Posted At Kaiser Network
BY : Terri Russel
Nevada: Attorney General George Chanos (R) on Dec. 27, 2005, issued an opinion asserting that a state law permitting residents to purchase lower-cost prescription drugs from Canada presents "insurmountable legal obstacles to the importation of virtually any drugs from Canada," the Reno Gazette-Journal reports (Damon, Reno Gazette-Journal, 12/28/05). Under a Nevada law that took effect on July 1, 2005, state residents can purchase a 90-day supply of medication from licensed Canadian pharmacies through a state-run Web site (Kaiser Daily Health Policy Report, 9/8/05). The Nevada Board of Pharmacy, which has four licensing applications pending from Canadian pharmacies, had sought Chanos' interpretation of a provision in the law requiring reimported drugs to be approved by FDA. The board now will decide whether to move ahead with the program (Reno Gazette-Journal, 12/28/05). In the opinion, Chanos wrote that the pharmacy board "could not reasonably be expected to confirm that the 'manufacturing process,' the 'formulation,' the 'storage' and/or the 'pedigree' [of prescription drugs] have been ensured and/or approved by the FDA." In addition, he said the legislature's intent in drafting the legislation was to require all drugs purchased from Canadian pharmacies to undergo the FDA approval process. However, state Sen. Joe Heck (R), who wrote the provision requiring FDA approval, said his intention was to ensure drugs purchased from Canada were the exact medications marketed in the U.S. Heck and Assembly Majority Leader Barbara Buckley (D), a co-author of the legislation, wrote a letter to Chanos aiming to clarify their intent in writing the provision (Riley, AP/Las Vegas Sun, 12/27/05). Chanos said, "Today the proponents of the bill are seeking to advance a different interpretation of 'FDA-approved' than the definition they advanced during the legislative session." He continued, "You can't do that. It's not just an issue of labeling" (Reno Gazette-Journal, 12/28/05). Buckley said she will urge the pharmacy board to move forward with the program despite Chanos' opinion (AP/Las Vegas Sun, 12/27/05).
Washington, D.C.: U.S. District Judge Richard Leon on Dec. 22, 2005, ruled that a Washington, D.C., law aimed at regulating prescription drug costs by making "excessive" prices illegal is unconstitutional, the Washington Post reports (Weiss, Washington Post, 12/23/05). The legislation, sponsored by District Council member David Catania, would allow residents to file suit against a drug company if a judge determines the drug's cost to be excessive, which is defined in the law as more than 30% of the drug's price in Germany, Australia, Canada or the United Kingdom. Companies found to charge excessive prices could be fined or forced to lower their prices. Mayor Anthony Williams signed the measure into law on Oct. 3, 2005, after the council approved it in September (Kaiser Daily Health Policy Report, 12/14/05). The Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization in October 2005 filed a legal challenge to the law. Leon ruled in favor of PhRMA and BIO, stating that the law violated constitutional protections of interstate commerce and was in opposition to the will of Congress. Leon's opinion stated that the law was in conflict with federal patent law "carefully crafted" by Congress to encourage the development of new prescription drugs. Catania said he would appeal the decision and added that he might consider modifying the law (Washington Post, 12/23/05). Billy Tauzin, president and CEO of PhRMA, said, "Today's decision ... protects both patients and the quality health care we enjoy in this country." Jim Greenwood, president and CEO of BIO, said the law would have slowed the development of new drugs, which "would have had a profound impact on the biotech industry, where most companies are still in the research stage and heavily dependent on investment capital" (McElhatton, Washington Times, 12/23/05).
