December 1st, 2006

More on Tim Fagan’s Law and Prescription Drugs

I speculated last week that the Democratic victory in the House and Senate bodes well for counterfeit drug legislation moving forward. The mover behind Tim Fagan’s Law is Tim’s congressman, Steve Israel. Tim, who I represent, was injected with counterfeit drugs after a liver transplant in 2002.

So I spoke this week to Rep. Israel’s new communications director and former health policy aide. She tells me that Rep. Israel will push for hearings in the Energy and Commerce Committee, where the bill is stalled. Significantly, the new chairman will be Rep. John Dingell, who was a champion of the Prescription Drug Marketing Act of 1987.

The PDMA, for those who follow the counterfeit drug issue, is the major piece of legislation that was designed to safeguard our pharmaceutical supply chain by forcing these companies to track the “pedigree” of the drugs — that is, who the prior owners of the drug were. It has never been fully implemented, and some companies continue to fight it today. From today’s WSJ Law Blog comes this story from Heather Won Tesorieo, who has been covering this subject for several years:

A federal magistrate recommended yesterday that a long-stalled provision of a drug law aimed at curtailing counterfeit drugs be stayed, giving a surprising upper hand to a group of small drug wholesalers that filed for an injunction to keep the law from going into effect. The plaintiffs and the government have until noon today to present further information to a federal judge, who is then expected to issue a ruling.

The drug law provision would require some drug wholesalers to supply a record, or pedigree, to track every middleman that handles a drug. It’s the latest regulatory measure aimed at improving transparency in the nation’s drug supply chain and stave off the growing number of incidents of counterfeit drugs.

With the continued obstinace of some wholesalers, who apparently refuse to make their industry safer so that they can continue to wheel and deal pharmaceuticals on the gray market, the passage of Tim Fagan’s Law becomes more important.

Change seems to be sweeping the industry — notwithstanding those who would like to keep it all secret — as light is shed on the loopholes in the system. So while some wholesalers continue to fight against the trend of greater safety, there is still good news out there for anyone who takes prescription drugs, which is to say, almost all of us at one time or another.


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.