The pedigree requirements of the Prescription Drug Marketing Act (PDMA) are back on hold. This is a big loss for the FDA and a big win for secondary wholesalers, especially RxUSA. I'll post tomorrow on possible implications for the pharmaceutical supply chain in 2007.
See my post from last Friday -- No PDMA for You! -- for background. Then read Federal Injunction Will Delay Part of Drug-Tracking Law in today's Wall Street Journal, which states:
"In a surprising decision that strikes a blow against Food and Drug Administration efforts to curb counterfeit drugs, a federal judge granted an injunction that delays part of a long-stalled drug law that was to have taken effect Friday of last week.
Yesterday, U.S. District Court Judge Joanna Seybert of the Eastern District of New York sided with a group of drug wholesalers who argued that the law is in breach of equal protection and due process because it requires certain recordkeeping of some wholesalers but not others, according to lawyers for both sides of the case."
BTW, Heather Won Tesoriero of the WSJ and I appear to be the only people writing about this topic. Although that's surprising given the hype leading up to Dec. 1, I think of it as just one more good reason to tell your friends in the industry to read this blog. 'nuff said.
Dr. Fein,
ReplyDeleteYou are correct that I can't information on this from any other sources than you or Ms. Tesoriero.
Have you seen the actual injunction? If so, can you post a link or something. I am curious about exactly what is enjoined
I have posted a legal analysis of the Report and Recommendation, along with a discussion of the objections filed by the parties, on my blog, Juvan's Health Law Update, which can be found here:
ReplyDeletehttp://juvanshealthlawupdate.typepad.com/juvans_health_law_update/2006/12/rx_usa_wholesal.html#more.
The injunction essentially maintains the status quo unless it is overturned on appeal or until a decision on the merits is reached.