November 22nd, 2006

Counterfeit Drugs: How the election helps consumers

Counterfeit drugs fly beneath the usual political radar of war, deficits, gay rights, and other issues that Washington often deals with. But to Kevin Fagan, the problem of pharmaceutical fakery is a real problem: Tim, his then 16 year old son, had been injected with counterfeits after a life-saving liver transplant in 2002.

Kevin’s crusade to help clean up our leaky drug distribution system — which all too often allows fake drugs to slip into the legitimate supply chain through shady secondary wholesalers — brought him to Washington, where Representative Steve Israel introduced Tim Fagan’s Law in 2005. The bill, and the significant problems with the distribution system that allows this to happen, are detailed more fully on my Counterfeit Drug Resource Page. Since I represent the Fagan family, it is a matter of some interest to me.

The problem with the proposed law doesn’t seem to be self-evident since it is non-partisan legislation that does the following:

  • Increases criminal penalties. The current federal law is three years in prison. Israel’s bill increases penalties and includes up to life in prison.
  • Mandates that a manufacturer must alert the FDA of a counterfeited drug in 2 days. Currently, there is no mandate. The pharmaceutical industry has said that it would voluntarily tell the FDA about counterfeited drugs within 5 business days.
  • Provides the FDA with the authority to require companies to use anti-counterfeiting technology, as the technology becomes feasible and available.
  • Mandates that the FDA implement the paper pedigree rule that was mandated in 1988 and has been postponed for 17 years. It also closes the “authorized wholesaler” loophole and includes manufacturers as needed to start the pedigree.
  • Authorizes $60 million for spot-checking for counterfeits for each year between fiscal years 2006 and 2010.
  • Authorizes $5 million for each year between fiscal years 2006 and 2010 for educating the public and health care professionals on how to identify counterfeit drugs.
  • Provides recall authority to the FDA for prescription drugs. Currently, the FDA can only recall equipment and can only encourage private companies to recall their drugs.
  • Authorizes the FDA to issue subpoenas with respect to preventing threats to public health.

So why would a bill that has no partisan agenda languish in a committee despite it being sound public policy? The answer, I’m afraid, is that it languishes simply because it came from the minority party. Israel, who is the Fagans’ congressman, happens to be a Democrat. So too is New York Senator Chuck Schumer, who introduced a counterfeit drug bill in the Senate.

With the Democrats taking control of Congress, it is hoped that this bill can now move out of the committees where it is stuck and out on to the floor for debate and voting.