FDAnews Drug Daily Bulletin

Senate Delays Decision on Importation Amendment to PDUFA Bill

May 7, 2007

An amendment to allow importation of prescription drugs stalled again during the Senate’s May 3 debate on a bill to renew the Prescription Drug User Fee Act (PDUFA).

Sens. Byron Dorgan (D-N.D.), Chuck Grassley (R-Iowa) and Olympia Snowe (R-Maine) introduced an amendment May 1 to allow U.S. citizens to purchase drugs from pharmacies in other countries. “We have a golden opportunity to allow drug importation,” Grassley said.

A statement of administration policy issued by the White House said the president’s advisors would recommend he veto S. 1082, the PDUFA reauthorization bill, if it included legislation allowing importation.

The Senate invoked cloture on the Dorgan amendment May 3 by a vote of 63-28.

To moderate the amendment, Sen. Thad Cochran (R-Miss.) offered an amendment May 2 to Dorgan’s amendment that would require the secretary of HHS to certify that allowing imported drug products would not pose additional safety risks to Americans and would bring lower costs to consumers. Prescription drug importation “should occur only if necessary safeguards are in place,” Cochran said. 

The amendment would allow imported drugs into the country without FDA approval, Cochran said. However, Dorgan called that “demonstrably untrue” and said only FDA-approved drugs could come into the country under his amendment.

Dorgan’s amendment would permit companies to import drugs from Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, the UK, Iceland, Liechtenstein and Norway. In addition, the HHS secretary could add countries if he found their pharmaceutical infrastructures equaled or exceeded that of the U.S. The secretary could also remove countries from the list whose infrastructures were determined inferior.

An individual could import drugs from countries not included in the legislation if the drug is approved for commercial distribution in the country where it was obtained, if it enters the U.S. with the individual, and if the drug’s quantity does not exceed a 14-day supply, the amendment says.