Critical Condition

FDA Ire

From the Wall Street Journal:

The Food and Drug Administration cast doubt on some Democratic senators’ efforts to allow reimportation of prescription drugs from Canada and other countries, saying it would be “logistically challenging” to guarantee the safety of the medicines.

In a letter to Republican Sen. Sam Brownback of Kansas, FDA Commissioner Margaret Hamburg also said overseeing importation would be “resource intensive.” The letter was a response to a request by Sen. Brownback, who in the past has opposed reimportation of drugs.

Dr. Hamburg commended some aspects of the amendment to the broad health-overhaul bill in the Senate submitted by Sen. Byron Dorgan (D., N.D.). The amendment includes several protective measures regarding imported drugs.

However, Dr. Hamburg wrote, it still cannot overcome such issues as the lack of FDA jurisdiction over foreign supply chains. “In addition, there are significant safety concerns related to allowing the reimportation of non-bioequivalent products,” she wrote. She also cited potential “confusion” in labeling and distribution.

NRO Staff — Members of the National Review Online editorial and operational teams are included under the umbrella “NR Staff.”

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