Drug Importation Could Cause Increase In Illegal Internet Rx Sales, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA continues to oppose drug importation proposals at a Senate Health Committee hearing. However, safety concerns could be minimized if Congress provides adequate resources and authority for the agency, FDA’s Hubbard says.
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Legalized drug importation could lead to even more illegal drug sales over the Internet, FDA Associate Commissioner for Policy & Planning Bill Hubbard told a Senate Health Committee hearing May 20. FDA wants to "make sure that you understand that these sorts of essentially criminal activities are very difficult to police now, and if we open the borders, our concern is that that becomes even worse," Hubbard said. Hubbard told the committee about an illegal Internet pharmacy FDA has recently investigated. The site claims to sell Canadian generic versions of U.S. brand-name drugs. "We don't know where this business is," he said, "but we do know there are no Canadian generics of these drugs. We also know that this business is hard to find. It's obviously not a legitimate business selling legitimate drugs, and the patients that receive these drugs are obviously getting some sort of fake knockoffs." Importation legislation that would allow only drugs from FDA inspected facilities to be imported would not necessarily prevent Internet pharmacies from taking advantage of the new system, Hubbard said. "Proponents of reimportation would say, 'Well, these drugs shouldn't be allowed in. These would not be allowed in under our bills,'" Hubbard said. "Our concern is that our investigators tell us that they can make some minor change in the way this business operates and could then stay in business by for instance establishing a mail drop in Canada, perhaps faking a return address." "Now that would require a lie, but this whole thing is a lie," he added. Recent importation proposals in Congress would start by allowing drug imports from Canada before expanding the program to other countries (1 (Also see "Senate GOP Import Bill Will Start With Canada, Leave FDA In Control Of Expansion" - Pink Sheet, 6 May, 2004.)). FDA continues to oppose legalization of drug importation based on the potential safety problems. However, it also continues to suggest that safety concerns could be minimized if the legislation provides the agency with additional resources and authority to oversee the program. Before taking his new post at CMS, former FDA Commissioner McClellan cited recent legislation giving FDA more money and legal authority to oversee the safety of imported food as a possible model for drug importation (2 (Also see "Rx Import Bill Could Be Modeled On Food Inspection Program – McClellan" - Pink Sheet, 11 Mar, 2004.)). FDA witnesses at the May 20 hearing also referred to the food safety bill. "If we had the resources and authority, we could presumably set up a system in which you could...at least ameliorate the safety concerns in a very substantial way," Hubbard said. - Scott Steinke |