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.
I don’t follow your point about “wheeling and dealing” by large wholesalers.
The secondary market is already dramatically smaller than it once was. Wholesalers such as AmerisourceBergen and Cardinal Health publicly renounced secondary market sourcing, the HDMA tightened its membership requirements, and major pharmacy chains such as CVS committed to secure sourcing. In addition, manufacturers signed fee-for-service agreements with their wholesalers that limit product leakage into the grey market, closing a significant entry point for counterfeiters. Drug makers literally pay for greater product security by purchasing data from wholesalers to monitor orders, inventories, and product movement in real-time.
I posted my comments on the latest decision this morning:
No PDMA for You
My comment about wheeling and dealing has to do with the smaller, secondary market wholesalers who brought the legal challenge, not with the three large wholesalers. The major wholesalers are not parties to this action.
Narrowing the scope of full pedigree makes it more likely that we can catch the bad guys. Diversion is the main entry point for counterfeit drugs, so secondary wholesalers should expect a higher level of scrutiny.
There’s an analogy to airport screening that you can see on my blog about H.B. 371 in Florida, which operates similar to the PDMA model:
H.B. 371 signed by Gov. Bush
If you bothered to actually read the lawsuit, and the magistrate’s support for her decisions, you will see that the legitimate non-AD wholesalers are very serious about eliminating the criminal element from our industry. We simply object to being summarily eliminated from business by this legislation that has been mis-interpreted by the FDA. We totally support a pedigree system, but demand one that doesn’t discriminate on us do to our size, and one that actually strengthens instead of threatens the security of the supply chain. Patient safety is our chief concern, period.
Are you familiar with the FDA’s Q&A guide published 11/13/06. If you are, how can take the position you are in light of the answer to question #11.
Is it your position that the world would be better off with only the big 3 to serve all markets?
Are you aware that less than 5% of the secondary distributors have ever been guilty of distributing counterfeit drugs, while 80% of the big 5 have. So much like Florida, you want to punish all the small distributors for the sins of a few. That’s tantamount to expelling all of Congress for the sins of Foley, Cunningham, etc.
Last time I looked, we are still operating under the Constitution, and the exemptions given the AD’s and the requiring the non-AD’s to provide pedigree info back to the manufacturer, information that the AD’s to date have been unwilling to provide and are not required statutorily to provide, is unconstitutional.
I’m aware that the PDMA mandates pedigrees for secondary wholesalers and not primary, and in that regard it has a loophole that needs to be closed.
Nevertheless, in my opinion half a loaf is better than no loaf at all, and if secondary wholesalers aren’t required to provide accurate pedigrees, the loophole is larger.