The law allows U.S. pharmacists and wholesalers to do so only if the Secretary of Health and Human Services (HHS) first certifies that those drugs would be safe and that the program lowered drug costs for U.S. consumers. Department of Homeland Security Appropriations Act, 2007

For the past few years, Members have tried to use the agriculture appropriations bill (which includes FDA) to get around administrative blocks to prescription drug importation. The act required that, before publishing implementing regulations to put the import provisions into effect, the Secretary must first:
... demonstrate[s] to Congress that the implementation of this section will (1) pose no additional risk to the public's health and safety; and (2) result in a significant reduction in the cost of covered products to the American consumer. The Secretary would have to promulgate regulations that:
allow a pharmacist or a wholesaler to import prescription drugs from Canada; waive the law's restrictions on personal use imports, so an individual could import a 90-day supply of a prescription drug from Canada; and continue the ban on the importation of personal-use drugs from any other country unless the Secretary granted, by regulation or on a case-by-case basis, personal-use waivers to individuals. Encouragement from States and Municipalities

Several states and municipalities are looking at ways to control expenditures for prescription drugs in their Medicaid budgets and for employees and retirees. They are pursuing legislative, judicial, and administrative approaches. Some states—such as Minnesota and Wisconsin—have created websites to direct U.S. consumers to Canadian sources; several Governors have proposed pilot import programs to gain information about the savings benefits. As public discussions of the bills introduced in the 110 th Congress build, updates of this report will reflect them. A striking difference between these bills and current law is their elimination of the provision that has so far been the chief obstacle to imports: HHS Secretary certifications about risk and cost. Opponents of legalization say it would. Registration . Enforcement includes ongoing and onsite physical monitoring of a drug's manufacturer, registered exporters and importers, and records of all transactions involving the drug. Several bills require that medications from overseas come in anti-tampering and anti-counterfeit packaging. The Dorgan-Emerson bills mandate that the FDA, during inspections, verify the chain of custody of a statistically significant sample of the drugs that are to be imported. How would they react to the new laws? Variables concerning patent law and international trade agreements may influence decisions despite being seemingly unrelated to FDA's responsibility for drug safety and efficacy and some Members of Congress and the public's concerns about drug cost to consumers. Australia is listed as a "permitted country" in two of the three pairs of import bills discussed in this report. If Congress wants to lower the cost of drugs to U.S. consumers, there are options—some more feasible than others—other than importation. These include encouraging the use of generics and disease management techniques, providing research and development incentives to industry, studying the comparative effectiveness of similar drugs and applying that information judiciously in benefit package and prescribing decisions, instituting price controls or other regulatory measures on prescription drugs in this country, encouraging more market action (such as with purchasing agreements), encouraging reciprocal arrangements with other nations' regulatory authorities, and promoting or providing insurance coverage for pharmaceuticals to a wider population than have it today.
Can purchases from abroad lower the cost of prescription drugs to U.S. consumers? Current law allows pharmacists and wholesalers to import prescription drugs from Canada commercially, and codifies the Food and Drug Administration's (FDA) current practice of allowing imports of prescription drugs by individuals under certain defined circumstances. There is, however, one proviso. The Secretary of Health and Human Services (HHS) must first certify that the drugs to be imported under the program would "pose no additional risk to the public's health and safety; and result in a significant reduction in the cost of covered products to the American consumer"—a step no Secretary has been willing to take.
FDA has argued that it is impossible to monitor the millions of transactions and guarantee that these drugs would be safe. Meanwhile, some states and municipalities, looking at ways to control their expenditures for prescription drugs, have created websites to direct U.S. consumers to Canadian sources, and several state Governors have proposed pilot import programs. In October 2006, Congress took limited action regarding personal-use importation. The Department of Homeland Security Appropriations Act, 2007, blocks Customs and Border Protection from using those funds to stop an individual's importing, for personal use, a limited supply of a drug that meets FDA standards.
Drug importation was addressed in three pairs of comprehensive bills in the 109th Congress, none of which saw legislative action. To date, two revised versions have been introduced in the 110th (S. 242/H.R. 380 and S. 251). All would allow commercial and personal-use imports and replace the need for HHS Secretary certification with different ways to assure safety and effectiveness, among them requiring tamper-resistant and anti-counterfeit packaging; inspecting samples of imported drugs; requiring registration of importers, exporters, and Internet pharmacies; and enforcing extensive chain-of-custody monitoring and documentation. They also present different approaches for influencing industry response. Updates of this report will address bills and continuing discussions in the 110th Congress.
Opponents of the legislation raise concerns about safety, added costs, the feasibility of imports as a long-term solution to high domestic prices, and whether, beyond the short term, U.S. consumers would pay less for their prescription drugs. Other points of contention include issues of patent law and international trade agreements.
This report examines these issues, spells out how they are treated from bill to bill, and refers to the following alternatives to importation that might ease the burden of prescription drug costs on consumers: use of generics and disease management techniques; research and development incentives to industry; study of the drugs' comparative effectiveness and judicious application of the findings to benefit package and prescribing decisions; and assumption of some of the consumers' cost.