Bills on Reimportation of Prescription Drugs Introduced in House, Senate
A bipartisan group of eight lawmakers led by Rep. Gil Gutknecht (R-Minn.) on Wednesday introduced identical bills in the House and Senate that would allow U.S. residents to reimport lower-cost prescription drugs from Canada and other nations, Bloomberg/Boston Globe reports (Bloomberg/Boston Globe, 1/27). Senate Budget Committee Chair Judd Gregg (R-N.H.) on Wednesday also introduced a reimportation bill, indicating "intensifying efforts" to pass such legislation "early in the new Congress," CQ HealthBeat reports (CQ HealthBeat, 1/26).
The new bills "join" reimportation legislation sponsored by Sen. Byron Dorgan (D-N.D). On Tuesday, Senate Majority Leader Bill Frist (R-Tenn.) and Senate Health, Education, Labor and Pensions Committee Chair Michael Enzi (R-Wyo.) agreed to schedule a hearing within 90 days on the Dorgan bill (Heil, CongressDaily, 1/26).
The Gutknecht bill, called the Pharmaceutical Market Access Act of 2005, represents "the broadest of all the reimportation bills" introduced to date and takes a "more liberal approach" than Republican congressional leaders support. The Gutknecht bill has support from Sens. David Vitter (R-La.), Jim DeMint (R-S.C.), John Thune (R-S.D.) and Ken Salazar (D-Colo.) (CongressDaily, 1/26).
The Gutknecht bill is a revised version of legislation he sponsored in 2003 (HR 2427), which passed the House in July of that year. The original bill would have allowed U.S. pharmacists to import prescription drugs manufactured in 25 industrialized nations, provided that the medications are manufactured by companies that use counterfeit-resistant technologies and that the companies have registered their production operations with FDA (California Healthline, 3/2/04). Gutknecht said that he hopes to have the revised bill passed in the House by the end of March.
The Gregg bill, co-sponsored by Senate Special Committee on Aging Chair Gordon Smith (R-Ore.), is called the Safe Import Act of 2005 and is identical to legislation (S 2493) that Gregg introduced in the last congressional session (CQ HealthBeat, 1/26).
The bill would allow the reimportation of prescription drugs from Canada within one year and the reimportation of medications from European Union nations within three years. The bill would require pharmaceutical companies, prescription drug wholesalers and other entities involved in reimportation to register with FDA and pay a fee that would supplement the cost of implementation and maintenance of the system. The legislation only would allow the reimportation of FDA-approved medications from FDA-approved manufacturing facilities. The legislation also would require pharmaceutical companies to label reimported medications separately from other U.S.-manufactured treatments.
Under the bill, the HHS secretary could restrict, inspect and control the ports of access through which reimported medications enter the United States. In addition, the legislation would require online pharmacies to obtain licenses and mandate that physicians in other nations co-sign prescriptions for reimported medications. The bill would not penalize pharmaceutical companies that limit the number of prescription drugs available for reimportation (California Healthline, 9/20/04). Supporters of the bill said that they plan to make revisions to the legislation and introduce a revised version in March.
According to CQ HealthBeat, the four freshmen senators who support the Gutknecht bill "bring fresh energy" and a "sense of urgency from both the election just concluded and the upcoming one." Vitter said that passage of the bill would help him "fulfill a promise" he made to constituents in his Senate campaign (CQ HealthBeat, 1/26). Vitter added that the legislation is "the only bill that addresses all the legitimate concerns of importation without adding significant cost and bureaucracy to the process which would wipe out consumer savings" (Gannett News/Detroit News, 1/27).
DeMint said of the legalization of reimportation, "If we don't establish this with a good law, Americans are going to revolt" (Bloomberg/Boston Globe, 1/27). Salazar said, "This is not a panacea to the health care issues that we face here in our country, but it is a step in the right direction" (Sand, Minneapolis Star Tribune, 1/27).
Gutknecht said, "We have for the first time people in the Senate and in the House who are on the same page. This is a new day in this whole debate" (Bloomberg/Boston Globe, 1/27). He added, "We are going continue to be pleasantly persistent" about passage of the bill (CQ HealthBeat, 1/26).
The Senate Special Committee on Aging on Wednesday met to review the role of Internet pharmacies in reimportation. At the hearing, U.S. Surgeon General Richard Carmona said, "There is no realistic level of resources that could ensure that personally imported drugs are adequately inspected to assure their safety" (CongressDaily, 1/26). He added, "It would be extraordinarily difficult and costly for personal importation to be implemented in a way that ensures the safety and effectiveness of the imported drugs."
In addition, Smith said, "Estimates indicate more than two million Americans spend over $700 million each year on reimported drugs, and two-thirds of that spending is done on the Internet. I believe we have become so focused on debating whether importation should be legalized we have lost track of the reality that importation is happening." He added, "We must find a regimen for this happening legally."
Sen. Hillary Rodham Clinton (D-N.Y.) said, "Legislation for drug importation is inevitable" (Maltin, Cox News/Lexington Herald-Leader, 1/27).