FDA Warns TX About Bill to License Canadian Pharmacies

Texas state Senator Rodney Ellis, who cosponsored the bill, said in a statement that Canadian pharmacies would be held to the same safety standard as any other pharmacy in the state. However, in a letter dated June 17, the FDA warned Perry that “if an entity or person were to import prescription drugs into the State of Texas from Canada, that importation would violate [the Federal Food, Drug, and Cosmetic Act] (FFDCA) in virtually every instance.”

In the continuing effort by many states to obtain less expensive prescription drugs from Canada, the FDA has sent several such letters, including one to the attorney general of Rhode Island in January ( RI First to License Canadian Pharmacies ). California, Illinois ( Illinois Becomes Fifth State to Import Prescription Drugs from Abroad ), Minnesota, New Hampshire, Rhode Island, Wisconsin, and the District of Columbia all received letters in 2004. In spite of its opposition, the FDA has not yet taken any legal action against states, wanting to avoid hostilities with governors. However, it is considering filing a test case against a state. The letter to Perry warned that there are “many sources of civil and criminal liability” for parties who violate the FFDCA.

“In our experience, many drugs obtained from foreign sources that purport and appear to be the same as FDA-approved prescription drugs have been of unknown quality and origin,” stated the letter, reiterating prior statements by the agency that its main concern is that it cannot ensure the safety of imported drugs. The FDA has also said it is taking steps to reduce the costs of drugs, including efforts to accelerate drug approvals and regulatory and process changes to expedite generic drugs.

-Rebecca Moore