E-drug: NYTimes: Accord Likely on Measure Allowing Drug Imports
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[Copied as fair use. BS]
http://www.nytimes.com/2000/09/27/politics/27DRUG.html
September 27, 2000
By LIZETTE ALVAREZ and ROBERT PEAR
WASHINGTON, Sept. 26 A proposal to allow imports of low-priced
prescription drugs won support from House Republican leaders today,
making it all but certain that Congress and President Clinton could
eventually agree on the legislation.
Although the pharmaceutical industry has lobbied furiously against
the measure, the House Republican leaders announced that they would
approve the Senate-passed version of the bill, which Mr. Clinton
also supports. Their decision to make the bill a priority, just six
weeks before the elections, suggests how potent the cost of
prescription drugs has become as a political issue.
"We are comfortable with the Senate bill," Representative Dick
Armey of Texas, the majority leader, said today.
The White House spokesman, Jake Siewert, said the bill "may well
emerge from the rubble," and added, "if they want to do the Senate
bill, it's fine with us."
The measure, drafted by Senator James M. Jeffords, Republican of
Vermont, addresses the disparities that force American consumers to
pay two or three times as much for some American-made drugs as do
people in Canada, Mexico and some other countries. Prices for many
prescription drugs are often lower in other countries because
foreign governments regulate the prices.
The measure would allow pharmacies and wholesale distributors to
buy prescription drugs abroad, reimport them and then sell them to
consumers at a lower cost. Although the measure is designed to
reduce drug prices in a roundabout way, it is not likely to do so
for about two years. That is how long it is expected to take for
the Food and Drug Administration to write regulations that would
govern this new business. Experts say it is too early to know with
any accuracy what volume of sales may flow through such a route.
The Senate bill, approved on July 19 by a vote of 74 to 21, also
includes safeguards to protect consumers, something the F.D.A. said
was necessary. It would require the importer to provide large
amounts of data to the agency to ensure that the drugs were
authentic and complied with federal standards. Tests would be
conducted by the pharmacist, the wholesaler or the manufacturer.
Somewhat different proposals to relax restrictions on the import
of prescription drugs were approved by the House with overwhelming
support on July 10.
Vice President Al Gore supports the bill, and Gov. George W. Bush
has not taken a position.
"We think there is something that should be done there," said
Senator Trent Lott of Mississippi, the majority leader. "We do want
to make sure about the safety aspects, and that's one of the things
that concerned the industry. The potential for fraud is very
strong, and you want to make sure that our people are not being
duped."
Mr. Lott said Congress might want to tighten up the safety provisions.
Mr. Clinton today praised the Republican leadership for agreeing "in
the face of the drug companies' opposition, to give Americans access
to prescription drugs that are cheaper in other countries."
At an event celebrating the economic expansion, he added, "I think
it's wrong when drug companies sell the same drugs for a much
higher price at home than they do overseas, even when those drugs
are manufactured right here in America."
Despite today's accord, the bill's path to the president's desk
remains somewhat rocky. The measure is now attached to an
agriculture spending bill, which is tangled up in a dispute over
legislation to weaken the United States economic embargo against
Cuba. That conflict must be resolved before the bill can be voted
on in the House or the Senate.
Still, at some point, Congress must pass a bill to finance the
Department of Agriculture, and if all goes as expected, the measure
would be tucked inside. "If it's not done, it's as close to done as
anything can be," said Senator Byron L. Dorgan, Democrat of North
Dakota, a co-sponsor of the legislation.
John P. Feehery, a spokesman for Speaker J. Dennis Hastert, said
the Senate language might be "tweaked" a bit, but should not pose
an obstacle.
By pushing the prescription drug reimportation bill, over protests
of the pharmaceutical industry, Republicans hope to inoculate
themselves against Democratic charges that they have done nothing
to make prescription drugs more affordable for the elderly.
Drug manufacturers have lobbied vigorously to kill the drug
reimportation measure in recent weeks, running expensive television
advertisements to get their message out.
Mr. Hastert and Mr. Lott sent a letter to Mr. Clinton this week
indicating their desire to act on the drug reimportation bill, among
other things. They said time was running out for action on
broader legislation to establish prescription drug benefits for the
elderly under Medicare.
While Democrats said they were pleased with today's developments,
they made it clear they would not back down from the goal of securing
drug coverage through Medicare.
The provisions of the Senate bill would take effect only if the
secretary of health and human services certified to Congress that the
measure would "pose no risk to the public's health and safety,"
and that it would produce "a significant reduction in the cost" of
prescription drugs to American consumers.
Ronald J. Streck, president of the National Wholesale Druggists'
Association, said, "The demand for imported prescription drugs
could be quite high because importers will advertise low-price
imported medicines in newspapers and magazines, on television and
over the Internet."
The White House said the F.D.A. would need $23 million to develop
a new system of regulating imported drugs. House Republicans said
they were willing to provide that amount.
Under the Senate bill, importers would have to provide large
amounts of data to the F.D.A. to show, for example, that a
statistically valid sample of all drug shipments had been tested to
ensure compliance with federal standards.
Imported drugs would have to have the same color, formulation,
labeling and dosage as products approved for domestic sale.
Importers would have to maintain records showing the "chain of
custody" of the drugs. They would have to inform the F.D.A. of the
"points of origin and destination" for imported drugs; the
wholesale and retail prices, and "the manufacturer's lot or control
number" for each shipment.
Under existing law, a prescription drug made in the United States and
exported to another country may not be reimported, in large
quantities, except by the manufacturer. The law, adopted in 1988 as
a consumer protection measure, sought to choke off a "gray market"
for drugs that were counterfeit, adulterated or too old to be used
safely.
The National Wholesale Druggists' Association opposed the
legislation. Mr. Streck, the president of the association, said
"wholesalers do not have the experience, equipment or personnel" to
sample, test, re-label and track imported drugs.
Wholesalers also expressed concern that they could incur costly
new legal liability for the imported drugs, and they said they would
have to pass on such costs to consumers.
It is not clear whether drug companies would cooperate in efforts to
import low-price versions of their products. "Why would
manufacturers produce additional product in Canada, or export
additional product from the United States to Canada, so it could be
sold at a lower price in this country?" Mr. Streck asked.
Mr. Streck said he feared that low- price counterfeit drugs would
flow into the United States to meet the demand not met by manufacturers.
John C. Rother, chief lobbyist for AARP, formerly known as the
American Association of Retired Persons, said: "This legislation
should not be viewed as a substitute for insurance coverage. We
still need Medicare drug benefits."
Alan F. Holmer, president of the Pharmaceutical Research and
Manufacturers of America, said drug companies opposed the
legislation because "it would put American patients at risk by making
it easier for counterfeit, adulterated or subpotent
medicines to enter the country."
The New York Times on the Web
http://www.nytimes.com
Paul Davis
pdavis@critpath.org