[Pharm-policy] [Fwd: NYTimes.com Article: Accord Likely on Measure Allowing Drug
Imports]
Paul Davis
pdavis@CritPath.Org
Wed, 27 Sep 2000 13:17:30 -0500
pdavis@CritPath.Org wrote:
>
> This article from NYTimes.com
> has been sent to you by pdavis@critpath.org.
>
>
>
> pdavis@critpath.org
>
> /-------------------- advertisement -----------------------\
>
> Olympic Greats Photo Screensaver
>
> Download Olympic Greats Photo Screensaver from NYTimes.com, featuring the unforgettable Times's photos of past Olympic games. Enjoy these images every day on your computer, absolutely FREE.
>
> http://www.nytimes.com/partners/screensaver/index.html?eta3
>
> \----------------------------------------------------------/
>
> Accord Likely on Measure Allowing Drug Imports
> 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
>
> /-----------------------------------------------------------------\
>
> Visit NYTimes.com for complete access to the most authoritative
> news coverage on the Web, updated throughout the day.
>
> Become a member today! It's free!
>
> http://www.nytimes.com?eta
>
> \-----------------------------------------------------------------/
>
> HOW TO ADVERTISE
> ---------------------------------
> For information on advertising in e-mail newsletters
> or other creative advertising opportunities with The
> New York Times on the Web, please contact Alyson
> Racer at alyson@nytimes.com or visit our online media
> kit at http://www.nytimes.com/adinfo
>
> For general information about NYTimes.com, write to
> help@nytimes.com.
>
> Copyright 2000 The New York Times Company
--
Paul Davis
pdavis@critpath.org
_____________________________________________________
ACT UP Philadelphia
215.731.1844 Voice
215.731.1845 Fax
215.474.6886 Home Office