Health Canada says it has a plan to better communicate with the public about risks from recalled products after an independent review criticized how the recall of Alysena 28 birth-control pills was handled earlier this year.
The federal department asked Ottawa-based Risk Sciences International (RSI) to examine its actions following the recall of the oral contraceptive by its manufacturer, generic drug maker Apotex Inc.
Apotex pulled Alysena 28 from the market when it was discovered one lot contained too little active drug and too much placebo, leaving women who took it vulnerable to becoming pregnant. The lot contained about 50,000 faulty packets, which were sold across Canada.
In its report released Tuesday, RSI noted that Health Canada wasn’t told of the recall until 15 days after Apotex first became aware that incorrect packaging of the product could pose a risk to the public.
RSI concluded that Health Canada followed all of its recall procedures once it was informed by the company that Alysena 28 was being pulled from pharmacy shelves.
Where department staff were lax, it suggested, was in their failure to notify the public as soon as possible – before news of the recall reached Canadians by other means and implied a delay in Health Canada’s response.
Health Canada did not notify the media and the public of the recall until April 8 – on the Monday following the Easter long weekend – despite learning of the company’s actions four days earlier.
“Health Canada personnel did not act on the opportunity to issue a public communication of the recall of the drug on the afternoon of Friday, April 5, to respond to the social concern associated with unplanned pregnancies,” the RSI report said.
“Communications strategists, who are experienced in communicating about socially sensitive issues, were not informed of the recall until Monday, April 8,” when an advisory was sent to the media.
Two Canadian class-action lawsuits have been filed against Apotex on behalf of women who became pregnant while taking Alysena 28.
The law firm that filed one suit in Alberta that’s seeking unspecified damages says more than a dozen women have come forward after becoming pregnant while on the pill. In Ontario, a previously filed $800-million suit claims 40 women became pregnant.
RSI pointed out that federal drug regulations don’t give clear direction to companies about notification requirements relating to drug recalls, nor do they give Health Canada authority to enforce notification.
The report recommended that laws governing recalls should be strengthened to “include clear statements of the requirements of industry to notify Health Canada within 24 hours of a decision to recall a marketed health product, and provide clear powers to Health Canada to enforce compliance with the requirement.”
It also said Health Canada needs to improve its capacity to inform the public about recalls in a more timely fashion.
“Improve awareness of the 24-7 news and information-sharing environment, and revise procedures to enable and support a prompt, inclusive and appropriate response to an emerging drug recall or risk issue,” the report advised.
Federal Health Minister Rona Ambrose said her department will explore expanding its recall powers and will work with industry to ensure they provide early notification of any drug recall.
“The independent review has provided timely and practical recommendations to further strengthen the Canadian drug recall system,” Ambrose said in a statement. “We are committed to ensuring Canadians get the information they need, as quickly as possible.”
On March 20, Apotex received a complaint of a faulty package, along with a photo, and verified the defect five days later. Then on March 28 – the Thursday before the Easter long weekend – the company decided to recall the lot from which the defective sample had come.
However, it wasn’t until Wednesday, April 3, that Apotex sent a notice of recall to wholesalers, distributors and retailers, and it did not notify Health Canada until April 4 – more than two weeks after it was first apprised of the problem.
According to Health Canada’s recall policy, Apotex should have notified the federal department’s Ontario office verbally or in writing within 24 hours of deciding to pull the affected lot, in other words, on Friday, March 29.
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