Wednesday, July 12, 2006
Prescription Drugs
Senate Approves Legislation That Would Allow the
Reimportation of Prescription Drugs From Canada
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).
House Bills
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).
Reaction
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).