How to combat fake drugs without harming the poor

Last week, the Prescription Drug User Fee Act (PDUFA) passed reauthorization in the Senate, but not before an amendment offered by Senator John McCain (R-AZ) lost quite narrowly (43-54). McCain wanted to allow Americans with poor insurance coverage to personally import medicines from credentialed foreign pharmacies — a move opposed by U.S. pharmacists and drug makers. Hundreds of thousands of underinsured Americans currently buy medicine online from overseas sellers, sometimes at significant risk. The McCain amendment would have helped them buy medicine more safely.

McCain expected the amendment to flounder because of drug industry influence in the Senate. “I’m proud that many of our country’s drugs originate in New Jersey,” said Senator Frank Lautenberg (D-NJ). “It would be wrong to undercut the work of these trained New Jerseyans only to put Americans in danger.” Other senators from states with drug industry interests also voted down the amendment. Democrats like Charles Schumer (D-NY) had supported personal importation amendments in the past, as did Barack Obama when he was a senator. But in exchange for the pharmaceutical industry’s support of Obamacare, Democrats stopped opposing the industry’s positions.

Michael Enzi (R-WY), one of the promoters of PDUFA reauthorization, was obviously annoyed by the delay caused by McCain’s amendment, and was well-schooled by the pharmaceutical industry in trotting out the usual anti-importation arguments to The Washington Times: “The problem is not knowing where the drugs really come from that go through Canada to the United States.”

It seems unlikely that Senators Lautenberg, Enzi or Schumer actually read Senator McCain’s amendment, because its whole point was to ensure, as far as possible, that the drugs only enter the U.S. via licensed foreign Internet pharmacies and are as safe as possible. In my own research, which was cited by Senators McCain and Olympia Snowe (R-ME) in last week’s amendment debate, none of the 210 drug samples bought from credentialed pharmacies failed authentication. Of course that doesn’t mean all drugs from all of these sites will be authentic, but I have no evidence of any that are suspect.

To be fair to Mr. Enzi, he has a point: We do not know where many drugs coming into the U.S. actually come from — but that problem affects a large number of pharmaceutical providers, not just Canadian Internet pharmacies.

As I describe in my book Phake, the ultimate source of many drug ingredients and finished drugs coming into the U.S. is uncertain. After analyzing audits of Chinese producers, I concluded that more than one-third of the chemicals coming from Chinese drug suppliers to Western companies come from unknown sources.