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McClellan Criticizes Drug Reimportation Legislation by Rep. Gutknecht

FDA Commissioner Mark McClellan issued a "scathing condemnation" of drug reimportation legislation (HR 2427) by Rep. Gil Gutknecht (R-Minn.), in a letter McClellan sent July 18 to House Energy and Commerce Chair Billy Tauzin (R-La.), CongressDaily/AM reports (Koffler, CongressDaily/AM, 7/22). Gutknecht's bill would allow U.S. pharmacists to import prescription drugs manufactured in a number of 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 the FDA. Provisions in the House and Senate Medicare bills (HR 1 and S 1) are more stringent, allowing the reimportation of U.S.-manufactured prescription drugs only from Canada (Kaiser Daily Health Policy Report, 7/15). Gutknecht's bill also does not include provisions in the Medicare bills that would require the HHS secretary to certify that reimported U.S.-made medications pose "no additional risk" to U.S. consumers, the New York Times reports (Gay Stolberg/Harris, New York Times, 7/22). In the letter, McClellan said that a provision in Gutknecht's bill that requires the federal government to develop anti-counterfeiting technology for reimported drugs would be "costly." He added, "The agency estimates, based on initial discussions with the Bureau of Engraving and Printing, that the cost of anti-counterfeiting technology ... is substantial and could raise the cost of prescription drugs by as much as $2 billion in the first year." McClellan said that consumers would bear much of the cost increase. He also said that a provision in the bill that would require the federal government to create a regulatory program to "sample incoming products" might cost $50 million in the first year. McClellan added that the bill would "creat[e] a wide channel" for drugs not approved by the FDA to enter the United States and could "pose a threat to the security of our nation's drug supply." According to the letter, many drugs from foreign nations that appear or claim to be the same as FDA-approved medications actually are of "unknown" quality and might be an "expired, subpotent, contaminated or counterfeit product; the wrong or contraindicated product; an incorrect dose; or drugs unaccompanied by adequate directions." Republican leaders have agreed to put Gutknecht's bill on the floor this week, CongressDaily/AM reports (CongressDaily/AM, 7/22).

'Surprising' Support
Despite criticism from McClellan, Gutknecht's bill is gaining support among some House Republicans, the New York Times reports. While many Republicans have tended to side with the drug industry's claim that reimportation is unsafe and would slow research and development, that opinion "appears to be changing," according to the Times. The Times reports that some lawmakers now support bills that would allow drug reimportation because there have been few reports of people being hurt by drugs they purchased from other countries; many voters are "fed up" with paying more than residents of nations whose governments control prices; and allowing reimportation would lower the cost of a Medicare drug benefit. If approved, Gutknecht's bill could become the House's "official" position on the issue and influence the conference committee reconciling the House and Senate Medicare bills. Rep. Dave Weldon (R-Fla.), who has opposed reimportation measures in the past but said he would likely support Gutknecht's bill, said, "I just think politically, this is an unsustainable scenario, where the American consumer is shouldering the bulk of research and development costs and corporate profits. The drug companies have to come to terms with this." Tauzin said, "Obviously, people are distressed over the cost of drugs in this country, and I don't blame them," but he added that drug reimportation would be "a disaster to the health and safety of Americans." Tauzin also said that the outcome of a House vote on the reimportation bill is "too close to call," the Times reports.

More Opposition
Gutknecht's bill and other reimportation measures still face opposition from the drug industry, which has sent "armies of lobbyists" to convince members of Congress to oppose the measure, according to the Times. According to the Times, drug industry executives fear that the potential failure of conference committee negotiations on Medicare could cause the reimportation issue to "gather steam." Jeffrey Trewhitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said, "We're fighting [the reimportation bill] tooth and nail" (New York Times, 7/22). Several other groups oppose drug reimportation. Last week, the Seniors Coalition launched a nationwide radio and print advertising campaign against the reimportation bill. The U.S. Chamber of Commerce, the National Association of Manufacturers, the Healthcare Leadership Council, the Hispanic Business Roundtable and the Latino Coalition also oppose the measure (Mitchell/Fulton, CongressDaily, 7/18). The bill also faces opposition from abortion-rights opponents, who contend drug reimportation would allow U.S. resident easier access to mifepristone, which is used in conjunction with the drug misprostol to induce a medical abortion (New York Times, 7/22). The California-based Traditional Values Coalition sent fliers to voters and conservative members of Congress who support the bill; one of the fliers says that under the reimportation bill, "Any 14-year-old with her dad's or mom's credit card is in business when it comes to buying" mifepristone (Minneapolis Star Tribune, 7/20). However, Rep. Dan Burton (R-Ind.), who opposes abortion rights and supports the reimportation bill, said that the claim regarding mifepristone "is a bogus issue" (New York Times, 7/22).

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