Prescription Drug Importation and Internet Sales: A Legal Overview [January 8, 2004] [open pdf - 119KB]
"As prescription drug prices have escalated in recent years, so too has consumer interest in purchasing less costly medications abroad. Meanwhile, in July, 2003, the House of Representatives passed H.R. 2427, a bill that would allow wholesalers, pharmacists, and consumers to import certain prescription drugs from 25 different countries, including Canada, where drug prices are often lower than in the United States. Although H.R. 2427 passed the House, the provisions allowing drug importation faced opposition in the Senate and were not included in the conference agreement on Medicare prescription drug benefits. Instead, the final Medicare bill, H.R. 1, modified a provision of existing law that authorizes the Food and Drug Administration (FDA) to allow the importation of prescription drugs if the Secretary of Health and Human Services certifies that implementing such a program is safe and reduces costs, a determination that no Secretary has made in the years since a similar certification requirement was established in 2000. In response to concerns about prescription drug imports and Internet sales, several congressional lawmakers have introduced the following bills: H.R. 616, H.R. 780, H.R. 847, H.R. 2497, H.R. 2652, H.R. 2717, H.R. 2769, S. 1781, S. 1974, and S. 1992. Currently, the following federal and state agencies are involved in regulating aspects of prescription drug importation and Internet sales: the Food and Drug Administration, the U.S. Customs and Border Protection (CBP), the Drug Enforcement Agency (DEA), state boards of pharmacy, and state medical boards. Although this report is intended to focus on legal aspects of prescription drug importation and Internet sales, both legal and policy issues are addressed because they are closely linked."
CRS Report for Congress, RL32191