FDA Warns Prescription Drug Reimporter CanaRx To End Operations
The FDA yesterday sent a letter warning officials at Ontario-based CanaRx Services, which reimports U.S.-manufactured prescription drugs to the United States, that company operations are illegal and may endanger the health of customers, the AP/Las Vegas Sun reports. The FDA letter said that CanaRx has 15 days to respond before the agency subjects the company to prosecution (Baldor, AP/Las Vegas Sun, 9/16). CanaRx supplies prescription drugs for a new program in Springfield, Mass. Under the program, which began in July, Springfield employees, retirees and dependents who receive health insurance through the city can fax their prescriptions to a group of Ontario pharmacies and receive their medications in the mail (California Healthline, 9/16). The FDA sent the letter to a Detroit address maintained by CanaRx. The FDA did not make the letter public but issued a news release that cited an investigation into CanaRx in August in which insulin ordered from the company was delivered at room temperature (Rowland, Boston Globe, 9/17). "Firms like this should not continue to profit through illegal actions that put the health of the American public at risk," FDA Commissioner Dr. Mark McClellan said, adding, "Our investigation has shown that CanaRx operates a drug purchasing arrangement that channels drugs through companies other than licensed pharmacies and does not consistently use shipping practices that ensure its drugs are safe and effective." FDA Senior Associate Commissioner William Hubbard said that the FDA has examined packages and purchased prescription drugs from Canadian pharmacies such as CanaRx and "found that quite a bit of it is really sketchy stuff" (Heldt Powell, Boston Herald, 9/17).
Meanwhile, Springfield Mayor Michael Albano yesterday traveled to Washington, D.C., to meet with FDA officials about concerns over the Springfield program, the Globe reports. In a 90-minute meeting, Albano said that Springfield saves between $4 million and $9 million per year through the program and that he has "full confidence" in the safety of prescription drugs reimported from Canada. Albano said after the meeting that the FDA is "selectively enforcing" laws that protect the safety of the U.S. prescription drug supply, adding, "If you're going to shut down CanaRx, you have to shut down those buses going to Canada, or those making their purchases via the Internet. There is no difference" (Boston Globe, 9/17). Albano said that the FDA "didn't tell me to stop" the Springfield program, adding, "We're going to stay the course" (Silverman, Newark Star-Ledger, 9/17). Hubbard said that the FDA does not plan to take action against Springfield or Albano, the AP/Sun reports. Sen. Edward Kennedy (D-Mass.) yesterday said that he plans to work with Albano and the FDA to "find a way to satisfy the FDA concerns regarding the safety of importing drugs from Canada" (AP/Las Vegas Sun, 9/16). Hubbard said, "We understand the price concerns. But yet, we feel Americans expect us to provide the safest drug system in the world, and we take that responsibility very seriously" (Boston Globe, 9/17). The FDA news release is available online.
Summaries of several related broadcast reports appear below.
- CBS' "Evening News": The segment includes comments from Albano and McClellan (Brzezinski, "Evening News," CBS, 9/16). The full transcript of the segment is available online. The full segment is available online in RealPlayer.
- NPR's "NPR News": The segment reports on the FDA letter (Rovner, "NPR News," NPR, 9/17). The full segment is available online in RealPlayer.
- WBUR's "The Connection": Guests on the program will include Albano, Hubbard, Rx Depot Canada owner Russell Machover and Stanley Wallack, associate dean for research at the Heller School for Social Policy and Management at Brandeis University (Gordon, "The Connection," WBUR, 9/17). The full segment will be available online in RealPlayer after the broadcast.