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Tensions over the importation of prescription drugs are heating up, and Texas attorneys need to be aware of the battle simmering in the courts and Congress between federal, state and local governments in the administrative arena. On Feb. 26, in Andrews v. U.S. Dept. of Health and Human Services, et al., an elderly couple sued the federal government in the U.S. District Court for the District of Columbia, challenging the constitutionality of federal laws prohibiting the importation of prescription drugs from Canada and claiming that elderly American citizens could save approximately 26 percent to 67 percent on particular drugs if they purchased them from Canada. The class-action complaint filed by Ray and Gaylee Andrews alleges that the Food and Drug Administration violates the equal protection clause of the U.S. Constitution because it “has actively interfered with and sought to prosecute [individual Americans] for the purchase and sale of Canadian prescription drugs by mail order,” but “does not seek prosecution of individuals living in areas adjacent to the Canadian border and who travel into Canada to purchase prescription drugs for personal use.” Also alleged in the suit are claims sounding in denial of right to privacy, denial of substantive due-process, and violation of the vesting and presentment clauses of the Constitution. Here’s the legal backdrop against which the suit is playing out. The Federal Food, Drug and Cosmetics Act bans the importation of prescription drugs by anyone other than the original manufacturer, except in emergencies. However, the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MPDIM) grants broad discretionary authority to the secretary of the Department of Health and Human Services to approve importation of prescription drugs from Canada. Additionally, the MPDIM mandates that HHS complete a comprehensive study of drug importation by December. It also provides a drug benefit for Medicare beneficiaries, which does not go into effect until 2006. But some elderly activists say that’s not soon enough. The Commonwealth Fund estimates that by 2006, approximately 51 percent of Medicare beneficiaries will be spending in excess of $2,000 each for prescriptions; on average, each beneficiary will have 23 different prescriptions and spend $3,320 per year paying for drugs. Senior citizens are not the only ones complaining about the high cost of drugs. Mayors and governors seek to buy prescription drugs from Canada to reduce their governments’ spending on health care. Although Springfield, Mass., and Montgomery, Ala., are the only governments buying drugs from Canada so far, several states have initiated programs to assist their residents with purchasing prescription drugs from Canada. The Wisconsin and Minnesota governors unveiled Web sites that claim to help state residents find safe but cheaper drugs at Canadian pharmacies that have been approved by their states. In response, the FDA contends that local and state governments have ignored the studies that show U.S. generic drugs, which comprise approximately one-half of all prescriptions, are cheaper than Canadian branded drugs and Canadian generic drugs. Unsafe Drugs? On the same day the Andrews filed their class action, Congress waded into the fray. Sen. Byron Dorgan, D-N.D., introduced the Pharmaceutical Market Access Act of 2003 (S.B. 2137), which would authorize the HHS secretary to promulgate regulations for the importation of prescription drugs. That’s not all. Also on Feb. 26, HHS Secretary Tommy Thompson announced the creation of the MPDIM-mandated task force to advise and assist HHS in determining how drug importation might be conducted safely and its potential impact on the health of American patients, medical costs and the development of new medicine. At first, Thompson named FDA Commissioner Mark B. McClellan as chairman of the task force. But, Dorgan felt McClellan’s views on imported drugs were already a foregone conclusion. The two had clashed during McClellan’s confirmation hearings (for the post of administrator of the Centers for Medicare & Medicaid Services) over McClellan’s refusal to answer questions about his opposition to the importation of drugs from Canada. Thompson pulled McClellan’s name from consideration for chair and announced Surgeon General Richard H. Carmona as chairman (McClellan will remain on the task force as a member). Under McClellan’s watch, the FDA has warned repeatedly that Canadian drugs are unsafe because they are not subject to FDA oversight and might be outdated, contaminated, counterfeit, or packaged under inappropriate conditions or in the wrong dosage. While historically the agency looks the other way when individual Americans travel to Canada to purchase their pharmaceuticals, the FDA says that cities and states could face legal action if they set up programs to facilitate the sales. The FDA has written a letter to Minnesota Gov. Tim Pawlenty stating, “We strongly believe that [Minnesota's] endorsement of foreign Internet “pharmacies’ is unsafe, unsound and ill-considered. “ The FDA recently issued letters warning several Texas businesses to stop importing drugs from Canada, saying it believes the programs are illegal and pose a risk to public health. The letters allege the firms facilitate illegal imports of prescription drugs from Canada and mislead the public about the safety of Canadian drugs. Those opposed to drug importation, including the pharmaceutical industry, argue that whatever savings may be involved in buying pharmaceuticals across U.S. borders are not worth the safety risks. They argue that lack of monitoring and management of products and patient care will increase overall costs and contribute to poorer quality of care. The fight over the MPDIM will not have an immediate effect in Texas, even though a shared border with Mexico makes prescription drug importation a significant issue. Such importation is escalating; one estimate is that from 25 percent to 40 percent of all U.S. residents who travel to Mexico bring back pharmaceutical products, according to Dr. Marvin Shepherd, a University of Texas professor who testified before Congress on the issue of drug importation. The pharmaceutical businesses in border towns with Texas have become tourist attractions and funnel hundreds of millions of U.S. dollars to the Mexican economy. However, the MPDIM allows only Canada as a source country for potential federally approved pharmaceutical drug importation; therefore, pharmaceuticals from Mexico will remain illegal unless lawmakers expand the MPDIM. Government lawyers, in addition to those representing the pharmaceutical industry and senior citizens’ groups, will be busy during the coming months as debates rage and the class-action suit gets under way, the tension between governments on the federal, state and local levels increases, and the MPDIM-mandated task force charged with studying the issue works toward conclusions on an issue that affects the health of millions of Americans. Lew Lefko and Michael L. Hood are partners in the Dallas office of Haynes and Boone. Lefko practices health-care law, and Hood’s business litigation practice includes health-care litigation.

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