On Oct. 6, the U.S. House and Senate are slated to end their legislating for the year and return home to concentrate on the last month of election-year politicking. However, before they can adjourn, senators must clarify the language of an amendment attached to the Agricultural Appropriations Bill, which should be of interest to anyone who takes prescription drugs.
The amendment would lift the ban on the re-importation of drugs that has been in place since 1988. As a sub-committee member of the Agricultural Committee Conference, Sen. Conrad Burns will have a significant role in crafting the language of this amendment, which would overturn a landmark consumer protection act. Consequently, Burns will bear the praise, blame, or political football that emerges from this huddle.
At issue are the lower prices paid by foreign countries for drugs developed, tested and manufactured in the United States. Supporters of the plan say that by lifting the ban on re-importation, the same drugs could be purchased from foreign countries and re-imported with considerable consumer savings. Burns’ spokesman Larry Akey explains, “The Senate version [of the bill] is more moderate than the House’s and allows wholesale distributors and community pharmacies to re-import drugs whose safety has been certified by the Department of Health and Human Services.”
Detractors of the plan, most notably the Pharmaceutical Research and Manufacturers Association (PhRMA), a lobbying group for the industry, have shrilly zeroed in on the safety concerns involved in re-importing drugs.
Jeff Trewhitt of PhRMA says that lower prices for consumers are a less likely outcome than an increase in unsafe, possibly even counterfeit, drugs. His concern is that, when the drugs are out of the country, they are “outside of the FDA’s chain of custody and there is no way to guarantee against improper storage or handling that could render a drug ineffective or toxic.” The bottom line, says Trewhitt, is that the bill amounts to little more than an election-year ploy. “This bill could very well pass,” he notes, “but it cannot be implemented because no money is allocated in the bill for resources.”
Lawrence Bachorick, a spokesman for the FDA, says that the plan “looks workable on paper but is an untested system.” According to FDA estimates, the program would cost $23 million annually for the first two years of planning, $46 million for the first year of implementation and $93 million seven years from now.