FDA Letter Warns of Safety Concerns With Re-Importation of Prescription Drugs

photo: nvinacco via Flickr

photo: nvinacco via Flickr

The FDA has sent a letter to a Republican Senator about the Dorgan prescription drug amendment, claiming that the reimportation of drugs into this country from Canada and other developed nations would be “difficult to implement” and “resource-intensive,” and would involve “significant safety concerns.”

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.

Dr. Hamburg said the Obama administration supports a program to allow Americans to buy drugs from other countries, and noted that the budget includes $5 million to study it and develop options.

Mr. Dorgan, speaking on the Senate floor, called the FDA letter “completely bogus” and said he would address its points Wednesday. In his remarks, he advocated reimportation along the lines of Europe’s “parallel trading” system, which he said “works well.”

What you have is a federal agency saying that they cannot carry out their mission of allowing the safe passage of prescription drugs into this country. I would argue that drugs of this type is the last worry of an FDA working to get to market pet food and toothpaste from China and contaminated spinach and produce from all over the country. These drugs are manufactured and bottled in the same exact facilities as domestic drugs, with the exact same labeling. It’s honestly incredible for the FDA to involve themselves in this, especially on the issue of safety.

Supporters of the amendment on reimportation have savaged the FDA letter on the Senate floor over the past 24 hours, including Byron Dorgan and John McCain. Dorgan said, “U.S. consumers are charged the highest prices in the world for FDA-approved prescription drugs, and that’s just not fair.” He added that 40% of the active ingredients in current domestic prescription drugs are coming from China and India anyway. It would be as “resource-intensive” to check domestic drugs as it would these prescription drugs.

This is nothing new, as FDA commissioners in the Clinton and Bush 43 Administrations cited similar safety concerns for reimportation, which would save the federal government $19 billion over ten years and save consumers roughly $100 billion. However, as a Senator Barack Obama supported this very reimportation bill. You’d think he would have found an FDA commissioner who agreed with him.

The reimportation amendment would damage the pharmaceutical industry’s backroom deal with Senate Finance Committee Chair Max Baucus and the White House, which limited the drug industry’s exposure to “losses” in the deal to $80 billion dollars over ten years, in exchange for support of the bill.

UPDATE: Just to take a trip down memory lane for our Republican friends on this, in 2007 the Senate passed reimportation, but Republican Thad Cochran (R-MS) introduced an amendment neutralizing its effects. Here’s how that vote broke down, mostly along party lines:

Thirty-three Republicans, 15 Democrats and one independent voted in favor of the Cochran amendment, and 28 Democrats, 11 Republicans and one independent voted against the amendment (Armstrong, CQ Today, 5/7). According to The Hill, the passage of the Cochran amendment also might allow President Bush to approve the reauthorization bill, which he has threatened to veto in the event that the legislation includes the Dorgan amendment (The Hill, 5/7).

So George Bush threatened a veto of this amendment the last time it came up, and by a 3:1 margin Republicans helped him out by passing something that neutralized it. So the Republicans have already cost Americans $20 billion or so just in the past couple years on reimportation, which should be the law of the land already. I’m interested in getting their votes on this measure, but not so interested in hearing them jabber about it.

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