Health Leaders Urge U.S. Senate to Refrain From Adding Drug Importation Amendments to PDUFA Legislation

WASHINGTON – In the interests of patient safety and medical innovation, U.S. Senators should reject any attempts to attach prescription drug importation amendments to the Food and Drug Administration Safety and Innovation Act, the president of the Healthcare Leadership Council said today.

“There is no compelling reason to shatter a ban on imported drugs that both Democratic and Republican administrations have consistently upheld,” said HLC President Mary R. Grealy.  “By contrast, there is a litany of reasons to preserve the sanctity of our pharmaceutical supply chain.  When the world is seeing hundreds of cases of counterfeit or illegally diverted drugs yearly, why would we take any action that could endanger Americans’ health?”

The Healthcare Leadership Council is a coalition of chief executives of the nation’s leading healthcare companies and organizations, representing all health sectors.

“The idea that prescription drugs imported from Canada, compared to other countries, are ‘safe’ is a severe misconception,” Ms. Grealy said.  The U.S. Food and Drug Administration has no authority over Canadian import-export policies and could not know the origin point of drugs passing through on the way to the U.S.  Trans-shipments originating in third party countries, she said, pose a serious threat to pharmaceutical safety.

Ms. Grealy added that healthcare distribution companies have publicly stated that repackaging, relabeling, inspection, liability coverage and other costs associated with imported drugs would largely negate any anticipated cost savings.

She said, as well, that importing prescription drugs will hurt patients in the long run by undermining the revenue stream necessary for research and development of new cures and treatments.