The Senate early Friday morning by voice vote confirmed FDA Commissioner Mark McClellan as the new CMS administrator with no debate, the AP/Houston Chronicle reports. Sen. Byron Dorgan (D-N.D.), who had placed a hold on the nomination, said that he agreed to lift the hold because Senate Majority Leader Bill Frist (R-Tenn.) had secured the votes required for confirmation, the AP/Chronicle reports. Dorgan added that Frist had agreed to begin a process that could lead to legislation that would allow the reimportation of lower-cost, U.S.-manufactured prescription drugs from other nations. "We're trying to move the ball forward here, to make progress" toward reimportation, Dorgan said. Frist said that he, Dorgan and others would begin to develop legislation to allow the safe reimportation of prescription drugs, although "no timetable was specified," the AP/Chronicle reports. In a statement, Frist said that McClellan is "an extremely bright and capable public servant" who will provide "strong leadership at this critical time" at CMS (AP/Houston Chronicle, 3/12). Dorgan, a member of the Senate Commerce, Science and Transportation Committee, had placed the hold on the McClellan nomination because McClellan previously said he would testify before the committee about the safety of reimportation only after his confirmation as CMS administrator. However, McClellan on Wednesday agreed to testify before his confirmation (Kaiser Daily Health Policy Report, 3/11).
Committee Testimony
In testimony during a Senate Commerce
Committee hearing on Thursday, McClellan discussed his opposition to
reimportation (AP/Houston Chronicle, 3/12). According to the
Washington Post, the testimony "did little
to calm the growing political storm over soaring drug prices and FDA's
long-standing opposition to drug importation" (Connolly, Washington
Post, 3/12). McClellan said that FDA cannot guarantee the safety of
reimported prescription drugs, adding that "we neither have the authority
nor the resources to assure safety" of such medications (Rovner,
CongressDaily, 3/11). However, McClellan said that he would
work with Congress on legislation to provide FDA with the resources
required to make the reimportation safe, CQ Today reports.
"I'm absolutely willing to work with Congress to come up with the right
answer," McClellan said (Schuler, CQ Today, 3/11). McClellan
"avoided specifics" on legislation that would allow the safe reimportation
of prescription drugs, the Wall Street Journal reports
(Mathews, Wall Street Journal, 3/12). He said that FDA would
require "several hundred million dollars a year" to regulate reimported
medications, adding that the federal program that inspects the safety of
food imports "might be a good model" (Pear, New York Times, 3/12). McClellan also said
that the cost of a program to regulate reimported prescription drugs could
prove "higher or lower" than his estimate (CQ Today, 3/11).
"We want to be flexible in working with Congress to address these safety
concerns," McClellan said. The "lack of specifics provoked" committee
Chair John McCain (R-Ariz.) "to pepper him with questions and complaints,"
the Journal reports. "We rely on the administration and
people like you to give us proposals so we can examine them. ... I think
it's time the administration came up with a proposal," McCain said
(Wall Street Journal, 3/12). McCain added, "Despite the power
of the pharmaceutical companies, we will pass ... requirements for the
ability to reimport drugs from Canada. My suggestion is that you prepare
for it and be part of the solution" (CQ Today, 3/11).
Lott, Cornyn Switch Positions on Reimportation
During the
Senate Commerce Committee hearing, supporters of reimportation "gained a
significant convert" when Sen. Trent Lott (R-Miss.) said that he supports
the practice, the Times reports. "I cannot explain to my
mother any longer why she should pay twice or two-thirds more than what is
paid in Canada and Mexico," Lott said (New York Times, 3/12).
Lott added, "I've warned the (pharmaceutical) industry for years -- fix
this problem" of high prescription drug prices, "because if you don't, we
will" (CQ Today, 3/11). In addition, Sen. John Cornyn
(R-Texas), who had opposed reimportation, said that he has decided to
switch his position because "he has become convinced that drug imports can
be regulated much as imported food is," the Post reports. AARP CEO Bill Novelli also
"expressed growing frustration" with pharmaceutical companies and said
that the group has taken a "tougher stance" against them because they have
moved to end supplies to Canadian pharmacies that sell prescription drugs
to U.S. residents, the Post reports. AARP recently purchased
full-page advertisements in newspapers and sent a letter to pharmaceutical
companies about prescription drug prices. "We think the industry has got
to see the writing on the wall and begin to help" develop a safe system
for reimportation from Canada, Novelli said (Washington Post,
3/12).