Monday, December 29, 2003

"'With more Americans looking beyond their border for affordable prescription drugs, the issue of safety must be addressed', said Robert Fraser, Director of Pharmacy.
'The rising costs of prescription drugs have left many people with some difficult choices, and having safe options available to purchase their medication starts with accreditation.'"
Online Canadian Pharmacy - Discount Prescription Drug Internet Drugstore - About Online Pharmacies:

"'Full' range of medication, just as you would find in a large pharmacy.
'Semi-Full' range of medications, covering those medication representing the majority of sales
'Popular' medications, the 10 to 50 top selling prescription drugs.
'Lifestyle' medications, such as those used for sexual enhancement, hair growth, contraception, weight loss, herpes, and smoking cessation.
'Specialized' medications for a single purpose, such as for pain, or specific medical conditions." About Online Pharmacies:

Importing prescription medication into the U.S., even for personal use, is illegal. Exceptions have been made for years (particularly since the AIDS epidemic hit in the 1980s) for drugs that are not available or approved in the U.S. but have nonetheless helped people with serious conditions. In practice, however, Americans who import medicine for private use by either taking it across the border or having it mailed to them are not typically prevented from doing so. "
Subcommittee on Health, Committee on Energy and Commerce:

"In September 1999, OCI received information regarding the Norfolk Men's Clinic and the website. Based on this information, several covert purchases were made via the Internet. Search warrants were executed in October 1999 that resulted in the seizure of prescription drugs along with numerous business records. Additional covert purchases were made from part of the Internet operation in West Virginia. Based on these purchases and numerous interviews, several individuals were indicted. In addition to defendants Pusztai and Yates, the president of a prescription drug wholesaler located in Miami, Florida, and the company itself, pled guilty to distributing midbranded drugs and to obstruction of justice. In conjunction with the indictment, a second search warrant was executed in Clanton, Alabama along with two search warrants in West Virginia. While most of the drugs sold in this operation were domestic product, some appeared to have originated in New Zealand."
Subcommittee on Health, Committee on Energy and Commerce:

"The vast majority of the shipments were identified as containing prescription drugs, which by definition have a degree of toxicity and/or risk associated with them such that they are not safe for use except under the supervision of a licensed health care practitioner (Title 21, U.S.C. section 353(b)). We believe that very few foreign Internet sellers require a prescription from a practitioner licensed in the U.S. before dispensing drugs to U.S. residents. Moreover, after detention notices were issued to the intended recipients of the 721 drug shipments, fewer than four percent responded with evidence of prescriptions or that a physician would provide oversight of the use of the drugs purchased from abroad. "
Subcommittee on Health, Committee on Energy and Commerce

Due to the huge volume of drug parcels entering the U.S. through the international mail and courier services, the requirements for notice and hearing, and our limited resources, it is difficult for FDA to detain and refuse mail imports for personal use. As a consequence, tens of thousands of parcels that FDA does not review are eventually released by Customs and sent on to their addressees
Subcommittee on Health, Committee on Energy and Commerce

The current personal importation policy permits the exercise of enforcement discretion to allow entry of an unapproved prescription drug only if the intended use is for a serious condition for which effective treatment may not be available domestically; the product is considered not to represent an unreasonable risk; the product is for personal use; there is no known commercialization or promotion to U.S. residents by those involved in the distribution of the product; and the individual seeking to import the product affirms in writing that it is for the patient's own use and provides the name and address of the U.S. licensed doctor responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country.

Subcommittee on Health, Committee on Energy and Commerce
eHelp Corporation