FDA Stings Springfield's Canadian Drug Supplier

August 29, 2003 (PLANSPONSOR.com) - The US Food and Drug Administration (FDA) has apparently caught the supplier of Springfield, Massachusetts' Canadian drug shipments red handed in the improper handling of insulin.

The FDA said it used an assumed name and address to order insulin, from the city’s supplier CanaRx Services, Inc. When the insulin arrived via regular mail, it was at room temperature, instead of chilled and delivered via overnight mail as it is supposed to be handled to ensure its effectiveness, according to a Boston Globe report.

This represents the latest move in the chess-match battle between the city of Springfield and the FDA. Earlier this month, the FDA Commissioner Mark McClellan urged the city to reconsider its prescription drug plan, fearing that by purchasing from Canada, participants were putting their lives at risk (See FDA Calls Out Springfield Canada Drug Buying Plan ).

As an alternative, McClellan said the FDA would welcome discussions with Springfield Mayor Michael Albano over the city’s program, one that would not lead the American city to look across international borders.

However, the sting operation takes it one step further. Even though McClellan called the program illegal before, the commissioner stopped short of saying the FDA would take any enforcement action. This made Albano all the more furious, calling the tactics “underhanded,” and saying he felt blindsided by the agency after speaking with McClellan about the city’s plans earlier this month. Albano said he listened to McClellan’s safety and legal warnings about importing foreign pharmaceuticals, and the two agreed to discuss the matter further next month in Washington.

Peter Pitts, the FDA’s associate commissioner for external affairs, said that McClellan did not advise Albano about the sting during their phone call because it was part of a confidential investigation.With the alleged improper handling of orders by CanaRx, the FDA will likely issue a warning letter, Pitts said.

The City’s Plan

Under the plan, Springfield entices city employees and retirees to take advantage of the voluntary system by waiving copayments on prescription drugs – currently ranging from $6 to $20 per prescription – for participants that place their orders though CanaRx Services Inc., an Ontario company that mails three-month supplies of prescribed drugs from Canadian pharmacies. Overall, this appears to be a small price to pay for the city that cites savings on drugs ranging from 20% to 80% and ultimately could put between $4 million and $9 million in savings back into city coffers (See Springfield, Mass. Pushes Canadian Drug Order Program ).

City officials contend that the plan does not require federal approval because it is voluntary and because individuals, not the city, place the order for drugs (current US law forbids anyone other than manufacturers from importing drugs). However, while the program currently is voluntary, the city hopes to implement it for all employees and retirees by the end of the year once it receives required approval from city unions. All but two school department unions have endorsed the plan.

Springfield, the Bay State’s third largest city with a population of some 152,000, is being eyed by city officials in Worcester, Lowell, Revere, and Pittsfield, and the drug plan has the potential to spread to other places if it is successful, Albano said.