enjoined Canada Care Drugs, Inc. et al from causing the importation of drugs, receiving commissions from the importation of drugs, and advertising or promoting any drug sale.

What should I do if I can not afford to purchase medication from U.S. pharmacies? The FDA advises consumers that they must use great care when purchasing prescription drugs on-line. Although a Web site may appear to be hosted by a reputable source and may look similar to other retail pharmacy Web sites, it may be that the sites operate from outside the United States and are providing unapproved drugs from unreliable sources. The National Association of Boards of Pharmacy (NABP) has established a program to certify Web sites that meet industry standards. For more information on this program and for a list of pharmacies visit the National Association of Boards of Pharmacy website at https://vipps.nabp.net/verify.asp.