>The new proposal – Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004 (S.2307), or the REMEDIES Act – would immediately open the door for U.S. consumers to buy prescription drugs from Canadian pharmacies while the FDA gets a new drug importation system up and running, which the agency would have 90 days to establish. Under the new system that must be established by the FDA, individuals, pharmacies and drug wholesalers would be allowed to buy “qualified drugs” for import to the United States from foreign exporters who register with the FDA.
>Under the system that would have to be established by the FDA should the measure become law, a foreign exporter would have to register with the FDA. To register, the export must demonstrate compliance with safety measures, submit to the jurisdiction of U.S. courts and take other steps to verify the safety of its drugs. A user fee charged to registered foreign exporters would provide the financing needed for the FDA to register and oversee foreign drug exporters and ensure the safety of imported drugs.
>The legislation was introduced by Grassley as a reflection of “consumer demand for the lower-priced pharmaceuticals available in Canada and responds to the fact that the U.S. Food and Drug Administration (FDA) has declined to take action that could lead to certification of prescription drugs from Canada”, the Senator said in a news release announcing the bill
“Free trade principles argue for allowing importation of drugs from Canada and other countries as long as those drugs are safe,” the Senator said. “The FDA has been unresponsive for years, and U.S. consumers have been going around the FDA. Congress needs to take action to make sure that prescription drug imports are both safe and available to U.S. consumers.”
In addition, Grassley said the REMEDIES Act includes both a “carrot and a stick” to keep U.S. drug manufacturers from preventing legal importation.Under the measure, drug companies that attempted to limit supply to countries that export pharmaceuticals to theUnited States would see the tax credits currently claimed by the companies dry up. Further, if a company certifies certify that it has not taken any action during the taxable year to prevent or condition the authorized importation of a qualified drug into the United States from a registered exporter in accordance with the legislation then the pharmaceutical would be eligible for a new 20% research and development tax credit.