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Halt sought on foreign drugs by mail
FDA proposal would stop unapproved medicines at border
WASHINGTON, June 7 — Health officials Thursday proposed denying U.S. entry of most drug products shipped by mail to individuals from foreign countries in order to keep illegal or dangerous medicines from American consumers.
NUMBER of packages containing drugs from overseas has soared in recent years, primarily from Internet sales, and has overwhelmed regulators’ ability to inspect them, agency officials told Congress. The Food and Drug Administration estimated that 2 million packages containing drugs enter the United States through international mail each year. “The inescapable conclusion is these drugs are virtually all unapproved in the United States ... they may be counterfeit or worse,” William Hubbard, the FDA’s senior associate commissioner for policy, told a House Energy and Commerce subcommittee. With the large volume, it is impractical for U.S. Customs Service agents or FDA inspectors to verify if the products are legitimate and safe, Hubbard said. The FDA has recommended to Health and Human Services Secretary Tommy Thompson that he “approve a requirement that Customs deny entry of all these drugs,” Hubbard told the panel. “I fear it’s all or nothing. You can’t distinguish between these little packages,” Hubbard said. Currently, Customs must contact recipients if it detains drugs at the border. The FDA plan would waive that requirement.
The FDA proposals still would allow individuals to obtain medicines that are not approved in United States for personal use in some cases. The drugs must be for treatment of a serious disease, and the patient must have exhausted other approved options. Patients also need to work with a doctor and obtain proper documentation. The proposal would not apply to people who travel to other countries and bring medicines back to the United States or to commercial shipments of bulk ingredients to pharmaceutical companies. © 2001 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters.
FDA proposal would stop unapproved medicines at border
WASHINGTON, June 7 — Health officials Thursday proposed denying U.S. entry of most drug products shipped by mail to individuals from foreign countries in order to keep illegal or dangerous medicines from American consumers.
NUMBER of packages containing drugs from overseas has soared in recent years, primarily from Internet sales, and has overwhelmed regulators’ ability to inspect them, agency officials told Congress. The Food and Drug Administration estimated that 2 million packages containing drugs enter the United States through international mail each year. “The inescapable conclusion is these drugs are virtually all unapproved in the United States ... they may be counterfeit or worse,” William Hubbard, the FDA’s senior associate commissioner for policy, told a House Energy and Commerce subcommittee. With the large volume, it is impractical for U.S. Customs Service agents or FDA inspectors to verify if the products are legitimate and safe, Hubbard said. The FDA has recommended to Health and Human Services Secretary Tommy Thompson that he “approve a requirement that Customs deny entry of all these drugs,” Hubbard told the panel. “I fear it’s all or nothing. You can’t distinguish between these little packages,” Hubbard said. Currently, Customs must contact recipients if it detains drugs at the border. The FDA plan would waive that requirement.
The FDA proposals still would allow individuals to obtain medicines that are not approved in United States for personal use in some cases. The drugs must be for treatment of a serious disease, and the patient must have exhausted other approved options. Patients also need to work with a doctor and obtain proper documentation. The proposal would not apply to people who travel to other countries and bring medicines back to the United States or to commercial shipments of bulk ingredients to pharmaceutical companies. © 2001 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters.
