FDA Confiscates Prescription Drugs at Illinois-Based Repackager Because of Alleged Label Violations
FDA officials yesterday announced that they seized prescription drugs from an Illinois-based repackager and distributor because the companies did not meet U.S. manufacturing and labeling requirements, the Wall Street Journal reports. The repackager, Local Repack, and the distributor, Alliance Wholesale Distributors, are divisions of Illinois-based Phil and Kathy's. FDA officials said that yesterday's seizure was requested in a complaint filed by the U.S. attorney's office for the Northern District of Illinois in U.S. District Court in Chicago. They added that the complaint stemmed from a series of inspections that found some drugs at the Local Repack facility were misbranded and others had foreign-language labels. The inspections also reportedly found quality-control violations and record-keeping problems. "We did not believe they had the requisite controls in place to ensure that Americans were getting safe and effective products," John Taylor, FDA associate commissioner for regulatory affairs, said, adding that the FDA has not yet cataloged what was seized. He did not say which drugs were included or if any drugs were counterfeit. Howard Hoffmann, an attorney for Phil and Kathy's, said the company was legally repackaging domestically produced drugs into different containers. The seizure is a sign of the FDA's "increasing focus" on smaller distributors and repackagers that might "provide windows -- knowingly or not -- for counterfeit or mislabeled" drugs to enter the U.S. distribution system, the Journal reports (Wilde Mathews, Wall Street Journal, 9/16). "We will take action against those who put patients at risk by trying to import and sell unapproved, mislabeled and counterfeit drugs," FDA Commissioner Dr. Mark McClellan said in a statement (Schwab, Newark Star-Ledger, 9/16).
At a town hall meeting in Indianapolis this week, Eli Lilly employees "boo[ed]" Rep. Dan Burton (R-Ind.) over his support of legislation (HR 2427) that would allow U.S. residents to buy drugs approved by the FDA from Canada and 24 other countries, the Indianapolis Star reports. Lilly bused in about 100 employees and several patients who use its drugs to speak against the bill, which Lilly contends would have a negative effect on the development of new drugs by cutting profits that are used to fund research and development. Lilly spokesperson Edward Sagebiel said that the company brought the employees to the meeting because Burton "needs to know it is more than a spokesperson opposing him. It is many in this company." However, Burton said that he will continue to support the legislation even though it could lose him re-election votes, adding, "I am going to win anyhow. You are going to have to live with it." The meeting gave a "vivid look" at the "growing clash" between some of the nation's senior citizens, who "find it hard" to afford their prescription drugs, and drug companies and government agencies that oppose reimportation because of safety and economic concerns, the Star reports (Swiatek, Indianapolis Star, 9/16).
The Boston Globe today examines criticisms that the FDA is only "serious about monitoring the safety of mail-order drug shipments" if they come from Canada and that it is taking a "hands-off approach" to monitoring the safety of prescription shipments from U.S. Internet mail-order pharmacies. The criticisms center on a sting in which the FDA, using an assumed name and address, ordered insulin from CanaRx Services, which supplies Springfield, Mass., with U.S.-made prescription drugs from Canada (Rowland, Boston Globe, 9/16). Under Springfield's program, which began in July and is the first municipal program of its kind in the nation, the city's 20,000 employees, retirees and dependents who receive health insurance through the city can choose to fax their prescription drug orders to a group of Ontario pharmacies and receive their medications in the mail (California Healthline, 7/30). FDA officials said that the insulin they ordered from CanaRx was delivered at room temperature when it should have been delivered refrigerated, the Globe reports. Critics contend that the sting shows that the FDA is "in the pocket of U.S. drug makers," which have "vigorously" attempted to stop Canadian reimportation, and that the FDA does not enforce drug shipment standards for U.S. mail-order companies, according to the Globe. However, FDA Senior Associate Commissioner William Hubbard said, "No American pharmacist is going to give you hot insulin. He's going to be subject to licensure, subject to inspection, subject to a complaint from a patient. His business is going to be at risk." He added that Canadian pharmacists have "nothing at risk" because no such mechanisms hold Canadian companies accountable (Boston Globe, 9/16).
The New York Times today reports on Illinois Gov. Rod Blagojevich's (D) decision to look into creating a plan to reimport drugs from Canada for the state's current and retired employees (Davey, New York Times, 9/16). Blagojevich ordered the state special advocate to create a plan for buying drugs from Canada. The special advocate would analyze how such a plan could be consistent with federal laws and give the report to Blagojevich in 90 days (American Health Line, 9/15). Blagojevich acknowledged that FDA opposition to drug reimportation "could be a hurdle," the Times reports. "We're not going to violate the law, we're going to urge a changing of the law," Blagojevich said, adding, "If the study shows what we think it might, that this could be a cheap and safe method, this will be powerful evidence. Hopefully, we can persuade them" (New York Times, 9/16).
The following broadcast programs reported on programs to reimport U.S.-made medications from Canada:
- ABCNews' "World News Tonight": The segment includes comments from Blagojevich, Hubbard and Canadian Minister of Health Anne McLellan (McKenzie, "World News Tonight," ABCNews, 9/15). The full segment is available online in RealPlayer.
- NPR's "Morning Edition": The segment includes comments from Blagojevich; Hubbard; Springfield Mayor Michael Albano; and Uwe Reinhardt, a professor of health economics at Princeton University (Rovner, "Morning Edition," NPR, 9/16). The full segment is available online in RealPlayer.
- MPR's "Marketplace": The segment includes comments from Dr. Gerald Kominski, associate director of the UCLA Center for Health Policy Research, and Dr. Sam Ho, senior vice president and chief medical officer of PacifiCare Health Systems (Palmer, "Marketplace," MPR, 9/15). The full segment is available online in RealPlayer.