NewsMine — cabal-elite — w-administration — big-money — drug-bill — Viewing Item

FDA and states at odds over drugs { February 22 2004 } Original Source Link: (May no longer be active)    http://www.washingtonpost.com/wp-dyn/articles/A60620-2004Feb21.html http://www.washingtonpost.com/wp-dyn/articles/A60620-2004Feb21.html FDA, States at Odds Over Drugs Minnesota Web Site Points Way to Canadian Pharmacies By Marc Kaufman Washington Post Staff Writer Sunday, February 22, 2004; Page A11 The Food and Drug Administration is headed for a collision with the leaders of Minnesota and Wisconsin over state-operated Web sites that direct residents to specific pharmacies in Canada where they can reliably buy cheap prescription drugs. Minnesota put up its Web site late last month, and Wisconsin officials say theirs will go up this week. Officials in both states say they are trying to make sure that residents, who are already buying many drugs from Canadian Internet sites, purchase them from safe and professional operations. Wisconsin officials said that they decided to go ahead with their Web site because the FDA did not order Minnesota to take its site down. They also said they expected that governors of other states, who have voiced strong interest in the idea, would follow suit. But the FDA, which opposes any efforts by governments or businesses to expedite the purchase of drugs from foreign locations, especially through Internet sites, says it is gearing up to respond. The agency says that it cannot vouch for the safety of drugs illegally imported from Canada or elsewhere, and that Americans who use them are making a bad and potentially dangerous choice. "We absolutely do not approve of it, and see it as risky, unsafe behavior," Peter J. Pitts, FDA associate commissioner for external affairs, said of the Minnesota Web site and Wisconsin's plan. "We are weighing our enforcement options now and deciding how to proceed." Political pressure to allow the importation of drugs from Canada is great and growing because of the high price of many prescription drugs in the United States. Prices for the same drugs in Canada, where the government buys in bulk and imposes price controls, are sometimes 50 percent to 70 percent less. Although it is illegal to purchase prescription drugs abroad and bring them into the United States, the FDA has generally not interfered with individuals and small groups doing it -- especially since many are seniors. However, the agency has shut down a number of U.S. businesses that served as middlemen for Canadian pharmacies and has tried to dissuade governors and mayors from setting up programs to buy Canadian drugs. The Minnesota Web site poses a new challenge, however, because it neither purchases drugs from Canada nor directly links residents to Canadian pharmacies. Rather, it names two Canadian pharmacies that it says Minnesota pharmacy officials concluded were especially well run and provides online information about how much the pharmacies charge for specific drugs. The Wisconsin Web site is expected to be similar. "We see this as an issue of public health and can't understand why the FDA might disapprove of it," said Commissioner Kevin Goodno of the Minnesota Department of Human Services. "We know that many of our residents are buying drugs from Canada, and we have concerns about some of the sites they are buying from," he said. "So we sent a team to Canada, inspected a number of pharmacies, and concluded that two were excellent and safe. The FDA should be applauding us and not trying to shut us down." But in a letter sent earlier this month by FDA Commissioner Mark McClellan to his Canadian counterpart, Diane Gorman, the agency labels the Minnesota effort a problem, not a solution. In addition, the letter uses the Minnesota survey of eight Canadian pharmacies as evidence that it is unsafe and unwise to buy drugs from Canadian sites. After listing 32 deficiencies identified by the Minnesota team at the Canadian pharmacies -- ranging from improper refrigeration to having technicians, rather than pharmacists, fill many prescriptions -- McClellan wrote that many of them "could result in fine or suspension in Minnesota." "It is of great concern to us that these Canadian pharmacies apparently do not feel compelled to adhere to the high standards of pharmacy practice set by Canadian regulatory authorities or U.S. regulatory authorities for our own citizens, apparently because they believe they can operate outside of the regulatory control of either of our nations," McClellan wrote. But Goodno said that the large majority of problems found by his survey team were minor and that five of the six pharmacies could be brought up to Minnesota standards "with very minor changes." He said that one Canadian pharmacy was clearly not acceptable, while another -- the Granville Pharmacy of Vancouver, B.C. -- "is as good or better than anything we have in Minnesota." Granville is one of the two Canadian pharmacies recommended on the Minnesota Web site. According to Sharmani Pillay, a spokeswoman for Granville, the company has received hundreds of queries from Minnesota since its name was posted on Jan. 30. She said that only a limited number of those contacts have resulted in filled orders so far -- largely because of the need to obtain written prescriptions before drugs can be dispensed -- but she said the volume "is picking up daily." The drug importation issue will be highlighted on Tuesday when U.S. governors meet in Washington for a prescription drug summit aimed at making it easier to import cheaper drugs from Canada. The gathering, which will follow the National Governors Association winter meeting, is scheduled to include members of Congress, pharmaceutical industry experts and regulators. Bills to make drug importing legal were passed in the House and Senate last year, but died after a conference committee in charge of the Medicare bill insisted on allowing the Department of Health and Human Services to reject the plan if was deemed unsafe. Advocates of reimportation did succeed, however, in including money for a study of the costs and benefits of importing drugs from abroad. Late last year, Illinois Gov. Rod R. Blagojevich (D) asked for federal permission to set up a pilot program that would import medications from Canada. HHS has not replied to the request. Importing drugs from abroad -- or reimporting drugs shipped from the United States to Canada for use there, but then shipped back to customers here -- is strongly opposed by the pharmaceutical industry and many American pharmacists. They argue that drug importing would be unsafe because there is currently no way to monitor the quality of drugs crossing the border. But both groups have financial reasons to oppose importation, which could reduce drug prices considerably and take away business from American pharmacists. According to Terry Gunderson, communications director for the Minnesota Human Services Department, the new Web site -- www.minnesotarxconnect.com -- has been receiving about 1,000 hits a day. In addition to giving contact information for the two Canadian pharmacies, the site lists prices for 829 drugs, averaging about 35 percent lower than U.S. prices, Minnesota officials said. In deciding to go ahead with their Web site, Wisconsin officials said the FDA's inaction regarding Minnesota was key. "The FDA has made all kinds of threats through the media, but we've been watching what they're doing in Minnesota, and they haven't taken any action," Dan Leistikow, press secretary for Gov. Jim Doyle (D), said. "We take this as a sign of approval and are pretty sure that other governors will be following the Minnesota and Wisconsin lead." Staff writer Gilbert M. Gaul contributed to this story. © 2004 The Washington Post Company

6 democratic candidates attack medicare measure { November 19 2003 } Aarp members burn cards Aarp spends 7m ad campaign supporting gop bill { November 19 2003 } Candidates take on aarp over drug bill Congressman bribed to pass medicare { November 27 2003 } Democrats threaten sue over medicare cost estimates Drug makers protect their turf { November 21 2003 } Drug plan faces enrollment challenge Drug prices for elderly climb 50 percent { July 1 2004 } FDA and states at odds over drugs { February 22 2004 } House probe medciare bribery allegation Medicare administrator withheld cost estimates for congress { September 8 2004 } Medicare costs kept secret Medicare drug benefit will cost more than reported { February 9 2005 } Medicare drug bill could be tough sell { November 17 2003 } Medicare drug cards produce confusion { July 29 2004 } Medicare drug cost estimate increases { January 30 2004 } Medicare reform bill is a disaser { November 28 2003 } Medicare secrecy inquiry is silenced { April 2 2004 } Medicare wont cover cancer drug costs { September 8 2004 } Medicares hidden bonanza { March 4 2004 } New drug benefits too complicated for seniors Nine dems back medicare bill Offered money to change vote { December 8 2003 } Some experts foresee revolt by elderly { November 26 2003 } Top democrats want us house probe on medicare vote US offers senior drug cards amid criticism { May 3 2004 } Files Listed: 27

Correction/submissions

CIA FOIA Archive

National Security Archives

This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more information, go to: http://www.law.cornell.edu/uscode/17/107.shtml. If you wish to use copyrighted material from this site for purpose of your own that go beyond 'fair use', you must obtain permission from the copyright owner.