Limits on Re-Importation of Prescription Drugs

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The FD&C Act also states that prescription drugs made in the United States and exported to a foreign country can only be re-imported by the drug's original manufacturer. Even when original manufacturers re-import drugs, the drugs must be real, properly handled, and relabeled for sale in the United States if necessary.

The Medicine Equity and Drug Safety Act (MEDS), enacted in 2000, would have allowed prescription drugs manufactured in the United States and exported to certain foreign countries to be re-imported from those countries for sale to American consumers. Supporters of the bill hoped that lower drug pricing in other countries would be passed along to consumers. But Health and Human Services Secretary Tommy G. Thompson responded by saying that, while he believed strongly in access to affordable drugs, he could not implement the act because it would sacrifice public safety by opening up the closed distribution system in the United States.

Though the law was enacted in 2000, before the bill can take effect, one provision requires that the HHS secretary determine whether adequate safety could be maintained and whether costs could be reduced significantly. Both Thompson and his predecessor, Donna Shalala, concluded that these conditions could not be guaranteed.

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"Once an FDA-approved prescription drug is exported for sale in another country, it is no longer subject to U.S. requirements and it can no longer be monitored by U.S. regulators," Thompson wrote in a letter to Sen. James Jeffords (I-Vt.), one of the bill's sponsors. "In addition, it may not have the U.S.-approved labeling. Instead it may have labeling for the country to which it is exported."

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By Michelle Meadows www.fda.gov

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