An unlikely group of allies won a surprise victory in their battle to ease restrictions on importation or reimportation of prescription drugs from specified foreign countries.
By a 248-186 vote on July 25, the House of Representatives passed HR 2427, the Pharmaceutical Market Access Act of 2003.
As described by its sponsor, Gil Gutknecht (R-Minn.), the bill would require the Food and Drug Administration (FDA) to design and implement a system to grant individuals, pharmacists, and wholesalers in America access to FDA-approved drugs from FDA-approved facilities in industrialized nations abroad.
The countries would be limited to those in the European Union and Australia, Canada, Iceland, Israel, Japan, Lichtenstein, New Zealand, Norway, Switzerland, and South Africa.
The legislation would also require that prescription drugs be in counterfeit-resistant packaging or that wholesalers test each pharmaceutical shipment for safety and purity.
It would eliminate the requirement that the secretary of Health and Human Services (HHS) certify that imported or reimported drugs pose "no additional risk" to Americans.
The bill attracted an eclectic group of supporters. Among the 46 House members who signed onto it were Republicans Dan Burton (Ind.) and Christopher Shays (Conn.).
Democratic suppporters included presidential candidate Dennis Kucinich (Ohio) and Rahm Emmanuel (Ill.), who had been a key advisor to President Bill Clinton.
The vote took place as a result of a bargain between the Republican leadership in the House and Rep. Jo Ann Emerson (R-Mo.), who agreed to vote in favor of the House Medicare bill (HR 1) only if the drug-reimportation bill were put to a vote by the House.
The drug-reimportation bill is now part of HR 1 and thus subject to conference deliberations in which the House and Senate will work out differences in the Medicare prescription-drug legislation. More than half of the senators have expressed opposition to HR 2427, however, according to the July 26 New York Times.
In late June, William Hubbard, the FDA’s associate commissioner for policy and planning, testified before the House Committee on Energy and Commerce that the FDA could not assure the American public that drugs imported from foreign countries are the identical products approved by the FDA.
He warned that "outlets may dispense expired, subpotent, contaminated, or counterfeit product, the wrong or contraindicated product, an incorrect dose, or medication unaccompanied by adequate directions for use."
On July 18 FDA Commissioner Mark McClellan wrote to the House committee that the bill "creates a wide channel for large volumes of unapproved drugs and other products to enter the United States that are potentially injurious to public health and pose a threat to the security of the nation’s drug supply."
The FDA has developed educational materials about Internet drug sales and a Web site, www.fda.gov/oc/buyonline/default.htm, that includes tips and warnings about Internet sales of prescription drugs.
APA Medical Director James H. Scully Jr., M.D., urged the House to reject HR 2427 because of concerns about patient safety.
In a July 16 letter to Rep. Billy Tauzin (R-La.), chair of the House Committee on Energy and Commerce, he said that psychotropic medications "are complex medications that impact brain chemistry and can have myriad interactions with other medications patients may be taking. Manufacturing quality is critically important to patient safety."
The National Alliance for the Mentally Ill and the American Medical Association also wrote in opposition to the bill.
An estimated 1 million Americans import or reimport drugs from across the northern border, usually via an Internet site. Sales have been projected to double in 2003 to $1.4 billion (Psychiatric News, June 6).
In the United States, it is those without insurance who typically pay the highest prices for prescription drugs.
The U.S. Public Interest Research Group, a consumer advocacy organization, on July 15 released the results of a survey that found that throughout the country, on average, uninsured consumers were charged 72 percent more for 10 common prescription drugs than was the federal government.
Both the Department of Veterans Affairs and the Medicaid program require pharmaceutical companies to provide discounts to the populations they serve. Pharmaceutical benefits managers negotiate discounts with pharmaceutical companies, and those savings are then passed on to private insurance companies or retained as profits.
Although the majority of senators now are said to be opposing HR 2427, both the Senate and the House had passed amendments to their respective Medicare prescription-drug bills that would permit importation or reimportation of prescription drugs if certain conditions were met.
The Senate version stipulates that the drug must be imported or reimported from a licensed pharmacy for personal use by an individual—not for resale—in quantities that do not exceed a 90-day supply. It must be accompanied by a valid prescription, come from a seller registered with the HHS secretary, and be imported under conditions the secretary determines "to be necessary to ensure public safety."
The Senate legislation also requests the Institute of Medicine and U.S. Comptroller General to conduct studies of compliance with regulations and the effect of the law on drug prices.
If, a year after the effective date of the legislation, the HHS secretary submits to Congress a certification based on evidence from the studies and other sources that the benefits of the implementation did not outweigh the risks, the section of the law concerning reimportation would no longer be valid.
The House passed legislation containing the language of the Senate’s bill along with additional requirements, such as that for tamper-resistant packaging. That legislation has now been replaced in HR 1 by HR 2427. ▪