NEW LAW ALLOWS DRUG IMPORTATION
President Bush signed legislation Oct. 4 legalizing limited importation of prescription drugs from Canada, but a policy reversal by a federal agency could lead to even broader use of the practice.
Bush signed the fiscal 2007 Homeland Security Appropriations bill, which includes a provision prohibiting federal officials from stopping individuals from personally transporting prescription drugs across the Canadian border. The provision only applies to a "personal-use quantity," defined as less than a 90-day supply.
The move brought immediate criticism from the pharmaceutical industry. This new law is the "first step down a dark and dangerous road," leading to more counterfeit drugs entering the country, PhRMA Senior Vice President Ken Johnson said.
Meanwhile, the U.S. Customs and Border Protection (CBP) has gone a step further, deciding that it will no longer seize prescription drug shipments beginning Oct. 9, the agency said in an Oct. 2 email. Instead the CBP will refer these shipments to the FDA for action, although it was not clear in the announcement what effect this would have on shipments.
The CBP reviewed its policy and determined a change was necessary, an agency spokeswoman said. Under the new policy, the CBP will only act if there is evidence that a drug is counterfeit. The agency will then send the product to the FDA for a final decision.
This represents broader importation than that allowed in the appropriations language. The bill only allows citizens to carry drugs with them across the border, while the CBP decision covers mailed shipments as well.
"This is a huge victory," Sen. Bill Nelson (D-Fla.) said in an Oct. 3 release. Nelson, who had been challenging the CBP seizure policy, said that more than 40,000 people have had their prescriptions seized since the agency first implemented this policy last November. "Senator Nelson believes the change in policy was due to the pressure exerted by the senator and the American public," a Nelson staffer added.
Nelson had criticized the policy and sought a congressional investigation. Nelson will continue trying to get a congressional investigation to determine why the government began seizing these shipments in the first place, the staffer added.