Political Quotes

On the recordNovember 20, 2004
Isn't it true that the disadvantage to U.S. businesses of requiring smaller, more frequent shipments to each country of use is substantial? When a foreign entity seeks to import a schedule I or II drug, or a schedule III or IV narcotic from the United States, they must first secure an import permit that is shared with the U.S. manufacturer and DEA. Our companies then have 60 days in which to obtain independent safety and quality testing on each separate product batch to be shipped. Upon completion of that testing, the manufacturer submits a highly detailed export permit application for DEA's approval. If DEA fails to issue the permit within 60 days, the entire process must be restarted. Because independent testing is expensive and the export process is highly paper intensive, it is not unusual for companies to struggle against the 60-day deadline only to have to begin again. Unfortunately, while we engage in this burdensome process, patients suffer without their drugs and foreign physicians seek out substitutes to unreliable U.S. supplies. This process was put in place long before the adoption of our international drug control treaties and the anti-diversion protections they provide. It is now outdated and unnecessary.
Said by
Joe Biden
Democratic · Delaware

Editor's note · Context

Discussing the burdensome export process for U.S. pharmaceutical companies.

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