US FDA seeks to halt foreign drug mailings

The US Food and Drug Administration is proposing that mostpharmaceutical products mailed from overseas pharmacies into the USA should be returned, because the sheer volume of the trade now means that the agency is unable to track illegal, counterfeit or contaminated products. The agency estimates that two million packages containing medications now enter the USA from overseas every year.

Testifying before a House Energy and Commerce subcommittee hearing, held to discuss Congressional concern over the problem (Marketletter June 11), FDA senior associate commissioner for policy William Hubbard said that the inescapable conclusion is that virtually all of these products are unapproved in the USA. The agency has asked Health and Human Services Secretary Tommy Thompson to approve a requirement that Customs deny entry to all such products.

Under the FDA plan, US citizens would still be permitted to import drugs unapproved in the USA for their personal use if they were to be used to treat serious illnesses and the patients had exhausted all other approved options. Nor would the ban apply to US citizens bringing back small quantities of drugs from overseas, or to bulk ingredients shipped by drug manufacturers.