December 12th, 2006

Fighting Fake Drugs: NYT Editorial

The New York Times today jumps into the fray regarding the dangers of counterfeit drugs in an editorial. They do so from the perspective of those buying drugs over the Internet:

Tempted to buy cheap medicines from a pharmacy Web site? Think twice. If the Web site shows no verifiable street address for the pharmacy, there is a 50 percent chance the drugs are counterfeit.

In rich countries, fake medicines mainly come from virtual stores. Elsewhere, they are on the pharmacy shelves. In much of the former Soviet Union, 20 percent of the drugs on sale are fakes. In parts of Africa, Asia and Latin America, 30 percent are counterfeit. The culprits range from mom-and-pop operations processing chalk in their garages to organized-crime networks that buy the complicity of regulators, customs officials and pharmacists.

The editorial goes on to the deaths from counterfeits and the ways developing countries have been fighting it, and otherwise serves to further sound the alarm of buying medication when you don’t know its origins.

As those in the pharmaceutical drug trade know, the issue of counterfeits has been a hot topic before the FDA in recent years. It is also, most certainly, not confined to foreign counterfeits as we have purely domestic counterfeiting going on.

After identifying the problem, the Times makes its pitch for action, writing:

An international convention is also needed to establish stiffer penalties for counterfeiting drugs, and marshal more funds and support to fight this deadly crime.

That’s a great idea. And we can start right here at home with legislation currently stuck in congressional committees. The pending legislation before both the House and the Senate comes in the form of Tim Fagan’s Law, named for one of my clients.

For more on the issues, you can visit my own Counterfeit Drug Resource Page, and read more about the problem by clicking on the Counterfeit Crugs label on your left and seeing other posts on the subject.

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 27th, 2006

New York Counterfeit Drug Bill Affected by Election?

The recent election seems destined to play a role in the counterfeit drug bill pending in New York. While last week I wrote about Tim Fagan’s Law pending in Washington, that is not the only proposed legislation designed to bring greater safety to our drug distribution system. In Albany, Assemblywoman Amy Paulin (D-Scarsdale) introduced her own bill to track drugs and increase pharmaceutical safety. From the press release:

This legislation requires drug manufacturers to establish a pedigree for each prescription drug, requires every wholesaler to submit a bond of $100,000, punishes manufacturers and wholesalers who intentionally package, sell, transfer, distribute or deliver a counterfeit drug with a class D Felony, establishes a fine of up to two thousand dollars per violation for offending drug manufacturers, and authorizes criminal background checks for manufacturers and wholesalers.

But two things happened in the election. First on the negative side, Paulin’s Republican co-sponsor lost his Senate seat. Nick Spano (R-Yonkers) had hung on to re-election by a mere 18 votes in 2004, but this time lost. Paulin was bold to reach across the aisle to ask Spano to co-sponsor this bill — both pictured with me here after the press conference annoucing the legislation — especially given the vulnerability of his seat. But sound public policy comes first for this bill she cares passionately about. She now needs a new sponsor on the Senate side.

And second, on the far more positive side, Eliot Spitzer blew away his opponent to win the governorship. Since Spitzer as Attorney General started an investigation into drug distribution practices in New York, it is presumably a matter he knows and cares much about. One of the subpoenas he dropped in this investigation was on my firm, for the records that I have for representing Tim Fagan and investigating the problem of counterfeit drugs.

This bill is one of many in state legislatures across the country that have popped up give the extraordinary risks from counterfeit drugs that exists due to our leaky drug supply chain. Hopefully the holes can be plugged before more people are injured.

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.