Canadians kept in dark about defective drugs

North American patients have been put at risk by prescription drugs that Canadian pharmaceutical companies sold with knowledge that their products were defective, a Star investigation has found.

Using records obtained through U.S. freedom of information laws, the Star also found other Canadian companies have:

Hidden, altered and in some cases destroyed test data that showed their products were tainted or potentially unsafe.

Not reported evidence of side-effects suffered by consumers taking their drugs.

Since 2008, more than 40 Canadian drug companies, including Toronto-based generic giant Apotex, have been cited for serious manufacturing violations.

All of these violations are detailed in inspection reports provided to the Star not by Health Canada but the American Food and Drug Administration (FDA), which also inspects Canadian facilities.

The Star investigation found that while the FDA strictly and transparently enforces drug manufacturing laws, Health Canada leaves Canadians in the dark by keeping secret details of problems its inspectors find.

Meanwhile, drugs and drug ingredients banned from the U.S. market have been allowed by Health Canada into Canadian pharmacies.

The inspection documents obtained by the Star reveal:

In June, at a facility in Bangalore, India, that makes drugs destined for North America, Apotex employees did not report undesirable test results and doctored bacterial growth test records.

Generic drug maker Taro Pharmaceuticals of Brampton kept drugs on the market despite company tests showing batches of the medications deteriorated before the expiry date listed on the label.

Cangene Corp., a Winnipeg drug manufacturer, failed to tell authorities of blood clots, fever and other side-effects associated with their products.

The U.S. FDA inspects facilities in Canada and around the world where drug and drug ingredients bound for the U.S. market are made. The regulator may ban drugs from the U.S. market or prevent a company from introducing new products until the manufacturing and safety problems are fixed.

The FDA reports do not specify all the countries where drugs made by the inspected companies were shipped. The Star found many of these same drugs are also made for Canadian consumers, and the factories are subject to Health Canada inspections as well.

There have been at least 19 Apotex inspections by the FDA since 2008, 16 of them resulting in findings termed “objectionable” or noted as “repeated deficiencies.” In one case, the FDA said the company failed to uphold “its legal obligation.”

During an interview at one of Apotex’s Toronto factories, and in email correspondence, company president and CEO Dr. Jeremy Desai and another manager did not challenge the FDA’s findings and told the Star that the firm is fixing the problems and its products are safe.

Desai told the Star “compliance is a journey” and his company has addressed what he calls the “procedural lapses” identified by the FDA and has invested in improved data collection and staff training programs.

http://www.thestar.com/news/canada/2014/09/11/canadians_kept_in_dark_about_defective_drugs.html