Rx Importation Would Require Increased Wholesaler Regulation, PhRMA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
PhRMA Assistant General Counsel Lassman says a commercial drug importation program would be unsafe until wholesalers are “adequately” regulated. Certain states are strengthening wholesaler regulation, but the problem is “not solved by any means right now,” Lassman says.
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Improving control over U.S. wholesalers is necessary before allowing commercial drug importation, the Pharmaceutical Research & Manufacturers of America said. "When we're talking about commercial importation, we're talking about allowing U.S. wholesalers and pharmacies to import in commercial quantities of drug products," PhRMA Assistant General Counsel Scott Lassman explained during a Food & Drug Law Institute audio conference Jan. 13. "We've got a fairly serious issue within the U.S. on the adequate regulation of our U.S. wholesalers, and I think unless and until we get that issue solved…it's a bad idea to permit these folks to start importing drug products fairly willy-nilly," he said. In a letter accompanying HHS' importation task force report, Secretary Tommy Thompson said a Canada-only program focusing solely on high-volume brands would be the only feasible importation plan (1 (Also see "HHS Import Report Gives No Ground: Savings Would Not Exceed 1%" - Pink Sheet, 21 Dec, 2004.)). Lassman cited cases from 2002 of drug counterfeiting through "secondary wholesalers" as evidence of insufficient regulation in the supply chain. "If you just look at Florida, we've seen what can happen just internally with unregulated wholesalers," Lassman said. "Now you allow them kind of free range on the world market of drug products and you're going to see even bigger problems." Florida, Nevada and California are strengthening wholesaler regulation, Lassman said, but the problem is "not solved by any means right now." Florida enhanced wholesaler regulation in 2003 through the Prescription Drug Protection Act, which, among other components, requires pedigree enforcement of commonly counterfeited or adulterated products. The Healthcare Distribution Management Association said wholesalers should be responsible for ensuring the integrity of any importation program (2 (Also see "Wholesalers Are Key To Safety Of Any Rx Importation Plan, HDMA Tells Task Force" - Pink Sheet, 15 Apr, 2004.)). HDMA strengthened membership requirements by requiring members to provide details of their value-added services as part of an initiative to ensure product integrity throughout the supply chain (3 (Also see "Rx Wholesalers Must Provide "Value-Added Services" For HDMA Membership" - Pink Sheet, 18 Feb, 2004.)). PhRMA acknowledged that one reason U.S. citizens continue to turn to foreign countries for inexpensive drugs is that member companies have not done a good enough job in publicizing patient assistance programs (see 4 (Also see "Patient Assistance Program Awareness Efforts Were Insufficient - PhRMA" - Pink Sheet, 14 Jan, 2005.)). - Andrew Kasper |