The Senate on Tuesday voted 68-32 to approve an amendment that would prohibit seizures by U.S. Customs and Border Protection of prescription drugs purchased from Canadian pharmacies by U.S. residents, the Los Angeles Times reports (Girion, Los Angeles Times, 7/12). Customs officials have seized thousands of packages of prescription drugs sent from Canadian pharmacies to U.S. residents since Nov. 17, 2005, when the agency began to increase enforcement of federal laws that restrict the purchase of prescription drugs from abroad. The purchase of medications from abroad is illegal, but customs and FDA officials generally have allowed the practice. Some Canadian pharmacy officials have said that they believe the increased seizures are related to the launch of the new Medicare prescription drug benefit. Customs officials in February acknowledged the increased enforcement against the purchase of medications from abroad but said the policy change was not related to the launch of the Medicare prescription drug benefit (Kaiser Daily Health Policy Report, 3/14). Sen. David Vitter (R-La.) proposed the amendment as part of the fiscal year 2007 Homeland Security appropriations bill (Strohm, CongressDaily, 7/11). No Senate Democrats opposed the amendment (McCormack, The Hill, 7/12).
The House has approved two FY 2007 appropriations bills — Homeland Security and Agriculture — that include provisions to allow the purchase of prescription drugs from abroad, according to Kirstin Brost, a spokesperson for House Appropriations Committee ranking member David Obey (D-Wis.) (AP/San Francisco Chronicle, 7/12). The provision included in the House Homeland Security appropriations bill would allow the purchase of prescription drugs from any nation (Los Angeles Times, 7/12). According to the AP/Chronicle, the “Bush administration has opposed efforts to loosen the restrictions” on the purchase of prescription drugs from abroad, and FDA officials have said that the agency “cannot guarantee the safety of imported drugs” (AP/San Francisco Chronicle, 7/12).
Vitter called the passage of the amendment a “breakthrough” on the issue of prescription drug reimportation and “the first clean vote on the issue in the Senate” (Crowley, CQ Today, 7/11). He added, “We should demand that (Customs and Border Protection) focus on the true priority that we face on the war on terror. Stripping small amounts of prescription drugs from the hands of seniors … should not be a priority.” Sen. Ben Nelson (D-Fla.) said, “This is going to ensure that Americans, especially the frail, elderly or those with debilitating conditions, are going to be able to at least have a chance of affording the medications that they need.” However, Sen. Judd Gregg (R-N.H.) said that the amendment would lead to “a massive hole in our capacity to secure our borders and protect ourselves.” He added, “If I were a creative terrorist, I would say to myself, ‘Hey, listen, all I’ve got to do is produce a can here that says ‘Lipitor’ on it, make it look like the original Lipitor bottle, which isn’t too hard to do, fill it with anthrax’” (AP/San Francisco Chronicle, 7/11). Sen. Rick Santorum (R-Pa.) said, “There’s a profound risk … with respect to these drugs that come in. This is a dangerous, dangerous piece of legislation” (CongressDaily, 7/11). Ken Johnson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said that the amendment “undermines the U.S. Customs and Border Protection from doing its job of protecting Americans as well as protecting our borders. It also undermines the government’s ability to assure the American public that our drug supply is safe and secure” (Shields, Baton Rouge Advocate, 7/12). Customs officials did not respond to requests for comment on the amendment (Los Angeles Times, 7/12).
Counterfeit Rx Hearing
In related news, lawmakers and pharmacy industry experts on Tuesday at a House hearing said that FDA should implement federal standards to prevent the entry of counterfeit prescription drugs to the U.S. market, CQ HealthBeat reports. At a House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources hearing, Rep. Gil Gutknecht (R-Minn.), said, “Ultimately, we’re going to end up with 50 different regulations. What we’ve encountered from the FDA so far is little more than foot dragging.” However, Randall Lutter, acting associate commissioner for policy and planning at FDA, said the agency has taken action to address the issue of counterfeit prescription drugs. FDA in June announced plans to require prescription drug distributors to document the chain of custody, or pedigree, of medications that enter the U.S. market as of Dec. 1. Lutter said that the requirement will not include electronic tracking of prescriptions because the transition to the technology will take time. According to CQ HealthBeat, witnesses at the hearing “advocated the need for ‘track’ and ‘trace’ technologies and said accompanying resources and consistency would be necessary to make the system work.” Carmen Catizone, executive director of the National Association of Boards of Pharmacy, said, “We’re not happy that the states are embarking on this individually without a national standard” (Barrett, CQ HealthBeat, 7/11).
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