Sen. David Vitter (R., La.) has resurrected a bad idea, and is demanding a vote on an amendment he has been pushing for years to legalize the importation of prescription drugs from Canada. The Senate could take up the amendment as early as tonight.
Vitter’s amendment would prohibit the use of funds for the Food and Drug Administration “to prevent an individual . . . from importing a prescription drug from Canada that complies with the Federal Food, Drug, and Cosmetic Act.”
We have more than enough problems with health care right now in the United States — including serious shortages of prescription drugs — without opening this highway to potential contamination of our drug supply and violation of the integrity of the supply chain, potentially even inviting a channel for those who are determined to do harm to U.S. citizens.
Former FDA commissioner Mark McClellan warned that drug importation “creates a wide channel for large volumes of unapproved drugs and other products to enter the United States that are potentially injurious to public health and pose a threat to the security of our nation’s drug supply.”
Several states, including Illinois and Minnesota, have allowed citizens to import drugs from Canada to take advantage of our northern neighbor’s price controls on prescription drugs. The plans fizzed.
But the bigger issue is public safety: The FDA did an inspection blitz in November 2003 at the Buffalo, Dallas, Chicago, and Seattle mail facilities and the Memphis and Cincinnati courier hubs. The FDA found 1,728 unapproved drugs among the 1,982 parcels inspected. The unapproved drugs included “foreign versions” of FDA-approved drugs, recalled drugs, drugs requiring special storage conditions, drugs requiring close physician monitoring, and drugs containing addictive controlled substances.
Drug importation is a bad, old idea. It is time to step up and look at the real reasons that prescription drugs are so expensive: the slow, cumbersome, rule-driven drug-approval process that leads to a $1.2 to $1.8 billion cost and 12 years to bring a single new drug to market. Congress should focus instead on modernizing the prescription-drug approval process to get safe drugs to patients who need them, faster and at a lower cost. The upcoming renewal of the Prescription Drug User Fee Act in 2012 is where Congress’s — and Senator Vitter’s — energies should be focused.