FDA Asks Canada To Increase Regulation of Online Pharmacies
FDA Commissioner Mark McClellan last week sent a letter to officials for Health Canada, which regulates prescription drugs in the nation, to request that the agency "take more aggressive steps to regulate" Canadian online pharmacies after Minnesota regulators found problems with some pharmacies in a recent inspection, the AP/Detroit News reports (Frommer, AP/Detroit News, 2/14). The week-long inspection of eight Canadian online pharmacies found a number of problems, such as lack of proper supervision of pharmacy technicians; failure to obtain complete medical histories from patients, such as past allergic reactions to medications; failure to use child-resistant safety caps on prescription drug containers; shipment of generic medications not approved for sale in the United States; and shipment of medications sold over-the-counter in Canada but available only by prescription in the United States. Minnesota regulators conducted the inspection to determine which pharmacies should appear on the state reimportation Web site. Minnesota Rx Connect Online, which the state launched two weeks ago, lists the prices for 829 brand-name and generic medications and phone, mail and e-mail contact information for the two state-approved Canadian online pharmacies -- Total Care Pharmacy of Calgary and Granville Pharmacy of Vancouver. Minnesota residents must fax or mail a prescription for as much as a three-month supply of their medications, medical history forms and order forms from one of the state-approved pharmacies. The pharmacies must have a Canadian-licensed physician review the information submitted by state residents and write new prescriptions before they ship the medications (California Healthline, 1/28).
In the letter, sent to Diane Gorman, assistant deputy minister of Health Canada, McClellan cited the problems found in the inspection by Minnesota regulators. "Our concerns about the need for your assistance with such inspections were highlighted by the recent experience of officials from the state of Minnesota," McClellan wrote, adding, "We very much need your assistance in assuring that appropriate inspections of these pharmacies are conducted and that enforcement actions are taken, to prevent the growth of unsafe practices." He also wrote that FDA officials have concerns about whether Canadian online pharmacies "can operate outside of the regulatory control of either of our nations." Emmanuel Chabot, a spokesperson for Health Canada, said that the agency has not completed a review of the letter from McClellan.
According to the AP/News, FDA hopes to use the results of the Minnesota inspection "as ammunition against the state." FDA Associate Commissioner Peter Pitts said, "We absolutely intend to be communicating with the state of Minnesota, because the people of Minnesota don't deserve a Web site that represents the best of the worst," Pitts said, adding that the results of the state inspection call to the "public's attention that these are very dangerous gray zones and that you can't really trade some savings for safety." However, Kevin Goodno, commissioner of the Minnesota Department of Human Services, said the letter from McClellan failed to cite that the state inspection found that Total Care Pharmacy "met or exceeded" state standards and that three other pharmacies could meet those standards "with minor modifications," the AP/News reports. He added said that the state has an "obligation to step in and do site visits and provide for some safety mechanisms for the people that are purchasing these drugs" (AP/Detroit News, 2/14).
The Dallas Morning News on Sunday examined McClellan, the "leading candidate" to become the new administrator of CMS and a potential candidate to replace HHS Secretary Tommy Thompson, who has said he would resign after 2004. According to the Morning News, McClellan is a "multitasking workaholic" who seeks to "leave a legacy" at FDA of "applying science -- not ideology or politics -- to benefit public health" (Dodge, Dallas Morning News, 2/15).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.