FDA Commissioner Mark McClellan last week sent a letter to Health Canada, the country's pharmaceutical regulatory agency, to request that it "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 (Kaiser Daily Health Policy Report, 2/12).
Letter Details
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.
Impact on Minnesota
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 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).
Dallas Morning News Examines McClellan
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).